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SERTRALINE 100MG TABLETS

Active substance(s): SERTRALINE / SERTRALINE HYDROCHLORIDE / SERTRALINE / SERTRALINE HYDROCHLORIDE / SERTRALINE / SERTRALINE HYDROCHLORIDE

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S439 LEAFLET Lustral 20170127
S439 LEAFLET Lustral 20160627

Reporting of side effects



nighttime urination, unable to urinate, increase in urination,
increase in frequency of urination, problem urinating, urinary
incontinence,
vaginal haemorrhage, sexual dysfunction, female sexual
dysfunction, menstrual irregularities, swelling in legs, chills,
fever, weakness, thirst, increase in liver enzyme levels, weight
decreased, weight increased.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly (see details below). By reporting side
effects you can help provide more information on the safety of this
medicine.
United Kingdom

LUSTRAL® 100mg TABLETS
(sertraline hydrochloride)
Your medicine is known as Lustral 100 Tablets but will be referred to
as Lustral throughout the following leaflet.
Information of other strength of Lustral (Lustral 50mg Tablets) may
also be present in this leaflet.

Yellow Card Scheme website:
Rare (may affect up to 1 in 1,000 people):

PACKAGE LEAFLET: INFORMATION FOR THE USER

www.mhra.gov.uk/yellowcard

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.



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

5. How to store Lustral





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

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



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



If you have any further questions, ask your doctor or pharmacist.



Do not store above 30°C.





severe allergic reaction,





This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.

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

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.



If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.



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



problems controlling blood sugar levels (diabetes),



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




skin problem with blisters, hair rash, hair texture abnormal, skin
odour abnormal, bone disorder,
decreased urination, urinary hesitation, blood in urine,



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



hernia, drug tolerance decreased, difficulty walking, semen
abnormal, increase in blood cholesterol levels, 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,
endocrine problem, low blood salt, increase in blood sugar
levels,



terrifying abnormal dreams, suicidal behaviour,



muscular movement problems (such as moving a lot, tense
muscles, difficulty walking and stiffness, spasms and
involuntary movements of muscles), sudden severe headache
(which may be a sign of a serious condition known as
Reversible Cerebral Vasoconstriction Syndrome (RCVS)),







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







vision abnormal, unequal sized pupils, bleeding problems
(such as stomach bleeding), progressive scarring of lung tissue
(Interstitial Lung Disease), pancreatitis, serious liver function
problems, yellow skin and eyes (jaundice),
skin oedema, skin reaction to sun, muscle cramps, breast
enlargement, problems with clotting, abnormal laboratory tests,
bedwetting.

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.
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.

2. What you need to know before you take Lustral
4. Possible side effects
5. How to store Lustral

If you have epilepsy (fit) 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).



If you have 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.



If you are elderly as you may be more at risk of having low
sodium level in your blood (see above).



If you have liver disease; your doctor may decide that you should
have a lower dose of Lustral.

6. Contents of the pack and other information



If you have 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- Children and adolescents).



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



If you have eye problems, such as certain kinds of glaucoma
(increased pressure in the eye).



If you have been told that you have an abnormality of your heart
tracing after an electrocardiogram (ECG) known as prolonged
QT interval.

6. Contents of the pack and other information
What Lustral contains

1. What Lustral is and what it is used for



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



Lustral also contains the following inactive ingredients: calcium
hydrogen phosphate, microcrystalline cellulose,
hydroxypropylcellulose, sodium starch glycollate, magnesium
stearate, hypromellose, polyethylene glycol, polysorbate 80 and
titanium dioxide (E171).

Lustral contains the active substance 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.

What Lustral looks like and contents of the pack



The tablets are white, film-coated, capsule shaped and marked
’100’ on one face and ‘are|mis’ on the other.
Lustral is available as blister packs of 30 tablets.

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).

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 Laboratorios Dr Esteve SA, Sant
Marti, s/n. Poligono Industrial La Roca., 08107 Martorelles, Spain.
POM

PL 19488/0439

Leaflet revision date: 27 January 2017

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).



Symptoms that can occur when treatment is discontinued

Lustral is a registered trade mark of Pfizer Products Inc, USA.

If you are allergic to sertraline or any of the other ingredients of
this medicine (listed in section 6).



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 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”).



3. How to take Lustral

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.

Additional side effects in children and adolescents

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:

1. What Lustral is and what it is used for

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

Light-headedness, fainting, or chest discomfort which could be
signs of changes in the electrical activity (seen on
electrocardiogram) or abnormal rhythm of the heart.

Talk to your doctor or pharmacist before taking Lustral.

What is in this leaflet:

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD or
Braille.



Warnings and precautions

You should ask your doctor if you are unsure why you have been
given Lustral.
2. What you need to know before you take Lustral
Do not take Lustral:

S439 LEAFLET Lustral 20160627

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


If you are taking another medicine called pimozide (a medicine
for mental disorders such as psychosis).

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.

S439 LEAFLET Lustral 20170127

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.



Medicines used to treat high blood pressure, chest pain or
regulate the rate and rhythm of the heart (such as verapamil,
diltiazem, flecainide, propafenone).



Medicines used to treat bacterial infections (such as rifampicin,
clarithromycin, telithromycin, erythromycin).



Medicines used to treat fungal infections (such as ketoconazole,
itraconazole, posaconazole, voriconazole, fluconazole).

If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.



Medicines used to treat HIV/AIDS and Hepatitis C (protease
inhibitors such as ritonavir, telaprevir).

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.




Children and adolescents:

Lustral with food, drink and alcohol:

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.
Other medicines and Lustral:
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
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), the antibiotic linezolid and methylene blue
(to treat high levels of methaemoglobin in the blood). 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 medicines:


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 (e.g.
fentanyl, mivacurium and suxamethonium).



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



Blood thinning medicine (warfarin).

3. How to take Lustral

4. Possible side effects

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

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

The recommended dose is:

Nausea is the most common side effect. The side effects depend on
the dose and often disappear or lessen with continued treatment.

Adults:
Depression and Obssessive Compulsive Disorder

Tell your doctor immediately:

Medicines used to prevent nausea and vomiting after an
operation or chemotherapy (aprepitant).

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 experience any of the following symptoms after taking this
medicine, these symptoms can be serious.

Medicines known to increase the risk of changes in the electrical
activity of the heart (e.g. some antipsychotics and antibiotics).

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

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.



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.

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.



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

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 “Warnings and
precautions”).

Use in children and adolescents:
Pregnancy, breast-feeding and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for
advice before taking this 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.
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,



irritability,



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 fertility has not been observed as yet.



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



Sedatives (diazepam).



Diuretics (also called ‘water’ tablets).

Driving and using machines:



Medicines to treat epilepsy (phenytoin, phenobarbital,
carbamazepine).



Medicines to treat diabetes (tolbutamide).



Medicines to treat excessive stomach acid, ulcers and heartburn
(cimetidine, omeprazole, lanzoprazole, pantoprazole,
rabeprazole).

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 mania and depression (lithium).



Other medicines to treat depression (such as amitriptyline,
nortriptyline, nefazodone, fluoxetine, fluvoxamine).



Medicines to treat schizophrenia and other mental disorders
(such as perphenazine, levomepromazine and olanzapine).

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.
Method of administration:
Lustral tablets may be taken with or without food.
Take your medication once daily either in the morning or evening.

The following side effects were seen in clinical trials in adults.

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.

Very common (may affect more than 1 in 10 people):
Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick,
dry mouth, ejaculation failure, fatigue.
Common (may affect up to 1 in 10 people):

If you take more Lustral than you should:



Sore throat, anorexia, increased appetite,

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.



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, erectile dysfunction,
chest pain,



joint pain,



malaise.

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:
Do not take a double dose to make up for a forgotten dose. If you
forget to take a dose, do not take the missed dose. Just take the next
dose at the right time.
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.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

Uncommon (may affect up to 1 in 100 people):
 Chest cold, runny nose,
 hypersensitivity,
 low thyroid hormones,
 hallucination, feeling too happy, lack of caring, thinking
abnormal, aggression,
 convulsion, involuntary muscle contractions, abnormal
coordination, moving a lot, amnesia, decreased feeling, speech
disorder, dizziness while standing up, passing out, migraine,
 enlarged pupils,
 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,
 eye swelling, purple spots on skin, face oedema, hair loss, cold
sweat, dry skin, hives, itching,


osteoarthritis, muscular weakness, back pain, muscle
twitching,

S439 LEAFLET Sertraline 20170127
S439 LEAFLET Sertraline 20170127

Reporting of side effects



nighttime urination, unable to urinate, increase in urination,
increase in frequency of urination, problem urinating, urinary
incontinence,
vaginal haemorrhage, sexual dysfunction, female sexual
dysfunction, menstrual irregularities, swelling in legs, chills,
fever, weakness, thirst, increase in liver enzyme levels, weight
decreased, weight increased.

Rare (may affect up to 1 in 1,000 people):



Intestine problem, ear infection, cancer, swollen glands, high
cholesterol, low blood sugar,
physical symptoms due to stress or emotions, drug
dependence, psychotic disorder, paranoia, suicidal thoughts,
sleep walking, premature ejaculation,



severe allergic reaction,



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,



problems controlling blood sugar levels (diabetes),



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

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly (see details below). By reporting side
effects you can help provide more information on the safety of this
medicine.
United Kingdom
Yellow Card Scheme website:
www.mhra.gov.uk/yellowcard

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.



Sertraline also contains the following inactive ingredients:
calcium hydrogen phosphate, microcrystalline cellulose,
hydroxypropylcellulose, sodium starch glycollate, magnesium
stearate, hypromellose, polyethylene glycol, polysorbate 80 and
titanium dioxide (E171).

Light-headedness, fainting, or chest discomfort which could be
signs of changes in the electrical activity (seen on
electrocardiogram) or abnormal rhythm of the heart.

Additional 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”).



If you have diabetes; your blood glucose levels may be altered
due to Sertraline and your diabetes medicines may need to be
adjusted.

1. What Sertraline is and what it is used for



Sertraline contains the active substance 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.

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- Children and adolescents).

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.

hernia, drug tolerance decreased, difficulty walking, semen
abnormal, increase in blood cholesterol levels, injury,
relaxation of blood vessels procedure,



If you have liver disease; your doctor may decide that you should
have a lower dose of Sertraline.





skin oedema, skin reaction to sun, muscle cramps, breast
enlargement, problems with clotting, abnormal laboratory tests,
bedwetting.



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.

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



If you are elderly as you may be more at risk of having low
sodium level in your blood (see above).





vision abnormal, unequal sized pupils, bleeding problems
(such as stomach bleeding), progressive scarring of lung tissue
(Interstitial Lung Disease), pancreatitis, serious liver function
problems, yellow skin and eyes (jaundice),



This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.

What Sertraline contains



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.

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

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

muscular movement problems (such as moving a lot, tense
muscles, difficulty walking and stiffness, spasms and
involuntary movements of muscles), sudden severe headache
(which may be a sign of a serious condition known as
Reversible Cerebral Vasoconstriction Syndrome (RCVS)),









If you have 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 any further questions, ask your doctor or pharmacist.



6. Contents of the pack and other information

terrifying abnormal dreams, suicidal behaviour,





Do not store above 30°C.

decreased urination, urinary hesitation, blood in urine,



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).





Decrease in white blood cells, decrease in clotting cells,
endocrine problem, low blood salt, increase in blood sugar
levels,



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

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



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





What is in this leaflet:
1. What Sertraline is and what it is used for
2. What you need to know before you take Sertraline
3. How to take Sertraline
4. Possible side effects
5. How to store Sertraline
6. Contents of the pack and other information

Sertraline can be used to treat:


Depression and prevention of recurrence of depression (in
adults).



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



Social anxiety disorder (in adults).





Post traumatic stress disorder (PTSD) (in adults).

If you have eye problems, such as certain kinds of glaucoma
(increased pressure in the eye).



Panic disorder (in adults).





Obsessive compulsive disorder (OCD) (in adults and children
and adolescents aged 6-17 years old).

If you have been told that you have an abnormality of your heart
tracing after an electrocardiogram (ECG) known as prolonged
QT interval.

What Sertraline looks like and contents of the pack



The tablets are white, film-coated, capsule shaped and marked
’100’ on one face and ‘are|mis’ on the other.
Sertraline is available as blister packs of 30 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 Laboratorios Dr Esteve SA, Sant
Marti, s/n. Poligono Industrial La Roca., 08107 Martorelles, Spain.
POM

PL 19488/0439

Leaflet revision date: 27 January 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD or
Braille.
S439 LEAFLET Sertraline 20170127

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:



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

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.

Talk to your doctor or pharmacist before taking Sertraline.

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





Warnings and precautions



5. How to store Sertraline



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

Your medicine is known as Sertraline 100mg Tablets but will be
referred to as Sertraline throughout the following leaflet.

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

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

Cases of suicidal ideation and suicidal behaviours have
been reported during sertraline therapy or early after
treatment discontinuation (see section 2).

SERTRALINE 100mg TABLETS
(sertraline hydrochloride)

Information of other strength of Sertraline (Sertraline 50mg Tablets)
may also be present in this leaflet.





PACKAGE LEAFLET: INFORMATION FOR THE USER

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 Sertraline.
2. What you need to know before you take Sertraline
Do not take Sertraline:



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


If you are allergic to sertraline or any of the other ingredients of
this medicine (listed in section 6).
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).

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.

S439 LEAFLET Sertraline 20170127

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.



Medicines used to treat high blood pressure, chest pain or
regulate the rate and rhythm of the heart (such as verapamil,
diltiazem, flecainide, propafenone).



Medicines used to treat bacterial infections (such as rifampicin,
clarithromycin, telithromycin, erythromycin).



Medicines used to treat fungal infections (such as ketoconazole,
itraconazole, posaconazole, voriconazole, fluconazole).

If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.



Medicines used to treat HIV/AIDS and Hepatitis C (protease
inhibitors such as ritonavir, telaprevir).

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.




Children and adolescents:

Sertraline with food, drink and alcohol:

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.
Other medicines and Sertraline:
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
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), the antibiotic linezolid and methylene blue
(to treat high levels of methaemoglobin in the blood). 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 medicines:


Herbal medicine containing St. John’s Wort (Hypericum
perforatum). The effects of St. John’s Wort may last for 1-2
weeks.

3. How to take Sertraline

4. Possible side effects

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

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

The recommended dose is:

Nausea is the most common side effect. The side effects depend on
the dose and often disappear or lessen with continued treatment.

Adults:
Depression and Obssessive Compulsive Disorder

Tell your doctor immediately:
If you experience any of the following symptoms after taking this
medicine, these symptoms can be serious.

Medicines used to prevent nausea and vomiting after an
operation or chemotherapy (aprepitant).

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.

Medicines known to increase the risk of changes in the electrical
activity of the heart (e.g. some antipsychotics and antibiotics).

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

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, breast-feeding and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for
advice before taking this 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.
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:


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,



irritability,



low blood sugar.



Products containing the amino acid tryptophan.



Medicines to treat severe pain (e.g. tramadol).



Medicines used in anaesthesia or to treat chronic pain (e.g.
fentanyl, mivacurium and suxamethonium).



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).

Driving and using machines:



Medicines to treat epilepsy (phenytoin, phenobarbital,
carbamazepine).



Medicines to treat diabetes (tolbutamide).



Medicines to treat excessive stomach acid, ulcers and heartburn
(cimetidine, omeprazole, lanzoprazole, pantoprazole,
rabeprazole).

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 mania and depression (lithium).



Other medicines to treat depression (such as amitriptyline,
nortriptyline, nefazodone, fluoxetine, fluvoxamine).



Medicines to treat schizophrenia and other mental disorders
(such as perphenazine, levomepromazine and olanzapine).

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 fertility has not been observed as yet.



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.

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.



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

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 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 “Warnings and
precautions”).

Use in children and adolescents:
Sertraline 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.
Method of administration:
Sertraline tablets may be taken with or without food.
Take your medication once daily either in the morning or evening.

The following side effects were seen in clinical trials in adults.

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.

Very common (may affect more than 1 in 10 people):
Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick,
dry mouth, ejaculation failure, fatigue.
Common (may affect up to 1 in 10 people):

If you take more Sertraline than you should:



Sore throat, anorexia, increased appetite,

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.



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, erectile dysfunction,
chest pain,



joint pain,



malaise.

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:
Do not take a double dose to make up for a forgotten dose. If you
forget to take a dose, do not take the missed dose. Just take the next
dose at the right time.
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.

Uncommon (may affect up to 1 in 100 people):
 Chest cold, runny nose,
 hypersensitivity,
 low thyroid hormones,
 hallucination, feeling too happy, lack of caring, thinking
abnormal, aggression,
 convulsion, involuntary muscle contractions, abnormal
coordination, moving a lot, amnesia, decreased feeling, speech
disorder, dizziness while standing up, passing out, migraine,
 enlarged pupils,
 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,
 eye swelling, purple spots on skin, face oedema, hair loss, cold
sweat, dry skin, hives, itching,


osteoarthritis, muscular weakness, back pain, muscle
twitching,

Expand Transcript

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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