Zotral

Package Leaflet: Information for the Patient

Zotral, 50 mg, Film-Coated Tablets

Zotral, 100 mg, Film-Coated Tablets

Sertraline

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

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Zotral and What is it Used For
• 2. Important Information Before Taking Zotral
• 3. How to Take Zotral
• 4. Possible Side Effects
• 5. How to Store Zotral
• 6. Package Contents and Other Information

1. What is Zotral and What is it Used For

Zotral contains the active substance sertraline. Sertraline belongs to a group of medications called selective serotonin reuptake inhibitors (SSRIs); these medications are used to treat depression and/or anxiety disorders.

Zotral May 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 disease characterized by symptoms of sadness, increased sleep problems or loss of interest in life.
OCD and panic disorder are anxiety-related diseases characterized by symptoms of persistent anxiety due to persistent 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 certain 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).
The doctor has decided that this medication is suitable for treating the patient's disease. The patient should consult their doctor if they are unsure why they are taking Zotral.

2. Important Information Before Taking Zotral

When Not to Take Zotral:

• if the patient is allergic to sertraline or any of the other ingredients of this medication (listed in section 6);
• if the patient is taking or has taken monoamine oxidase inhibitors (MAOIs, e.g., selegiline, moclobemide) or medications similar to MAOIs (e.g., linezolid). After stopping sertraline treatment, the patient should wait at least one week before starting MAOI treatment. After stopping MAOI treatment, the patient should wait at least two weeks before starting sertraline treatment.
• if the patient is taking pimozide (a medication used to treat mental disorders, such as psychoses).

Warnings and Precautions

Medications do not always suit everyone. The patient should consult their doctor before taking Zotral if they currently have or have had any of the following conditions:

• epilepsy or a history of seizures. In case of a seizure, the patient should contact their doctor immediately.
• a history of manic-depressive illness (bipolar) or schizophrenia. In case of a manic episode, the patient should contact their doctor immediately.
• a history of suicidal thoughts (see below - suicidal thoughts and worsening of depressive or anxiety disorders).
• serotonin syndrome. In rare cases, this syndrome may occur in patients taking certain medications at the same time as sertraline. (Symptoms - see section 4. Possible Side Effects). The doctor should inform the patient if they have had serotonin syndrome in the past.
• malignant neuroleptic syndrome. In rare cases, this syndrome may occur in patients taking certain medications at the same time as sertraline. (Symptoms - see section 4. Possible Side Effects). The doctor should inform the patient if they have had this syndrome in the past.
• low sodium levels in the blood, as this may occur due to Zotral treatment. The patient should also inform their doctor about taking certain medications used to treat high blood pressure, as they may also change sodium levels in the blood.
• old age, due to increased risk of low sodium levels in the blood (see above).
• liver disease; the doctor may decide to reduce the dose of Zotral.
• diabetes; Zotral may affect blood sugar levels, so a change in the dosage of antidiabetic medications may be necessary.
• bleeding disorders or a history of taking medications that prevent blood clotting (e.g., acetylsalicylic acid or warfarin) or may increase the risk of bleeding or if the patient is pregnant (see "Pregnancy, Breastfeeding, and Fertility").
• children or adolescents under 18 years of age. Zotral may only be used in the treatment of children and adolescents aged 6-17 years with obsessive-compulsive disorder (OCD). Patients treated for this condition should be closely monitored by their doctor (see use in children and adolescents).
• electroconvulsive therapy (ECT).
• eye diseases, such as a certain type of glaucoma (increased pressure inside the eye).
• while taking Zotral, urine screening tests for benzodiazepines may give false-positive results. Specific confirmatory tests will distinguish sertraline from benzodiazepines.
• medications like Zotral (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was stopped.
• acute or chronic pain or other conditions treated with opioid medications. Taking these medications at the same time as Zotral may lead to serotonin syndrome, a potentially life-threatening disease (see "Zotral and Other Medications").

Psychomotor Restlessness/Akathisia

Sertraline treatment has been associated with the occurrence of psychomotor restlessness and a compulsion to perform movements - often with an inability to sit or stand still (akathisia). This condition usually occurs within the first few weeks of treatment. Increasing the dose of the medication may be harmful to patients with these symptoms, so they should inform their doctor.

Withdrawal Symptoms

After stopping treatment, withdrawal symptoms often occur, especially if treatment is stopped abruptly (see section 3. Stopping Zotral 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 may 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 may persist for longer (for 2-3 months or longer).
In case of a decision to stop sertraline treatment, it is recommended to gradually reduce the dose over several weeks or months. The patient should always discuss with their doctor the best way to stop treatment.

Suicidal Thoughts, Worsening of Depressive or Anxiety Disorders

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

The Occurrence of Suicidal Thoughts, Self-Harm, or Suicidal Behavior is More Likely if:

• the patient has had suicidal thoughts or self-harm in the past;
• the patient is a young adult; clinical trial data indicate an increased risk of suicidal behavior in individuals under 25 years of age with mental disorders who are treated with antidepressants. If the patient has suicidal thoughts or self-harm, they should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friends about depression or anxiety disorders and ask them to read this package leaflet. The patient may ask relatives or friends for help and ask them to inform them if they notice that depression or anxiety has worsened or if there are any worrying changes in behavior.

Children and Adolescents

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

Zotral and Other Medications

The patient should tell their doctor about all medications they are currently taking or plan to take.
Certain medications may affect how Zotral works or Zotral may reduce the effectiveness of other medications taken at the same time.

Taking Zotral with the Following Medications May Cause Serious Side Effects

• 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. Zotral should not be taken with these medications.
• medications used to treat mental disorders, such as psychoses (pimozide). Zotral should not be taken with pimozide.
• opioid medications used to treat acute or chronic pain (e.g., buprenorphine) and opioid medications in combination with opioid antagonists for the treatment of opioid dependence (e.g., buprenorphine/naloxone). Sertraline should not be taken with opioids without prior consultation with a doctor. These medications may interact with Zotral and cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness, and body temperature above 38°C. If such symptoms occur, the doctor should be contacted.

The Patient Should Inform Their Doctor if They are Taking the Following Medications

• herbal preparations 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.
• medications used to treat severe pain (e.g., tramadol, buprenorphine, and other opioid pain medications).
• medications used for anesthesia or chronic pain treatment (fentanyl).
• medications used to treat migraines (e.g., sumatriptan).
• blood thinners (warfarin).
• medications used to treat pain/joint inflammation (non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen, acetylsalicylic acid).
• sedatives (diazepam).
• diuretics.
• medications used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• medications used to treat diabetes (tolbutamide).
• medications used to treat excessive stomach acid and stomach ulcers (cimetidine).
• 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 (such as perphenazine, levomepromazine, and olanzapine).
• medications used to regulate heart rate and rhythm (such as flecainide, propafenone).
• medications used to treat bacterial infections (clarithromycin, telithromycin, erythromycin, rifampicin).
• medications used to reduce stomach acid (e.g., omeprazole, lansoprazole, pantoprazole, rabeprazole).
• medications used to prevent vomiting and nausea after surgery or chemotherapy (e.g., aprepitant).
• medications used to treat and prevent fungal infections (e.g., ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• verapamil and diltiazem (medications used to treat high blood pressure, angina pectoris).
• medications used to treat HIV (e.g., protease inhibitors).
• metamizole, a medication used to treat pain and fever.

Zotral with Food, Drink, and Alcohol

Zotral film-coated tablets can be taken with or without food.
During Zotral treatment, the patient should avoid consuming alcohol.
The medication should not be taken with grapefruit juice, as it may increase sertraline levels in the body.

Pregnancy, Breastfeeding, and Fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
The safety of sertraline use in pregnant women has not been fully confirmed. The medication can be used in pregnant women only if the doctor believes that the benefits of the medication to the mother outweigh the potential risks to the developing fetus. Women of childbearing age taking sertraline should use effective contraception (e.g., birth control pills).
The patient should inform their doctor and/or midwife about taking Zotral. Taking medications like Zotral during pregnancy, especially in the last three months, may increase the risk of the newborn developing a serious complication called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and bluish discoloration. These symptoms usually appear within the first day of life. If such symptoms occur in the newborn, the doctor and/or midwife should be contacted immediately.
Taking Zotral at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if the patient has a history of bleeding disorders. If the patient is taking Zotral, they should inform their doctor or midwife so that they can provide appropriate advice.
Newborns may also experience other symptoms, which usually occur within the first 24 hours of life. These symptoms include:

• breathing difficulties,
• bluish discoloration of the skin, feeling hot or cold,
• bluish lips,
• vomiting or difficulty feeding,
• feeling tired, difficulty sleeping, or constant crying,
• stiffness or limpness of muscles,
• tremors, shivering, or seizures,
• increased reflexes,
• irritability,
• low blood sugar,
• low or high blood pressure.

If the newborn has any of these symptoms, or if the caregiver is concerned about the baby's health, they should contact the doctor or midwife, who will provide advice.
There is evidence that sertraline passes into breast milk. The medication can be used in breastfeeding women if the doctor believes that the benefits of the medication outweigh the potential risks to the baby.
In animal studies, some medications similar to sertraline have been shown to decrease sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans.

Driving and Using Machines

Psychotropic medications, such as sertraline, may affect the ability to drive or operate machinery. The patient should wait until it is known how Zotral affects their ability to perform these activities.

Zotral Contains Lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medication.

Zotral Contains Sodium

The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to Take Zotral

This medication should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Zotral film-coated tablets can be taken with or without food.
The medication should be taken once a day, in the morning or evening.

Recommended Dose is

Adults:

Depression and Obsessive-Compulsive Disorder

The usual effective dose for treating depression and OCD is 50 mg per 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 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, which can be increased to 50 mg per 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 per day.

Children and Adolescents:

Zotral can only be used to treat children and adolescents with obsessive-compulsive disorder (OCD) aged 6-17 years.

Obsessive-Compulsive Disorder

Children aged 6-12 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 13-17 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.
The doctor will inform the patient how long they should take the medication. The treatment period depends on the type of disease and the patient's response to treatment. Improvement may begin only after several weeks of treatment. Depression treatment should usually be continued for another six months after symptoms have resolved.
The tablet can be divided into equal doses.

Taking a Higher Than Recommended Dose of Zotral

If the patient accidentally takes too much Zotral, they should immediately contact their doctor or go to the emergency department of the nearest hospital. They should always take the medication packaging with them, regardless of whether there is medication left in it or not.
Overdose symptoms may include drowsiness, nausea, and vomiting, rapid heart rate, muscle tremors, agitation, dizziness, and, in rare cases, loss of consciousness.

Missing a Dose of Zotral

If the patient forgets to take a tablet, they should not take the missed tablet. They should simply take the next tablet at the right time.
The patient should not take a double dose to make up for the missed dose.

Stopping Zotral Treatment

The patient should not stop taking Zotral on their own. The doctor will recommend gradually reducing the dose of Zotral over several weeks before the patient stops taking it.
If the patient suddenly stops taking the medication, they may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors (see section 3. Stopping Zotral Treatment).
If the patient experiences any of these side effects or any other side effects after stopping Zotral treatment, they should contact their doctor.
In case of any further doubts about taking this medication, the patient should contact their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Zotral can cause side effects, although not everyone gets them.
If any side effects worsen or if any side effects not listed in this package leaflet occur, the patient should inform their doctor or pharmacist.
The most common side effect is nausea. Side effects depend on the dose and usually resolve or decrease as treatment continues.

The Patient Should Immediately Contact Their Doctor

If, after taking this medication, the patient experiences any of the following symptoms (as they may be serious):

• if the patient develops a severe skin rash that causes blisters (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 stop the patient's treatment with Zotral.
• an allergic reaction or allergy, which may include symptoms such as an itchy skin rash, breathing difficulties, wheezing, swelling of the eyelids, face, or lips.
• if the patient experiences: agitation, confusion, diarrhea, high temperature and blood pressure, excessive sweating, and rapid heart rate. These are symptoms of serotonin syndrome or malignant neuroleptic syndrome. In rare cases, these syndromes may occur when the patient takes certain medications at the same time as sertraline. The doctor may then stop 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.
• if the patient feels restless and unable to sit or stand still.
• if the patient has seizures (epileptic fits).
• if the patient experiences a manic episode (see section 2. Warnings and Precautions).

The following side effects have been observed in clinical trials in adult patients.

Very Common (Occurring in More Than 1 in 10 Patients):

• insomnia, dizziness, drowsiness, headaches, diarrhea, nausea, dry mouth, ejaculation disorders, fatigue.

Common (Occurring in Less Than 1 in 10 Patients):

• sore throat, loss of appetite, increased appetite,
• depression, "strange" feeling, nightmares, anxiety, agitation, nervousness, decreased interest in sex, teeth grinding,
• numbness and tingling, muscle tremors, increased muscle tone, taste disorders, concentration disorders,
• vision disorders, ringing in the ears,
• palpitations, hot flashes, yawning,
• abdominal pain, vomiting, constipation, gastrointestinal disorders, gas,
• rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, chest pain.

Uncommon (Occurring in Less Than 1 in 100 Patients):

• common cold, runny nose,
• hallucinations, euphoria, apathy, thought disorders,
• seizures, involuntary muscle contractions, coordination disorders, increased restlessness, memory loss, sensation disorders, speech disorders, dizziness when standing up, migraine,
• ear pain, rapid heart rate, high blood pressure, hot flashes,
• breathing difficulties, possible snoring, shortness of breath, nosebleeds,
• esophageal inflammation, difficulty swallowing, hemorrhoids, increased salivation, tongue disorders, belching,
• eye swelling, purplish spots on the skin, abnormal hair structure, abnormal skin odor, bone disorders,
• decreased urination, urinary incontinence, delayed urination,
• excessive vaginal bleeding, vaginal dryness, painful red penis and foreskin, discharge, prolonged erection, nipple discharge,
• hernia, decreased drug tolerance, walking difficulties, abnormal laboratory test results, abnormal sperm test results, injuries, blood vessel weakness,
• cases of suicidal thoughts and behaviors in patients during sertraline treatment or soon after stopping treatment (see section 2).

Rare (Occurring in Less Than 1 in 1000 Patients):

• gastrointestinal disorders, ear infections, cancer, gland swelling, increased cholesterol levels, decreased glucose levels in the blood,
• physical symptoms caused by stress or emotions, drug dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation,
• coma, abnormal movements, difficulty moving, increased sensitivity, sensation disorders,
• spots before the eyes, glaucoma, double vision, light sensitivity, eye bleeding, uneven pupil size, vision disorders, tear secretion disorders
• heart attack, slow heart rate, heart problems, worsening of blood circulation in the arms and legs, laryngospasm, rapid breathing, slow breathing, speech difficulties, hiccups,
• bloody stools, painful mouth, tongue ulcers, tooth disorders, tongue inflammation, mouth ulcers, liver disorders,
• skin disorders with blistering, hairy skin rash, abnormal hair structure, abnormal skin odor, bone disorders,
• decreased urination, urinary incontinence, delayed urination,
• excessive vaginal bleeding, vaginal dryness, painful red penis and foreskin, discharge, prolonged erection, nipple discharge,
• hernia, decreased drug tolerance, walking difficulties, abnormal laboratory test results, abnormal sperm test results, injuries, blood vessel weakness,

Frequency Not Known (Cannot be Estimated from Available Data):

• decreased white blood cell count, decreased platelet count, decreased thyroid hormone levels, endocrine disorders, decreased sodium levels in the blood, difficulty controlling blood sugar levels (diabetes), increased blood sugar levels,
• nightmares,
• movement disorders (such as increased motor activity, increased muscle tone, and difficulty walking, as well as stiffness, muscle spasms, and involuntary movements), fainting, sudden, severe headache (which may be a symptom of a serious condition called reversible cerebral vasoconstriction syndrome or Call-Fleming syndrome),
• vision disorders, uneven pupil size, partial vision loss, bleeding disorders (including nosebleeds, gastrointestinal bleeding, or blood in the urine), pancreatitis, severe liver function disorders, yellowing of the skin and eyes (jaundice),
• skin swelling, sun allergy, itching, joint pain, muscle spasms, bladder problems, blood clotting disorders (including bleeding from the nose, gastrointestinal bleeding, or blood in the urine), severe allergic reactions, and progressive scarring of lung tissue (interstitial lung disease)
• inflammatory bowel disease (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 in Children and Adolescents

In clinical trials with 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.

Symptoms that May Occur After Stopping Treatment

When stopping treatment with this medication, side effects may occur, such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors (see section 3. Stopping Zotral Treatment).
Patients taking medications from this group have been observed to have an increased risk of fractures.

Reporting Side Effects

If side effects occur, including those not listed in this package leaflet, the patient should inform their 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 gather more information on the safety of this medication.

5. How to Store Zotral

The medication should be stored out of sight and reach of children.
The medication should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
The notation on the packaging after the abbreviation EXP indicates the expiration date, and after the abbreviation Lot/LOT, it indicates the batch number.
There are no special storage instructions.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Zotral Contains

• The active substance of the medication is sertraline. Zotral 50 mg film-coated tablets: Each film-coated tablet contains 50 mg of sertraline (as hydrochloride). Zotral 100 mg film-coated tablets: Each film-coated tablet contains 100 mg of sertraline (as hydrochloride).
• Other ingredients of the medication are: tablet core: lactose monohydrate, microcrystalline cellulose (Avicel PH 102), povidone K30, sodium carboxymethyl cellulose, magnesium stearate; 50 mg tablet coating: hypromellose 6, talc, propylene glycol, titanium dioxide (E 171); 100 mg tablet coating: hypromellose 6, hypromellose 15, talc, propylene glycol, titanium dioxide (E 171).

What Zotral Looks Like and What the Package Contains

Zotral 50 mg film-coated tablets:
White, oval, biconvex, with a score line on one side and the letter L embossed on the other.
The tablets can be divided into equal doses.
The package contains 28 tablets in a cardboard box.
Zotral 100 mg film-coated tablets:
White, round, biconvex, with a score line on one side and the letter C embossed on the other.
The tablets can be divided into equal doses.
The package contains 28 tablets in a cardboard box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
Actavis Ltd., BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000, Malta

Date of Last Update of the Package Leaflet: