SERTRALINE 50MG FILM COATED TABLETS

Active substance: SERTRALINE HYDROCHLORIDE

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S1034-35 LEAFLET Lustral 20120402

Uncommon side effects (occurs in between 1 and 10 out of
1.000 patients):


Chest cold, runny nose,



hallucination, feeling too happy, lack of caring, thinking
abnormal,



convulsion, involuntary muscle contractions, abnormal
coordination, moving a lot, amnesia, decreased feeling, speech
disorder, dizziness while standing up, migraine,



ear pain, fast heartbeat, high blood pressure, flushing,



breathing difficulty, possible wheezing, shortness of breath, nose
bleed,



inflammation of the oesophagus, difficulty swallowing,
haemorrhoids, increased saliva, tongue disorder, burping,

Side effects in children and adolescents

S1034-35 LEAFLET Lustral 20120402

PACKAGE LEAFLET: INFORMATION FOR THE USER

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”).

LUSTRAL 50mg TABLETS
LUSTRAL 100mg TABLETS
(sertraline hydrochloride)
Your medicine is known by either of the above name but will be
referred to as Lustral throughout the following leaflet.

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.



eye swelling, purple spots on skin, hair loss, cold sweat, dry skin,
hives,



osteoarthritis, muscular weakness, back pain, muscle twitching,





Do not use after the expiry date printed on the carton label or
blister strip.



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):





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.

If your doctor tells you to stop taking the tablets, take any which
you have left back to your pharmacist for safe disposal. Only
keep them if the doctor tells you to.
If the medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who
will tell you what to do.

4. Possible side effects.

Intestine problem, ear infection, cancer, swollen glands, high
cholesterol, low blood sugar,



physical symptoms due to stress or emotions, drug dependence,
psychotic disorder, aggression, paranoia, suicidal thoughts,
sleep walking, premature ejaculation,



coma, abnormal movements, difficulty moving, increased
sensation, sensory disturbance,



glaucoma, tear problem, spots in front of eyes, double vision,
light hurts eye, blood in the eye, enlarged pupils,

6. Further information



heart attack, slow heart beat, heart problem, poor circulation of
arms and legs, closing up of throat, breathing fast, breathing
slow, difficulty talking, hiccups,



Each Lustral 50mg film-coated tablet contains 50mg of the active
ingredient, sertraline (as the hydrochloride).



Each Lustral 100mg film-coated tablet contains 100mg of the
active ingredient, sertraline (as the hydrochloride).



Lustral also contain the following inactive ingredients: calcium
hydrogen phosphate, microcrystalline cellulose,
hydroxypropylcellulose, sodium starch glycollate, magnesium
stearate, Opadry white and Opadry.



blood in stool, sore mouth, tongue ulceration, tooth disorder,
tongue problem, mouth ulceration, problems with liver function,



skin problem with blisters, hair rash, hair texture abnormal, skin
odour abnormal, bone disorder,



excessive vaginal bleeding, dry vaginal area, red painful penis
and 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
reported during sertraline therapy or early after treatment
discontinuation (see section 2.).
After marketing sertraline, the following side effects have been
reported:


Decrease in white blood cells, decrease in clotting cells, low
thyroid hormones, endocrine problem, low blood salt, problems
controlling blood sugar levels (diabetes), increase in blood sugar
levels,



terrifying abnormal dreams, suicidal behaviour,



muscular movement problems (such as moving a lot, tense
muscles and difficulty walking), passing out,



vision abnormal, bleeding problems (such as nose bleed,
stomach bleeding, or blood in urine), pancreatitis, serious liver
function problems, yellow skin and eyes (jaundice),



skin oedema, skin reaction to sun, itching, joint pain, muscle
cramps, breast enlargement, menstrual irregularities, swelling in
legs, problems with clotting, bedwetting and severe allergic
reaction.

Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. These measures will help
to protect the environment.

What Lustral contains

decreased urination, urinary incontinence, urinary hesitation,





In this leaflet:
1. What Lustral is and what it is used for.



What Lustral looks like and contents of the pack


Each Lustral 50mg tablets are white capsule shaped, marked
‘Pfizer’ on one side and 'ZLT 50' on the other side.



Each Lustral 100mg tablets are white capsule shaped, marked
‘Pfizer’ on one side and 'ZLT 100' on the other side.

 Lustral is available as blister packs of 28 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence
holder: S & M Medical Ltd, Chemilines House, Alperton Lane,
Wembley, Middlesex, HA0 1DX.
Manufacturer
This product is manufactured by Pfizer Italia S.r.l., S.S. 156, Km 5004010, Borgo San Michele, Latina, Italy.
POM

PL No. 19488/1034

Lustral 50mg Tablets

PL No. 19488/1035

Lustral 100mg Tablets

Leaflet revision date: 2 April 2012.
Lustral is a registered trade mark of Pfizer Products Inc, USA.
S1034-35 LEAFLET Lustral 20120402



If you are allergic (hypersensitive) to sertraline or any of the other
ingredients of Lustral (see 6. Further Information for a 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).

Keep this leaflet. You may need to read it again.



KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.





5. How to store Lustral

nighttime urination, unable to urinate, increase in urination,
increase in frequency of urination, problem urinating,

Do not take Lustral:

Read all of this leaflet carefully before you start taking this
medicine.



An increased risk of bone fractures has been observed in patients
taking this type of medicines.

2. Before you take Lustral

2. Before you take Lustral.

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 (e.g. 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 below - Use in children and
adolescents).



If you are having electro-convulsive therapy (ECT).

3. How to take Lustral.
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 characterized 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.

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.

S1034-35 LEAFLET Lustral 20120402

Withdrawal reactions:

Talk to your doctor if you are taking the following medicine:

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.



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 anesthesia 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).

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.

Taking Lustral with food and drink:

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.

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.
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.

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:

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.

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.

3. How to take Lustral
Always take Lustral exactly as your doctor has told you. Lustral
tablets may be taken with or without food.

4. Possible side effects

Take your medication once daily either in the morning or evening.
You should check with your doctor or pharmacist if you are not sure.

Like all medicines, Lustral can cause side effects, although not
everybody gets them.

The usual dose is:

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.

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.

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 newborn baby might also have other conditions, which
usually begin during the first 24 hours after birth. Symptoms
include:

If you take more Lustral than you should:

trouble with breathing,



a blueish skin or being too hot or cold,



blue lips,



vomiting or not feeding properly,



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.


If you develop a severe skin rash that causes blistering
(erythema multiforme), (this can affect the mouth and tongue).
These may be signs of a condition known as Stevens Johnson
Syndrome, or Toxic Epidermal Necrolysis (TEN). Your doctor will
stop your treatment in these cases.



Allergic reaction or allergy, which may include symptoms such as
an itchy skin rash, breathing problems, wheezing, swollen
eyelids, face or lips.



If you experience agitation, confusion, diarrhoea, high
temperature and blood pressure, excessive sweating and rapid
heartbeat. These are 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.



If you develop yellow skin and eyes which may mean liver
damage.



If you experience depressive symptoms with ideas of harming or
killing yourself (suicidal thoughts).



If you start to get feelings of restlessness and are not able to sit
or stand still after you start to take Lustral. You should tell your
doctor if you start to feel restless.



If you have a fit (seizure).



If you have a manic episode (see section 2 “Take special care
with Lustral”).

Children and adolescents:

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.



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

Alcohol should be avoided whilst taking Lustral.

Lustral tablets can be taken with or without food.

If you stop taking Lustral:

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 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.

being very tired, not able to sleep or crying a lot,

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):



stiff or floppy muscles,
tremors, jitters or fits,



increased reflex reactions,

If you forget to take a dose, do not take the missed dose. Just take
the next dose at the right time.



irritability,



low blood sugar.

Sore throat, anorexia, increased appetite,



depression, feeling strange, nightmare, anxiety, agitation,
nervousness, decreased sexual interest, teeth grinding,
numbness and tingling, shaking, muscle tense, abnormal taste,
lack of attention,



visual disturbance, ringing in ears,



palpitations, hot flush, yawning,



abdominal pain, vomiting, constipation, upset stomach, gas,



rash, increased sweating, muscle pain, sexual dysfunction,
erectile dysfunction, chest pain.

If you forget to take Lustral:







Symptoms of overdose may include drowsiness, nausea and
vomiting, rapid heart rate, shaking, agitation, dizziness and in rare
cases unconsciousness.

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.

Do not take a double dose to make up for a forgotten dose.

S1034-35 LEAFLET Sertraline 20120402

Uncommon side effects (occurs in between 1 and 10 out of
1.000 patients):


Chest cold, runny nose,



hallucination, feeling too happy, lack of caring, thinking
abnormal,



convulsion, involuntary muscle contractions, abnormal
coordination, moving a lot, amnesia, decreased feeling, speech
disorder, dizziness while standing up, migraine,



ear pain, fast heartbeat, high blood pressure, flushing,



breathing difficulty, possible wheezing, shortness of breath, nose
bleed,



inflammation of the oesophagus, difficulty swallowing,
haemorrhoids, increased saliva, tongue disorder, burping,

Side effects in children and adolescents

S1034-35 LEAFLET Sertraline 20120402

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.

PACKAGE LEAFLET: INFORMATION FOR THE USER
SERTRALINE 50mg TABLETS
SERTRALINE 100mg TABLETS
(sertraline hydrochloride)

Symptoms that can occur when treatment is discontinued

Your medicine is known by either of the above name but will be
referred to as Sertraline throughout the following leaflet.

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”).

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.

Do not take Sertraline:


If you are allergic (hypersensitive) to sertraline or any of the other
ingredients of Sertraline (see 6. Further Information for a 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.

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.



An increased risk of bone fractures has been observed in patients
taking this type of medicines.

2. Before you take Sertraline

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.



eye swelling, purple spots on skin, hair loss, cold sweat, dry skin,
hives,



osteoarthritis, muscular weakness, back pain, muscle twitching,



5. How to store Sertraline

nighttime urination, unable to urinate, increase in urination,
increase in frequency of urination, problem urinating,



KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop taking the tablets, take any which
you have left back to your pharmacist for safe disposal. Only
keep them if the doctor tells you to.

1. What Sertraline is and what it is used for.

If the medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who
will tell you what to do.



If you are taking another medicine called Pimozide (a medicine
for mental disorders such as psychosis).
Take special care with Sertraline:

4. Possible side effects.



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 problem, ear infection, cancer, swollen glands, high
cholesterol, low blood sugar,



physical symptoms due to stress or emotions, drug dependence,
psychotic disorder, aggression, paranoia, suicidal thoughts,
sleep walking, premature ejaculation,





coma, abnormal movements, difficulty moving, increased
sensation, sensory disturbance,



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. These measures will help
to protect the environment.
6. FURTHER INFORMATION



glaucoma, tear problem, spots in front of eyes, double vision,
light hurts eye, blood in the eye, enlarged pupils,

6. Further information



heart attack, slow heart beat, heart problem, poor circulation of
arms and legs, closing up of throat, breathing fast, breathing
slow, difficulty talking, hiccups,





blood in stool, sore mouth, tongue ulceration, tooth disorder,
tongue problem, mouth ulceration, problems with liver function,



skin problem with blisters, hair rash, hair texture abnormal, skin
odour abnormal, bone disorder,



excessive vaginal bleeding, dry vaginal area, red painful penis
and foreskin, genital discharge, prolonged erection, breast
discharge,




decreased urination, urinary incontinence, urinary hesitation,



What Sertraline contains



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
reported during sertraline therapy or early after treatment
discontinuation (see section 2.).

After marketing sertraline, the following side effects have been
reported:


Decrease in white blood cells, decrease in clotting cells, low
thyroid hormones, endocrine problem, low blood salt, problem
controlling blood sugar levels (diabetes), increase in blood sugar
levels,



terrifying abnormal dreams, suicidal behaviour,



muscular movement problems (such as moving a lot, tense
muscles and difficulty walking), passing out,



vision abnormal, bleeding problems (such as nose bleed,
stomach bleeding, or blood in urine), pancreatitis, serious liver
function problems, yellow skin and eyes (jaundice),



skin oedema, skin reaction to sun, itching, joint pain, muscle
cramps, breast enlargement, menstrual irregularities, swelling in
legs, problems with clotting, bedwetting and severe allergic
reaction.

Each Sertraline 50mg film-coated tablet contains 50mg of the
active ingredient, sertraline (as the hydrochloride).
Each Sertraline 100mg film-coated tablet contains 100mg of the
active ingredient, sertraline (as the hydrochloride)
Sertraline also contain the following inactive ingredients: calcium
hydrogen phosphate, microcrystalline cellulose,
hydroxypropylcellulose, sodium starch glycollate, magnesium
stearate, Opadry white and Opadry.

What Sertraline looks like and contents of the pack



Each Sertraline 50mg tablets are white capsule shaped, marked
‘Pfizer’ on one side and 'ZLT 50' on the other side.
Each Sertraline 100mg tablets are white capsule shaped,
marked ‘Pfizer’ on one side and 'ZLT 100' on the other side.

 Sertraline is available as blister packs of 28 tablets.
Product Licence holder


In this leaflet:

3. How to take Sertraline.
5. How to store Sertraline.
6. Further information.

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).




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.

Leaflet revision date: 2 April 2012
S1034-35 LEAFLET Sertraline 20120402



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 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 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 (e.g. 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 below - Use in children and
adolescents).



If you are having electro-convulsive therapy (ECT).

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).

Your doctor has decided that this medicine is suitable for treating
your illness.

PL No. 19488/1035 Sertraline 100mg Tablets

If you have suffered from manic depressive illness (bipolar
disorder) or schizophrenia. If you have a manic episode, contact
your doctor immediately.

Panic disorder (in adults).

This product is manufactured by Pfizer Italia S.r.l., S.S. 156, Km 5004010, Borgo San Michele, Latina, Italy.
PL No. 19488/1034 Sertraline 50mg Tablets



1. What Sertraline is and what it is used for

Manufacturer

POM

Epilepsy or a history of seizures. If you have a fit (seizure),
contact your doctor immediately.

2. Before you take Sertraline.

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 characterized 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).

Procured from within the EU and repackaged by the Product Licence
holder: S & M Medical Ltd, Chemilines House, Alperton Lane,
Wembley, Middlesex, HA0 1DX.

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:

You should ask your doctor if you are unsure why you have been
given Sertraline.

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.

S1034-35 LEAFLET Sertraline 20120402

Withdrawal reactions:

Talk to your doctor if you are taking the following medicine:

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.



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 anesthesia or to treat chronic pain (fentanyl)



Medicines to treat migraines (e.g. sumatriptan).



Blood thinning medicine (warfarin).

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.



Medicines to treat pain/arthritis (Non steroidal anti-inflammatory
drug (NSAID) such as ibuprofen, acetylsalicylic acid (aspirin).

3. How to take Sertraline



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).

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.



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
Sertraline. When taken during pregnancy, particularly in the last
3 months of pregnancy, medicines like Sertraline 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:

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.
Driving and using machines:

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.

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


If you develop a severe skin rash that causes blistering
(erythema multiforme), (this can affect the mouth and tongue).
These may be signs of a condition known as Stevens Johnson
Syndrome, or Toxic Epidermal Necrolysis (TEN). Your doctor will
stop your treatment in these cases.

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.



Allergic reaction or allergy, which may include symptoms such as
an itchy skin rash, breathing problems, wheezing, swollen
eyelids, face or lips.

The daily dose then may be increased in 50 mg increments
over a period of weeks. The maximum recommended dose is
200 mg/day.



If you experience agitation, confusion, diarrhoea, high
temperature and blood pressure, excessive sweating and rapid
heartbeat. These are 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.



If you develop yellow skin and eyes which may mean liver
damage.



If you experience depressive symptoms with ideas of harming or
killing yourself (suicidal thoughts).

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.

If you start to get feelings of restlessness and are not able to sit
or stand still after you start to take Sertraline. You should tell
your doctor if you start to feel restless.



If you have a fit (seizure).



If you have a manic episode (see section 2 “Take special care
with Sertraline”).

Panic disorder, Social anxiety disorder and Post
Traumatic Stress Disorder:

Children and adolescents:
Sertraline must only be used to treat children and adolescents
suffering from OCD aged 6-17 years old.
Obsessive Compulsive Disorder:

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.

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):



trouble with breathing,



a blueish skin or being too hot or cold,

If you take more Sertraline than you should:



Sore throat, anorexia, increased appetite,



blue lips,
vomiting or not feeding properly,

depression, feeling strange, nightmare, anxiety, agitation,
nervousness, decreased sexual interest, teeth grinding,



being very tired, not able to sleep or crying a lot,





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.





stiff or floppy muscles,

numbness and tingling, shaking, muscle tense, abnormal taste,
lack of attention,



tremors, jitters or fits,



visual disturbance, ringing in ears,



increased reflex reactions,

Symptoms of overdose may include drowsiness, nausea and
vomiting, rapid heart rate, shaking, agitation, dizziness and in rare
cases unconsciousness.



palpitations, hot flush, yawning,



irritability,



abdominal pain, vomiting, constipation, upset stomach, gas,



rash, increased sweating, muscle pain, sexual dysfunction,
erectile dysfunction, chest pain.



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.

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.

Expand view ⇕

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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