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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.

6. Contents of the pack and other
What Lustral contains
Lustral film-coated tablets:
Each film-coated tablet contains sertraline hydrochloride
equivalent to 50 mg sertraline.
Each film-coated tablet contains 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:
Sertraline 50 mg film-coated tablets are white, capsular
shaped (10.3 x 4.2 mm), film-coated scored tablets
marked “ZLT 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” 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
Kent CT13 9NJ
United Kingdom

Bulgaria, Cyprus, Czech Republic, Denmark, Zoloft
Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Italy, Latvia, Lithuania,
Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Sweden
Ireland, Malta, United Kingdom
This leaflet was last revised in 08/2017
Ref: LU 46_0

Package leaflet: Information for the user

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

1. What Lustral is and what it is used for
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.
Lustral can be used to treat:
• Depression and prevention of recurrence of depression
(in adults).
• Social anxiety disorder (in adults).
• Post traumatic stress disorder (PTSD) (in adults).
• Panic disorder (in adults).
• Obsessive compulsive disorder (OCD) (in adults and
children and adolescents aged 6–17 years old).
Depression is a clinical illness with symptoms like feeling
sad, unable to sleep properly or to enjoy life as you used to.
OCD and Panic disorders are illnesses linked to anxiety
with symptoms like being constantly troubled by
persistent ideas (obsessions) that make you carry out
repetitive rituals (compulsions).
PTSD is a condition that can occur after a very emotionally
traumatic experience, and has some symptoms that are
similar to depression and anxiety. Social anxiety disorder
(social phobia) is an illness linked to anxiety. It is
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.

Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg

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

This medicinal product is authorised in the Member
States of the EEA under the following names:

Do not take Lustral:
• 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

Belgium, Luxembourg

2. What you need to know before you take



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).
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.
• 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.
• 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
• 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.
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.
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
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
(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).
• Medicines to treat epilepsy (phenytoin, phenobarbital,
• 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,
• Medicines to treat schizophrenia and other mental
disorders (such as perphenazine, levomepromazine and
• 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,
• 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
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
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 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
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.

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.

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

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.

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.

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.

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.

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 or
pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
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
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 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
• 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
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,
• 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,

• 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
• 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,
• lock jaw, 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)),
• 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
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 (see details below). By reporting side effects you
can help provide more information on the safety of this
United Kingdom
Yellow Card Scheme website:
ADR Reporting

+ 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.