SERTRALINE 50 MG TABLETS

Active substance: SERTRALINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sertraline 50mg film coated tablets
Sertraline 100mg film coated tablets
Read all of this leaflet carefully before you start taking the medicine because it contains
important information for you.
 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 only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet.
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.

1. What sertraline is and what it is used for
The name of your medicine is Sertraline 50 mg and 100 mg Tablets, referred to as sertraline
throughout this leaflet.
Sertraline contains the active ingredient sertraline. Sertraline is one of a group of medicines
called Selective Serotonin Re-uptake Inhibitors (SSRIs); these medicines are used to treat
depression and or anxiety disorders.
Sertraline can be used to treat
 Depression and prevention of recurrence of depression (in adults).
 Social anxiety disorder (in adults).
 Post traumatic stress disorder (PTSD) (in adults).
 Panic disorder (in adults).
 Obsessive compulsive disorder (OCD) (in adults and children and adolescents aged
6 – 17 years old).
Depression is a clinical illness with symptoms like feeling sad, unable to sleep properly
or to enjoy life as you used to.
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).
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.
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
 If you are allergic to sertraline or any of the other ingredients of sertraline 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 (an antipsychotic medicine).
Warnings and precautions
Medicines are not always suitable for everyone. Talk to your doctor or pharmacist before
taking sertraline, if you suffer from or have suffered in the past from any of the following
conditions:
 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). 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.
 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 suicidal thoughts (see below-thoughts of suicide
and worsening of your depression or anxiety disorder).
 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. If you are being treated for this disorder, your doctor will want to monitor you
closely (see Use in children and adolescents below).
 If you are having electro-convulsive therapy (ECT).
Restlessness/Akathisia
The use of sertraline has been linked to akathisia (a distressing restlessness and need to move,
often being unable to sit or stand still). This is most likely to occur during the first few weeks
of treatment. Increasing the dose may be harmful to patients who develop such symptoms.
Withdrawal reactions
Withdrawal reactions when treatment is stopped are common, particularly if the treatment
is stopped suddenly (see section 4). 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, depending on the patient's needs.
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. Patients under 18 have an increased
risk of undesirable effects, such as suicide attempt, 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 a
patient 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 when a patient under
18 is taking sertraline, you should inform your doctor. Also, the long-term safety of sertraline

in regard to growth, maturation and 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 moclobemid (to treat
depression) and selegiline (to treat Parkinson's disease) and the antibiotic linezolid.
Do not use sertraline together with MAOIs.
 Medicines to treat mental disorders (pimozide). Do not use sertraline together
with pimozide.
Talk to your doctor if you are taking the following medicine:
 Herbal medicine containing St. John's Wort (Hypericum perforatum). The effects
of St. John's Wort may last for 1 – 2 weeks. Talk to your doctor.
 Products containing the amino acid tryptophan.
 Medicines to treat severe pain (e.g. tramadol).
 Medicines to treat migraines (e.g. sumatriptan).
 Blood thinning medicine (warfarin).
 Medicines to treat pain/arthritis (Non steroidal antiinflammatory drug (NSAID) such
as ibuprofen, acetylsalicylic acid (aspirin).
 Sedatives (diazepam).
 Diueretics.
 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).
Sertraline with food, drink and alcohol
Sertraline tablets can be taken with or without food.
Alcohol should be avoided whilst taking sertraline.
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 for advice before taking this medicine.
The safety of sertraline has not fully been established in pregnant women. Sertraline should
only be given to pregnant women if the doctor considers that the benefit for the mother
exceeds any possible risk to the foetus. Women of childbearing potential should employ an
adequate method of contraception if 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 appeal 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.
There is evidence that sertraline is excreted in human breast milk. Sertraline should only be
used in women during lactation, if the doctor considers that the benefit for the mother 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.
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 tablets contain lactose
If you have been told by your doctor that you cannot tolerate some sugars, contact your doctor
before taking this medicine.

3. How to take sertraline
Always take sertraline exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Take your medication once daily either in the morning or evening. Sertraline tablets may be
taken with or without food.
The recommended dose is:
Adults
 Depression and Obsessive Compulsive Disorder
For depression and OCD, the usual effective dose is 50 mg/day. The daily dose may
be increased in 50 mg increments and at intervals of at least one week over a period
of weeks. The maximum recommended dose is 200 mg/day.
 Panic disorder, Social anxiety disorder and Post Traumatic Stress Disorder
For panic disorder, social anxiety disorder and post traumatic stress disorder, treatment
should be started at 25 mg/day, and increased to 50 mg/day after one week. The daily
dose then may be increased in 50 mg increments over a period of weeks. The maximum
recommended dose is 200 mg/day.
Children and adolescents:
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.
If you take more sertraline than you should
If you accidentally take too much sertraline contact your doctor at once or go to the nearest
hospital casualty department. Always take the labelled medicine package with you, whether
there is any medication left or not.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heart rate,
shaking, agitation, dizziness and in rare cases unconsciousness.
If you forget to take sertraline
If you forget to take a dose, do not take the missed dose. Just take the next dose at the right time.
Do not take a double dose to make up for a forgotten dose.
If you stop taking sertraline
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.
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, this medicine can cause side effects, although not everybody gets them.
Nausea is the most common side effect. The side effects depend on the dose and are often transient
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 suicidal ideas.
 If you start to get feelings of restlessness and not be able to sit or stand still after you start
to take sertraline. You should tell your doctor if you start to feel restless.
The following side effects were seen in clinical trials in adults
Very common side effects (may affect more than 1 in 10 people):
Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry mouth, ejaculation
failure, fatigue.
Common side effects (may affect up to 1 in 10 people):
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.
Uncommon side effects (may affect up to 1 in 100 people):
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, oesophageal problem, difficulty swallowing, haemorrhoids, increased
saliva, tongue disorder, burping, eye swelling, purple spots on skin, hair loss, cold sweat, dry
skin, hives, osteoarthritis, muscular weakness, back pain, muscle twitching, night-time
urination, unable to urinate, increase in urination, increase in frequency of urination, problem
urinating, vaginal haemorrhage, female sexual dysfunction, malaise, chills, fever, weakness,
thirst, weight decreased, weight increased.
Rare side effects (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,
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, 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, decreased urination, urinary incontinence, urinary hesitation,
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.
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, 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 jaundice, skin oedema, skin reaction
to sun, itching, joint pain, muscle cramps, breast enlargement, menstrual irregularities,
swelling in legs, problems with clotting and severe allergic reaction.
An increased risk of bone fractures has been observed in patients taking this type
of medicines.
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.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.

5. How to store sertraline
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use sertraline after the expiry date which is stated on the pack (EXP). The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect
the environment.

6. Contents of the pack and other information
What sertraline contains
Sertraline tablets contain 50 mg or 100 mg of sertraline as the active ingredient.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone,
croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), talc
and propylene glycol.
What sertraline looks like and contents of the pack
This medicine comes in blister packs of 7 tablets, 14 tablets, 15 tablets, 20 tablets, 28 tablets,
30 tablets, 50 tablets, 60 tablets, 98 tablets and 100 tablets (not all pack-sizes may
be marketed).

Sertraline 50 mg Tablets are white, oval biconvex film-coated tablets with a score on one side
and marked ‘L’ on the other.
Sertraline 100 mg Tablets are white, round biconvex film-coated tablets with a score on one
side and marked ‘C’ on the other.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is
Winthrop pharmaceuticals
P.O. Box 611
Guildford, Surrey, GU1 4YS, UK
OR
Zentiva
One Onslow Street, Guildford, Surrey, GU1 4YS, UK
The manufacturer is
Sanofi-Aventis Sp. Z.o.o.
Pharmaceutical Production Plant
Ul. Lubelska 52
35-233 Rzeszów
Poland
This medicinal product is authorised in the Member States of the EEA under
the following names:
United Kingdom
Hungary
Italy

Sertraline
Sertralin-Zentiva 50 mg filmtabletta
Sertralin-Zentiva 100 mg filmtabletta
Sertralina Zentiva 50 mg Compresse rivestite con film
Sertralina Zentiva 100 mg Compresse rivestite con film

This leaflet was last revised in June 2012

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.

Hide
(web4)