Gisartan

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Gisartan, 80 mg + 12.5 mg, tablets
Telmisartan + Hydrochlorothiazide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• Consult a doctor or pharmacist if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Gisartan and what is it used for
• 2. Important information before taking Gisartan
• 3. How to take Gisartan
• 4. Possible side effects
• 5. How to store Gisartan
• 6. Package contents and other information

1. What is Gisartan and what is it used for

Gisartan is a combination medicine that contains two active substances, telmisartan and hydrochlorothiazide, in one tablet. Both substances help control high blood pressure.

• Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to constrict, thereby increasing blood pressure. Telmisartan blocks the action of angiotensin II, which causes blood vessels to dilate and blood pressure to decrease.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which increase urine production, leading to a decrease in blood pressure.

Untreated high blood pressure can cause damage to blood vessels in organs, and in some cases, it can lead to complications such as heart attack, heart failure, or kidney failure, stroke, or vision loss. Most often, before these complications occur, no symptoms of high blood pressure are observed. Therefore, it is essential to regularly measure blood pressure to check if it is within the normal range.
Gisartan is usedto treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by telmisartan or hydrochlorothiazide alone.

2. Important information before taking Gisartan

When not to take Gisartan

• if the patient is allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to hydrochlorothiazide or other sulfonamide derivatives;
• after the third month of pregnancy (also, avoid taking Gisartan during early pregnancy - see "Pregnancy");
• if the patient has severe liver disease, such as cholestasis or biliary obstruction (disorders of bile flow from the liver and gallbladder) or any other severe liver disease;
• if the patient has severe kidney disease;
• if the doctor finds low potassium levels or high calcium levels in the blood that do not improve with treatment;
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to the patient, they should inform their doctor or pharmacist before taking Gisartan.

Warnings and precautions

Before starting to take Gisartan, the patient should inform their doctor if they have or have had any of the following conditions or diseases:

• low blood pressure (hypotension), which is more likely to occur if the patient is dehydrated (with excessive water loss from the body) or has a salt deficiency due to the use of diuretics (water pills), a low-salt diet, diarrhea, vomiting, or hemodialysis;
• kidney disease or kidney transplant;
• renal artery stenosis (narrowing of the blood vessels of one or both kidneys);
• liver disease;
• heart problems;
• diabetes;
• gout;
• increased aldosterone levels (water and salt retention in the body, along with electrolyte imbalance);
• systemic lupus erythematosus (also known as "lupus" or "SLE"), a disease in which the immune system attacks the body;
• the active substance hydrochlorothiazide may cause rare reactions that lead to vision loss and eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure in the eyeball, which may occur within a few hours to a few weeks after taking Gisartan. If left untreated, they can lead to permanent vision loss;
• if the patient has a history of skin cancer or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially with high doses over a long period, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). During treatment with Gisartan, the patient should protect their skin from sunlight and UV radiation;
• if the patient has a history of breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient experiences severe shortness of breath or difficulty breathing after taking Gisartan, they should seek medical help immediately.

The patient should consult their doctor before taking Gisartan:

• if the patient is taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes.
• aliskiren. The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also the information under "When not to take Gisartan".
• if the patient is taking digoxin.

The patient should inform their doctor about suspected or planned pregnancy. It is not recommended to take Gisartan during early pregnancy. Do not take it after the third month of pregnancy, as it may seriously harm the fetus (see "Pregnancy").
Treatment with hydrochlorothiazide may lead to electrolyte imbalance in the body.
Typical symptoms of fluid or electrolyte imbalance include dryness of the mucous membranes in the mouth, weakness, lethargy, drowsiness, anxiety, muscle cramps, nausea (vomiting), vomiting, muscle fatigue, and abnormally rapid heart rate (faster than 100 beats per minute). If any of these symptoms occur, the patient should inform their doctor.
The patient should also inform their doctor about increased skin sensitivity to sunlight, in the form of sunburn (e.g., redness, itching, swelling, blistering) that occurs more quickly than usual.
In the case of planned surgery or anesthesia, the patient should inform their doctor about taking Gisartan.
Gisartan may be less effective in lowering blood pressure in black patients.

Children and adolescents

Gisartan is not recommended for children and adolescents under 18 years of age.

Other medicines and Gisartan

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The doctor may decide to change the dose of these medicines or take other precautions. In some cases, it may be necessary to stop taking one of the medicines. This is especially true for the following medicines taken with Gisartan:

• lithium preparations used to treat certain types of depression;
• medicines associated with low potassium levels in the blood (hypokalemia), such as other diuretics (water pills), laxatives (e.g., castor oil), corticosteroids (e.g., prednisolone), adrenocorticotropic hormone (ACTH), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (an antibiotic), salicylic acid, and its derivatives;
• medicines that can increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporine (an immunosuppressive medicine), and other medicinal products, such as sodium heparin (an anticoagulant);
• medicines that are affected by changes in potassium levels in the blood, such as heart medicines (e.g., digoxin) or medicines used to control heart rhythm (e.g., quinidine, disopyramide, amiodarone, sotalol), medicines used to treat mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), and other medicines, such as certain antibiotics (e.g., sparfloxacin, pentamidine) or certain medicines used to treat allergic reactions (e.g., terfenadine);
• medicines used to treat diabetes (insulin or oral medicines such as metformin);
• cholestyramine and colestipol, medicines that lower blood fat levels;
• medicines that increase blood pressure, such as noradrenaline;
• muscle relaxants, such as tubocurarine;
• calcium and/or vitamin D supplements;
• medicines with anticholinergic effects (used to treat various disorders, such as spasms in the digestive tract, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an adjunct to anesthesia), such as atropine and biperiden;
• amantadine (a medicine used to treat Parkinson's disease and to treat or prevent certain viral diseases;
• other medicines used to treat high blood pressure, corticosteroids, pain relievers (e.g., nonsteroidal anti-inflammatory drugs, NSAIDs), medicines used to treat cancer, gout, or arthritis;
• if the patient is taking an ACE inhibitor or aliskiren (see also the information under "When not to take Gisartan" and "Warnings and precautions");
• digoxin.

Gisartan may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that can potentially lower blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure may be exacerbated by alcohol, barbiturates, narcotics, or antidepressants. The patient may experience this as dizziness when standing up.
It is recommended to consult a doctor if it is necessary to adjust the dose of another medicine while taking Gisartan.
The effect of Gisartan may be reduced when taken with NSAIDs (nonsteroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen).

Taking Gisartan with food and alcohol

Gisartan can be taken with or without food.
It is recommended to avoid alcohol until consulting a doctor. Alcohol may further lower blood pressure and (or) increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

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 medicine.
Pregnancy
The patient should inform their doctor about suspected or planned pregnancy. Usually, the doctor will advise stopping Gisartan before planned pregnancy or immediately after pregnancy is confirmed and will prescribe another medicine instead of Gisartan. It is not recommended to take Gisartan during pregnancy. Do not take it after the third month of pregnancy, as it may seriously harm the fetus, if taken after 3 months of pregnancy.
Breastfeeding
The patient should tell their doctor about breastfeeding or intending to breastfeed. Gisartan is not recommended during breastfeeding. The doctor may choose another treatment during breastfeeding.

Driving and using machines

Some patients taking Gisartan may experience dizziness or fatigue. In such cases, they should not drive or operate machines.

Gisartan contains sodium

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

3. How to take Gisartan

Gisartan should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose of Gisartan is one tablet per day. The patient should try to take the tablet at the same time every day. Gisartan can be taken with or without food.
The tablets should be swallowed with water or a non-alcoholic drink. It is essential to take Gisartan every day, unless the doctor advises otherwise.
If the patient has liver problems, the usual dose should not exceed 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide per day.

4. Possible side effects

Like all medicines, Gisartan can cause side effects, although not everybody gets them.

Some side effects can be serious and require immediate medical attention:

If the patient experiences any of the following symptoms, they should contact their doctor immediately:
Septicaemia (often referred to as blood poisoning) is a severe infection with an inflammatory reaction throughout the body, sudden swelling of the skin and mucous membranes (angioedema), blistering and peeling of the outer skin layer (toxic epidermal necrolysis).
These side effects are rare (may occur in up to 1 in 1,000 patients) or have an unknown frequency (in the case of toxic epidermal necrolysis), but they are extremely severe, and the patient should stop taking the medicine and contact their doctor immediately. If left untreated, they can be fatal.
The increased frequency of sepsis has been observed in patients taking telmisartan monotherapy, but it cannot be ruled out in the case of Gisartan therapy.
Very rare (may occur in less than 1 in 10,000 patients): acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).

Possible side effects of Gisartan:

Common side effects (may occur in up to 1 in 10 patients):
Dizziness
Uncommon side effects (may occur in up to 1 in 100 patients):
Low potassium levels in the blood, anxiety, fainting, tingling or numbness (paresthesia), spinning sensation, rapid heartbeat (tachycardia), irregular heartbeat, low blood pressure, sudden drop in blood pressure when standing up, shortness of breath (dyspnea), diarrhea, dryness of the mucous membranes in the mouth, bloating, back pain, muscle cramps, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, increased uric acid levels in the blood.
Rare side effects (may occur in up to 1 in 1,000 patients):
Bronchitis (inflammation of the airways), exacerbation of systemic lupus erythematosus (a disease in which the immune system attacks the body, causing joint pain, skin rashes, and fever), sore throat, sinusitis, depression, insomnia, vision disturbances, abdominal pain, constipation, bloating (indigestion), nausea (vomiting), gastritis (inflammation of the stomach lining), abnormal liver function (more common in patients of Japanese origin), skin redness (rash), allergic reactions, such as itching or hives, increased sweating, urticaria, joint pain and limb pain, muscle cramps, flu-like symptoms, pain, low sodium levels, increased creatinine levels, increased liver enzyme activity or creatine phosphokinase in the blood.
Side effects reported for one of the active substances may also occur during treatment with Gisartan, even if they were not observed during clinical trials of the product.

Telmisartan

In patients taking telmisartan alone, the following additional side effects have been observed:
Uncommon side effects (may occur in up to 1 in 100 patients):
Upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), urinary tract infections, low red blood cell count (anemia), high potassium levels, slow heart rate (bradycardia), kidney problems, including acute kidney failure, weakness, cough.
Rare side effects (may occur in up to 1 in 1,000 patients):
Low platelet count (thrombocytopenia), increased white blood cell count (eosinophilia), severe allergic reaction (e.g., hypersensitivity, anaphylactic reaction, allergic dermatitis), low blood sugar levels (in patients with diabetes), gastritis, skin rash, joint degeneration, tendonitis, decreased hemoglobin levels (a protein in the blood), drowsiness.
Very rare side effects (may occur in less than 1 in 10,000 patients):
Progressive interstitial lung disease (a condition in which the lungs become scarred)**
*This phenomenon may be coincidental or related to a mechanism that has not yet been understood.
**Cases of interstitial lung disease have been reported in association with telmisartan. However, a causal relationship has not been established.

Hydrochlorothiazide

In patients taking hydrochlorothiazide alone, the following additional side effects have been observed:
Common side effects (may occur in up to 1 in 10 patients):
Nausea, low magnesium levels in the blood.
Rare side effects (may occur in up to 1 in 1,000 patients):
Low platelet count, which can increase the risk of bleeding or bruising (small, purple spots on the skin or in other tissues, caused by bleeding), high calcium levels in the blood, headache.
Very rare side effects (may occur in less than 1 in 10,000 patients):
Increased pH (disturbed acid-base balance) due to low chloride levels in the blood.
Side effects with unknown frequency (frequency cannot be estimated from available data):
Salivary gland inflammation, malignant skin tumors and lip tumors (non-melanoma skin cancer), decreased blood cell count, including low red and white blood cell count, severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), decreased or lost appetite, anxiety, feeling of emptiness in the head, blurred vision or yellow vision, limited vision and eye pain (likely symptoms of fluid accumulation in the vascular layer surrounding the eye or increased pressure in the eyeball), vasculitis (inflammation of blood vessels), pancreatitis, gastritis, jaundice (yellowing of the skin and eyes), systemic lupus erythematosus-like syndrome (a disease that mimics systemic lupus erythematosus, in which the immune system attacks the body), skin disorders, such as vasculitis, increased sensitivity to sunlight, rash, skin redness, blistering on the lips, eyes, and mouth, skin peeling, fever (possible symptoms of erythema multiforme), weakness, kidney problems or kidney dysfunction, glucose in the urine (glycosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, increased blood sugar levels, difficulty controlling blood sugar levels/urine in patients with diagnosed diabetes.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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 Gisartan

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the packaging, blister, or label after "EXP". The expiry date refers to the last day of the month.
Aluminium/Aluminium blisters and HDPE container
No special storage precautions are required.
PVC/PVDC/Aluminium blisters
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Gisartan contains

• The active substances of Gisartan are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
• The other ingredients are magnesium stearate (E 470b), potassium hydroxide, meglumine, povidone, sodium carboxymethylcellulose (type A), microcrystalline cellulose, mannitol (E 421).

What Gisartan looks like and contents of the pack

Gisartan 80 mg + 12.5 mg tablets are white or almost white, capsule-shaped, and 9.0 x 17 mm in size, marked "TH 12.5" on both sides.
Package sizes
Blister packs: 14, 28, 56 tablets
Plastic container: 30, 90, and 250 tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
phone: (22) 345 93 00
Manufacturer
Actavis Ltd.
BLB 016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków
Date of last revision of the leaflet:October 2022

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious and require immediate medical attention:

In case of any of the following symptoms, you should immediately contact a doctor: sepsis* (often referred to as blood poisoning) being a severe infection, with an inflammatory reaction of the whole body, sudden swelling of the skin and mucous membranes (angioedema), blistering and peeling of the outer layer of the skin (toxic epidermal necrolysis). The above side effects are rare (may occur in up to 1 in 1,000 patients) or of unknown frequency (in the case of toxic epidermal necrolysis), but are extremely severe, in which case the medication should be discontinued and a doctor should be contacted immediately. If the above symptoms are not treated, they may result in death. An increased incidence of sepsis has been observed in patients taking telmisartan monotherapy, but it cannot be ruled out in the case of Gisartan therapy. Very rarely (may occur in fewer than 1 in 10,000 patients): acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).

Possible side effects of Gisartan:

Common side effects (may occur in up to 1 in 10 patients): dizziness. Uncommon side effects (may occur in up to 1 in 100 patients): low potassium levels in the blood, anxiety, fainting, tingling and numbness (paresthesia), spinning sensation, rapid heartbeat (tachycardia), heart rhythm disturbances, low blood pressure, sudden drop in blood pressure when standing up, shortness of breath (dyspnea), diarrhea, dryness of the mucous membranes in the mouth, bloating, back pain, muscle cramps, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, elevated uric acid levels in the blood. Rare side effects (may occur in up to 1 in 1,000 patients): pneumonia (bronchitis), onset or exacerbation of systemic lupus erythematosus (a disease in which the body is attacked by its own immune system, causing joint pain, skin rashes, and fever), sore throat, sinusitis, depression, insomnia, vision disturbances, abdominal pain, constipation, bloating (indigestion), nausea (vomiting), gastritis, abnormal liver function (more common in patients of Japanese origin), skin redness (erythema), allergic reactions, such as itching or rash, increased sweating, hives, joint pain and limb pain, muscle cramps, flu-like symptoms, pain, low sodium levels, elevated creatinine levels, elevated liver enzyme activity or creatine phosphokinase in the blood. Side effects reported for one of the components may also occur during Gisartan therapy, even if they were not observed during clinical trials of the product.

Telmisartan

In patients taking only telmisartan, the following additional side effects have been observed: uncommon side effects (may occur in up to 1 in 100 patients): upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), urinary tract infections, low red blood cell count (anemia), high potassium levels, slow heart rate (bradycardia), kidney function disorders, including acute kidney failure, weakness, cough. Rare side effects (may occur in up to 1 in 1,000 patients): low platelet count (thrombocytopenia), increased count of certain white blood cells (eosinophilia), severe allergic reaction (e.g., hypersensitivity, anaphylactic reaction, drug rash), low blood glucose levels (in patients with diabetes), gastritis, skin eruption (skin disorder), joint degeneration, tendonitis, decreased hemoglobin levels (blood protein), drowsiness. Very rare side effects (may occur in fewer than 1 in 10,000 patients): progressive scarring of the lung tissue (interstitial lung disease)** *This phenomenon may be coincidental or related to a mechanism that has not yet been understood. **Cases of interstitial lung disease have been reported in association with telmisartan. However, a causal relationship has not been established.

Hydrochlorothiazide

In patients taking only hydrochlorothiazide, the following additional side effects have been observed: common side effects (may occur in up to 1 in 10 patients): nausea, low magnesium levels in the blood. rare side effects (may occur in up to 1 in 1,000 patients): low platelet count, which increases the risk of bleeding or bruising (small, purple-red spots on the skin or in other tissues, caused by bleeding), high calcium levels in the blood, headache. very rare side effects (may occur in fewer than 1 in 10,000 patients): increased pH (disturbed acid-base balance) due to low chloride levels in the blood. side effects of unknown frequency (frequency cannot be estimated from available data): parotitis, skin and lip cancer (non-melanoma skin cancer), decreased blood cell count, including low red and white blood cell count, severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), decreased or lost appetite, anxiety, feeling of emptiness in the head, blurred vision or yellow vision, limited vision and eye pain (likely symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma), vasculitis, pancreatitis, jaundice, lupus-like syndrome (a disease that mimics systemic lupus erythematosus, in which the body is attacked by its own immune system), skin disorders, such as vasculitis, increased sensitivity to sunlight, rash, skin redness, blistering on the lips, eyes, and mouth, skin peeling, fever (possible symptoms of erythema multiforme), weakness, kidney inflammation or kidney function disorders, glucose in the urine (glucosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, elevated blood glucose levels, difficulty controlling blood glucose levels/urine in patients with diagnosed diabetes or blood lipid levels.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +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. By reporting side effects, you can help provide more information on the safety of the medication.

5. How to store Gisartan

The medication should be stored out of sight and reach of children. Do not use this medication after the expiration date stated on the carton, blister, or label on the bottle after: "EXP". The expiration date refers to the last day of the specified month. Aluminum/Aluminum blisters and HDPE container: No special precautions for storage. PVC/PVDC/Aluminum blisters: Do not store above 30°C. Medications should not be disposed of in wastewater or household waste containers. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Gisartan contains

• The active substances of the medication are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.
• Other ingredients are: magnesium stearate (E 470b), potassium hydroxide, meglumine, povidone, sodium carboxymethyl cellulose (type A), microcrystalline cellulose, mannitol (E 421).

What Gisartan looks like and what the pack contains

Gisartan tablets, 80 mg + 25 mg, are white or almost white, biconvex, oval, 9.0 x 17 mm in size, marked "TH" on one side and "25" on the other side Package sizesBlister packs: 14, 28, 56 tablets, Plastic container: 30, 90, and 250 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holderTeva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00 ManufacturerActavis Ltd., BLB 016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta, Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków Date of last revision of the leaflet:October 2022