Zoloft

Leaflet accompanying the packaging: information for the user

ZOLOFT, 50 mg, coated tablets

ZOLOFT, 100 mg, coated tablets

Sertraline

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Zoloft and what is it used for

Zoloft contains the active substance sertraline. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors; these medicines are used to treat depression and (or) anxiety disorders.
Zoloft can be used to treat:

• depression and prevention of depression relapse (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).

Depression is a disorder whose symptoms include: sadness, difficulty sleeping or lack of joy in life.
Obsessive-compulsive disorder and panic disorder are anxiety disorders with accompanying constant anxiety due to persistent thoughts (obsessions), which cause the performance of repetitive rituals (compulsive actions, compulsions).
Post-traumatic stress disorder is a condition that can occur after a very traumatic experience and is characterized by symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety disorder. It is characterized by intense anxiety or stress 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).
The doctor has decided that this medicine is suitable for treating the disorder that you are suffering from. You should consult a doctor if you are not sure why you are taking Zoloft.

2. Important information before taking Zoloft

When not to take Zoloft:

• 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 monoamine oxidase inhibitors (MAOIs, e.g. selegiline, moclobemide) or medicines similar to MAOIs (e.g. linezolid). If you have finished taking sertraline, you should wait at least one week before starting treatment with an MAOI. After stopping treatment with an MAOI, you should wait at least two weeks before you can start taking sertraline;
• if you are taking pimozide (a medicine used to treat mental disorders, such as psychoses).

Warnings and precautions

Before starting to take Zoloft, you should discuss it with your doctor or pharmacist.
Medicines do not always suit everyone. You should tell your doctor before taking Zoloft if you currently have or have had any of the following:

• Seizures (fits) or a history of seizures. If you have a seizure (fit), you should contact your doctor immediately.
• A history of manic-depressive disorder (bipolar) or schizophrenia. If you experience a manic episode, you should contact your doctor immediately.
• Current or past thoughts of self-harm or suicide (see below - Suicidal thoughts, worsening of depression or anxiety).
• Serotonin syndrome. In rare cases, this syndrome may occur in patients who take certain medicines with sertraline. (Symptoms, see section 4. Possible side effects). Your doctor should tell you if you have had serotonin syndrome in the past.
• Decreased sodium levels in the blood, as it may occur due to the use of Zoloft. You should also inform your doctor about taking medicines used to treat high blood pressure, as they may also change sodium levels in the blood.
• Elderly people: the risk of decreased sodium levels in the blood (see above) is higher in them.
• Liver disease: your doctor may decide to reduce the dose of Zoloft.
• Diabetes: Zoloft may affect changes in blood sugar levels, so it may be necessary to change the dosage of antidiabetic medicines.
• A history of bleeding disorders (tendency to bruise) or if you are pregnant (see "Pregnancy, breastfeeding and fertility"), as well as taking medicines that prevent blood clotting [e.g. acetylsalicylic acid (aspirin) or warfarin] or that may increase the risk of bleeding.
• Children or adolescents under 18 years of age. Zoloft should only be used in children and adolescents aged 6-17 years for the treatment of obsessive-compulsive disorder (OCD). Patients treated for this condition should be closely monitored by a doctor (see below - Children and adolescents).
• Electroconvulsive therapy.
• Eye problems, such as certain types of glaucoma (increased pressure in the eye).
• ECG abnormalities, known as prolonged QT interval.
• Heart disease, low potassium or magnesium levels, a family history of prolonged QT interval, slow heart rate, and concomitant use of medicines that cause prolonged QT interval.

Psychomotor restlessness/Akathisia:

Sertraline use has been associated with the occurrence of a state characterized by psychomotor restlessness and a compulsion to move – often with an inability to sit or stand still (akathisia). This condition usually occurs within the first few weeks of treatment. You should contact your doctor if you experience an increase in dose, as it may be harmful to patients with these symptoms.

Withdrawal symptoms:

After stopping treatment, side effects often occur, especially if treatment is stopped abruptly (see section 3. Stopping Zoloft and section 4. Possible side effects). The risk of withdrawal symptoms depends on the duration of treatment, dosage, and rate of dose reduction. These symptoms are usually mild or moderate, but in some patients, they can be severe. They usually occur within the first few days after stopping treatment. They usually resolve on their own within two weeks, but in some patients, they may persist for longer (for 2-3 months or longer). If you decide to stop taking sertraline, it is recommended to gradually reduce the dose over several weeks or months and consult your doctor on the best way to stop treatment.

Suicidal thoughts, worsening of depression or anxiety:

People with depression and (or) anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually start working after a few weeks, and sometimes later.

The occurrence of suicidal thoughts, self-harm, or suicidal behavior is more likely if:

• you have had suicidal thoughts or self-harm in the past;
• you are a young adult; clinical trial data indicate an increased risk of suicidal behavior in people under 25 years of age with mental disorders who were treated with antidepressant medicines. If you experience suicidal thoughts or self-harm, you should immediately contact your doctor or go to the hospital.

It may be helpful to inform your relatives or friends about your depression or anxiety disorder and ask them to read this leaflet. You can ask your relatives or friends for help and ask them to inform you if they notice that your depression or anxiety has worsened or if there are any worrying changes in your behavior.

Sexual dysfunction

Medicines like Zoloft (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment.

Children and adolescents:

Generally, sertraline should not be used in children and adolescents under 18 years of age, except for patients with obsessive-compulsive disorder (OCD). In patients under 18 years of age taking medicines from this group, an increased risk of side effects such as suicidal attempts, self-harm, or suicidal thoughts (suicidal thoughts) and hostility (mainly aggressive, defiant, and angry behavior) has been observed.
Your doctor may, however, decide to prescribe Zoloft to a patient under 18 years of age if it is in the patient's interest. If your doctor prescribes Zoloft to a patient under 18 years of age and the child's caregiver wants to discuss this, they should contact the doctor.
Moreover, if any of the above symptoms appear or worsen while taking Zoloft, you should inform your doctor.
In a long-term observational study lasting three years with over 900 children aged 6-16 years, the safety of long-term use of Zoloft was evaluated in terms of its effect on growth, maturation, learning (cognitive functions), and behavior. In general, the study results showed that children treated with sertraline developed normally, except for a slight increase in body weight in children treated with a higher dose.

Zoloft and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as medicines you plan to take.
Some medicines may affect how Zoloft works or Zoloft may reduce the effectiveness of other medicines taken at the same time.
Taking Zoloft with the following medicines may cause serious side effects:

• Medicines that are 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 (used to treat high methemoglobin levels in the blood). You should not take Zoloft with these medicines.
• Medicines used to treat mental disorders, such as psychoses (pimozide). You should not take Zoloft with pimozide.

You should inform your doctor if you are taking any of the following medicines:

• Medicines containing amphetamine derivatives (used to treat attention deficit hyperactivity disorder (ADHD), excessive sleepiness, 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, e.g. tramadol, fentanyl).
• Medicines used for anesthesia (e.g. fentanyl, mivacurium, and suxamethonium).
• Medicines used to treat migraines (e.g. sumatriptan).
• Medicines that prevent blood clotting (warfarin).
• Medicines used to treat pain/joint inflammation [e.g. metamizole, non-steroidal anti-inflammatory medicines (NSAIDs), e.g. ibuprofen, acetylsalicylic acid (aspirin)].
• Sedatives (diazepam).
• Diuretics.
• Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines used to treat diabetes (tolbutamide).
• Medicines used to treat excessive stomach acid production, stomach ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazol).
• 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 mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medicines used to treat high blood pressure, chest pain, or heart rate regulation (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 infections (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. antipsychotic medicines and antibiotics).

Taking Zoloft with food, drink, and alcohol:

Zoloft tablets can be taken with or without food.
You should not drink alcohol while taking Zoloft.
You should not take Zoloft with grapefruit juice, as it may increase the level of sertraline in the body.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
The safety of sertraline use in pregnant women has not been fully established. The medicine can be used in pregnant women only if the doctor considers that the benefits to the mother outweigh the potential risks to the fetus.
Taking Zoloft at the end of pregnancy may increase the risk of severe vaginal bleeding occurring shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Zoloft, you should inform your doctor or midwife so that they can give you appropriate advice. Taking medicines like Zoloft during pregnancy, especially in the last trimester, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), characterized by rapid breathing and blue skin color in the baby. These symptoms usually appear within the first day of life. If your baby experiences any of these symptoms, you should immediately contact your midwife or doctor.
Newborns may also experience other complications, which usually appear within the first 24 hours after birth. Symptoms include:

• breathing difficulties,
• bluish skin, too hot or cold skin,
• bluish lips,
• vomiting or feeding problems,
• excessive tiredness, difficulty sleeping, or constant crying,
• increased or decreased muscle tone,
• shivering, muscle spasms, or seizures,
• increased reflexes,
• restlessness,
• low blood sugar.

If your baby experiences any of these symptoms or if their condition is worrying, you should contact your doctor or midwife.
Sertraline passes into breast milk. The medicine can be used in breastfeeding women if the doctor considers that the benefits of the medicine outweigh the potential risks to the baby.
In animal studies, some medicines similar to sertraline have been shown to decrease sperm quality. This could theoretically affect fertility, although no effect on fertility has been observed in humans.

Driving and using machines:

Psychotropic medicines, such as sertraline, may affect your ability to drive or use machines. You should wait until you know how Zoloft affects you before performing these activities.

Zoloft contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Zoloft

This medicine should always be taken exactly as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.

Recommended dose of Zoloft:

Adults:

Depression and obsessive-compulsive disorder:

The usual effective dose for the treatment of depression and OCD is 50 mg/day.
The daily dose can be increased gradually by 50 mg at intervals of at least one week over several weeks. The maximum recommended dose is 200 mg/day.

Panic disorder, social anxiety disorder, and post-traumatic stress disorder:

Treatment of panic disorder, social anxiety disorder, and post-traumatic stress disorder should be started with a dose of 25 mg/day, which can be increased to 50 mg/day after one week.
The daily dose can then be increased gradually by 50 mg over several weeks. The maximum recommended dose is 200 mg/day.

Use in children and adolescents:

Zoloft can be used in children and adolescents only for the treatment of obsessive-compulsive disorder (OCD) in patients aged 6-17 years.

Obsessive-compulsive disorder:

Children aged 6-12 years:The recommended initial dose is 25 mg/day. After one week, the doctor may increase the dose to 50 mg/day. The maximum dose is 200 mg/day.
Adolescents aged 13-17 years:The recommended initial dose is 50 mg/day.
The maximum dose is 200 mg/day.
Patients with liver or kidney disease should inform their doctor and follow their instructions.
Method of administration:
Zoloft tablets can be taken with or without food.
The medicine should be taken once a day, in the morning or evening.
Your doctor will tell you how long you should take the medicine. The treatment period depends on the type of disease and the patient's response to treatment. Improvement may occur only after several weeks of treatment. Treatment of depression should usually last for six months from the time of improvement.

Taking a higher dose of Zoloft than recommended:

If you accidentally take too much Zoloft, you should immediately inform your doctor or go to the emergency department of the nearest hospital. You should always take the packaging with the label with you, regardless of whether there is medicine left in it or not.
Symptoms of overdose may include drowsiness, nausea, and vomiting, rapid heart rate, muscle tremors, agitation, dizziness, and in rare cases, loss of consciousness.

Missing a dose of Zoloft:

You should not take a double dose to make up for a missed dose.
If you forget to take a tablet, you should not take the missed tablet. You should simply take the next tablet at the right time.

Stopping Zoloft:

You should never stop taking Zoloft on your own. Your doctor should gradually reduce the dose of Zoloft over several weeks until you finally stop taking it. If you suddenly stop taking Zoloft, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors. If you experience any of these side effects or any other side effects after stopping Zoloft, you should contact your doctor.
If you have any further doubts about taking the medicine, you should contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effect is nausea. Side effects depend on the dose and usually disappear or decrease as treatment continues.

You should immediately inform your doctor

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

• If you develop a severe skin rash that causes 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, your doctor will stop treatment.
• An allergic reaction or allergy, with symptoms such as an itchy skin rash, breathing problems, wheezing, swelling of the eyelids, face, or lips.
• If you experience: agitation, confusion, diarrhea, high temperature, and high blood pressure, excessive sweating, and rapid heart rate. These are symptoms of serotonin syndrome. In rare cases, this syndrome may occur when you take certain medicines at the same time as sertraline. Your doctor may then stop the treatment.
• If you develop yellowing of the skin and eyes, which may indicate liver damage.
• If you experience symptoms of depression with thoughts of self-harm or suicide (suicidal thoughts).
• If you start to feel restless and cannot sit or stand still. If you feel restless, you should tell your doctor.
• If you have a seizure (fit).
• If you experience manic episodes (see section 2. Warnings and precautions).

The following side effects have been observed in clinical trials in adults and after the medicine was placed on the market.
Very common (may affect more than 1 in 10 people):
insomnia, dizziness, drowsiness, headaches, diarrhea, nausea, dry mouth, ejaculation disorder, fatigue.
Common (may affect up to 1 in 10 people):

• bronchitis, sore throat, cold,
• loss of appetite, increased appetite,
• anxiety, depression, agitation, decreased sexual interest, nervousness, strange feeling, nightmares, teeth grinding,
• muscle tremors, movement disorders (such as increased muscle activity, increased muscle tone, difficulty walking, and stiffness of the muscles, spasms, and involuntary muscle movements), numbness and tingling, increased muscle tone, lack of concentration, taste disorders,
• vision disturbances,
• ringing in the ears,
• palpitations,
• hot flushes,
• yawning,
• gastrointestinal disorders, constipation, abdominal pain, vomiting, flatulence,
• increased sweating, rash,
• back pain, joint pain, muscle pain,
• irregular menstrual cycle, erectile dysfunction,
• malaise, chest pain, weakness, fever,
• weight gain,
• injuries.

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

• diverticulitis, ear infection,
• tumor,
• hypersensitivity, seasonal allergy,
• decreased thyroid hormone levels,
• suicidal thoughts, suicidal behavior, psychotic disorders, thought disorders, apathy, hallucinations, aggression, euphoria, delusions,
• amnesia, decreased sensation, involuntary muscle spasms, loss of consciousness, increased muscle activity, migraine, seizures, dizziness when standing up, coordination disorders, speech disorders,
• pupil dilation,
• ear pain,
• rapid heart rate, heart problems,
• bleeding disorders (including gastrointestinal bleeding), high blood pressure, flushing, blood in the urine,
• shortness of breath, nosebleeds, breathing difficulties, wheezing,
• tarry stools, dental disorders, esophagitis, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders,
• eye swelling, hives, hair loss, itching, purpura, skin disorders with blistering, dry skin, facial swelling, cold sweats,
• degenerative joint disease, muscle twitches, painful muscle spasms, muscle weakness,
• increased urination frequency, urination problems, inability to urinate, urinary incontinence, increased urine production, nocturia,
• sexual dysfunction, excessive menstrual bleeding, menstrual bleeding, sexual dysfunction in women,
• swelling of the legs, chills, difficulty walking, increased thirst,
• increased liver enzyme activity, weight loss.
• During treatment with sertraline or shortly after its discontinuation, cases of suicidal thoughts and behaviors have been reported (see section 2).

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

• diverticulitis, lymphadenopathy, decreased platelet count, decreased white blood cell count,
• severe allergic reactions,
• endocrine disorders,
• high cholesterol levels, problems with maintaining normal blood sugar levels (diabetes), low blood sugar levels, high blood sugar levels, low sodium levels in the blood,
• physical symptoms caused by stress or emotions, nightmares, drug dependence, sleepwalking, premature ejaculation,
• coma, 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,
• floaters, glaucoma, double vision, sensitivity to light, blood in the eye, uneven pupil size*, abnormal vision*, tear disorders,
• heart attack, feeling of impending faint, fainting or discomfort in the chest, which may be symptoms of changes in the electrical activity of the heart (visible on an electrocardiogram) or abnormal heart rhythm, slow heart rate,
• worsening of blood circulation in the arms and legs,
• rapid breathing, progressive scarring of lung tissue (interstitial lung disease), laryngospasm, speech difficulties, slow breathing, hiccups,
• a form of lung disease in which eosinophils (a type of white blood cell) appear in the lungs in increased numbers (eosinophilic pneumonia),
• mouth ulcers, pancreatitis, blood in the stool, tongue pain, oral discomfort,
• liver function disorders, severe liver function disorders, yellowing of the skin and eyes (jaundice),
• sunburn, skin swelling, abnormal hair structure, abnormal skin odor, hairy skin rash,
• muscle breakdown, bone disorders,
• difficulty starting urination, decreased urination,
• breast discharge, vaginal dryness, genital discharge, painful red penis and foreskin, breast enlargement, prolonged erection,
• hernia, decreased drug tolerance,
• increased cholesterol levels in the blood, abnormal laboratory test results, abnormal semen test results, bleeding disorders,
• vasodilation.

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

• jaw pain
• nocturnal enuresis
• partial loss of vision
• colitis (causing diarrhea)
• severe postpartum hemorrhage, occurring shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2.

side effects reported after the medicine was placed on the market

Additional side effects in children and adolescents:

In clinical trials in children and adolescents, side effects were generally similar to those in adults (see above). The most common side effects in children and adolescents were headaches, insomnia, diarrhea, and nausea.

Withdrawal symptoms:

After stopping treatment, side effects may occur, such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors (see section 3. Stopping Zoloft).
Patients taking this type of medicine have been observed to have an increased risk of fractures.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
phone: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Zoloft

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Zoloft contains

Zoloft, coated tablets:
Zoloft, 50 mg
Each coated tablet contains 50 mg of sertraline in the form of sertraline hydrochloride.
Zoloft, 100 mg
Each coated tablet contains 100 mg of sertraline in the form of sertraline hydrochloride.
Other ingredients are:
calcium hydrogen phosphate dihydrate (E341), microcrystalline cellulose (E460),
hydroxypropyl cellulose (E463), sodium carboxymethyl cellulose (type A) (see section 2: "Zoloft contains sodium"), magnesium stearate (E572), hypromellose 2910/3 mPas (E464), hypromellose 2910/6 mPas (E464), titanium dioxide (E171), macrogol 400 (E1521), macrogol 8000 (E1521), and polysorbate 80 (E433).

What Zoloft looks like and contents of the pack

Zoloft, coated tablets:
Zoloft, 50 mg: white, oblong (10.3 x 4.2 mm), scored coated tablets with "ZLT 50" on one side and "VLE" on the other side of the tablet. The tablet can be divided into two halves.
Zoloft, 100 mg: white, oblong (13.1 x 5.2 mm) coated tablets with "ZLT 100" on one side and "VLE" on the other side of the tablet.
The tablets are available in aluminum/PVC blisters containing 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 98, 100, 200, 294, 300, or 500 tablets, as well as blisters containing 30x1.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands
Manufacturer:
Pfizer Manufacturing Deutschland GmbH, Mooswaldallee 1, 79108 Freiburg Im Breisgau, Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

To obtain more detailed information on this medicine, you should contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

phone: 22 546 64 00
Date of last revision of the leaflet: 04/2025