Sastium

Package leaflet: Information for the patient

Sastium, 50 mg, film-coated tablets
Sastium, 100 mg, film-coated tablets
Sertralinum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Sastium is and what it is used for
2. Important information before taking Sastium
3. How to take Sastium
4. Possible side effects
5. How to store Sastium
6. Contents of the package and other information

1. What Sastium is and what it is used for

Sastium contains the active substance sertraline. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs); these medicines are used in the treatment of depressive and/or anxiety disorders.
Sastium may be used in the treatment of:

• 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 in children and adolescents aged 6–17 years).

Depression is a disorder characterized by symptoms such as sadness, difficulty sleeping, or loss of enjoyment in life.
Obsessive-compulsive disorder and panic disorder are anxiety-related disorders, associated with persistent anxiety due to intrusive thoughts (obsessions), leading to repetitive behaviors (compulsions).
Post-traumatic stress disorder is a condition that may occur after a traumatic event and is characterized by symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related disorder. It is characterized by marked fear or anxiety in social situations (such as talking to strangers, speaking in front of a group of people, eating or drinking in the presence of others, or fear of potentially embarrassing behavior).
Your doctor has decided that this medicine is suitable for treating your condition.
You should consult your doctor if you are unsure why you are taking Sastium.
You should inform your doctor if you do not feel better or if you feel worse.

2. Important information before using Sastium

When not to use Sastium

• if the patient is allergic to sertraline or any of the other ingredients of this medicine (listed in section 6);
• if the patient is currently taking or has recently taken monoamine oxidase inhibitors (MAO inhibitors, e.g. selegiline, moclobemide) or medicines similar to MAO inhibitors (e.g. linezolid). After stopping treatment with sertraline, at least one week must elapse before starting treatment with an MAO inhibitor. After stopping treatment with an MAO inhibitor, at least two weeks must elapse before sertraline treatment can be started;
• if the patient is taking pimozide (a medicine used to treat psychiatric disorders such as psychosis).

Warnings and precautions
Before starting treatment with Sastium, discuss this with your doctor or pharmacist.
Not every medicine is suitable for everyone. You should tell your doctor before taking Sastium if any of the following apply to the patient, either currently or in the past:

• Epilepsy (seizures) or a history of convulsive seizures. If a seizure occurs, contact your doctor immediately.
• A history of bipolar disorder (manic-depressive illness) or schizophrenia. If a manic episode occurs, contact your doctor immediately.
• Current or past thoughts about self-harm or suicide (see below – Suicidal thoughts, worsening of depression or anxiety disorders).
• Serotonin syndrome. In rare cases, this syndrome may occur in patients who are taking sertraline together with certain other medicines (symptoms, see section 4. Possible side effects). Your doctor should ask whether you have previously experienced serotonin syndrome.
• Low sodium levels in the blood, which may occur as a result of treatment with Sastium. You should also inform your doctor if you are taking medicines used to treat high blood pressure, as these may also affect blood sodium levels.
• Advanced age: the risk of low blood sodium levels (see above) is higher in such patients.
• Liver disease: your doctor may decide to reduce the dose of Sastium.
• Diabetes: Sastium may affect blood glucose levels, so it may be necessary to adjust the dose of antidiabetic medicines.
• A history of bleeding disorders (tendency to bruise easily), or if the patient is pregnant (see – Pregnancy, breastfeeding and fertility) or has previously taken medicines that prevent blood clotting [e.g. acetylsalicylic acid (aspirin) or warfarin] or medicines that may increase the risk of bleeding.
• Children or adolescents under 18 years of age. Sastium may be used in children and adolescents aged 6 to 17 years only for the treatment of obsessive-compulsive disorder (OCD). Patients being treated for this condition should be closely monitored by a doctor (see below – Children and adolescents).
• Electroconvulsive therapy (ECT).
• Eye problems, such as certain types of glaucoma (increased eye pressure).
• Abnormalities on ECG, known as prolonged QT interval.
• Heart disease, low potassium or magnesium levels, prolonged QT interval in any family member, slow heart rate, and concomitant use of medicines that cause QT prolongation.

Sexual dysfunction
Medicines such as Sastium (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Psychomotor agitation/akathisia
Use of sertraline has been associated with the development of a condition characterised by motor restlessness and an urge to move—often with an inability to sit still or remain motionless (akathisia). This condition usually occurs within the first few weeks of treatment. Contact your doctor if the dose of the medicine is increased, as this may be harmful in patients experiencing such symptoms.
Withdrawal symptoms
After stopping treatment, adverse effects (withdrawal symptoms) often occur, especially if treatment is stopped abruptly (see section 3. Discontinuing Sastium and section 4. Possible side effects). The risk of withdrawal symptoms depends on the duration of treatment, dose, and rate of dose reduction. These symptoms are generally mild or moderate in intensity, but may be severe in some patients. They usually occur in the first few days after stopping treatment. They usually resolve spontaneously within 2 weeks, but may persist longer (up to 2–3 months or more) in some patients. When deciding to discontinue sertraline treatment, gradual dose reduction over several weeks or months is recommended, and the best way to stop treatment should be discussed with your doctor.
Suicidal thoughts, worsening of depression or anxiety disorders
People with depression and/or anxiety disorders may sometimes have thoughts about self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually take at least 2 weeks to start working, and sometimes longer.
The occurrence of suicidal thoughts, thoughts about self-harm or suicide is more likely if:

• the patient has previously had suicidal thoughts or a desire to self-harm;
• the patient is a young adult; clinical trial data indicate an increased risk of suicidal behaviour in people under 25 years of age with psychiatric disorders who are being treated with antidepressant medicines.

If the patient experiences suicidal thoughts or thoughts about self-harm or suicide, contact a doctor immediately or go to hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask family or friends for help and request them to inform him or her if they notice that depression or anxiety has worsened, or if there are any worrying changes in behaviour.
Children and adolescents
Sertraline should generally not be used in children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder (OCD). In patients under 18 years of age, an increased risk of adverse reactions such as suicide attempts, thoughts about self-harm or suicide (suicidal thoughts), and hostility (mainly aggressive behaviour, defiance, and anger) has been observed during treatment with medicines of this class.
However, a doctor may decide to prescribe Sastium to a patient under 18 years of age if it is in the patient's best interest. If the doctor prescribes Sastium to a patient under 18 years of age and the child's caregiver wishes to discuss this, contact the doctor.
Moreover, if any of the symptoms listed above appear or worsen during treatment with Sastium, inform the doctor.
The long-term safety of Sastium with regard to its effects on growth, maturation, learning (cognitive function), and behaviour was evaluated in a long-term study involving over 900 children aged 6 to 16 years, monitored for a period of 3 years. The study results showed that children treated with sertraline developed normally, except for a mild increase in body weight in children treated with higher doses.
Sastium and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Some medicines may affect how Sastium works, or Sastium may reduce the effectiveness of other medicines taken at the same time.
Taking Sastium together with the following medicines may cause serious adverse effects:

• Monoamine oxidase inhibitors (MAOIs), e.g. moclobemide (used to treat depression) and selegiline (used to treat Parkinson’s disease), the antibiotic linezolid, and methylene blue (a substance used to treat high levels of methemoglobin in the blood). Do not take Sastium together with these medicines.
• Medicines used to treat psychiatric disorders such as psychosis (pimozide). Do not take Sastium together with pimozide.

The patient should inform the doctor if taking the following medicines:

• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).
• Herbal medicines containing St John’s wort ( Hypericum perforatum ). The effect of St John’s wort may persist for 1–2 weeks.
• Preparations containing the amino acid tryptophan.
• Medicines used to treat severe or chronic pain (opioids such as tramadol, fentanyl).
• Medicines used in anaesthesia (e.g. fentanyl, mivacurium, and suxamethonium).
• Medicines used to treat migraines (e.g. sumatriptan).
• Medicines that prevent blood clotting (warfarin).
• Medicines used to treat joint pain/inflammation [e.g. metamizole, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, acetylsalicylic acid (aspirin)].
• Sedatives (diazepam).
• Diuretics (so-called water tablets).
• Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines used to treat diabetes (tolbutamide).
• Medicines used to treat excessive stomach acid secretion, peptic ulcer disease, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medicines used to treat mania and depression (lithium).
• Other medicines used to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medicines used to treat schizophrenia and other psychiatric disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medicines used to treat high blood pressure, chest pain, or to regulate heart rate and rhythm (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 virus infection (protease inhibitors such as ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after chemotherapy (aprepitant).
• Medicines that increase the risk of changes in the electrical activity of the heart (e.g. antipsychotics and antibiotics).

Taking Sastium with food, drink and alcohol
Sastium tablets may be taken with or without food.
Do not drink alcohol while taking Sastium.
Do not take Sastium with grapefruit juice, as this may lead to increased levels of sertraline in the body.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
The safety of sertraline use in pregnant women has not been fully established. The medicine may be used in pregnant women only if, in the doctor’s opinion, the benefits to the mother outweigh the potential risks to the developing child.
Taking Sastium late in pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Sastium, she should inform her doctor or midwife so that appropriate advice can be provided.
Taking medicines such as Sastium during pregnancy, particularly in the third trimester, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), characterised by rapid breathing and blue skin colouration. These symptoms usually appear within the first day of life.
If the newborn shows any of these symptoms, contact the midwife or doctor immediately.
Other complications may also occur in the newborn, usually within the first 24 hours after birth. These may include:

• breathing difficulties,
• bluish or pale skin, skin that is too hot or too cold,
• blue lips,
• vomiting or feeding difficulties,
• extreme tiredness, difficulty sleeping, or constant crying,
• increased or decreased muscle tone,
• tremors, muscle twitches, or seizures,
• increased reflexes,
• irritability,
• low blood sugar.

If any of these symptoms occur in the newborn after birth, or if the baby’s health is a cause for concern, contact the doctor or midwife.
There is evidence that sertraline passes into breast milk. The medicine may be used in breastfeeding women if, in the doctor’s opinion, the benefits outweigh the potential risks to the infant.
Animal studies have shown that some medicines similar to sertraline reduce semen quality. This could theoretically affect fertility, although no effects on human fertility have been observed to date.
Driving and operating machinery
Psychotropic medicines such as sertraline may affect the ability to drive or operate machinery. Wait until you know how Sastium affects your ability before performing these activities.
Sastium contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Sastium

This medicine should always be used as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
Recommended dosage of Sastium:
Adults:
Depression and obsessive-compulsive disorder (OCD)
The usual effective dose in the treatment of depression and OCD is 50 mg per day.
The daily dose may be gradually increased by 50 mg at intervals of at least one week over several weeks.
The maximum recommended dose is 200 mg per day.
Panic disorder, social anxiety disorder, and post-traumatic stress disorder (PTSD)
Treatment of panic disorder, social anxiety disorder, and PTSD should be initiated at a dose of 25 mg per day,
increased after one week to 50 mg per day.
The daily dose may then be gradually increased by 50 mg at a time over several weeks.
The maximum recommended dose is 200 mg per day.
Use in children and adolescents
Sastium may be used in children and adolescents aged 6–17 years only for the treatment of
obsessive-compulsive disorder (OCD).
Obsessive-compulsive disorder (OCD)
Children aged 6 to 12 years: The recommended initial dose is 25 mg per day.
After one week, the doctor may increase the dose to 50 mg per day.
The maximum dose is 200 mg per day.
Adolescents aged 13 to 17 years: The recommended initial dose is 50 mg per day.
The maximum dose is 200 mg per day.
Patients with liver or kidney disease should inform their doctor and follow medical advice.
Method of administration:
Sastium tablets may be taken with or without food.
The medicine should be taken once daily, either in the morning or in the evening.
The doctor will inform the patient how long the treatment should continue. The duration of treatment depends on the type of illness and the patient's response to therapy. Improvement may take several weeks. Treatment for depression should usually continue for 6 months after symptoms improve.
Taking more than the recommended dose of Sastium
If a patient accidentally takes too much Sastium, contact a doctor immediately or go to the emergency department of the nearest hospital. Always bring the medicine package with the label, regardless of whether any medicine remains.
Symptoms of overdose may include drowsiness, nausea and vomiting, increased heart rate, muscle tremors, agitation, dizziness, and in rare cases, loss of consciousness.
Missing a dose of Sastium
Do not take a double dose to make up for a missed dose.
If a patient forgets to take a tablet, do not take the missed tablet. Simply take the next tablet at the usual time.
Stopping Sastium
The patient must not stop taking Sastium on their own. The doctor should gradually reduce the dose of Sastium over several weeks until the patient stops taking it completely.
If treatment with Sastium is stopped abruptly, adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and muscle tremors may occur.
If any of these or other adverse effects occur after stopping Sastium, consult a doctor.
If there are any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
The most commonly occurring adverse reaction is nausea. Adverse reactions depend on
dose and often diminish or weaken with continued treatment.
You should inform your doctor immediately
if any of the following symptoms occur in the patient after taking this medicine, as
they may be serious.

• If the patient develops a severe skin rash causing blistering (erythema multiforme; blisters may appear in the mouth and on the tongue). These may be symptoms of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis. In such cases, the doctor will discontinue treatment.
• Allergic reaction or allergy, with symptoms such as: itchy skin rash, breathing difficulties, wheezing, eyelid, facial or lip swelling.
• If the patient experiences: agitation, confusion, diarrhoea, high temperature and blood pressure, excessive sweating and increased heart rate. These are symptoms of serotonin syndrome. In rare cases, this syndrome may occur when the patient is taking certain medicines at the same time as sertraline. The doctor may then discontinue the patient's treatment.
• If the patient develops yellowing of the skin and eyes, which may indicate liver damage.
• If the patient experiences symptoms of depression with thoughts of self-harm or suicide (suicidal thoughts).
• If, after starting treatment with Sastium, the patient begins to feel inner restlessness and is unable to sit or stand still. If the patient experiences such restlessness, they should inform their doctor.
• If the patient has a seizure (epileptic fit).
• If the patient experiences manic episodes (see section 2. Warnings and precautions).

The following adverse reactions have been observed in clinical trials in adult patients
and after the product has been placed on the market.
Very common (may affect more than 1 in 10 patients):
insomnia, dizziness, somnolence, headache, diarrhoea, nausea, dry mouth,
ejaculation disorders, fatigue.
Common (may affect less than 1 in 10 patients):

• cold, sore throat, nasal congestion
• decreased appetite, increased appetite
• anxiety, depression, agitation, decreased interest in sex, nervousness, strange feelings, nightmares, teeth grinding
• muscle tremors, movement disorders (such as increased motor activity, increased muscle tension, difficulty walking, and muscle stiffness, cramps, and involuntary movements)*, numbness and tingling sensations, muscle tension, lack of concentration, taste disturbances
• visual disturbances,
• tinnitus,
• palpitations,
• hot flushes,
• yawning,
• gastrointestinal disturbances, constipation, abdominal pain, vomiting, flatulence,
• increased sweating, rash,
• back pain, joint pain, muscle pain,
• irregular menstruation, erectile dysfunction,
• malaise, chest pain, weakness, fever
• weight gain
• injuries

Uncommon (may affect less than 1 in 100 patients):

• gastritis and enteritis, ear infection,
• tumour,
• hypersensitivity, seasonal allergy,
• decreased concentration of thyroid hormones in blood,
• suicidal thoughts and behaviour*, psychotic disorders, thinking disorders, emotional blunting, hallucinations, aggression, feelings of euphoria, paranoia,
• memory impairment, reduced sensation, involuntary muscle contractions, fainting, increased motor activity, migraine, seizures, dizziness upon standing, speech disorders,
• pupil dilation,
• ear pain,
• increased heart rate, heart problems,
• haemorrhagic disorders (including gastrointestinal bleeding)*, high blood pressure, skin redness, presence of blood in urine,
• shortness of breath, nosebleeds, breathing difficulties, gasping,
• tarry stools, dental disorders, oesophagitis, tongue problems, haemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders,
• eye swelling, urticaria, hair loss, itching, purpuric skin spots, blistering skin disorders, dry skin, facial swelling, cold sweats,
• degenerative joint disease, muscle tics, muscle cramps*, muscle weakness,
• increased frequency of urination, problems with urination, inability to urinate, urinary incontinence, increased urine output, nocturia,
• sexual disorders, excessive vaginal bleeding, vaginal bleeding, sexual disorders in women,
• leg swelling, chills, difficulty moving, increased thirst
• increased liver enzyme levels, weight loss.

Cases of suicidal thoughts and behaviour have been reported during treatment with
sertraline or shortly after its discontinuation (see section 2).
Rare (may affect less than 1 in 1000 patients):

• diverticulitis, enlarged lymph nodes, decreased number of clotting cells*, decreased white blood cell count*,
• severe allergic reactions,
• endocrine disorders,
• high cholesterol levels, problems maintaining normal blood sugar levels (diabetes), low blood glucose, increased blood glucose, low blood sodium levels,
• physical symptoms caused by stress or emotions, nightmares*, drug dependence, sleepwalking, premature ejaculation,
• stupor, abnormal movements, difficulty moving, increased sensitivity, sudden severe headache (which may be a symptom of a serious condition called reversible cerebral vasoconstriction syndrome), sensory disturbances,
• visual scotoma, glaucoma, double vision, photophobia, blood in the eye, unequal pupil size, visual disturbances, tearing problems,
• myocardial infarction, feeling of emptiness in the head, fainting or discomfort in the chest, which may be symptoms of changes in the heart's electrical activity (visible on electrocardiogram) or irregular heart rhythm*, slowed heart rate,
• impaired circulation in the upper and lower limbs,
• rapid breathing, lung tissue fibrosis (interstitial lung disease), laryngospasm, difficulty speaking, slowed breathing, hiccups,
• lung disease in which eosinophils (a type of white blood cell) accumulate in the lungs in increased numbers (eosinophilic pneumonia),
• oral ulceration, pancreatitis*, bloody stools, tongue ulceration, oral pain,
• liver disorders, severe liver function impairment*, yellow skin and eyes (jaundice)*,
• skin reaction to sunlight*, skin swelling*, abnormal hair structure, abnormal skin odour, scalp rash,
• rhabdomyolysis*, bone disorders,
• decreased urine output, delayed urination,
• nipple discharge, vaginal dryness, vaginal discharge, painful red penis and foreskin, breast enlargement*, prolonged erection,
• hernia, decreased drug tolerance,
• increased blood cholesterol levels, abnormal laboratory test results, abnormal semen analysis, blood clotting problems*,
• vasodilation.

Frequency not known (cannot be estimated from available data):

• bruxism*,
• nocturnal enuresis*,
• partial loss of vision,
• colitis (causing diarrhoea)*,
• severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection Pregnancy, breastfeeding and effects on fertility in section 2*.
• muscle weakness and severe muscle pain, which may be symptoms of a disorder resembling glutaric aciduria type II.

*Adverse reactions reported after the product has been placed on the market.
Additional adverse reactions in children and adolescents:
In clinical trials involving children and adolescents, adverse reactions were generally similar
to those occurring in adults (see above). The most commonly occurring adverse
reactions in children and adolescents were: headache, insomnia, diarrhoea and nausea.
Symptoms occurring after discontinuation:
After abrupt discontinuation of the medicine, adverse reactions such as dizziness,
numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and muscle
tremors may occur (see section 3. Discontinuing treatment with Sastium).
An increased risk of bone fractures has been observed in patients taking this type of medicine.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet,
the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Sastium

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry (EXP) and on the blister after: EXP. The expiry date refers to the last day of the specified month.
No special storage conditions are required for this medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Sastium contains
Each 50 mg film-coated tablet contains sertraline hydrochloride equivalent to
50 mg sertraline.
Each 100 mg film-coated tablet contains sertraline hydrochloride equivalent to
100 mg sertraline.
Other ingredients are:
Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose,
hydroxypropylcellulose, sodium carboxymethylstarch (type A), magnesium stearate.
Tablet coating: Hypromellose 2910, macrogol 400, polysorbate 80, titanium dioxide (E 171).

What Sastium looks like and contents of the pack
Sastium 50 mg are white, oval, biconvex film-coated tablets, 10.5 mm in length and 4.2 mm in width, with the imprint “I” on one side and “C” on the other side of the breakline on one tablet side and smooth on the reverse. The tablet may be divided into two equal doses.
Sastium 100 mg are white, oval, biconvex film-coated tablets, 13.3 mm in length and 5.2 mm in width, with the imprint “IJ” on one side and smooth on the reverse.
Sastium 50 mg/100 mg, film-coated tablets, are packed in PVC/Aluminium blisters or HDPE bottles.
Pack sizes:
Blisters: 10, 14, 28, 30, 42, 50, 56, 84, 90 or 100 film-coated tablets per cardboard box.
HDPE bottles: 50 mg – 250 film-coated tablets; 100 mg – 250 or 500 film-coated tablets (packs intended for hospital use).
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer:
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex HA1 4HF
United Kingdom
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
The Netherlands
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare Single Member S.A.
64th Km National Road Athens, Schimatari
32009 Lamia
Greece

This medicinal product is authorised in the European Economic Area countries under the following names: