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LUSTRAL 100MG FILM COATED TABLETS

Active substance(s): SERTRALINE / SERTRALINE HYDROCHLORIDE

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Package leaflet: Information for the user

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.

Lustral® 50 mg film coated tablets
Lustral® 100 mg film coated 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
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany
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

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.

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).

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

• 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
adolescents).
• If you are having electro-convulsive therapy (ECT).
• If you have eye problems, such as certain kinds of glaucoma
(increased pressure in the eye).
• If you have been told that you have an abnormality of your
heart tracing after an electrocardiogram (ECG) known as
prolonged QT interval.

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
Besitran

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).

This leaflet was last revised in 02/2016
Ref: LU 44_0

Depression is a clinical illness with symptoms like feeling sad,
unable to sleep properly or to enjoy life as you used to.
OCD and Panic disorders are illnesses linked to anxiety with
symptoms like being constantly troubled by persistent ideas
(obsessions) that make you carry out repetitive rituals
(compulsions).
PTSD is a condition that can occur after a very emotionally
traumatic experience, and has some symptoms that are similar
to depression and anxiety. Social anxiety disorder (social phobia)
is an illness linked to anxiety. It is characterised by feelings of
intense anxiety or distress in social situations (for example:
talking to strangers, speaking in front of groups of people,
eating or drinking in front of others or worrying that you might
behave in an embarrassing manner).
Your doctor has decided that this medicine is suitable for
treating your illness.
You should ask your doctor if you are unsure why you have been
given Lustral.

2. What you need to know before you take
Lustral
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 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
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Sertraline

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:

Restlessness/Akathisia:
The use of sertraline has been linked to a distressing
restlessness and need to move, often being unable to sit or
stand still (akathisia). This is most likely to occur during the first
few weeks of treatment. Increasing the dose may be harmful so
if you develop such symptoms you should talk to your doctor.
Withdrawal reactions:
Side effects relating to stopping treatment (withdrawal
reactions) are common, particularly if the treatment is stopped
suddenly (see section 3 If you stop taking Lustral and section
4 Possible side effects). The risk of withdrawal symptoms
depends on the length of treatment, dosage, and the rate at
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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 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.
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• Medicines to treat severe pain (e.g. tramadol).
• Medicines used in anaesthesia or to treat chronic pain
(fentanyl, mivacurium and suxamethonium).
• 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).
• 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).
• 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 or pharmacist
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.
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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,
• 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 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 (see details below). By
reporting side effects you can help provide more information on
the safety of this medicine.
United Kingdom
Yellow Card Scheme website:
www.mhra.gov.uk/yellowcard
Malta
ADR Reporting 
www.medicinesauthority.gov.mt/adrportal  

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 information
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.

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· 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
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 (see details below). By reporting side effects you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme website:
www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
www.medicinesauthority.gov.mt/adrportal

6. Contents of the pack and other information
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
Sandwich
Kent CT13 9NJ
United Kingdom
Manufacturer
Haupt Pharma Latina S.r.l
S.S. 156 Km 47,600,
04100 Borgo San Michele, Latina,
Italy
This medicinal product is authorised in the Member States of the EEA
under the following names:
Austria
Tresleen
Belgium, Luxembourg
Serlain
Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Zoloft
France, Germany, Greece, Hungary, Iceland, Italy, Latvia,
Lithuania, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Sweden
Ireland, Malta, United Kingdom
Lustral
Spain
Besitran
This leaflet was last revised in 02/2016
Ref: LU 44_0

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.

Pag. 4

Package leaflet: Information for the user

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.

51730877new

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.
1. What Lustral is and what it is used for · 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
Lustral contains the active substance sertraline. Sertraline is one of a group
taking certain medicines for hypertension, since these medicines may
of medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs); these
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
Lustral can be used to treat:
in your blood (see above).
· Depression and prevention of recurrence of depression (in adults).
· If you have liver disease; your doctor may decide that you should have a
· Social anxiety disorder (in adults).
lower dose of Lustral.
· Post traumatic stress disorder (PTSD) (in adults).
· If you have diabetes; your blood glucose levels may be altered due to
· Panic disorder (in adults).
Lustral and your diabetes medicines may need to be adjusted.
· Obsessive compulsive disorder (OCD) (in adults and children and
· If you have suffered from bleeding disorders or have been taking
adolescents aged 6-17 years old).
medicines which thin the blood (e.g. acetylsalicyclic acid (aspirin), or
warfarin) or may increase the risk of bleeding.
Depression is a clinical illness with symptoms like feeling sad, unable to
sleep properly or to enjoy life as you used to.
· 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
OCD and Panic disorders are illnesses linked to anxiety with symptoms like
from obsessive compulsive disorder (OCD). If you are being treated for
being constantly troubled by persistent ideas (obsessions) that make you
this disorder, your doctor will want to monitor you closely (see belowcarry out repetitive rituals (compulsions).
Children and adolescents).
PTSD is a condition that can occur after a very emotionally traumatic
· If you are having electro-convulsive therapy (ECT).
experience, and has some symptoms that are similar to depression and
· If you have eye problems, such as certain kinds of glaucoma (increased
anxiety. Social anxiety disorder (social phobia) is an illness linked to anxiety.
pressure in the eye).
It is characterised by feelings of intense anxiety or distress in social situations · If you have been told that you have an abnormality of your heart tracing after
(for example: talking to strangers, speaking in front of groups of people,
an electrocardiogram (ECG) known as prolonged QT interval.
eating or drinking in front of others or worrying that you might behave in an
Restlessness/Akathisia:
embarrassing manner).
The use of sertraline has been linked to a distressing restlessness and need
Your doctor has decided that this medicine is suitable for treating your illness.
to move, often being unable to sit or stand still (akathisia). This is most likely
You should ask your doctor if you are unsure why you have been given Lustral. 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 of
· If you are allergic to sertraline or any of the other ingredients of this
withdrawal symptoms depends on the length of treatment, dosage, and the
medicine (listed in section 6).
rate at which the dose is reduced. Generally, such symptoms are mild to
· If you are taking or have taken medicines called monoamine oxidase
moderate. However, they can be serious in some patients. They normally
inhibitors (MAOIs such as selegiline, moclobemide) or MAOI like drugs
occur within the first few days after stopping treatment. In general, such
(such as linezolid). If you stop treatment with sertraline, you must wait
symptoms disappear on their own and wear off within 2 weeks. In some
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 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
you can start treatment with sertraline.
of several weeks or months, and you should always discuss the best way of
· If you are taking another medicine called pimozide (a medicine for
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,
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, 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 or pharmacist 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.

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.
4. Possible side effects
Rare (may affect up to 1 in 1,000 people):
· Intestine problem, ear infection, cancer, swollen glands, high
Like all medicines, this medicine can cause side effects, although not
cholesterol, low blood sugar,
everybody gets them.
· physical symptoms due to stress or emotions, drug dependence,
Nausea is the most common side effect. The side effects depend on the dose
psychotic disorder, paranoia, suicidal thoughts, sleep walking,
and often disappear or lessen with continued treatment.
premature ejaculation,
· severe allergic reaction,
Tell your doctor immediately:
· coma, abnormal movements, difficulty moving, increased sensation,
If you experience any of the following symptoms after taking this medicine,
sensory disturbance,
these symptoms can be serious.
· glaucoma, tear problem, spots in front of eyes, double vision, light
· If you develop a severe skin rash that causes blistering (erythema
hurts eye, blood in the eye,
multiforme), (this can affect the mouth and tongue). These may be signs

Pag. 3

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.

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