TATIG 50MG TABLETS

Active substance: SERTRALINE

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Lustral®50mg Tablets

Ref:0973/040712/1/F

(sertraline hydrochloride)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Lustral 50mg Tablets but will be referred to as Lustral
throughout this Patient Information Leaflet. Please note that the leaflet also
contains information about other strengths of the medicine, Lustral 100mg.
In this leaflet:
1

What Lustral is and what it is used for

2

Before you take Lustral

3

How to take Lustral

4

Possible side effects

5

How to store Lustral

6

Further information

1

What Lustral is and what it is used for

Lustral contains the active ingredient sertraline. Sertraline is one of a group
of medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs); these
medicines are used to treat depression and or anxiety disorders.
Lustral can be used to treat:
* Depression and prevention of recurrence of depression (in adults).
* Social anxiety disorder (in adults).
* Post traumatic stress disorder (PTSD) (in adults).
* Panic disorder (in adults).
* Obsessive compulsive disorder (OCD) (in adults and children and
adolescents aged 6-17 years old).
Depression is a clinical illness with symptoms like feeling sad, unable to
sleep properly or to enjoy life as you used to.
OCD and Panic disorders are illnesses linked to anxiety with symptoms like
being constantly troubled by persistent ideas (obsessions) that make you
carry out repetitive rituals (compulsions).
PTSD is a condition that can occur after a very emotionally traumatic
experience, and has some symptoms that are similar to depression and
anxiety. Social anxiety disorder (social phobia) is an illness linked to anxiety.
It is characterised by feelings of intense anxiety or distress in social
situations (for example: talking to strangers, speaking in front of groups of
people, eating or drinking in front of others or worrying that you might
behave in an embarrassing manner).
Your doctor has decided that this medicine is suitable for treating your
illness.
You should ask your doctor if you are unsure why you have been given
Lustral.
2

Before you take Lustral

Do not take Lustral:
* If you are allergic (hypersensitive) to sertraline or any of the other
ingredients of Lustral.
(see 6. Further information for the list of ingredients).
* If you are taking or have taken medicines called monoamine oxidase
inhibitors (MAOIs such as selegiline, moclobemide) or MAOI like drugs
(such as linezolid). If you stop treatment with sertraline, you must wait
until at least one week before you start treatment with a MAOI. After
stopping treatment with a MAOI, you must wait at least 2 weeks before
you can start treatment with sertraline.
* If you are taking another medicine called Pimozide (a medicine for mental
disorders such as psychosis).
Take special care with Lustral:
Medicines are not always suitable for everyone. Tell your doctor before you
take Lustral, if you suffer from or have suffered in the past from any of the
following conditions:
* Epilepsy or a history of seizures. If you have a fit (seizure), contact your
doctor immediately.
* If you have suffered from manic depressive illness (bipolar disorder) or
schizophrenia. If you have a manic episode, contact your doctor
immediately.
* If you have or have previously had thoughts of harming or killing yourself
(see below-Thoughts of suicide and worsening of your depression or
anxiety disorder).
* Serotonin Syndrome. In rare cases this syndrome may occur when you
are taking certain medicines at the same time as sertraline. (For
symptoms, see section 4. Possible Side Effects). Your doctor will have
told you whether you have suffered from this in the past.
* If you have low sodium level in your blood, since this can occur as a result
of treatment with Lustral. You should also tell your doctor if you are taking
certain medicines for hypertension, since these medicines may also alter
the sodium level in your blood.
* Take special care if you are elderly as you may be more at risk of having
low sodium level in your blood (see above).
* Liver disease; your doctor may decide that you should have a lower dose
of Lustral.
* Diabetes; your blood glucose levels may be altered due to Lustral and
your diabetes medicines may need to be adjusted.
* If you have suffered from bleeding disorders or have been taking
medicines which thin the blood (eg acetylsalicyclic acid (aspirin), or
warfarin) or may increase the risk of bleeding.
* If you are a child or adolescent under 18 years old. Lustral should only be
used to treat children and adolescents aged 6-17 years old, suffering from
obsessive compulsive disorder (OCD). If you are being treated for this
disorder, your doctor will want to monitor you closely (see Use in children
and adolescents below).
* If you are having electro-convulsive therapy (ECT).
Restlessness/Akathisia:
The use of sertraline has been linked to a distressing restlessness and need
to move, often being unable to sit or stand still (akathisia). This is most likely
to occur during the first few weeks of treatment. Increasing the dose may be
harmful so if you develop such symptoms you should talk to your doctor.
Withdrawal reactions:
Side effects relating to stopping treatment (withdrawal reactions) are
common, particularly if the treatment is stopped suddenly (see section 3 If
you stop taking Lustral and section 4 Possible side effects). The risk of
withdrawal symptoms depends on the length of treatment, dosage, and the
rate at which the dose is reduced. Generally, such symptoms are mild to
moderate. However, they can be serious in some patients. They normally
occur within the first few days after stopping treatment. In general, such
symptoms disappear on their own and wear off within 2 weeks. In some
patients they may last longer (2-3 months or more). When stopping
treatment with sertraline it is recommended to reduce the dose gradually
over a period of several weeks or months, and you should always discuss
the best way of stopping treatment with your doctor.

Thoughts of suicide and worsening of your depression or anxiety
disorder:
If you are depressed and/or have anxiety disorders you can sometimes have
thoughts of harming or killing yourself. These may be increased when first
starting antidepressants, since these medicines all take time to work, usually
about two weeks but sometimes longer.
You may be more likely to think like this:
* If you have previously had thoughts about killing or harming yourself.
* If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in adults aged less than 25 years with
psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed
or have an anxiety disorder, and ask them to read this leaflet. You might ask
them to tell you if they think your depression or anxiety is getting worse, or if
they are worried about changes in your behaviour.
Use in children and adolescents:
Sertraline should not usually be used in children and adolescents less than
18 years old, except for patients with Obsessive Compulsive Disorder
(OCD). Patients under 18 have an increased risk of undesirable effects, such
as suicide attempt, thoughts of harming or killing themselves (suicidal
thoughts) and hostility (mainly aggressiveness, oppositional behaviour and
anger) when they are treated with this class of medicines. Nevertheless, it is
possible that your doctor decides to prescribe Lustral to a patient under 18 if
it is in the patient's interest. If your doctor has prescribed Lustral to you and
you are less than 18 years old and you want to discuss this, please contact
him/her. Furthermore, if any of the symptoms listed above appear or worsen
while you are taking Lustral, you should inform your doctor. Also, the
long-term safety of Lustral in regard to growth, maturation and learning
(cognitive) and behavioural development in this age group has not yet been
demonstrated.
Taking other medicines:
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Some medicines can affect the way Lustral works, or Lustral itself can
reduce the effectiveness of other medicines taken at the same time.
Taking Lustral together with the following medicines may cause
serious side effects:
* Medicines called monoamine oxidase inhibitors (MAOIs), like
moclobemide (to treat depression) and selegiline (to treat Parkinson’s
disease) and the antibiotic linezolid.
Do not use Lustral together with these medicines.
* Medicines to treat mental disorders such as psychosis (pimozide). Do not
use Lustral together with pimozide.
Talk to your doctor if you are taking the following medicine:
* Herbal medicine containing St. John’s Wort (Hypericum perforatum). The
effects of St. John’s Wort may last for 1-2 weeks.
* Products containing the amino acid tryptophan.
* Medicines to treat severe pain (e.g. tramadol).
* Medicines used in anaesthesia or to treat chronic pain (fentanyl).
* Medicines to treat migraines (e.g. sumatriptan).
* Blood thinning medicine (warfarin).
* Medicines to treat pain/arthritis (Non steroidal anti-inflammatory drug
(NSAID) such as ibuprofen, acetylsalicylic acid (aspirin).
* Sedatives (diazepam).
* Diuretics (also called ‘water’ tablets).
* Medicines to treat epilepsy (phenytoin).
* Medicines to treat diabetes (tolbutamide).
* Medicines to treat excessive stomach acid and ulcers (cimetidine).
* Medicines to treat mania and depression (lithium).
* Other medicines to treat depression (such as amitriptyline, nortriptyline).
* Medicines to treat schizophrenia and other mental disorders (such as
perphenazine, levomepromazine and olanzapine).
* Medicines used to regulate the rate and rhythm of the heart (such as
flecainide, propafenone).
Taking Lustral with food and drink:
Lustral tablets can be taken with or without food.
Alcohol should be avoided whilst taking Lustral.
Sertraline should not be taken in combination with grapefruit juice, as this
may increase the level of sertraline in your body.
Pregnancy and breast-feeding:
Ask your doctor or pharmacist for advice before taking any medicine.
The safety of sertraline has not fully been established in pregnant
women. Sertraline will only be given to you when pregnant if your
doctor considers that the benefit for you is greater than any
possible risk to the developing baby. If you are a woman capable of
having children you should use a reliable method of
contraception (such as the contraceptive pill), when taking
sertraline.
Make sure your midwife and/or doctor know you are on Lustral. When
taken during pregnancy, particularly in the last 3 months of
pregnancy, medicines like Lustral may increase the risk of a serious
condition in babies, called persistent pulmonary hypertension of the
newborn (PPHN), making the baby breathe faster and appear bluish.
These symptoms usually begin during the first 24 hours after the baby
is born. If this happens to your baby you should contact your midwife
and/or doctor immediately.
Your newborn baby might also have other conditions, which usually
begin during the first 24 hours after birth.
Symptoms include:
* trouble with breathing,
* a blueish skin or being too hot or cold,
* blue lips,
* vomiting or not feeding properly,
* being very tired, not able to sleep or crying a lot,
* stiff or floppy muscles,
* tremors, jitters or fits,
* increased reflex reactions,
* irritabillity
* low blood sugar.
If your baby has any of these symptoms when it is born, or you are
concerned about your baby’s health, contact your doctor or midwife
who will be able to advise you.
There is evidence that sertraline passes into human breast milk.
Sertraline should only be used in women during breast-feeding, if your
doctor considers that the benefit exceeds any possible risk to the baby.
Some medicines like sertraline may reduce the quality of sperm in animal
studies. Theoretically, this could affect fertility, but impact on human ferility
has not been observed as yet.
Driving and using machines:
Psychotropic drugs such as sertraline may influence your ability to drive or
use machines. You should therefore not drive or operate machinery, until you
know how this medication affects your ability to perform these activities.

®

Ref:0973/040712/1/B

Lustral 50mg Tablets
(sertraline hydrochloride)
3

How to take Lustral

Always take Lustral exactly as your doctor has told you.
Lustral tablets may be taken with or without food.
Take your medication once daily either in the morning or evening.
You should check with your doctor or pharmacist if you are not sure.
The usual dose is:
Adults:
Depression and Obssessive Compulsive Disorder
For depression and OCD, the usual effective dose is 50 mg/day. The daily
dose may be increased in 50 mg increments and at intervals of at least
one week over a period of weeks. The maximum recommended dose is
200 mg/day.
Panic disorder, Social anxiety disorder and Post Traumatic Stress
Disorder:
For panic disorder, social anxiety disorder and post traumatic stress
disorder, treatment should be started at 25 mg/day, and increased to
50 mg/day after one week.
The daily dose then may be increased in 50 mg increments over a period
of weeks. The maximum recommended dose is 200 mg/day.
Children and adolescents:
Lustral must only be used to treat children and adolescents suffering from
OCD aged 6-17 years old.
Obsessive Compulsive Disorder:
Children aged 6 to 12: the recommended starting dose is 25 mg daily.
After one week, your doctor may increase this to 50 mg daily. The
maximum dose is 200 mg daily.
Adolescents aged 13 to 17: the recommended starting dose is 50 mg
daily.
The maximum dose is 200 mg daily.
If you have liver or kidney problems, please tell your doctor and follow the
doctor’s instructions.
Your doctor will advise you on how long to take this medication for. This will
depend on the nature of your illness and how well you are responding to the
treatment. It may take several weeks before your symptoms begin to
improve. Treatment of depression should usually continue for 6 months after
improvement.
If you take more Lustral than you should:
If you accidentally take too much Lustral contact your doctor at once or go to
the nearest hospital casualty department. Always take the labelled medicine
package with you, whether there is any medication left or not.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid
heart rate, shaking, agitation, dizziness and in rare cases unconsciousness.
If you forget to take Lustral:
If you forget to take a dose, do not take the missed dose. Just take the next
dose at the right time. Do not take a double dose to make up for a forgotten
dose.
If you stop taking Lustral:
Do not stop taking Lustral unless your doctor tells you to. Your doctor will
want to gradually reduce your dose of Lustral over several weeks, before
you finally stop taking this medicine. If you suddenly stop taking this
medicine you may experience side effects such as dizziness, numbness,
sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick
and shaking. If you experience any of these side effects, or any other side
effects whilst stopping taking Lustral, please speak to your doctor.

* osteoarthritis, muscular weakness, back pain, muscle twitching,
nighttime
* frequency urination, unable to urinate, increase in urination, increase in
of urination, problem urinating,
dysfunction, malaise,
* vaginal haemorrhage, female sexual weight increased. chills, fever,
weakness, thirst, weight decreased,
Rare side effects (occurs in between 1 and 10 out of 10.000 patients):
Intestine
* low bloodproblem, ear infection, cancer, swollen glands, high cholesterol,
sugar,
physical
psychotic
* disorder, symptoms due to stress or emotions, drug dependence,premature
aggression, paranoia, suicidal thoughts, sleep walking,
ejaculation,
coma, abnormal movements, difficulty moving, increased sensation,
* sensory disturbance,
glaucoma, tear problem, spots
* eye, blood in the eye, enlarged in front of eyes, double vision, light hurts
pupils,
heart attack, slow
* legs, closing up of heart beat, heart problem, poor circulation of arms and
throat, breathing fast, breathing slow, difficulty talking,
hiccups,
blood in
tongue ulceration,
* problem, stool, sore mouth, problems with livertooth disorder, tongue
mouth ulceration,
function,
skin problem with blisters,
* abnormal, bone disorder, hair rash, hair texture abnormal, skin odour
urination, urinary incontinence, urinary hesitation,
* decreasedvaginal bleeding, dry vaginal area, red painful penis and
excessive
* foreskin, genital discharge, prolonged erection, breast discharge,
hernia, injection site scarring, drug tolerance decreased, difficulty walking,
* abnormal laboratory tests, semen abnormal, injury, relaxation of blood
vessels procedure.
Cases of suicidal ideation and suicidal behaviours have been
* during lustral therapy or early after treatment discontinuation reported
(see section 2.).
After marketing sertraline, the following side effects have been
reported:
Decrease
low thyroid
* hormones,in white blood cells, decrease in clotting cells,controlling blood
endocrine problem, low blood salt, problems
sugar levels (diabetes), increase in blood sugar levels,
* terrifying abnormal dreams, suicidal behaviour, a lot, tense muscles and
muscular movement problems
* difficulty walking), passing out, (such as moving
vision abnormal,
* bleeding, or bloodbleeding problems (such as nose bleed, stomach
in urine), pancreatitis, serious liver function problems,
yellow skin and eyes (jaundice),
skin oedema, skin reaction to
* breast enlargement, menstrualsun, itching, joint pain, muscle cramps,
irregularities, swelling in legs, problems
with clotting, bedwetting and severe allergic reaction.
Side effects in children and adolescents
In clinical trials with children and adolescents, the side effects were generally
similar to adults (see above). The most common side effects in children and
adolescents were headache, insomnia, diarrhoea and feeling sick.
Symptoms that can occur when treatment is discontinued:
If you suddenly stop taking this medicine you may experience side effects
such as dizziness, numbness, sleep disturbances, agitation or anxiety,
headaches, feeling sick, being sick and shaking (see section 3. “If you stop
taking Lustral”).
An increased risk of bone fractures has been observed in patients taking this
type of medicines.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
5

If you have any further questions on the use of this product, ask your doctor
or pharmacist.
4

Possible side effects

Like all medicines, Lustral can cause side effects, although not everybody
gets them.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Nausea is the most common side effect. The side effects depend on the
dose and often disappear or lessen with continued treatment.
Tell your doctor immediately:
If you experience any of the following symptoms after taking this medicine,
these symptoms can be serious.
rash that
* If you develop a severe skinthe mouth causes blistering (erythema signs of
multiforme), (this can affect
and tongue). These may be
a condition known as Stevens Johnson Syndrome, or Toxic Epidermal
Necrolysis (TEN). Your doctor will stop your treatment in these cases.
Allergic reaction or
an
* skin rash, breathingallergy, which may include symptoms such as lips.itchy
problems, wheezing, swollen eyelids, face or
experience agitation, confusion, diarrhoea, high temperature
* If you pressure, excessive sweating and rapid heartbeat. These areand
blood
symptoms of Serotonin Syndrome. In rare cases this syndrome may occur
when you are taking certain medicines at the same time as sertraline.
Your doctor may wish to stop your treatment.
liver damage.
* If you develop yellow skin and eyes which may mean harming or killing
depressive
* If you experience thoughts). symptoms with ideas of
yourself (suicidal
get
of restlessness and are not
sit or
* If you start to startfeelings Lustral. You should tell your able to if you stand
still after you
to take
doctor
start
to feel restless.
* If you have a fit (seizure). (see section 2 “Take special care with
* If you have a manic episode
Lustral”).
The following side effects were seen in clinical trials in adults.
Very common side effects (occurs in more than 1 out of 10 patients):
Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry
mouth, ejaculation failure, fatigue.
Common side effects (occurs in between 1 and 10 out of 100 patients):
anorexia, increased appetite,
* Sore throat, feeling strange, nightmare, anxiety, agitation, nervousness,
* depression,sexual interest, teeth grinding,
decreased
numbness
* attention, and tingling, shaking, muscle tense, abnormal taste, lack of
* visual disturbance, ringing in ears,
* palpitations, hot flush, yawning,
vomiting,
* abdominal pain, sweating, constipation, upset stomach, gas,erectile
rash, increased
* dysfunction, chest pain. muscle pain, sexual dysfunction,
Uncommon side effects (occurs in between 1 and 10 out of 1.000
patients):
* Chest cold, runny nose, happy, lack of caring, thinking abnormal,
* hallucination, feeling too
convulsion,
muscle contractions, abnormal coordination,
* moving a lot,involuntary decreased feeling, speech disorder, dizziness while
amnesia,
standing up, migraine,
blood pressure, flushing,
* ear pain, fast heartbeat, highwheezing, shortness of breath, nose bleed,
* breathing difficulty, possible
inflammation of
* increased saliva,the oesophagus, difficulty swallowing, haemorrhoids,
tongue disorder, burping,
* eye swelling, purple spots on skin, hair loss, cold sweat, dry skin, hives,

How to store Lustral

Expiry date
Do not use this medicine after the expiry date shown on the carton label or
blister strip. If your doctor tells you to stop taking this medicine, return any
unused tablets to your pharmacist for safe disposal. Only keep this medicine,
if your doctor tells you to. If your tablets become discoloured or show any
other signs of deterioration, consult your pharmacist who will tell you what to
do.
Storing your medicine
OF
* KEEP OUT OF THE SIGHT AND REACHstrip CHILDERN to take your
until it is time
* Do not take your tablets out of the blister
dose.
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Further information

What Lustral contains
Each tablet contains sertraline hydrochloride equivalent to 50mg sertraline
as the active ingredient.
Other ingredients: calcium hydrogen phosphate, microcrystalline cellulose,
hydroxypropylcellulose, sodium starch glycollate, magnesium stearate,
titanium dioxide (E171), macrogol 400, macrogol 6000, polysorbate-80,
hypromellose E3, hypromellose E5.
What Lustral looks like and contents of the pack
Lustral are white, capsular shaped film-coated scored tablets coded with
‘ZLT-50’ on one side and ‘PFIZER’ on the other side.
Each blister pack contains 15 tablets and comes in boxes of 30 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Haupt Pharma Latina S.r.l : S.S. 156, Km
47, 600, Borgo San Michele, 04100 Latina, Italy and are procured from
within the EU and repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0973

Lustral is a registered trademark of Pfizer Products Inc.
Revision date: 04/07/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Tatig®50mg Tablets

Ref:0973/040712/3/F

(sertraline hydrochloride)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Tatig 50mg Tablets but will be referred to as Tatig
throughout this Patient Information Leaflet. Please note that the leaflet also
contains information about other strengths of this medicine, Tatig 100mg
In this leaflet:
1

What Tatig is and what it is used for

2

Before you take Tatig

3

How to take Tatig

4

Possible side effects

5

How to store Tatig

6

Further information

1

What Tatig is and what it is used for

Tatig contains the active ingredient sertraline. Sertraline is one of a group of
medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs); these
medicines are used to treat depression and or anxiety disorders.
Tatig can be used to treat:
* Depression and prevention of recurrence of depression (in adults).
* Social anxiety disorder (in adults).
* Post traumatic stress disorder (PTSD) (in adults).
* Panic disorder (in adults).
* Obsessive compulsive disorder (OCD) (in adults and children and
adolescents aged 6-17 years old).
Depression is a clinical illness with symptoms like feeling sad, unable to
sleep properly or to enjoy life as you used to.
OCD and Panic disorders are illnesses linked to anxiety with symptoms like
being constantly troubled by persistent ideas (obsessions) that make you
carry out repetitive rituals (compulsions).
PTSD is a condition that can occur after a very emotionally traumatic
experience, and has some symptoms that are similar to depression and
anxiety. Social anxiety disorder (social phobia) is an illness linked to anxiety.
It is characterised by feelings of intense anxiety or distress in social
situations (for example: talking to strangers, speaking in front of groups of
people, eating or drinking in front of others or worrying that you might
behave in an embarrassing manner).
Your doctor has decided that this medicine is suitable for treating your
illness.
You should ask your doctor if you are unsure why you have been given
Tatig.

2

Before you take Tatig

Do not take Tatig:
* If you are allergic (hypersensitive) to sertraline or any of the other
ingredients of Tatig.
(see 6. Further information for the list of ingredients).
* If you are taking or have taken medicines called monoamine oxidase
inhibitors (MAOIs such as selegiline, moclobemide) or MAOI like drugs
(such as linezolid). If you stop treatment with sertraline, you must wait
until at least one week before you start treatment with a MAOI. After
stopping treatment with a MAOI, you must wait at least 2 weeks before
you can start treatment with sertraline.
* If you are taking another medicine called Pimozide (a medicine for mental
disorders such as psychosis).
Take special care with Tatig:
Medicines are not always suitable for everyone. Tell your doctor before you
take Tatig, if you suffer from or have suffered in the past from any of the
following conditions:
* Epilepsy or a history of seizures. If you have a fit (seizure), contact your
doctor immediately.
* If you have suffered from manic depressive illness (bipolar disorder) or
schizophrenia. If you have a manic episode, contact your doctor
immediately.
* If you have or have previously had thoughts of harming or killing yourself
(see below-Thoughts of suicide and worsening of your depression or
anxiety disorder).
* Serotonin Syndrome. In rare cases this syndrome may occur when you
are taking certain medicines at the same time as sertraline. (For
symptoms, see section 4. Possible Side Effects). Your doctor will have
told you whether you have suffered from this in the past.
* If you have low sodium level in your blood, since this can occur as a result
of treatment with Tatig. You should also tell your doctor if you are taking
certain medicines for hypertension, since these medicines may also alter
the sodium level in your blood.
* Take special care if you are elderly as you may be more at risk of having
low sodium level in your blood (see above).
* Liver disease; your doctor may decide that you should have a lower dose
of Tatig.
* Diabetes; your blood glucose levels may be altered due to Tatig and
your diabetes medicines may need to be adjusted.
* If you have suffered from bleeding disorders or have been taking
medicines which thin the blood (eg acetylsalicyclic acid (aspirin), or
warfarin) or may increase the risk of bleeding.
* If you are a child or adolescent under 18 years old. Tatig should only be
used to treat children and adolescents aged 6-17 years old, suffering from
obsessive compulsive disorder (OCD). If you are being treated for this
disorder, your doctor will want to monitor you closely (see Use in children
and adolescents below).
* If you are having electro-convulsive therapy (ECT).
Restlessness/Akathisia:
The use of sertraline has been linked to a distressing restlessness and need
to move, often being unable to sit or stand still (akathisia). This is most likely
to occur during the first few weeks of treatment. Increasing the dose may be
harmful so if you develop such symptoms you should talk to your doctor.
Withdrawal reactions:
Side effects relating to stopping treatment (withdrawal reactions) are
common, particularly if the treatment is stopped suddenly (see section 3 If
you stop taking Tatig and section 4 Possible side effects). The risk of
withdrawal symptoms depends on the length of treatment, dosage, and the
rate at which the dose is reduced. Generally, such symptoms are mild to
moderate. However, they can be serious in some patients. They normally
occur within the first few days after stopping treatment. In general, such
symptoms disappear on their own and wear off within 2 weeks. In some
patients they may last longer (2-3 months or more). When stopping
treatment with sertraline it is recommended to reduce the dose gradually
over a period of several weeks or months, and you should always discuss
the best way of stopping treatment with your doctor.

Thoughts of suicide and worsening of your depression or anxiety
disorder:
If you are depressed and/or have anxiety disorders you can sometimes have
thoughts of harming or killing yourself. These may be increased when first
starting antidepressants, since these medicines all take time to work, usually
about two weeks but sometimes longer.
You may be more likely to think like this:
* If you have previously had thoughts about killing or harming yourself.
* If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in adults aged less than 25 years with
psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed
or have an anxiety disorder, and ask them to read this leaflet. You might ask
them to tell you if they think your depression or anxiety is getting worse, or if
they are worried about changes in your behaviour.
Use in children and adolescents:
Tatig should not usually be used in children and adolescents less than 18
years old, except for patients with Obsessive Compulsive Disorder (OCD).
Patients under 18 have an increased risk of undesirable effects, such as
suicide attempt, thoughts of harming or killing themselves (suicidal thoughts)
and hostility (mainly aggressiveness, oppositional behaviour and anger)
when they are treated with this class of medicines. Nevertheless, it is possible that your doctor decides to prescribe Tatig to a patient under 18 if it is in
the patient's interest. If your doctor has prescribed Tatig to you and you are
less than 18 years old and you want to discuss this, please contact him/her.
Furthermore, if any of the symptoms listed above appear or worsen while
you are taking Tatig, you should inform your doctor. Also, the
long-term safety of Tatig in regard to growth, maturation and learning
(cognitive) and behavioural development in this age group has not yet been
demonstrated.
Taking other medicines:
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Some medicines can affect the way Tatig works, or Tatig itself can reduce
the effectiveness of other medicines taken at the same time.
Taking Tatig together with the following medicines may cause
serious side effects:
* Medicines called monoamine oxidase inhibitors (MAOIs), like
moclobemide (to treat depression) and selegiline (to treat Parkinson’s
disease) and the antibiotic linezolid.
Do not use Tatig together with these medicines.
* Medicines to treat mental disorders such as psychosis (pimozide). Do not
use Tatig together with pimozide.
Talk to your doctor if you are taking the following medicine:
* Herbal medicine containing St. John’s Wort (Hypericum perforatum). The
effects of St. John’s Wort may last for 1-2 weeks.
* Products containing the amino acid tryptophan.
* Medicines to treat severe pain (e.g. tramadol).
* Medicines used in anaesthesia or to treat chronic pain (fentanyl).
* Medicines to treat migraines (e.g. sumatriptan).
* Blood thinning medicine (warfarin).
* Medicines to treat pain/arthritis (Non steroidal anti-inflammatory drug
(NSAID) such as ibuprofen, acetylsalicylic acid (aspirin).
* Sedatives (diazepam).
* Diuretics (also called ‘water’ tablets).
* Medicines to treat epilepsy (phenytoin).
* Medicines to treat diabetes (tolbutamide).
* Medicines to treat excessive stomach acid and ulcers (cimetidine).
* Medicines to treat mania and depression (lithium).
* Other medicines to treat depression (such as amitriptyline, nortriptyline).
* Medicines to treat schizophrenia and other mental disorders (such as
perphenazine, levomepromazine and olanzapine).
* Medicines used to regulate the rate and rhythm of the heart (such as
flecainide, propafenone).
Taking Tatig with food and drink:
Tatig tablets can be taken with or without food.
Alcohol should be avoided whilst taking Tatig.
Sertraline should not be taken in combination with grapefruit juice, as this
may increase the level of sertraline in your body.
Pregnancy and breast-feeding:
Ask your doctor or pharmacist for advice before taking any medicine.
The safety of sertraline has not fully been established in pregnant
women. Sertraline will only be given to you when pregnant if your
doctor considers that the benefit for you is greater than any
possible risk to the developing baby. If you are a woman capable of
having children you should use a reliable method of
contraception (such as the contraceptive pill), when taking
sertraline.
Make sure your midwife and/or doctor know you are on Lustral. When
taken during pregnancy, particularly in the last 3 months of
pregnancy, medicines like Lustral may increase the risk of a serious
condition in babies, called persistent pulmonary hypertension of the
newborn (PPHN), making the baby breathe faster and appear bluish.
These symptoms usually begin during the first 24 hours after the baby
is born. If this happens to your baby you should contact your midwife
and/or doctor immediately.
Your newborn baby might also have other conditions, which usually
begin during the first 24 hours after birth.
Symptoms include:
* trouble with breathing,
* a blueish skin or being too hot or cold,
* blue lips,
* vomiting or not feeding properly,
* being very tired, not able to sleep or crying a lot,
* stiff or floppy muscles,
* tremors, jitters or fits,
* increased reflex reactions,
* irritabillity
* low blood sugar.
If your baby has any of these symptoms when it is born, or you are
concerned about your baby’s health, contact your doctor or midwife
who will be able to advise you.
There is evidence that sertraline passes into human breast milk.
Sertraline should only be used in women during breast-feeding, if your
doctor considers that the benefit exceeds any possible risk to the baby.
Some medicines like sertraline may reduce the quality of sperm in animal
studies. Theoretically, this could affect fertility, but impact on human ferility
has not been observed as yet.
Driving and using machines:
Psychotropic drugs such as sertraline may influence your ability to drive or
use machines. You should therefore not drive or operate machinery, until you
know how this medication affects your ability to perform these activities.

Ref:0973/040712/3/B

Tatig® 50mg Tablets
(sertraline hydrochloride)
How to take Tatig

3

Always take Tatig exactly as your doctor has told you.
Tatig tablets may be taken with or without food.
Take your medication once daily either in the morning or evening.
You should check with your doctor or pharmacist if you are not sure.
The usual dose is:
Adults:
Depression and Obssessive Compulsive Disorder
For depression and OCD, the usual effective dose is 50 mg/day. The daily
dose may be increased in 50 mg increments and at intervals of at least
one week over a period of weeks. The maximum recommended dose is
200 mg/day.
Panic disorder, Social anxiety disorder and Post Traumatic Stress
Disorder:
For panic disorder, social anxiety disorder and post traumatic stress
disorder, treatment should be started at 25 mg/day, and increased to
50 mg/day after one week.
The daily dose then may be increased in 50 mg increments over a period
of weeks. The maximum recommended dose is 200 mg/day.
Children and adolescents:
Tatig must only be used to treat children and adolescents suffering from
OCD aged 6-17 years old.
Obsessive Compulsive Disorder:
Children aged 6 to 12: the recommended starting dose is 25 mg daily.
After one week, your doctor may increase this to 50 mg daily. The
maximum dose is 200 mg daily.
Adolescents aged 13 to 17: the recommended starting dose is 50 mg
daily.
The maximum dose is 200 mg daily.
If you have liver or kidney problems, please tell your doctor and follow the
doctor’s instructions.
Your doctor will advise you on how long to take this medication for. This will
depend on the nature of your illness and how well you are responding to the
treatment. It may take several weeks before your symptoms begin to
improve. Treatment of depression should usually continue for 6 months after
improvement.
If you take more Tatig than you should:
If you accidentally take too much Tatig contact your doctor at once or go to
the nearest hospital casualty department. Always take the labelled medicine
package with you, whether there is any medication left or not.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid
heart rate, shaking, agitation, dizziness and in rare cases unconsciousness.
If you forget to take Tatig:
If you forget to take a dose, do not take the missed dose. Just take the next
dose at the right time. Do not take a double dose to make up for a forgotten
dose.
If you stop taking Tatig:
Do not stop taking Tatig unless your doctor tells you to. Your doctor will want
to gradually reduce your dose of Tatig over several weeks, before you finally
stop taking this medicine. If you suddenly stop taking this
medicine you may experience side effects such as dizziness, numbness,
sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick
and shaking. If you experience any of these side effects, or any other side
effects whilst stopping taking Tatig, please speak to your doctor.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines, Tatig can cause side effects, although not everybody gets
them.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Nausea is the most common side effect. The side effects depend on the
dose and often disappear or lessen with continued treatment.
Tell your doctor immediately:
If you experience any of the following symptoms after taking this medicine,
these symptoms can be serious.
rash that
* If you develop a severe skinthe mouth causes blistering (erythema signs of
multiforme), (this can affect
and tongue). These may be
a condition known as Stevens Johnson Syndrome, or Toxic Epidermal
Necrolysis (TEN). Your doctor will stop your treatment in these cases.
Allergic reaction or
an
* skin rash, breathingallergy, which may include symptoms such as lips.itchy
problems, wheezing, swollen eyelids, face or
experience agitation, confusion, diarrhoea, high temperature
* If you pressure, excessive sweating and rapid heartbeat. These areand
blood
symptoms of Serotonin Syndrome. In rare cases this syndrome may occur
when you are taking certain medicines at the same time as sertraline.
Your doctor may wish to stop your treatment.
liver damage.
* If you develop yellow skin and eyes which may mean harming or killing
depressive
* If you experience thoughts). symptoms with ideas of
yourself (suicidal
get
of restlessness and
sit
* If you start to startfeelings Tatig. You should tellare not able to youor stand
still after you
to take
your doctor if
start
to feel restless.
* If you have a fit (seizure). (see section 2 “Take special care with
* If you have a manic episode
Tatig”).

* eye swelling, purple spots on skin, hair loss, cold sweat, dry skin, hives,
* osteoarthritis, muscular weakness, back pain, muscle twitching
nighttime
* frequency urination, unable to urinate, increase in urination, increase in
of urination, problem urinating,
vaginal haemorrhage, female sexual dysfunction, malaise, chills, fever,
weakness, thirst, weight decreased, weight increased.

*

Rare side effects (occurs in between 1 and 10 out of 10.000 patients):
Intestine
* low bloodproblem, ear infection, cancer, swollen glands, high cholesterol,
sugar,
physical
psychotic
* disorder, symptoms due to stress or emotions, drug dependence,premature
aggression, paranoia, suicidal thoughts, sleep walking,
ejaculation,
coma, abnormal movements, difficulty moving, increased sensation,
* sensory disturbance,
glaucoma, tear problem, spots
* eye, blood in the eye, enlarged in front of eyes, double vision, light hurts
pupils,
heart attack, slow
* legs, closing up of heart beat, heart problem, poor circulation of arms and
throat, breathing fast, breathing slow, difficulty talking,
hiccups,
blood in
tongue ulceration,
* problem, stool, sore mouth, problems with livertooth disorder, tongue
mouth ulceration,
function,
skin problem with blisters,
* abnormal, bone disorder, hair rash, hair texture abnormal, skin odour
urination, urinary incontinence, urinary hesitation,
* decreasedvaginal bleeding, dry vaginal area, red painful penis and
* excessivegenital discharge, prolonged erection, breast discharge,
foreskin,
hernia, injection site scarring, drug tolerance decreased, difficulty walking,
* abnormal laboratory tests, semen abnormal, injury, relaxation of blood
vessels procedure.
Cases of suicidal ideation and suicidal behaviours have been
* during lustral therapy or early after treatment discontinuation reported
(see section 2.).
After marketing sertraline, the following side effects have been
reported:
Decrease
low thyroid
* hormones,in white blood cells, decrease in clotting cells,controlling blood
endocrine problem, low blood salt, problems
sugar levels (diabetes), increase in blood sugar levels,
* terrifying abnormal dreams, suicidal behaviour, a lot, tense muscles and
muscular movement problems
* difficulty walking), passing out, (such as moving
vision abnormal,
* bleeding, or bloodbleeding problems (such as nose bleed, stomach
in urine), pancreatitis, serious liver function problems,
yellow skin and eyes (jaundice),
skin oedema, skin reaction to
* breast enlargement, menstrualsun, itching, joint pain, muscle cramps,
irregularities, swelling in legs, problems
with clotting, bedwetting and severe allergic reaction.
Side effects in children and adolescents
In clinical trials with children and adolescents, the side effects were generally
similar to adults (see above). The most common side effects in children and
adolescents were headache, insomnia, diarrhoea and feeling sick.
Symptoms that can occur when treatment is discontinued:
If you suddenly stop taking this medicine you may experience side effects
such as dizziness, numbness, sleep disturbances, agitation or anxiety,
headaches, feeling sick, being sick and shaking (see section 3. “If you stop
taking Tatig”).
An increased risk of bone fractures has been observed in patients taking this
type of medicines.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5

How to store Tatig

Expiry date
Do not use this medicine after the expiry date shown on the carton label or
blister strip. If your doctor tells you to stop taking this medicine, return any
unused tablets to your pharmacist for safe disposal. Only keep this medicine,
if your doctor tells you to. If your tablets become discoloured or show any
other signs of deterioration, consult your pharmacist who will tell you what to
do.
Storing your medicine
OF
* KEEP OUT OF THE SIGHT AND REACHstrip CHILDERN to take your
until it is time
* Do not take your tablets out of the blister
dose.
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Further information

What Tatig contains
Each tablet contains sertraline hydrochloride equivalent to 50mg sertraline
as the active ingredient.
Other ingredients: calcium hydrogen phosphate, microcrystalline cellulose,
hydroxypropylcellulose, sodium starch glycollate, magnesium stearate,
titanium dioxide (E171), macrogol 400, macrogol 6000, polysorbate-80,
hypromellose E3, hypromellose E5.
What Tatig looks like and contents of the pack
Tatig are white, capsular shaped film-coated scored tablets coded with
‘ZLT-50’ on one side and ‘PFIZER’ on the other side.
Each blister pack contains 15 tablets and comes in boxes of 30 tablets.

The following side effects were seen in clinical trials in adults.
Very common side effects (occurs in more than 1 out of 10 patients):
Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry
mouth, ejaculation failure, fatigue.
Common side effects (occurs in between 1 and 10 out of 100 patients):
anorexia, increased appetite,
* Sore throat, feeling strange, nightmare, anxiety, agitation, nervousness,
* depression,sexual interest, teeth grinding,
decreased
numbness
* attention, and tingling, shaking, muscle tense, abnormal taste, lack of
* visual disturbance, ringing in ears,
* palpitations, hot flush, yawning,
vomiting,
* abdominal pain, sweating, constipation, upset stomach, gas,erectile
rash, increased
* dysfunction, chest pain. muscle pain, sexual dysfunction,
Uncommon side effects (occurs in between 1 and 10 out of 1.000
patients):
* Chest cold, runny nose, happy, lack of caring, thinking abnormal,
* hallucination, feeling too
convulsion,
muscle contractions, abnormal coordination,
* moving a lot,involuntary decreased feeling, speech disorder, dizziness while
amnesia,
standing up, migraine,
blood pressure, flushing,
* ear pain, fast heartbeat, highwheezing, shortness of breath, nose bleed,
* breathing difficulty, possible
inflammation of
* increased saliva,the oesophagus, difficulty swallowing, haemorrhoids,
tongue disorder, burping,

Manufacturer and Licence Holder
The tablets are manufactured by Haupt Pharma Latina S.r.l : S.S. 156, Km
47, 600, Borgo San Michele, 04100 Latina, Italy and are procured from
within the EU and repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0973

Tatig is a registered trademark of Pfizer Products Inc.
Revision date: 04/07/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Sertraline®50mg Tablets

Ref:0973/040712/2/F

(sertraline hydrochloride)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Sertraline 50mg Tablets but will be referred to as
Sertraline throughout this Patient Information Leaflet. Please note that the
leaflet also contains information about other strengths of the medicine,
Sertraline 100mg.
In this leaflet:
1

What Sertraline is and what it is used for

2

Before you take Sertraline

3

How to take Sertraline

4

Possible side effects

5

How to store Sertraline

6

Further information

1

What Sertraline is and what it is used for

Sertraline contains the active ingredient sertraline. Sertraline is one of a
group of medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs);
these medicines are used to treat depression and or anxiety disorders.
Sertraline can be used to treat:
* Depression and prevention of recurrence of depression (in adults).
* Social anxiety disorder (in adults).
* Post traumatic stress disorder (PTSD) (in adults).
* Panic disorder (in adults).
* Obsessive compulsive disorder (OCD) (in adults and children and
adolescents aged 6-17 years old).
Depression is a clinical illness with symptoms like feeling sad, unable to
sleep properly or to enjoy life as you used to.
OCD and Panic disorders are illnesses linked to anxiety with symptoms like
being constantly troubled by persistent ideas (obsessions) that make you
carry out repetitive rituals (compulsions).
PTSD is a condition that can occur after a very emotionally traumatic
experience, and has some symptoms that are similar to depression and
anxiety. Social anxiety disorder (social phobia) is an illness linked to anxiety.
It is characterised by feelings of intense anxiety or distress in social
situations (for example: talking to strangers, speaking in front of groups of
people, eating or drinking in front of others or worrying that you might
behave in an embarrassing manner).
Your doctor has decided that this medicine is suitable for treating your
illness.
You should ask your doctor if you are unsure why you have been given
Lustral.

2

Before you take Sertraline

Do not take Sertraline:
* If you are allergic (hypersensitive) to sertraline or any of the other
ingredients of Sertraline.
(see 6. Further information for the list of ingredients).
* If you are taking or have taken medicines called monoamine oxidase
inhibitors (MAOIs such as selegiline, moclobemide) or MAOI like drugs
(such as linezolid). If you stop treatment with sertraline, you must wait
until at least one week before you start treatment with a MAOI. After
stopping treatment with a MAOI, you must wait at least 2 weeks before
you can start treatment with sertraline.
* If you are taking another medicine called Pimozide (a medicine for mental
disorders such as psychosis).
Take special care with Sertraline:
Medicines are not always suitable for everyone. Tell your doctor before you
take Sertraline, if you suffer from or have suffered in the past from any of the
following conditions:
* Epilepsy or a history of seizures. If you have a fit (seizure), contact your
doctor immediately.
* If you have suffered from manic depressive illness (bipolar disorder) or
schizophrenia. If you have a manic episode, contact your doctor
immediately.
* If you have or have previously had thoughts of harming or killing yourself
(see below-Thoughts of suicide and worsening of your depression or
anxiety disorder).
* Serotonin Syndrome. In rare cases this syndrome may occur when you
are taking certain medicines at the same time as sertraline. (For
symptoms, see section 4. Possible Side Effects). Your doctor will have
told you whether you have suffered from this in the past.
* If you have low sodium level in your blood, since this can occur as a result
of treatment with Sertraline. You should also tell your doctor if you are
takng certain medicines for hypertension, since these medicines may also
alter the sodium level in your blood.
* Take special care if you are elderly as you may be more at risk of having
low sodium level in your blood (see above).
* Liver disease; your doctor may decide that you should have a lower dose
of Sertraline.
* Diabetes; your blood glucose levels may be altered due to Sertraline and
your diabetes medicines may need to be adjusted.
* If you have suffered from bleeding disorders or have been taking
medicines which thin the blood (eg acetylsalicyclic acid (aspirin), or
warfarin) or may increase the risk of bleeding.
* If you are a child or adolescent under 18 years old.Sertraline should only
be used to treat children and adolescents aged 6-17 years old, suffering
from obsessive compulsive disorder (OCD). If you are being treated for
this disorder, your doctor will want to monitor you closely (see Use in
children and adolescents below).
* If you are having electro-convulsive therapy (ECT).
Restlessness/Akathisia:
The use of sertraline has been linked to a distressing restlessness and need
to move, often being unable to sit or stand still (akathisia). This is most likely
to occur during the first few weeks of treatment. Increasing the dose may be
harmful so if you develop such symptoms you should talk to your doctor.
Withdrawal reactions:
Side effects relating to stopping treatment (withdrawal reactions) are
common, particularly if the treatment is stopped suddenly (see section 3 If
you stop taking Sertraline and section 4 Possible side effects). The risk of
withdrawal symptoms depends on the length of treatment, dosage, and the
rate at which the dose is reduced. Generally, such symptoms are mild to
moderate. However, they can be serious in some patients. They normally
occur within the first few days after stopping treatment. In general, such
symptoms disappear on their own and wear off within 2 weeks. In some
patients they may last longer (2-3 months or more). When stopping
treatment with sertraline it is recommended to reduce the dose gradually
over a period of several weeks or months, and you should always discuss
the best way of stopping treatment with your doctor.

Thoughts of suicide and worsening of your depression or anxiety
disorder:
If you are depressed and/or have anxiety disorders you can sometimes have
thoughts of harming or killing yourself. These may be increased when first
starting antidepressants, since these medicines all take time to work, usually
about two weeks but sometimes longer.
You may be more likely to think like this:
* If you have previously had thoughts about killing or harming yourself.
* If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in adults aged less than 25 years with
psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed
or have an anxiety disorder, and ask them to read this leaflet. You might ask
them to tell you if they think your depression or anxiety is getting worse, or if
they are worried about changes in your behaviour.
Use in children and adolescents:
Sertraline should not usually be used in children and adolescents less than
18 years old, except for patients with Obsessive Compulsive Disorder
(OCD). Patients under 18 have an increased risk of undesirable effects, such
as suicide attempt, thoughts of harming or killing themselves (suicidal
thoughts) and hostility (mainly aggressiveness, oppositional behaviour and
anger) when they are treated with this class of medicines. Nevertheless, it is
possible that your doctor decides to prescribe Sertraline to a patient under
18 if it is in the patient's interest. If your doctor has prescribed Sertraline to
you and you are less than 18 years old and you want to discuss this, please
contact him/her. Furthermore, if any of the symptoms listed above appear or
worsen while you are taking Sertraline, you should inform your doctor. Also,
the long-term safety of Sertraline in regard to growth, maturation and
learning (cognitive) and behavioural development in this age group has not
yet been demonstrated.
Taking other medicines:
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Some medicines can affect the way Sertraline works, or Sertraline itself can
reduce the effectiveness of other medicines taken at the same time.
Taking Sertraline together with the following medicines may cause
serious side effects:
* Medicines called monoamine oxidase inhibitors (MAOIs), like
moclobemide (to treat depression) and selegiline (to treat Parkinson’s
disease) and the antibiotic linezolid.
Do not use Sertraline together with these medicines.
* Medicines to treat mental disorders such as psychosis (pimozide). Do not
use Sertraline together with pimozide.
Talk to your doctor if you are taking the following medicine:
* Herbal medicine containing St. John’s Wort (Hypericum perforatum). The
effects of St. John’s Wort may last for 1-2 weeks.
* Products containing the amino acid tryptophan.
* Medicines to treat severe pain (e.g. tramadol).
* Medicines used in anaesthesia or to treat chronic pain (fentanyl).
* Medicines to treat migraines (e.g. sumatriptan).
* Blood thinning medicine (warfarin).
* Medicines to treat pain/arthritis (Non steroidal anti-inflammatory drug
(NSAID) such as ibuprofen, acetylsalicylic acid (aspirin).
* Sedatives (diazepam).
* Diuretics (also called ‘water’ tablets).
* Medicines to treat epilepsy (phenytoin).
* Medicines to treat diabetes (tolbutamide).
* Medicines to treat excessive stomach acid and ulcers (cimetidine).
* Medicines to treat mania and depression (lithium).
* Other medicines to treat depression (such as amitriptyline, nortriptyline).
* Medicines to treat schizophrenia and other mental disorders (such as
perphenazine, levomepromazine and olanzapine).
* Medicines used to regulate the rate and rhythm of the heart (such as
flecainide, propafenone).
Taking Sertraline with food and drink:
Sertraline tablets can be taken with or without food.
Alcohol should be avoided whilst taking Sertraline.
Sertraline should not be taken in combination with grapefruit juice, as this
may increase the level of sertraline in your body.
Pregnancy and breast-feeding:
Ask your doctor or pharmacist for advice before taking any medicine.
The safety of sertraline has not fully been established in pregnant
women. Sertraline will only be given to you when pregnant if your
doctor considers that the benefit for you is greater than any
possible risk to the developing baby. If you are a woman capable of
having children you should use a reliable method of
contraception (such as the contraceptive pill), when taking
sertraline.
Make sure your midwife and/or doctor know you are on Lustral. When
taken during pregnancy, particularly in the last 3 months of
pregnancy, medicines like Lustral may increase the risk of a serious
condition in babies, called persistent pulmonary hypertension of the
newborn (PPHN), making the baby breathe faster and appear bluish.
These symptoms usually begin during the first 24 hours after the baby
is born. If this happens to your baby you should contact your midwife
and/or doctor immediately.
Your newborn baby might also have other conditions, which usually
begin during the first 24 hours after birth.
Symptoms include:
* trouble with breathing,
* a blueish skin or being too hot or cold,
* blue lips,
* vomiting or not feeding properly,
* being very tired, not able to sleep or crying a lot,
* stiff or floppy muscles,
* tremors, jitters or fits,
* increased reflex reactions,
* irritabillity
* low blood sugar.
If your baby has any of these symptoms when it is born, or you are
concerned about your baby’s health, contact your doctor or midwife
who will be able to advise you.
There is evidence that sertraline passes into human breast milk.
Sertraline should only be used in women during breast-feeding, if your
doctor considers that the benefit exceeds any possible risk to the baby.
Some medicines like sertraline may reduce the quality of sperm in animal
studies. Theoretically, this could affect fertility, but impact on human ferility
has not been observed as yet.
Driving and using machines:
Psychotropic drugs such as sertraline may influence your ability to drive or
use machines. You should therefore not drive or operate machinery, until you
know how this medication affects your ability to perform these activities.

Ref:0973/040712/2/B

Sertraline®50mg Tablets
(sertraline hydrochloride)
3

How to take Sertraline

Always take Sertraline exactly as your doctor has told you.
Sertraline tablets may be taken with or without food.
Take your medication once daily either in the morning or evening.
You should check with your doctor or pharmacist if you are not sure.
The usual dose is:
Adults:
Depression and Obssessive Compulsive Disorder
For depression and OCD, the usual effective dose is 50 mg/day. The daily
dose may be increased in 50 mg increments and at intervals of at least
one week over a period of weeks. The maximum recommended dose is
200 mg/day.
Panic disorder, Social anxiety disorder and Post Traumatic Stress
Disorder:
For panic disorder, social anxiety disorder and post traumatic stress
disorder, treatment should be started at 25 mg/day, and increased to
50 mg/day after one week.
The daily dose then may be increased in 50 mg increments over a period
of weeks. The maximum recommended dose is 200 mg/day.
Children and adolescents:
Lustral must only be used to treat children and adolescents suffering from
OCD aged 6-17 years old.
Obsessive Compulsive Disorder:
Children aged 6 to 12: the recommended starting dose is 25 mg daily.
After one week, your doctor may increase this to 50 mg daily.
The maximum dose is 200 mg daily.
Adolescents aged 13 to 17: the recommended starting dose is 50 mg
daily.
The maximum dose is 200 mg daily.
If you have liver or kidney problems, please tell your doctor and follow the
doctor’s instructions.
Your doctor will advise you on how long to take this medication for. This will
depend on the nature of your illness and how well you are responding to the
treatment. It may take several weeks before your symptoms begin to
improve. Treatment of depression should usually continue for 6 months after
improvement.
If you take more Sertraline than you should:
If you accidentally take too much Sertraline contact your doctor at once or go
to the nearest hospital casualty department. Always take the labelled
medicine package with you, whether there is any medication left or not.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid
heart rate, shaking, agitation, dizziness and in rare cases unconsciousness.
If you forget to take Sertraline:
If you forget to take a dose, do not take the missed dose. Just take the next
dose at the right time. Do not take a double dose to make up for a forgotten
dose.
If you stop taking Sertraline:
Do not stop taking Sertraline unless your doctor tells you to. Your doctor will
want to gradually reduce your dose of Sertraline over several weeks, before
you finally stop taking this medicine. If you suddenly stop taking this
medicine you may experience side effects such as dizziness, numbness,
sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick
and shaking. If you experience any of these side effects, or any other side
effects whilst stopping taking Sertraline, please speak to your doctor.

* eye swelling, purple spots on skin, hair loss, cold sweat, dry skin, hives,
* osteoarthritis, muscular weakness, back pain, muscle twitching,
nighttime
urinate,
* quency of urination, unable tourinating,increase in urination, increase in fre
urination, problem
*

vaginal haemorrhage, female sexual dysfunction, malaise, chills, fever,
weakness, thirst, weight decreased, weight increased.

Rare side effects (occurs in between 1 and 10 out of 10.000 patients):
Intestine
* low bloodproblem, ear infection, cancer, swollen glands, high cholesterol,
sugar,
physical
psychotic
* disorder, symptoms due to stress or emotions, drug dependence,premature
aggression, paranoia, suicidal thoughts, sleep walking,
ejaculation,
coma, abnormal movements, difficulty moving, increased sensation,
* sensory disturbance,
glaucoma, tear problem, spots
* eye, blood in the eye, enlarged in front of eyes, double vision, light hurts
pupils,
heart attack, slow
* legs, closing up of heart beat, heart problem, poor circulation of arms and
throat, breathing fast, breathing slow, difficulty talking,
hiccups,
blood in
tongue ulceration,
* problem, stool, sore mouth, problems with livertooth disorder, tongue
mouth ulceration,
function,
skin problem with blisters,
* abnormal, bone disorder, hair rash, hair texture abnormal, skin odour
urination, urinary incontinence, urinary hesitation,
* decreasedvaginal bleeding, dry vaginal area, red painful penis and
excessive
* foreskin, genital discharge, prolonged erection, breast discharge,
hernia, injection site scarring, drug tolerance decreased, difficulty walking,
* abnormal laboratory tests, semen abnormal, injury, relaxation of blood
vessels procedure.
Cases of suicidal ideation and suicidal behaviours have been
* during lustral therapy or early after treatment discontinuation reported
(see section 2.).
After marketing sertraline, the following side effects have been
reported:
Decrease
low thyroid
* hormones,in white blood cells, decrease in clotting cells,controlling blood
endocrine problem, low blood salt, problems
sugar levels (diabetes), increase in blood sugar levels,
* terrifying abnormal dreams, suicidal behaviour, a lot, tense muscles and
muscular movement problems
* difficulty walking), passing out, (such as moving
vision abnormal,
* bleeding, or bloodbleeding problems (such as nose bleed, stomach
in urine), pancreatitis, serious liver function problems,
yellow skin and eyes (jaundice),
skin oedema, skin reaction to
* breast enlargement, menstrualsun, itching, joint pain, muscle cramps,
irregularities, swelling in legs, problems
with clotting, bedwetting and severe allergic reaction.
Side effects in children and adolescents
In clinical trials with children and adolescents, the side effects were generally
similar to adults (see above). The most common side effects in children and
adolescents were headache, insomnia, diarrhoea and feeling sick.
Symptoms that can occur when treatment is discontinued:
If you suddenly stop taking this medicine you may experience side effects
such as dizziness, numbness, sleep disturbances, agitation or anxiety,
headaches, feeling sick, being sick and shaking (see section 3. “If you stop
taking Sertraline”).
An increased risk of bone fractures has been observed in patients taking this
type of medicines.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

If you have any further questions on the use of this product, ask your doctor
or pharmacist.
5
4

Possible side effects

Like all medicines, Sertraline can cause side effects, although not everybody
gets them.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Nausea is the most common side effect. The side effects depend on the
dose and often disappear or lessen with continued treatment.
Tell your doctor immediately:
If you experience any of the following symptoms after taking this medicine,
these symptoms can be serious.
rash that
* If you develop a severe skinthe mouth causes blistering (erythema signs of
multiforme), (this can affect
and tongue). These may be
a condition known as Stevens Johnson Syndrome, or Toxic Epidermal
Necrolysis (TEN). Your doctor will stop your treatment in these cases.
Allergic reaction or
an
* skin rash, breathingallergy, which may include symptoms such as lips.itchy
problems, wheezing, swollen eyelids, face or
experience agitation, confusion, diarrhoea, high temperature
* If you pressure, excessive sweating and rapid heartbeat. These areand
blood
symptoms of Serotonin Syndrome. In rare cases this syndrome may occur
when you are taking certain medicines at the same time as sertraline.
Your doctor may wish to stop your treatment.
liver damage.
* If you develop yellow skin and eyes which may mean harming or killing
depressive
* If you experience thoughts). symptoms with ideas of
yourself (suicidal
get
of restlessness and are not able to sit or stand
* If you start to startfeelings Sertraline. You should tell your doctor if you start
still after you
to take
to feel restless.
* If you have a fit (seizure). (see section 2 “Take special care with
* If you have a manic episode
Sertraline”).
The following side effects were seen in clinical trials in adults.
Very common side effects (occurs in more than 1 out of 10 patients):
Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry
mouth, ejaculation failure, fatigue.
Common side effects (occurs in between 1 and 10 out of 100 patients):
anorexia, increased appetite,
* Sore throat, feeling strange, nightmare, anxiety, agitation, nervousness,
* depression,sexual interest, teeth grinding,
decreased
numbness
* attention, and tingling, shaking, muscle tense, abnormal taste, lack of
* visual disturbance, ringing in ears,
* palpitations, hot flush, yawning,
vomiting,
* abdominal pain, sweating, constipation, upset stomach, gas,erectile
rash, increased
* dysfunction, chest pain. muscle pain, sexual dysfunction,
Uncommon side effects (occurs in between 1 and 10 out of 1.000
patients):
* Chest cold, runny nose, happy, lack of caring, thinking abnormal,
* hallucination, feeling too
contractions, abnormal
* convulsion, involuntary muscle feeling, speech disorder,coordination, mov
ing a lot, amnesia, decreased
dizziness while
standing up, migraine,
blood pressure, flushing,
* ear pain, fast heartbeat, highwheezing, shortness of breath, nose bleed,
* breathing difficulty, possible
inflammation of
* increased saliva,the oesophagus, difficulty swallowing, haemorrhoids,
tongue disorder, burping,

How to store Sertraline

Expiry date
Do not use this medicine after the expiry date shown on the carton label or
blister strip. If your doctor tells you to stop taking this medicine, return any
unused tablets to your pharmacist for safe disposal. Only keep this medicine,
if your doctor tells you to. If your tablets become discoloured or show any
other signs of deterioration, consult your pharmacist who will tell you what to
do.
Storing your medicine
OF
* KEEP OUT OF THE SIGHT AND REACHstrip CHILDERN to take your
until it is time
* Do not take your tablets out of the blister
dose.
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Further information

What Sertraline contains
Each tablet contains sertraline hydrochloride equivalent to 50mg sertraline
as the active ingredient.
Other ingredients: calcium hydrogen phosphate, microcrystalline cellulose,
hydroxypropylcellulose, sodium starch glycollate, magnesium stearate,
titanium dioxide (E171), macrogol 400, macrogol 6000, polysorbate-80,
hypromellose E3, hypromellose E5.
What Sertraline looks like and contents of the pack
Sertraline are white, capsular shaped film-coated scored tablets coded with
‘ZLT-50’ on one side and ‘PFIZER’ on the other side.
Each blister pack contains 15 tablets and comes in boxes of 30 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Haupt Pharma Latina S.r.l : S.S. 156, Km
47, 600, Borgo San Michele, 04100 Latina, Italy and are procured from
within the EU and repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0973

Sertraline is a registered trademark of Pfizer Products Inc.
Revision date: 04/07/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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