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LUSTRAL 100MG TABLETS

Active substance(s): SERTRALINE / SERTRALINE HYDROCHLORIDE / SERTRALINE / SERTRALINE

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Package leaflet: Information for the user
Lustral® 100mg tablets
(sertraline)
You medicine is known as the above but will be referred to as Lustral
throughout the remainder of this leaflet. This product is available in multiple
strengths and all strengths will be referred to.
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
long-term safety of Lustral in regard to growth, maturation and learning
(cognitive) and behavioural development in this age group has not yet been
demonstrated.
Other medicines and Lustral:
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Some medicines can affect the way Lustral works, or Lustral itself can reduce
the effectiveness of other medicines taken at the same time.
Taking Lustral together with the following medicines may cause serious side
effects:
 Medicines called monoamine oxidase inhibitors (MAOIs), like
moclobemide (to treat depression) and selegiline (to treat Parkinson’s
disease), the antibiotic linezolid and methylene blue (to treat high levels
of methaemoglobin in the blood). Do not use Lustral together with these
medicines.
 Medicines to treat mental disorders such as psychosis (pimozide). Do not
use Lustral together with pimozide.
Talk to your doctor if you are taking the following medicines:
 Herbal medicine containing St. John’s Wort (Hypericum perforatum). The
effects of St. John’s Wort may last for 1–2 weeks.
 Products containing the amino acid tryptophan.
 Medicines to treat severe pain (e.g. tramadol).
 Medicines used in anaesthesia or to treat chronic pain (e.g. fentanyl,
mivacurium and suxamethonium).
 Medicines to treat migraines (e.g. sumatriptan).
 Blood thinning medicine (warfarin).
 Medicines to treat pain/arthritis (Non steroidal anti-inflammatory drug
(NSAID) such as ibuprofen, acetylsalicylic acid (aspirin)).
 Sedatives (diazepam).
 Diuretics (also called ‘water’ tablets).
 Medicines to treat epilepsy (phenytoin, phenobarbital, 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 you r doctor considers
that the benefit for you is greater than any possible risk to the developing
baby.
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.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

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

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