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BESITRAN 50MG TABLETS
Active substance(s): SERTRALINE HYDROCHLORIDE
Symptoms that can occur when treatment is discontinued
ear pain, fast heartbeat, high blood pressure, flushing,
breathing difficulty, possible wheezing, shortness of breath, nose
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”).
inflammation of the oesophagus, difficulty swallowing,
haemorrhoids, increased saliva, tongue disorder, burping,
An increased risk of bone fractures has been observed in patients
taking this type of medicines.
eye swelling, purple spots on skin, face oedema, hair loss, cold
sweat, dry skin, hives, itching,
osteoarthritis, muscular weakness, back pain, muscle twitching,
nighttime urination, unable to urinate, increase in urination,
increase in frequency of urination, problem urinating, urinary
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 side effects (occurs in between 1 and 10 out of 10.000
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
By reporting side effects you can help provide more information on
the safety of this medicine.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Sertraline Tablets should be stored below 30°C
Intestine problem, ear infection, cancer, swollen glands, high
cholesterol, low blood sugar,
Do not use after the expiry date printed on the carton label or
physical symptoms due to stress or emotions, drug dependence,
psychotic disorder, paranoia, suicidal thoughts, sleep walking,
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.
severe allergic reaction,
coma, abnormal movements, difficulty moving, increased
sensation, sensory disturbance,
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.
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,
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 hesitation, blood in urine,
excessive vaginal bleeding, dry vaginal area, red painful penis
and foreskin, genital discharge, prolonged erection, breast
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
Decrease in white blood cells, decrease in clotting cells,
endocrine problem, low blood salt, increase in blood sugar
terrifying abnormal dreams, suicidal behaviour,
muscular movement problems (such as moving a lot, tense
muscles, difficulty walking and stiffness, spasms and involuntary
movements of the muscles), sudden severe headache (which
may be a sign of a serious condition known as Reversible
Cerebral Vasoconstriction Syndrome (RCVS)),
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, bedwetting.
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.
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 Sertraline contains
Each tablet contains the active ingredient, Sertraline either 50mg
(as the hydrochloride) per tablet.
Sertraline Tablets also contain the following inactive ingredients:
calcium hydrogen phosphate, hydroxypropylcellulose,
hydroxypropylmethylcellulose, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80,
sodium starch glycollate and titanium dioxide (E171).
What Sertraline looks like and contents of the pack
The 50mg tablet is white, capsule shaped, coded ZLT 50 and
contains a breakline on one side with PFIZER on the reverse.
Sertraline Tablets are 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.
This product is manufactured by
Farmasierra SA, Ctra N-1 Km 26,200, 28700 S. Sebastian de los
Reyes, Madrid, Spain.
Farmasierra Manufacturing S.L., Ctra N-1 Km 26,200, 28700 S.
Sebastian de los Reyes, Madrid, Spain
Your medicine is known as Sertraline 50mg Tablets but will be
referred to as Sertraline throughout the following leaflet.
Leaflet revision date: 26 June 2014
S1470 LEAFLET Sertraline 20140626
If you are taking another medicine called Pimozide (a medicine
for mental disorders such as psychosis).
Information for other strength of Sertraline (Sertraline 100mg
Tablets) may also be present in this leaflet.
Read all of this leaflet carefully before you start taking this
Take special care with Sertraline:
Medicines are not always suitable for everyone. Tell your doctor
before you take Sertraline, if you suffer from or have suffered in the
past from any of the following conditions:
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
Epilepsy or a history of seizures. If you have a fit (seizure),
contact your doctor immediately.
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
If you have suffered from manic depressive illness (bipolar
disorder) or schizophrenia. If you have a manic episode, contact
your doctor immediately.
If you have or have previously had thoughts of harming or killing
yourself (see below-Thoughts of suicide and worsening of your
depression or anxiety disorder).
Serotonin Syndrome. In rare cases this syndrome may occur
when you are taking certain medicines at the same time as
sertraline. (For symptoms, see section 4. Possible Side Effects).
Your doctor will have told you whether you have suffered from
this in the past.
If you have low sodium level in your blood, since this can occur
as a result of treatment with Sertraline. You should also tell your
doctor if you are 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).
If you have eye problems, such as certain kinds of glaucoma
(increased pressure in the eye).
In this leaflet:
1. What Sertraline is and what it is used for.
2. Before you take Sertraline.
3. How to take Sertraline.
4. Possible side effects.
5. How to store Sertraline.
6. Further information.
1. What Sertraline is and what it is used for
Sertraline can be used to treat:
Depression and prevention of recurrence of depression (in
Social anxiety disorder (in adults).
Post traumatic stress disorder (PTSD) (in adults).
Panic disorder (in adults).
Obsessive compulsive disorder (OCD) (in adults and children
and adolescents aged 6-17 years old).
Depression is a clinical illness with symptoms like feeling sad, unable
to sleep properly or to enjoy life as you used to.
OCD and Panic disorders are illnesses linked to anxiety with
symptoms like being constantly troubled by persistent ideas
(obsessions) that make you carry out repetitive rituals (compulsions).
PTSD is a condition that can occur after a very emotionally traumatic
experience, and has some symptoms that are similar to depression
and anxiety. Social anxiety disorder (social phobia) is an illness
linked to anxiety. It is characterised by feelings of intense anxiety or
distress in social situations (for example: talking to strangers,
speaking in front of groups of people, eating or drinking in front of
others or worrying that you might behave in an embarrassing
Your doctor has decided that this medicine is suitable for treating
You should ask your doctor if you are unsure why you have been
PL No.: 19488/1470
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
BESITRAN 50 mg TABLETS
SERTRALINE 50 mg TABLETS
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.
6. Further information
PACKAGE LEAFLET: INFORMATION FOR THE USER
5. How to store Sertraline
S1470 LEAFLET Sertraline 20140626
2. Before you take Sertraline
Do not take Sertraline:
If you are allergic (hypersensitive) to sertraline or any of the other
ingredients of Sertraline (see 6. Further Information for a list of
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.
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.
S1470 LEAFLET Sertraline 20140626
Thoughts of suicide and worsening of your depression or
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
Medicines to treat diabetes (tolbutamide).
Driving and using machines:
4. Possible side effects
Medicines to treat excessive stomach acid, ulcers and heartburn
(cimetidine, omeprazole, lanzoprazole, pantoprazole,
Like all medicines, Sertraline can cause side effects, although not
everybody gets them.
Medicines to treat mania and depression (lithium).
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.
Other medicines to treat depression (such as amitriptyline,
nortriptyline, nefazodone, fluoxetine, fluvoxamine).
Always take Sertraline exactly as your doctor has told you.
If you have previously had thoughts about killing or harming
Sertraline tablets may be taken with or without food.
Tell your doctor immediately:
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
Medicines used to treat high blood pressure, chest pain or
regulate the rate and rhythm of the heart (such as verapamil,
diltiazem, flecainide, propafenone).
Take your medication once daily either in the morning or evening.
You should check with your doctor or pharmacist if you are not sure.
If you experience any of the following symptoms after taking this
medicine, these symptoms can be serious.
Medicines used to treat bacterial infections (such as rifampicin,
clarithromycin, telithromycin, erythromycin).
The usual dose is:
Medicines used to treat fungal infections (such as ketoconazole,
itraconazole, posaconazole, voriconazole, fluconazole).
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 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.
Panic disorder, Social anxiety disorder and Post Traumatic
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
Children and adolescents:
Sertraline must only be used to treat children and adolescents
suffering from OCD aged 6-17 years old.
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 “Take special care
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
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
Medicines used to treat HIV/AIDS and Hepatitis C (protease
inhibitors such as ritonavir, telaprevir).
Medicines used to prevent nausea and vomiting after an
operation or chemotherapy (aprepitant).
Taking Sertraline with food and drink:
Sertraline tablets can be taken with or without food.
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
Taking Sertraline together with the following medicines may
cause serious side effects:
Nausea is the most common side effect. The side effects depend on
the dose and often disappear or lessen with continued treatment.
Medicines to treat schizophrenia and other mental disorders
(such as perphenazine, levomepromazine and olanzapine).
If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.
3. How to 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.
You may be more likely to think like this:
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.
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:
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
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,
Symptoms of overdose may include drowsiness, nausea and
vomiting, rapid heart rate, shaking, agitation, dizziness and in rare
visual disturbance, ringing in ears,
palpitations, hot flush, yawning,
abdominal pain, vomiting, constipation, upset stomach, gas,
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.
rash, increased sweating, muscle pain, erectile dysfunction,
Do not take a double dose to make up for a forgotten dose.
If you stop taking Sertraline:
Uncommon side effects (occurs in between 1 and 10 out of
trouble with breathing,
a blueish skin or being too hot or cold,
vomiting or not feeding properly,
being very tired, not able to sleep or crying a lot,
stiff or floppy muscles,
Medicines used in anaesthesia or to treat chronic pain (fentanyl).
Medicines to treat migraines (e.g. sumatriptan).
Blood thinning medicine (warfarin).
Medicines to treat pain/arthritis (Non steroidal anti-inflammatory
drug (NSAID) such as ibuprofen, acetylsalicylic acid (aspirin).
Diuretics (also called ‘water’ tablets).
Medicines to treat epilepsy (phenytoin, phenobarbital,
The following side effects were seen in clinical trials in adults.
The maximum dose is 200 mg daily.
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.
increased reflex reactions,
Medicines to treat severe pain (e.g. tramadol).
Adolescents aged 13 to 17: the recommended starting dose is
50 mg daily.
If you take more Sertraline than you should:
tremors, jitters or fits,
Products containing the amino acid tryptophan.
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.
Your newborn baby might also have other conditions, which
usually begin during the first 24 hours after birth. Symptoms
Obsessive Compulsive Disorder:
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.
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
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
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
Depression and Obssessive Compulsive Disorder
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.
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.
Very common side effects (occurs in more than 1 out of 10
Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick,
dry mouth, ejaculation failure, fatigue.
Common side effects (occurs in between 1 and 10 out of 100
Chest cold, runny nose,
low thyroid hormones,
hallucination, feeling too happy, lack of caring, thinking
convulsion, involuntary muscle contractions, abnormal
coordination, moving a lot, amnesia, decreased feeling, speech
disorder, dizziness while standing up, passing out, migraine,