LUSTRAL 50MG FILM COATED TABLETS

Active substance: SERTRALINE HYDROCHLORIDE

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Pag. 4

5. HOW TO STORE LUSTRAL

PACKAGE LEAFLET: INFORMATION FOR THE USER

Keep out of the reach and sight of children.
Do not use Lustral after the expiry date which is stated on the pack.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. FURTHER INFORMATION

FPO

•  ye swelling, purple spots on skin, hair loss, cold sweat, dry skin,
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hives,
•  steoarthritis, muscular weakness, back pain, muscle twitching,
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•  ighttime urination, unable to urinate, increase in urination,
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increase in frequency of urination, problem urinating,
•  aginal haemorrhage, female sexual dysfunction, malaise, chills,
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fever, weakness, thirst, weight decreased, weight increased.
Rare side effects (occurs in between 1 and 10 out of
10.000 patients):
• ntestine problem, ear infection, cancer, swollen glands, high
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cholesterol, low blood sugar,
•  hysical symptoms due to stress or emotions, drug dependence,
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psychotic disorder, aggression, paranoia, suicidal thoughts, sleep
walking, premature ejaculation,
•  oma, abnormal movements, difficulty moving, increased
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sensation, sensory disturbance,
•  laucoma, tear problem, spots in front of eyes, double vision,
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light hurts eye, blood in the eye, enlarged pupils,
•  eart attack, slow heart beat, heart problem, poor circulation
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of arms and legs, closing up of throat, breathing fast, breathing
slow, difficulty talking, hiccups,
•  lood in stool, sore mouth, tongue ulceration, tooth disorder,
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tongue problem, mouth ulceration, problems with liver function,
•  kin problem with blisters, hair rash, hair texture abnormal, skin
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odour abnormal, bone disorder,
• decreased urination, urinary incontinence, urinary hesitation,
•  xcessive vaginal bleeding, dry vaginal area, red painful penis
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and foreskin, genital discharge, prolonged erection, breast
discharge,
•  ernia, drug tolerance decreased, difficulty walking, abnormal
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laboratory tests, semen abnormal, injury, relaxation of blood
vessels procedure.
•  ases of suicidal ideation and suicidal behaviours have
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been reported during sertraline therapy or early after
treatment discontinuation (see section 2.).
After marketing sertraline, the following side effects have been
reported:
•  ecrease in white blood cells, decrease in clotting cells, low thyroid
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hormones, endocrine problem, low blood salt, problems controlling
blood sugar levels (diabetes), increase in blood sugar levels,
• terrifying abnormal dreams, suicidal behaviour,
•  uscular movement problems (such as moving a lot, tense
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muscles, difficulty walking and stiffness, spasms and involuntary
movements of the muscles), passing out, sudden severe
headache (which may be a sign of a serious condition known as
Reversible Cerebral Vasoconstriction Syndrome (RCVS)),
•  ision abnormal, unequal sized pupils, bleeding problems (such
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as nose bleed, stomach bleeding, or blood in urine), progressive
scarring of lung tissue (Interstitial Lung Disease), pancreatitis,
serious liver function problems, yellow skin and eyes (jaundice),
•  kin oedema, skin reaction to sun, itching, joint pain, muscle
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cramps, breast enlargement, menstrual irregularities, swelling
in legs, problems with clotting, bedwetting and severe allergic
reaction.
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.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

Lustral® 50 mg and 100 mg
film coated tablets



Sertraline

Read all of this leaflet carefully before you start taking this
medicine.

What Lustral contains

Lustral 50 mg film-coated tablets contain sertraline hydrochloride
equivalent to 50 mg sertraline.
Lustral 100 mg film-coated tablets 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, magnesium stearate (E572),
hypromellose (E464), titanium dioxide (E171), macrogol and
polysorbate 80 (E433).

What Lustral looks like and contents of the pack
Lustral 50 mg film-coated tablets are white, capsular shaped, filmcoated 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.
Lustral 100 mg film-coated tablets are white, capsular shaped, filmcoated tablets marked ‘ZLT 100’ or “LTL 100” or “SER 100” on one
side and ‘PFIZER’ on the other.
50 mg film-coated tablets:
Lustral 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:
Lustral 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:
Besitran: Spain
Lustral: Ireland, Malta, United Kingdom
Serlain: Belgium, Luxembourg
Sertralina Pfizer: Spain
Tatig: Italy
Tresleen: Austria
Zoloft: Bulgaria, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania,
Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic,
Slovenia, Sweden
This leaflet was last revised in 09/2013
LU 37_0 UK

51724054new

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,
•  eep this leaflet. You may need to read it again.
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you must wait at least 2 weeks before you can start treatment
• f you have any further questions, ask your doctor or pharmacist.
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with sertraline.
•  his medicine has been prescribed for you. Do not pass it on to
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others. It may harm them, even if their symptoms are the same • f you are taking another medicine called Pimozide (a medicine
for mental disorders such as psychosis).
as yours.
• f any of the side effects gets serious, or if you notice any
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Take special care with Lustral:
side effects not listed in this leaflet, please tell your doctor or
Medicines are not always suitable for everyone. Tell your doctor
pharmacist.
before you take Lustral, if you suffer from or have suffered in the
past from any of the following conditions:
In this leaflet:
1. What Lustral is and what it is used for.
E
•  pilepsy or a history of seizures. If you have a fit (seizure),
2. Before you take Lustral.
contact your doctor immediately.
3. How to take Lustral.
• f you have suffered from manic depressive illness (bipolar
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4. Possible side effects.
disorder) or schizophrenia. If you have a manic episode, contact
5. How to store Lustral.
your doctor immediately.
6. Further information.
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• f you have or have previously had thoughts of harming or killing
yourself (see below-Thoughts of suicide and worsening of your
1. 
WHAT LUSTRAL IS AND WHAT
depression or anxiety disorder).
S
•  erotonin Syndrome. In rare cases this syndrome may occur
IT IS USED FOR
when you are taking certain medicines at the same time as
Lustral contains the active ingredient sertraline. Sertraline is one of
sertraline. (For symptoms, see section 4. Possible Side Effects).
a group of medicines called Selective Serotonin
Your doctor will have told you whether you have suffered from
Re-uptake Inhibitors (SSRIs); these medicines are used to treat
this in the past.
depression and/or anxiety disorders.
• f you have low sodium level in your blood, since this can occur
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Lustral can be used to treat:
as a result of treatment with Lustral. You should also tell your
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•  epression and prevention of recurrence of depression (in
doctor if you are taking certain medicines for hypertension, since
adults).
these medicines may also alter the sodium level in your blood.
• Social anxiety disorder (in adults).
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•  ake special care if you are elderly as you may be more at risk of
• Post traumatic stress disorder (PTSD) (in adults).
having low sodium level in your blood (see above).
• Panic disorder (in adults).
•  iver disease; your doctor may decide that you should have a
L
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•  bsessive compulsive disorder (OCD) (in adults and children and
lower dose of Lustral.
adolescents aged 6-17 years old).
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•  iabetes; your blood glucose levels may be altered due to Lustral
and your diabetes medicines may need to be adjusted.
Depression is a clinical illness with symptoms like feeling sad,
• f you have suffered from bleeding disorders or have been
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unable to sleep properly or to enjoy life as you used to.
taking medicines which thin the blood (e.g. acetylsalicyclic acid
OCD and Panic disorders are illnesses linked to anxiety with
(aspirin), or warfarin) or may increase the risk of bleeding.
symptoms like being constantly troubled by persistent ideas
• f you are a child or adolescent under 18 years old. Lustral should
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(obsessions) that make you carry out repetitive rituals (compulsions).
only be used to treat children and adolescents aged 6-17 years
PTSD is a condition that can occur after a very emotionally
old, suffering from obsessive compulsive disorder (OCD). If you
traumatic experience, and has some symptoms that are similar
are being treated for this disorder, your doctor will want to monitor
to depression and anxiety. Social anxiety disorder (social phobia)
you closely (see below - Use in children and adolescents).
is an illness linked to anxiety. It is characterised by feelings of
• If you are having electro-convulsive therapy (ECT).
intense anxiety or distress in social situations (for example: talking • f you have eye problems, such as certain kinds of glaucoma
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to strangers, speaking in front of groups of people, eating or
(increased pressure in the eye).
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
Your doctor has decided that this medicine is suitable for treating
and need to move, often being unable to sit or stand still (akathisia).
your illness.
This is most likely to occur during the first few weeks of treatment.
Increasing the dose may be harmful so if you develop such
You should ask your doctor if you are unsure why you have been
symptoms you should talk to your doctor.
given Lustral.
Withdrawal reactions:
2. BEFORE YOU TAKE LUSTRAL
Side effects relating to stopping treatment (withdrawal reactions)
Do not take Lustral:
are common, particularly if the treatment is stopped suddenly (see
• f you are allergic (hypersensitive) to sertraline or any of the other section 3 If you stop taking Lustral and section 4 Possible side
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ingredients of Lustral (see 6. Further Information for a list of
effects). The risk of withdrawal symptoms depends on the length
ingredients).
of treatment, dosage, and the rate at which the dose is reduced.
• f you are taking or have taken medicines called monoamine
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Generally, such symptoms are mild to moderate. However, they can
be serious in some patients. They normally occur within the first few
oxidase inhibitors (MAOIs such as selegiline, moclobemide) or

Pag. 1

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:
• f you have previously had thoughts about killing or harming
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yourself.
• f you are a young adult. Information from clinical trials has
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shown an increased risk of suicidal behaviour in adults aged less
than 25 years with psychiatric conditions who were treated with
an antidepressant.
If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are
depressed or have an anxiety disorder, and ask them to read this
leaflet. You might ask them to tell you if they think your depression
or anxiety is getting worse, or if they are worried about changes in
your behaviour.
Use in children and adolescents:
Sertraline should not usually be used in children and adolescents
less than 18 years old, except for patients with Obsessive
Compulsive Disorder (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.

Taking other medicines:

Please tell your doctor if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription.
Some medicines can affect the way 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:
•  edicines called monoamine oxidase inhibitors (MAOIs), like
M
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.
•  edicines to treat mental disorders such as psychosis
M
(pimozide). Do not use Lustral together with pimozide.
Talk to your doctor if you are taking the following medicines:
•  erbal medicine containing St. John’s Wort (Hypericum
H
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).
•  edicines used in anaesthesia or to treat chronic pain (fentanyl).
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• Medicines to treat migraines (e.g. sumatriptan).
• Blood thinning medicine (warfarin).
•  edicines to treat pain/arthritis (Non steroidal anti-inflammatory
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drug (NSAID) such as ibuprofen, acetylsalicylic acid (aspirin).

Pag. 2

• Sedatives (diazepam).
• Diuretics (also called ‘water’ tablets).
•  edicines to treat epilepsy (phenytoin, phenobarbital,
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carbamazepine).
• Medicines to treat diabetes (tolbutamide).
•  edicines to treat excessive stomach acid, ulcers and
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heartburn (cimetidine, omeprazole, lanzoprazole, pantoprazole,
rabeprazole).
• Medicines to treat mania and depression (lithium).
•  ther medicines to treat depression (such as amitriptyline,
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nortriptyline, nefazodone, fluoxetine, fluvoxamine).
•  edicines to treat schizophrenia and other mental disorders
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(such as perphenazine, levomepromazine and olanzapine).
•  edicines used to treat high blood pressure, chest pain or
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regulate the rate and rhythm of the heart (such as verapamil,
diltiazem, flecainide, propafenone).
•  edicines used to treat bacterial infections (such as rifampicin,
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clarithromycin, telithromycin, erythromycin).
•  edicines used to treat fungal infections (such as ketoconazole,
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itraconazole, posaconazole, voriconazole, fluconazole).
•  edicines used to treat HIV/AIDS and Hepatitis C (protease
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inhibitors such as ritonavir, telaprevir).
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•  edicines used to prevent nausea and vomiting after an
operation or chemotherapy (aprepitant).

Taking Lustral with food and drink:

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:

Ask your doctor or pharmacist for advice before taking any medicine.
The safety of sertraline has not fully been established in
pregnant women. Sertraline will only be given to you when
pregnant if your doctor considers that the benefit for you is
greater than any possible risk to the developing baby. If you are
a woman capable of having children you should use a reliable
method of contraception (such as the contraceptive pill), when
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 If you experience any of these side effects, or any other side effects
in animal studies. Theoretically, this could affect fertility, but
whilst stopping taking Lustral, please speak to your doctor.
impact on human fertility has not been observed as yet.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
Driving and using machines:
Psychotropic drugs such as sertraline may influence your ability to
4. POSSIBLE SIDE EFFECTS
drive or use machines. You should therefore not drive or operate
Like all medicines, Lustral can cause side effects, although not
machinery, until you know how this medication affects your ability
everybody gets them.
to perform these activities.
If any of the side effects gets serious, or if you notice any side
3. HOW TO TAKE LUSTRAL
effects not listed in this leaflet, please tell your doctor or pharmacist.
Always take Lustral exactly as your doctor has told you.
Nausea is the most common side effect. The side effects depend on
Lustral tablets may be taken with or without food.
the dose and often disappear or lessen with continued treatment.
Take your medication once daily either in the morning or evening.
You should check with your doctor or pharmacist if you are not sure. Tell your doctor immediately:
If you experience any of the following symptoms after taking this
The usual dose is:
medicine, these symptoms can be serious.
Adults:
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• f you develop a severe skin rash that causes blistering
Depression and Obssessive Compulsive Disorder
(erythema multiforme), (this can affect the mouth and tongue).
For depression and OCD, the usual effective dose is 50 mg/
These may be signs of a condition known as Stevens Johnson
day. The daily dose may be increased in 50 mg increments
Syndrome, or Toxic Epidermal Necrolysis (TEN). Your doctor will
and at intervals of at least one week over a period of weeks.
stop your treatment in these cases.
A
•  llergic reaction or allergy, which may include symptoms such
The maximum recommended dose is 200 mg/day.
as an itchy skin rash, breathing problems, wheezing, swollen
Panic disorder, Social anxiety disorder and Post Traumatic
eyelids, face or lips.
Stress Disorder:
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For panic disorder, social anxiety disorder and post traumatic • f you experience agitation, confusion, diarrhoea, high
temperature and blood pressure, excessive sweating and rapid
stress disorder, treatment should be started at 25 mg/day, and
heartbeat. These are symptoms of Serotonin Syndrome. In rare
increased to 50 mg/day after one week.
cases this syndrome may occur when you are taking certain
The daily dose then may be increased in 50 mg increments
medicines at the same time as sertraline. Your doctor may wish
over a period of weeks. The maximum recommended dose is
to stop your treatment.
200 mg/day.
• f you develop yellow skin and eyes which may mean liver
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Children and adolescents:
damage.
Lustral must only be used to treat children and adolescents
• f you experience depressive symptoms with ideas of harming or
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suffering from OCD aged 6-17 years old.
killing yourself (suicidal thoughts).
Obsessive Compulsive Disorder:
• f you start to get feelings of restlessness and are not able to sit
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Children aged 6 to 12: the recommended starting dose is
or stand still after you start to take Lustral. You should tell your
doctor if you start to feel restless.
25 mg daily.
• If you have a fit (seizure).
After one week, your doctor may increase this to 50 mg daily.
• f you have a manic episode (see section 2 “Take special care
I
The maximum dose is 200 mg daily.
with Lustral”).
Adolescents aged 13 to 17: the recommended starting dose
The following side effects were seen in clinical trials in adults.
is 50 mg daily.
The maximum dose is 200 mg daily.
Very common side effects (occurs in more than 1 out of
10 patients):
If you have liver or kidney problems, please tell your doctor and
Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick,
follow the doctor’s instructions.
Your doctor will advise you on how long to take this medication for. dry mouth, ejaculation failure, fatigue.
This will depend on the nature of your illness and how well you are Common side effects (occurs in between 1 and 10 out of
responding to the treatment. It may take several weeks before your 100 patients):
symptoms begin to improve. Treatment of depression should usually • Sore throat, anorexia, increased appetite,
•  epression, feeling strange, nightmare, anxiety, agitation,
d
continue for 6 months after improvement.
nervousness, decreased sexual interest, teeth grinding,
If you take more Lustral than you should:
•  umbness and tingling, shaking, muscle tense, abnormal taste,
n
If you accidentally take too much Lustral contact your doctor at
lack of attention,
once or go to the nearest hospital casualty department. Always
take the labelled medicine package with you, whether there is any • visual disturbance, ringing in ears,
• palpitations, hot flush, yawning,
medication left or not.
• abdominal pain, vomiting, constipation, upset stomach, gas,
Symptoms of overdose may include drowsiness, nausea and
•  ash, increased sweating, muscle pain, sexual dysfunction,
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vomiting, rapid heart rate, shaking, agitation, dizziness and in rare
erectile dysfunction, chest pain.
cases unconsciousness.
Uncommon side effects (occurs in between 1 and 10 out of
If you forget to take Lustral:
1.000 patients):
If you forget to take a dose, do not take the missed dose. Just take • Chest cold, runny nose,
the next dose at the right time.
•  allucination, feeling too happy, lack of caring, thinking abnormal,
h
Do not take a double dose to make up for a forgotten dose.
•  onvulsion, involuntary muscle contractions, abnormal
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coordination, moving a lot, amnesia, decreased feeling, speech
If you stop taking Lustral:
disorder, dizziness while standing up, migraine,
Do not stop taking Lustral unless your doctor tells you to. Your
• ear pain, fast heartbeat, high blood pressure, flushing,
doctor will want to gradually reduce your dose of Lustral over
•  reathing difficulty, possible wheezing, shortness of breath, nose
b
several weeks, before you finally stop taking this medicine. If you
bleed,
suddenly stop taking this medicine you may experience side effects
• nflammation of the oesophagus, difficulty swallowing,
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such as dizziness, numbness, sleep disturbances, agitation or
haemorrhoids, increased saliva, tongue disorder, burping,
anxiety, headaches, feeling sick, being sick and shaking.

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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