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Sertranat

Package leaflet: Information for the user


Sertranat 50 mg film-coated tablets

Sertranat 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 Sertranat is and what it is used for

What you need to know before you take Sertranat

How to take Sertranat

Possible side effects

How to store Sertranat

Contents of the pack and other information


What Sertranat is and what it is used for


Sertranat 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.


Sertranat 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 Sertranat.


What you need to know before you take Sertranat


Do not take Sertranat:


Warnings and precautions:

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


Serotonin Syndrome or Neroleptic Malignant Syndrome. In rare cases these syndromes 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.


Urine tests for benzodiazepines can lead to false positive result when taking sertraline. By using more specific tests sertraline can be distinguished from benzodiazepines.


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 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, depending on the patient's needs.


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.


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. 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 Sertranat to a patient under 18 if it is in the patient's interest. If your doctor has prescribed Sertranat 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 Sertranat, you should inform your doctor. Also, the long-term safety of Sertranat in regard to growth, maturation and cognitive and behavioural development in this age group has not yet been demonstrated.


Other medicines and Sertranat:

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


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


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


Talk to your doctor if you are taking the following medicine:


Sertranatwith food, drink and alcohol:

Sertranat can be taken with or without food.


Grapefruit juice should not be taken in combination with Sertralin Actavis as this may increase the level of sertraline in your body.


Alcohol should be avoided whilst taking Sertranat.


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 Sertranat. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Sertranat 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 used in women during lactation, 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 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.


Sertranat contains lactose:

If you have been told by your doctor that you have intolerance to some sugars contact your doctor before taking this medicinal product.



How to take Sertranat


Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Sertranat tablets can be taken with or without food.


Take your medication once daily either in the morning or evening.


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 disorders, 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.


Children and adolescents:

Sertranat 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 Sertranatthan you should:

If you accidentally take too much Sertranat 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 heartrate, shaking, agitation, dizziness and in rare cases unconsciousness.


If you forget to take Sertranat:

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 Sertranat:

Do not stop taking Sertranat unless your doctor tells you to. Your doctor will want to gradually reduce your dose of Sertranat 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 Sertranat, 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.


Nausea is the most common side effect. The side effects depend on the dose and are often transient with continued treatment.


Tell your doctor immediately:

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


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


Very common side effects (occurs in more than 1 out of 10 patients):

Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry mouth, ejaculation failure, fatigue.


Common side effects (occurs in between 1 and 10 out of 100 patients):

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, sexual dysfunction, erectile dysfunction, chest pain.


Uncommon side effects (occurs in between 1 and 10 out of 1 000 patients):

Chest cold, runny nose, hallucination, feeling too happy, lack of caring, thinking abnormal, convulsion, involuntary muscle contractions, abnormal coordination, moving a lot, amnesia, decreased feeling, speech disorder, dizziness while standing up, migraine, ear pain, fast heartbeat, high blood pressure, flushing, breathing difficulty, possible wheezing, shortness of breath, nose bleed, oesophageal problem, difficulty swallowing, haemorrhoids, increased saliva, tongue disorder, burping, eye swelling, purple spots on skin, hair loss, cold sweat, dry skin, hives, osteoarthritis, muscular weakness, back pain, muscle twitching, nighttime urination, unable to urinate, increase in urination, increase in frequency of urination, problem urinating, vaginal haemorrhage, female sexual dysfunction, malaise, chills, fever, weakness, thirst, weight decreased, weight increased.


Rare side effects (occurs in between 1 and 10 out of 10 000 patients):

Intestine problem, ear infection, cancer, swollen glands, high cholesterol, low blood sugar, physical symptoms due to stress or emotions, drug dependence, psychotic disorder, aggression, paranoia, suicidal thoughts and behaviour, sleep walking, premature ejaculation, 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, enlarged pupils, 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 incontinence, urinary hesitation, excessive vaginal bleeding, dry vaginal area, red painful penis and foreskin, genital discharge, prolonged erection, breast discharge, hernia, drug tolerance decreased, difficulty walking, abnormal laboratory tests, semen abnormal, injury, relaxation of blood vessels procedure.


After marketing sertraline, the following side effects have been reported:

Decrease in white blood cells, decrease in clotting cells, low thyroid hormones, endocrine problem, diabetes, high blood sugar, low blood salt, terrifying abnormal dreams, sudden severe headache (which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS), muscular movement problems (such as moving a lot, tense muscles and difficulty walking), passing out,vision abnormal, unequal size of the pupils, bleeding problems (such as nose bleed, stomach bleeding, or blood in urine), lung disease, pancreatitis, serious liver function problems, yellow jaundice, skin oedema, skin reaction to sun, itching, joint pain, muscle cramps, breast enlargement, menstrual irregularities, swelling in legs, problems with clotting, and severe allergic reaction.


An increased risk of bone fractures has been observed in patients taking this type of medicines.


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.


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 informationon the safety of this medicine.


5. How to store Sertranat


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 blister and/or bottle and the boxafter “EXP”. The expiry date refers to the last day of that month.


This medicinal product does not require any special storage conditions.


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 Sertranat contains

- The active substance is: sertraline.

- The other ingredients are: lactose monohydrate, cellulose microcrystalline, povidone K30, croscarmellose sodium, magnesium stearate.

Coating (50 mg): hypromellose 6, talc, propylene glycol and titanium dioxide (E 171).

Coating (100 mg): hypromellose 6, hypromellose 15, talc, propylene glycol and titanium dioxide (E 171).


What Sertranat looks like and contents of the pack


Sertranat 50 mg film-coated tablets:

White, oval, 10 mm x 5 mm, biconvex film-coated tablet. Scored on one side and marked “L” on the other side.


Sertranat 100 mg film-coated tablets:

White, round, 10 mm, biconvex film-coated tablet. Scored on one side and marked “C” on the other side.


The tablets can be divided into equal doses


Sertranat 50 mg and 100 mg are available in blister packs of 7, 10, 14, 15, 20, 28, 28x1, 30, 30x1, 50, 50x1, 60, 98, 98x1, 100 and 100x1 tablets and in bottles with 100, 250 and 500 tablets.


Not all pack sizes may be marketed.


Marketing authorisation holder and manufacturer


Actavis Group PTC ehf.

Reykjavikurvegi 76-78

IS-220 Hafnarfjordur

Iceland



Actavis Ltd.

BLB016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta




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

Austria Sertralin Actavis 50 mg Filmtabletten

Sertralin Actavis 100 mg Filmtabletten

Belgium Sertralin Actavis 50 mg filmomhulde tabletten

Sertralin Actavis 100 mg filmomhulde tabletten

Bulgaria, Czech Republic Setaloft

Greece Sertraline / Actavis

Hungary Sertralin Actavis 50 mg filmtabletta

Sertralin Actavis 100 mg filmtabletta

Malta Sertralin Actavis

Poland Sertranorm 50 mg

Sertranorm 100 mg

Italy Sertralina Actavis

Sweden Sertranat

Romania Setaloft 50 mg comprimate filmate

Setaloft 100 mg comprimate filmate

Slovenia Sertralin Actavis 50mg filmsko obložene tablete

Sertralin Actavis 100mg filmsko obložene tablete


This leaflet was last revised in 14 June 2013


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