LUSTRAL 50MG FILM COATED TABLETS

Active substance: SERTRALINE HYDROCHLORIDE

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5. How to store Lustral
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack
after EXP. The expiry date refers to the last day of that month.
Do not store above 30° C.
Do not throw any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help to protect the environment.

Pag. 4

6. Contents of the pack and other information
What Lustral contains
Lustral film-coated tablets:
Each film-coated tablet contain sertraline hydrochloride equivalent to
50 mg sertraline.
Each film-coated tablet contain sertraline hydrochloride equivalent to
100 mg sertraline.
The other ingredients are:
calcium hydrogen phosphate dihydrate (E341), microcrystalline cellulose
(E460), hydroxypropylcellulose (E463), sodium starch glycollate (Type A),
magnesium stearate (E572), hypromellose 2910/3cP (E464), hypromellose
2910/5cP (E464), titanium dioxide (E171), macrogol 400 (E1521),
macrogol 6000 (E1521) and polysorbate 80 (E433).
What Lustral looks like and contents of the pack
Lustral film-coated tablets:
Sertralinel 50 mg film-coated tablets are white, capsular shaped
(10.3 x 4.2 mm), film-coated scored tablets marked “ZLT 50” or “LTL
50” or “SER 50” on one side and ‘PFIZER’ on the other. The tablet can be
divided into equal halves.
Sertraline 100 mg film-coated tablets are white, capsular shaped
(13.1 x 5.2 mm), film-coated tablets marked “ZLT 100” or “LTL 100” or
“SER 100” on one side and ‘PFIZER’ on the other.
50 mg film-coated tablets:
Sertraline tablets are available in blister packs containing 10, 14, 15, 20,
28, 30, 50, 56, 60, 84, 98, 100, 200, 294, 300, or 500 tablets.
100 mg film-coated tablets:
Sertraline tablets are available in blister packs containing 10, 14, 15, 20,
28, 30, 50, 56, 60, 84, 98, 100, 200, 294, 300, or 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
Manufacturer
Haupt Pharma Latina S.r.l
S.S. 156 Km 50,
04010 Borgo San Michele, Latina,
Italy
This medicinal product is authorised in the Member States of the
EEA under the following names:
Austria
Belgium, Luxembourg
Bulgaria, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Italy, Latvia, Lithuania,
Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Sweden
Ireland, Malta, United Kingdom
Spain

Tresleen
Serlain
Zoloft

Lustral
Besitran

This leaflet was last revised in 11/2014
Ref: LU 40_0

51728899new1

FPO

· 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,
· 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 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 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, abnormal laboratory tests,
bedwetting.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 Lustral”).
An increased risk of bone fractures has been observed in patients taking
this type of medicines.
Reporting of side effects
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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more information on the safety of
this medicine.

Package leaflet: Information for the user

Lustral® 50 mg film coated tablets
Lustral® 100 mg film coated tablets

Sertraline

Read all of this leaflet carefully before you start taking this 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. See section 4.
What is in this leaflet:
1. What Lustral is and what it is used for.
2. What you need to know before you take Lustral.
3. How to take Lustral.
4. Possible side effects.
5. How to store Lustral.
6. Contents of the pack and other information.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lustral.
Medicines are not always suitable for everyone. Tell your doctor before
you take Lustral, if you suffer from or have suffered in the past from any
of the following conditions:
· 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.
this can occur a
1. What Lustral is and what it is used for · If you have low sodium level in your blood, sincetell your doctor asyou
result of treatment with Lustral. You should also
if
Lustral contains the active substance sertraline. Sertraline is one of a group
are taking certain medicines for hypertension, since these medicines
of medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs); these
may also alter the sodium level in your blood.
medicines are used to treat depression and/or anxiety disorders.
· If you are elderly as you may be more at risk of having low sodium
level in your blood (see above).
Lustral can be used to treat:
· If you have liver disease; your doctor may decide that you should
· Depression and prevention of recurrence of depression (in adults).
have a lower dose of Lustral.
· Social anxiety disorder (in adults).
· If you have diabetes; your blood glucose levels may be altered due to
· Post traumatic stress disorder (PTSD) (in adults).
Lustral and your diabetes medicines may need to be adjusted.
· Panic disorder (in adults).
· If you have suffered from bleeding disorders or have been taking
· Obsessive compulsive disorder (OCD) (in adults and children and
medicines which thin the blood (e.g. acetylsalicyclic acid (aspirin), or
adolescents aged 6-17 years old).
warfarin) or may increase the risk of bleeding.
Depression is a clinical illness with symptoms like feeling sad, unable to
· If you are a child or adolescent under 18 years old. Lustral should
sleep properly or to enjoy life as you used to.
only be used to treat children and adolescents aged 6-17 years old,
OCD and Panic disorders are illnesses linked to anxiety with symptoms
suffering from obsessive compulsive disorder (OCD). If you are being
like being constantly troubled by persistent ideas (obsessions) that make
treated for this disorder, your doctor will want to monitor you closely
you carry out repetitive rituals (compulsions).
(see below-Children and adolescents).
· If you are having electro-convulsive therapy (ECT).
PTSD is a condition that can occur after a very emotionally traumatic
· If you have eye problems, such as certain kinds of glaucoma
experience, and has some symptoms that are similar to depression and
(increased pressure in the eye).
anxiety. Social anxiety disorder (social phobia) is an illness linked to
· If you have been told that you have an abnormality of your heart tracing after
anxiety. It is characterised by feelings of intense anxiety or distress in
an electrocardiogram (ECG) known as prolonged QT interval.
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 Restlessness/Akathisia:
might behave in an embarrassing manner).
The use of sertraline has been linked to a distressing restlessness and
Your doctor has decided that this medicine is suitable for treating your illness. need to move, often being unable to sit or stand still (akathisia). This is
You should ask your doctor if you are unsure why you have been given Lustral. 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.
2. 
What you need to know before you
Withdrawal reactions:
take Lustral
Side effects relating to stopping treatment (withdrawal reactions) are
common, particularly if the treatment is stopped suddenly (see section
Do not take Lustral:
3 If you stop taking Lustral and section 4 Possible side effects). The risk
· If you are allergic to sertraline or any of this medicine (listed in
of withdrawal symptoms depends on the length of treatment, dosage,
section 6).
· If you are taking or have taken medicines called monoamine oxidase and the rate at which the dose is reduced. Generally, such symptoms
are mild to moderate. However, they can be serious in some patients.
inhibitors (MAOIs such as selegiline, moclobemide) or MAOI like
They normally occur within the first few days after stopping treatment.
drugs (such as linezolid). If you stop treatment with sertraline, you
In general, such symptoms disappear on their own and wear off within
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. In some patients they may last longer (2-3 months or more).
When stopping treatment with sertraline it is recommended to reduce the
2 weeks before you can start treatment with sertraline.
dose gradually over a period of several weeks or months, and you should
· If you are taking another medicine called pimozide (a medicine for
always discuss the best way of stopping treatment with your doctor.
mental disorders such as psychosis).

Pag. 1

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.
Children and adolescents:
Sertraline should not usually be used in children and adolescents less
than 18 years old, except for patients with Obsessive Compulsive Disorder
(OCD). Patients under 18 have an increased risk of undesirable effects,
such as suicide attempt, thoughts of harming or killing themselves
(suicidal thoughts) and hostility (mainly aggressiveness, oppositional
behaviour and anger) when they are treated with this class of medicines.
Nevertheless, it is possible that your doctor decides to prescribe Lustral
to a patient under 18 if it is in the patient’s interest. If your doctor has
prescribed Lustral to you and you are less than 18 years old and you
want to discuss this, please contact him/her. Furthermore, if any of the
symptoms listed above appear or worsen while you are taking Lustral,
you should inform your doctor. Also, the long-term safety of Lustral in
regard to growth, maturation and learning (cognitive) and behavioural
development in this age group has not yet been demonstrated.
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 (fentanyl).
· Medicines to treat migraines (e.g. sumatriptan).
· Blood thinning medicine (warfarin).
· Medicines to treat pain/arthritis (Non steroidal anti-inflammatory drug
(NSAID) such as ibuprofen, acetylsalicylic acid (aspirin)).
· Sedatives (diazepam).
· Diuretics (also called ‘water’ tablets).
· Medicines to treat epilepsy (phenytoin, phenobarbital,
carbamazepine).
· Medicines to treat diabetes (tolbutamide).
· Medicines to treat excessive stomach acid, ulcers and heartburn
(cimetidine, omeprazole, lanzoprazole, pantoprazole, rabeprazole).
· 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).

Pag. 2

· 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).
· 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).
· Medicines known to increase the risk of changes in the electrical
activity of the heart (e.g. some antipsychotics and antibiotics).
Lustral with food, drink and alcohol:
Lustral tablets can be taken with or without food.
Alcohol should be avoided whilst taking Lustral.
Sertraline should not be taken in combination with grapefruit juice, as this
may increase the level of sertraline in your body.
Pregnancy, 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. If you are a woman capable of having children you should use a
reliable method of contraception (such as the contraceptive pill), when
taking sertraline.
Make sure your midwife and/or doctor know you are on Lustral. When taken
during pregnancy, particularly in the last 3 months of pregnancy, medicines
like Lustral may increase the risk of a serious condition in babies, called
persistent pulmonary hypertension of the newborn (PPHN), making the baby
breathe faster and appear bluish. These symptoms usually begin during the
first 24 hours after the baby is born. If this happens to your baby you should
contact your midwife and/or doctor immediately.
Your newborn baby might also have other conditions, which usually begin
during the first 24 hours after birth. Symptoms include:
· trouble with breathing,
· a blueish skin or being too hot or cold,
· blue lips,
· vomiting or not feeding properly,
· being very tired, not able to sleep or crying a lot,
· stiff or floppy muscles,
· tremors, jitters or fits,
· increased reflex reactions,
· 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.
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.

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

The recommended dose is:
Adults:
Depression and Obssessive Compulsive Disorder
For depression and OCD, the usual effective dose is 50 mg/day.
The daily dose may be increased in 50 mg increments and at
intervals of at least one week over a period of weeks. The maximum
recommended dose is 200 mg/day.
Panic disorder, Social anxiety disorder and Post Traumatic
Stress Disorder:
For panic disorder, social anxiety disorder and post traumatic stress
disorder, treatment should be started at 25 mg/day, and increased
to 50 mg/day after one week.
The daily dose then may be increased in 50 mg increments over a
period of weeks. The maximum recommended dose is 200 mg/day.
Use in children and adolescents:
Lustral must only be used to treat children and adolescents suffering from
OCD aged 6-17 years old.
Obsessive Compulsive Disorder:
Children aged 6 to 12: the recommended starting dose is 25 mg daily.
After one week, your doctor may increase this to 50 mg daily. The
maximum dose is 200 mg daily.
Adolescents aged 13 to 17: the recommended starting dose is
50 mg daily.
The maximum dose is 200 mg daily.
If you have liver or kidney problems, please tell your doctor and follow the
doctor’s instructions.
Method of administration:
Lustral tablets may be taken with or without food.
Take your medication once daily either in the morning or evening.
Your doctor will advise you on how long to take this medication for. This
will depend on the nature of your illness and how well you are responding
to the treatment. It may take several weeks before your symptoms begin
to improve. Treatment of depression should usually continue for 6 months
after improvement.
If you take more Lustral than you should:
If you accidentally take too much Lustral contact your doctor at once or go to
the nearest hospital casualty department. Always take the labelled medicine
package with you, whether there is any medication left or not.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid
heart rate, shaking, agitation, dizziness and in rare cases unconsciousness.
If you forget to take Lustral:
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.

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 often disappear or lessen with continued treatment.
Tell your doctor immediately:
If you experience any of the following symptoms after taking this
medicine, these symptoms can be serious.

· If you develop a severe skin rash that causes blistering (erythema
multiforme), (this can affect the mouth and tongue). These may be signs
of a condition known as Stevens Johnson Syndrome, or Toxic Epidermal
Necrolysis (TEN). Your doctor will stop your treatment in these cases.
· Allergic reaction or allergy, which may include symptoms such as an itchy
skin rash, breathing problems, wheezing, swollen eyelids, face or lips.
· If you experience agitation, confusion, diarrhoea, high temperature
and blood pressure, excessive sweating and rapid heartbeat. These
are symptoms of Serotonin Syndrome. In rare cases this syndrome
may occur when you are taking certain medicines at the same time
as sertraline. Your doctor may wish to stop your treatment.
· If you develop yellow skin and eyes which may mean liver damage.
· If you experience depressive symptoms with ideas of harming or
killing yourself (suicidal thoughts).
· If you start to get feelings of restlessness and are not able to sit or
stand still after you start to take Lustral. You should tell your doctor if
you start to feel restless.
· If you have a fit (seizure).
· If you have a manic episode (see section 2 “Warnings and
precautions”).
The following side effects were seen in clinical trials in adults.
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):
· 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, erectile dysfunction, chest
pain
· joint pain,
· malaise.
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,
· 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,

Pag. 3

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Source: Medicines and Healthcare Products Regulatory Agency

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

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