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Sertralin Mylan

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Package leaflet: Information for the patient


Sertralin Mylan 50 mg film-coated tablets

Sertralin Mylan 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.


What is in this leaflet

What Sertralin Mylan is and what it is used for.

What you need to know before you take Sertralin Mylan.

How to take Sertralin Mylan.

Possible side effects.

How to store Sertralin Mylan.

Contents of the pack and other information.


1. What Sertralin Mylan is and what it is used for


Sertralin Mylan contains the active ingredient 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.


Sertralin Mylan can be used to treat:


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 Sertralin Mylan.


You must talk to a doctor if you do not feel better or if you feel worse after taking Sertralin Mylan.


2. What you need to know before you take Sertralin Mylan


Do not take Sertralin Mylan:


Warnings and precautions

Talk to your doctor or pharmacist before taking Sertralin Mylan.

Medicines are not always suitable for everyone. Tell your doctor before you take Sertralin Mylan, if you suffer from or have suffered in the past from any of the following conditions:



If you are taking Sertralin Mylan, it may interfere with the urine screening test.


Restlessness/Akathisia

The use of sertraline has been linked to akathisia (a distressing restlessness and need to move, often being unable to sit or stand still). This is most likely to occur during the first few weeks of treatment.


Increasing the dose may be harmful to patients who develop such symptoms.


Withdrawal reactions

Withdrawal reactions when treatment is stopped are common, particularly if the treatment is stopped suddenly (see section 3 “If you stop taking Sertralin Mylan” 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 Sertralin Mylan 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 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

Sertralin Mylan should not usually be used in children and adolescents less than 18 years old, except for patients with Obsessive Compulsive Disorder. Patients under 18 have an increased risk of undesirable effects, such as suicide attempt, 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 Sertralin Mylan to a patient under 18 if it is in the patient's interest. If your doctor has prescribed Sertralin Mylan to a patient 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 when a patient under 18 is taking Sertralin Mylan, you should inform your doctor. Also, the long-term safety of Sertralin Mylan in regard to growth, maturation and cognitive and behavioural development in this age group has not yet been demonstrated.


Other medicines and Sertralin Mylan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.


Some medicines can affect the way Sertralin Mylan works, or Sertralin Mylan itself can reduce the effectiveness of other medicines taken at the same time.


Taking Sertralin Mylan together with the following medicines may cause serious side effects:


Talk to your doctor or pharmacist if you are taking the following medicines:


Sertralin Mylan with drink and alcohol

Alcohol should be avoided whilst taking Sertralin Mylan. Sertralin Mylan 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 should only be given to pregnant women if the doctor considers that the benefit for the mother exceeds any possible risk to the foetus. Women of childbearing potential should employ an adequate method of contraception if taking sertraline.


Make sure your midwife and/or doctor know you are on SertralinMylan. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like SertralinMylan 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.


There is evidence that sertraline is excreted in human breast milk. Sertraline should only be usedin breast-feeding women, if the doctor considers that the benefit for the mother 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 medicines 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 Sertralin Mylan


Always take this medicine exactly as your doctor or pharmacist has told you.

Sertralin Mylan tablets may be taken with or without food.


Take your medication once daily either in the morning or evening. The tablets can be divided into equal doses.


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 recommended 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:

Sertralin Mylan 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.


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.


If you take more Sertralin Mylan than you should:

If you accidentally take too much Sertralin Mylan 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 Sertralin Mylan:

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 Sertralin Mylan:

Do not stop taking Sertralin Mylan unless your doctor tells you to. Your doctor will want to gradually reduce your dose of Sertralin Mylan 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 Sertralin Mylan, please speak to your doctor.


If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.


Tell your doctor immediately:

If you experience any of the following symptoms after taking this medicine, these symptoms can be serious.


Uncommon(may affect up to 1 in 100 people):


Rare(may affect up to 1 in 1,000 people):


Not known (frequency cannot be estimated from the available data):


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


Very common(may affect more than 1 in 10people):

Insomnia (trouble sleeping), dizziness, sleepiness, headache, diarrhoea, feeling sick, dry mouth, ejaculation failure, fatigue.


Common(may affect up to 1 in 10 people):


Uncommon(may affect up to 1 in 100 people):


Rare(may affect up to 1 in 1,000 people):


Not known (frequency cannot be estimated fromthe available data):



Additional side effects in children and adolescents

In clinical trials with children and adolescents, the side effects were generally similar to adults (see above). After marketing sertraline, bedwetting was also reported. The most common side effects in children and adolescents were headache, insomnia, diarrhoea and feeling sick.


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 via [to be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Sertralin Mylan


Keep this medicine out of the sight and reach of children.

Store in the original package.


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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


6. Contents of the pack and other information


What Sertralin Mylan contains



What Sertralin Mylan looks like and contents of the pack


Sertralin Mylan 50 mg film-coated tablets:

White to off-white capsule shaped, film-coated tablet with 'ST/50' on one side and 'G' on the other.


Sertralin Mylan 100 mg film-coated tablets:

White to off-white capsule shaped, film-coated tablet with 'ST/100' on one side and 'G' on the other.


Sertralin Mylan 50 mg film-coated tablets are available in HDPE bottles (with an optional filler) and blisters with pack sizes of 14, 15, 20, 28, 30, 50, 60, 98, 100, 250, 300 and 500 tablets*.


Sertralin Mylan 100 mg film-coated tablets are available in HDPE bottles and blisters with pack sizes of 14, 15, 20, 28, 30, 50, 60, 98, 100, 250, 300 and 500 tablets*.


*Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer


[To be completed nationally]


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


Portugal: Sertralina Mylan Generics 50mg & 100mg


Austria: Sertralin Arcana 50 mg Filmtabletten


Hungary: Sertragen 50 mg


This leaflet was last revised in


2016-06-22