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SERTRALINE 100MG TABLETS

Active substance(s): SERTRALINE / SERTRALINE HYDROCHLORIDE

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Aremis® 100mg Tablets/
Sertraline 100mg Tablets/
Lustral® 100mg Tablets
(sertraline hydrochloride)
Your medicine is known by either of the above names, but will be referred to
as Lustral throughout this:
Patient Information Leaflet
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

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.
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 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 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.
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 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 longterm 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).
• 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 Obsessive 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:
If you forget to take a dose, do not take the missed dose. Just take the next
dose at the right time.
Do not take a double dose to make up for a forgotten dose.
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”).

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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

5) How to store Lustral





Keep all medicines out of the sight and reach of children.
There are no special storage conditions for Lustral 100mg Tablets
Do not use after the expiry date printed on the carton label or blister strip.
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.

If your doctor tells you to stop taking the tablets, please take them back to
the pharmacist for safe disposal. Only keep them if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to do.

6) Contents of the pack and other information
What Lustral contains:
The active substance is sertraline hydrochloride.
Each tablet contains 100mg of the active ingredient sertraline, as the
hydrochloride.
Lustral Tablets also contain the following: calcium hydrogen phosphate,
hydroxypropylcellulose, hydroxypropylmethylcellulose, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium
starch glycollate and titanium dioxide (E171).
What Lustral looks like and contents of the pack
The tablets are white, film-coated, capsule-shaped and coded ‘are breakline
mis’ on one side with ‘100’ on the reverse.
Lustral Tablets are available as blister packs of 30 tablets.

The following side effects were seen in clinical trials in adults.

PL 10383/1044

Very common (may affect more than 1 in 10 people):
Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry
mouth, ejaculation failure, fatigue.

Who makes and repackages your medicine?
Your medicine is manufactured by Laboratorios Dr. Esteve S.A, Sant Marti,
s/n. Pol. Industrial La Roca. Martorelles 08107, Spain Procured from within
the EU and repackaged by Product Licence Holder: Primecrown Ltd.,
Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

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.

POM

Leaflet date: 05.07.2016
Lustral is a trademark of the Pfizer group of companies.

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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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