Sertralina Krka

Package Leaflet: Information for the Patient

Sertraline Krka, 50 mg, Film-Coated Tablets

Sertraline Krka, 100 mg, Film-Coated Tablets

Sertraline

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• You should 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Sertraline Krka and what is it used for

The active substance of Sertraline Krka is sertraline. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders.

Sertraline Krka 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, children, and adolescents aged 6-17 years).

Depression is a disease characterized by symptoms of sadness, difficulty sleeping, or loss of interest in life.
OCD and panic disorder are anxiety-related diseases with symptoms of persistent anxiety due to recurring thoughts (obsessions) that cause repetitive behaviors (compulsive actions).
Post-traumatic stress disorder (PTSD) is a condition that may occur after a traumatic experience and is characterized by symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related disease. It is characterized by a feeling of 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 worrying about potentially embarrassing behavior).
Your doctor has decided that this medicine is suitable for treating your disease. You should consult your doctor if you are unsure why you have been prescribed Sertraline Krka.

2. Important information before taking Sertraline Krka

When not to take Sertraline Krka

• 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). After stopping sertraline treatment, you must wait at least one week before starting MAOI treatment. After stopping MAOI treatment, you must wait at least two weeks before starting sertraline treatment.
• If you are taking pimozide (a medicine used to treat mental disorders, such as psychoses).

Warnings and precautions

Before taking Sertraline Krka, you should discuss it with your doctor or pharmacist.
Not every medicine is suitable for everyone. You should tell your doctor if you currently have or have had any of the following conditions:

• Seizures (fits) or a history of seizure disorders. If a seizure occurs, you should contact your doctor immediately.
• A history of manic-depressive illness (bipolar affective disorder) or schizophrenia. If a manic episode occurs, 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 have taken certain medications at the same time as sertraline (symptoms, see section 4 "Possible side effects"). Your doctor should tell you if you have had serotonin syndrome in the past.
• Low sodium levels in the blood, as this may occur due to the use of Sertraline Krka. You should also inform your doctor about taking certain medications used to treat high blood pressure, as they may also change sodium levels in the blood.
• Elderly patients; they may be more susceptible to decreased sodium levels in the blood (see above).
• Liver disease; your doctor may decide to reduce the dose of Sertraline Krka.
• Diabetes; Sertraline Krka may affect blood sugar levels, so a change in the dosage of antidiabetic medications may be necessary.
• Bleeding disorders or past use of blood thinners [e.g., acetylsalicylic acid ("aspirin") or warfarin] or medications that may increase the risk of bleeding, or if you are pregnant (see "Pregnancy").
• Children or adolescents under 18 years of age. In the case of children and adolescents aged 6 to 17 years, Sertraline Krka can only be used to treat obsessive-compulsive disorder. Patients treated for this disease 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).
• Heart rhythm disorders visible on an ECG, known as a prolonged QT interval.
• Heart disease, low potassium or magnesium levels, a family history of prolonged QT interval, slow heart rate, and concurrent use of medications that prolong the 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 such symptoms.

Withdrawal symptoms

After stopping treatment, side effects (withdrawal symptoms) often occur, especially if treatment is stopped abruptly (see section 3 "Stopping Sertraline Krka treatment" 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 weeks after stopping treatment. They usually resolve on their own within two weeks, but in some patients, they can persist for longer (2-3 months or longer). If you decide to stop treatment with sertraline, your doctor will recommend a gradual reduction in dose over several weeks or months and will consult with you on the best way to stop treatment.

Suicidal thoughts, worsening of depression or anxiety

People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such thoughts or behaviors may worsen at the beginning of treatment with antidepressant medications, as these medications usually start working after 2 weeks, sometimes later.

The likelihood of such thoughts is higher 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 have been treated with antidepressant medications. If you have suicidal thoughts or thoughts of 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 to help you and ask them to inform you if they notice that your depression or anxiety has worsened or if you have made any disturbing changes in your behavior.

Sexual dysfunction

Medications like Sertraline Krka (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Children and adolescents

Sertraline should not be used in children and adolescents under 18 years of age, with the exception of patients with obsessive-compulsive disorder. In patients under 18 years of age, an increased risk of side effects such as suicide attempts, suicidal thoughts, or hostility (mainly aggressive, defiant, and angry behavior) has been observed during treatment with medications from this group. However, your doctor may decide to prescribe Sertraline Krka to a patient under 18 years of age if it is in the patient's best interest. If your doctor prescribes Sertraline Krka to a patient under 18 years of age and the child's caregiver wants to discuss this with the doctor, they should contact the doctor. Moreover, if any of the above symptoms occur or worsen during treatment with Sertraline Krka, the doctor should be informed. Additionally, there is currently a lack of data on the long-term safety of Sertraline Krka regarding its impact on growth, maturation, learning (cognitive function), and behavior.

Sertraline Krka and other medications

You should tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Some medications may affect the way Sertraline Krka works or Sertraline Krka may reduce the effectiveness of other medications taken at the same time.

Taking Sertraline Krka with the following medications may cause serious side effects:

• Medications that are monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression) and selegiline (used to treat Parkinson's disease), as well as the antibiotic linezolid and methylene blue (a substance used to treat high levels of methemoglobin in the blood). You should not take Sertraline Krka at the same time as these medications.
• Medications used to treat mental disorders, such as psychoses (pimozide). You should not take Sertraline Krka at the same time as pimozide.

You should inform your doctor about taking any of the following medications:

• Medications containing amphetamine derivatives [used to treat attention deficit hyperactivity disorder (ADHD), excessive sleepiness, and obesity].
• Herbal medications containing St. John's Wort (Hypericum perforatum). St. John's Wort may continue to work for 1 to 2 weeks.
• Medications containing the amino acid tryptophan.
• Medications used to treat severe pain (e.g., tramadol).
• Buprenorphine, a medication used to treat pain or opioid addiction.
• Medications used during anesthesia or to treat chronic pain (fentanyl, mivacurium, and suxamethonium).
• Medications used to treat migraines (e.g., sumatriptan).
• Blood thinners (warfarin).
• Medications used to treat pain and/or joint inflammation [non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen, acetylsalicylic acid ("aspirin")].
• Sedatives (diazepam).
• Diuretics.
• Medications used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medications used to treat diabetes (tolbutamide).
• Medications used to treat excessive stomach acid production, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medications used to treat mania and depression (lithium).
• Other medications used to treat depression (e.g., amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medications used to treat schizophrenia and other mental disorders (e.g., perphenazine, levomepromazine, and olanzapine).
• Medications used to treat high blood pressure, chest pain, or to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide, propafenone).
• Medications used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
• Medications used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Medications used to treat HIV/AIDS and hepatitis C (protease inhibitors, such as ritonavir, telaprevir).
• Medications used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
• Medications that increase the risk of changes in heart electrical activity (e.g., antipsychotic medications and antibiotics).
• Metamizole, a medication used to treat pain and fever.

Taking Sertraline Krka with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The safety of sertraline use during pregnancy has not been fully established. Sertraline can be used in pregnant women only if the doctor considers that the benefits to the mother outweigh the potential risk to the developing fetus.
You should inform your doctor and/or midwife about taking Sertraline Krka. Medications like Sertraline Krka, taken during pregnancy, especially during the last three months of pregnancy, may increase the risk of a serious complication in the newborn called persistent pulmonary hypertension of the newborn (PPHN), characterized by rapid breathing and bluish discoloration. These symptoms usually appear within the first day of life. If such symptoms occur in the newborn, you should immediately contact your doctor and/or midwife.
The newborn may also experience other symptoms, which usually appear within the first day of life. These symptoms include:

• breathing difficulties,
• bluish discoloration of the skin, low or high body temperature,
• bluish discoloration of the mouth,
• vomiting or difficulty feeding,
• excessive tiredness, sleeplessness, or very frequent crying,
• stiffness or floppiness of the muscles,
• tremors, tremors, or seizures,
• increased reflexes,
• irritability,
• low blood sugar.

If the newborn experiences any of these symptoms or if you are concerned about the baby's health, you should contact the midwife or doctor.
Taking Sertraline Krka at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Sertraline Krka, you should inform your doctor or midwife so that they can provide you with appropriate advice.
Breastfeeding
There is evidence that sertraline is excreted in human milk. Sertraline Krka can be used in breastfeeding women if the doctor considers that the benefits to the mother outweigh the risk to the baby.
Fertility
Animal studies have shown that some medications, such as sertraline, may decrease sperm quality. This effect may theoretically limit fertility, although it has not been observed in humans.

Driving and using machines

Psychotropic medications, such as sertraline, may affect your ability to drive and use machines. You should wait until you know how Sertraline Krka affects your ability to perform these activities.

Sertraline Krka contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is essentially "sodium-free".

3. How to take Sertraline Krka

You should always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose:

Adults:

Depression and obsessive-compulsive disorder

In the treatment of depression and OCD, the usually effective dose is 50 mg per day. The daily dose can be increased by 50 mg over several weeks, with an interval of at least one week between dose changes. The maximum recommended dose is 200 mg per 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 per day, and after one week, the dose should be increased to 50 mg per day. The daily dose can then be increased by 50 mg over several weeks. The maximum recommended dose is 200 mg per day.

Use in children and adolescents

Sertraline Krka can be used in children and adolescents aged 6 to 17 years only to treat obsessive-compulsive disorder.

Obsessive-compulsive disorder:

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 their instructions.
Method of administration
Sertraline Krka 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 this medicine. The treatment period depends on the type of disease and the patient's response to treatment. Improvement in condition may begin only after several weeks of treatment. Treatment of depression should usually be continued for 6 months after improvement.

Taking a higher dose of Sertraline Krka than recommended

If you have taken more Sertraline Krka than the recommended dose, you should immediately inform your doctor or go to the nearest hospital emergency department. You should always take the medicine packaging with you, whether or not it contains any medicine.
Overdose symptoms include: drowsiness, nausea, vomiting, rapid heart rate, tremors, agitation, dizziness, and rarely - loss of consciousness.

Missing a dose of Sertraline Krka

If you forget to take a dose, do not take the missed dose. Take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping Sertraline Krka treatment

You should not stop taking Sertraline Krka without consulting your doctor. Before stopping treatment, your doctor will gradually reduce the dose of Sertraline Krka over several weeks. If you stop taking the medicine abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors. If you experience any of these or any other side effects while stopping Sertraline Krka treatment, you should contact your doctor.
If you have any further questions about taking 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.
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 doctorif you experience any of the following symptoms after taking this medicine, as they may be serious:

• Severe skin rash with blisters (erythema multiforme) (may affect the mouth and tongue). These may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis. In this case, your doctor will decide to stop treatment.
• Allergic reaction or allergy, which may manifest as an itchy skin rash, breathing difficulties, wheezing, swelling of the eyelids, face, or lips.
• Agitation, confusion, diarrhea, high blood pressure and body temperature, excessive sweating, and rapid heart rate. These are symptoms of serotonin syndrome. Rarely, serotonin syndrome may occur during treatment with certain medications at the same time as sertraline. Your doctor may decide to stop treatment.
• Yellowing of the skin and whites of the eyes, which may indicate liver damage.
• Symptoms of depression with thoughts of self-harm or suicide (suicidal thoughts).
• Psychomotor restlessness - you are unable to sit or stand still after starting Sertraline Krka treatment. If you experience psychomotor restlessness, you should inform your doctor.
• Seizures (fits).
• Manic episodes (see section 2 "Warnings and precautions").

In clinical trials in adults, the following side effects were observed.

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

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

• inflammation of the intestines, lymph node inflammation, decreased platelet count*, decreased white blood cell count*,
• severe allergic reactions,
• endocrine disorders*,
• high cholesterol, problems with maintaining normal blood sugar levels (diabetes), low blood sugar, high blood sugar*, 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 sign of a serious condition called reversible cerebral vasoconstriction syndrome)*, sensory disturbances,
• spots before the eyes, glaucoma, double vision, sensitivity to light, blood in the eye, uneven pupil size*, abnormal vision*, tear disturbances,
• heart attack, feeling of "emptiness" in the head, fainting or discomfort in the chest, which may be symptoms of changes in heart electrical activity (visible on an ECG) or abnormal heart rhythm*, slow heart rate,
• poor circulation in the arms and legs,
• rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, narrowing of the airways (laryngospasm), difficulty speaking, slow breathing, hiccups,
• mouth ulcers, pancreatitis*, blood in the stool, mouth pain, difficulty eating,
• liver function disorders, severe liver function disorders*, yellowing of the skin and eyes (jaundice)*,
• skin reaction to sunlight*, skin swelling*, abnormal hair structure, abnormal skin odor, hair loss,
• muscle breakdown*, bone disorders,
• difficulty starting urination, decreased urination,
• nipple discharge, vaginal dryness, genital discharge, breast enlargement*, prolonged erection of the penis,
• hernia, decreased drug tolerance,
• increased cholesterol levels in the blood, abnormal laboratory test results*, abnormal sperm test results, bleeding disorders*,
• vasodilation.

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

• inflammation of the intestine, lymph node inflammation, decreased platelet count*, decreased white blood cell count*,
• severe allergic reactions,
• endocrine disorders*,
• high cholesterol, problems with maintaining normal blood sugar levels (diabetes), low blood sugar, high blood sugar*, 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 sign of a serious condition called reversible cerebral vasoconstriction syndrome)*, sensory disturbances,
• spots before the eyes, glaucoma, double vision, sensitivity to light, blood in the eye, uneven pupil size*, abnormal vision*, tear disturbances,
• heart attack, feeling of "emptiness" in the head, fainting or discomfort in the chest, which may be symptoms of changes in heart electrical activity (visible on an ECG) or abnormal heart rhythm*, slow heart rate,
• poor circulation in the arms and legs,
• rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, narrowing of the airways (laryngospasm), difficulty speaking, slow breathing, hiccups,
• mouth ulcers, pancreatitis*, blood in the stool, mouth pain, difficulty eating,
• liver function disorders, severe liver function disorders*, yellowing of the skin and eyes (jaundice)*,
• skin reaction to sunlight*, skin swelling*, abnormal hair structure, abnormal skin odor, hair loss,
• muscle breakdown*, bone disorders,
• difficulty starting urination, decreased urination,
• nipple discharge, vaginal dryness, genital discharge, breast enlargement*, prolonged erection of the penis,
• hernia, decreased drug tolerance,
• increased cholesterol levels in the blood, abnormal laboratory test results*, abnormal sperm test results, bleeding disorders*,
• vasodilation.

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

• partial loss of vision,
• inflammation of the colon (causing diarrhea),
• jaw spasms*,
• bedwetting*,
• severe vaginal bleeding shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy" in section 2.

*Side effect reported after the medicine was marketed.

Additional side effects in children and adolescents

In clinical trials in children and adolescents, side effects were usually 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 such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors may occur (see section 3 "Stopping Sertraline Krka treatment").
An increased risk of bone fractures has been reported in patients taking medications from this group.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Sertraline Krka

Keep the medicine out of the 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.
The batch number is stated on the packaging after "Lot".
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sertraline Krka contains

• The active substance of Sertraline Krka is sertraline. Each film-coated tablet contains 50 mg or 100 mg of sertraline, in the form of sertraline hydrochloride.
• The other ingredients are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), hydroxypropylcellulose, talc, and magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E 171), talc, and propylene glycol in the tablet coating. See section 2 "Sertraline Krka contains sodium".

What Sertraline Krka looks like and contents of the pack

50 mg, film-coated tablets: white, oval, slightly biconvex film-coated tablets with a score line on one side and an S3 mark on the other side. The tablet can be divided into equal doses.
100 mg, film-coated tablets: white, round film-coated tablets with a score line on one side.
The tablet can be divided into equal doses.
Packaging:10, 14, 20, 28, 30, 50, 98, or 100 film-coated tablets in blisters, in a cardboard box or an HDPE container with a PP closure containing 250 film-coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
SPECIFAR ABEE, 1, 28 Octovriou Str., Ag. Varvara, 123-51 Athens, Greece
To obtain more detailed information on the names of medicinal products in other EU member states, please contact the representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:24.06.2022