GISARTAN 80 mg/25 mg Tablets

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET
2. Leaflet accompanying the packaging: patient information
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Gisartan and what is it used for
4. Important information before taking Gisartan
   1. When not to take Gisartan
   2. Warnings and precautions
   3. Children and adolescents
   4. Other medicines and Gisartan
   5. Taking Gisartan with food and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Gisartan contains sodium
5. How to take Gisartan
   1. Taking more Gisartan than prescribed
6. Possible side effects
   1. Some side effects can be serious and require immediate medical attention:
   2. Side effects of Gisartan:
   3. Telmisartan
   4. Hydrochlorothiazide
   5. Reporting side effects
7. How to store Gisartan
8. Contents of the packaging and other information
   1. What Gisartan contains
   2. What Gisartan looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
9. Possible Adverse Reactions
   1. Some Adverse Reactions May Be Severe and Require Immediate Medical Attention:
   2. Possible Adverse Reactions of Gisartan:
   3. Telmisartan
   4. Hydrochlorothiazide
   5. Reporting Adverse Reactions
10. How to Store Gisartan
11. Package Contents and Other Information
    1. What Gisartan Contains
    2. Appearance of Gisartan and Package Contents
    3. Marketing Authorization Holder and Manufacturer

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, so you can read it again if you need to.
• Consult your 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 as yours.
• If you experience any side effects, including those not listed in the 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. Contents of the packaging and other information

1. What is Gisartan and what is it used for

Gisartan is a combination medicine containing 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, causing blood vessels to narrow, which increases blood pressure. Telmisartan blocks the action of angiotensin II, causing blood vessels to widen 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, can lead to complications such as heart attack, heart failure, or kidney failure, stroke, or vision loss. Usually, 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 you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to hydrochlorothiazide or other sulfonamide derivatives;
• after the third month of pregnancy (also, avoid taking Gisartan during early pregnancy - see "Pregnancy");
• if you have 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 you have severe kidney disease;
• if your doctor has found that you have low potassium or high calcium levels in your blood that do not improve with treatment;
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to you, inform your doctor or pharmacist before taking Gisartan.

Warnings and precautions

Before starting to take Gisartan, tell your doctor if you have or have had any of the following conditions or diseases:

• low blood pressure (hypotension), which is more likely to occur if you are dehydrated (with excessive water loss from the body) or have 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 (SLE), a disease in which the immune system attacks the body;
• hydrochlorothiazide may cause rare reactions leading 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 may lead to permanent vision loss;
• if you have had skin cancer or if an unexpected skin change occurs during treatment. Hydrochlorothiazide treatment, especially with high doses over a long period, may increase the risk of certain types of skin cancer (non-melanoma skin cancer). When taking Gisartan, protect your skin from sunlight and UV radiation.

Tell your doctor before taking Gisartan:

• if you are taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren. Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading "When not to take Gisartan".

• if you are taking digoxin.

Tell your doctor if you suspect (or plan) 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 baby (see "Pregnancy").
Hydrochlorothiazide treatment 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 heartbeat (faster than 100 beats per minute). If you experience any of these symptoms, inform your doctor.
Also, inform your doctor if you experience increased sensitivity of the skin to sunlight, in the form of sunburn (e.g., redness, itching, swelling, blistering) that occurs more quickly than usual.
If you are scheduled for surgery or anesthesia, inform your doctor that you are 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

Tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Your 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 may increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressive medicine), and other medicines, such as sodium heparin (an anticoagulant);
• medicines 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);
• colestipol and cholestyramine, medicines that lower cholesterol levels in the blood;
• 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 prevent or treat certain viral diseases);
• other medicines used to treat high blood pressure, corticosteroids, painkillers (e.g., nonsteroidal anti-inflammatory drugs, NSAIDs), medicines used to treat cancer, gout, or arthritis;
• if you are taking an ACE inhibitor or aliskiren (see also the information under the heading "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 may lower blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure may be exacerbated by alcohol, barbiturates, narcotics, or antidepressants. You may notice this as dizziness when standing up.
Consult your 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 nonsteroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen).

Taking Gisartan with food and alcohol

Gisartan can be taken with or without food.
Avoid alcohol until you have talked to your doctor. Alcohol may further lower your blood pressure and increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy
Tell your doctor if you suspect (or plan) pregnancy. Your doctor will normally advise you to stop taking Gisartan before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different 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 baby (see "Pregnancy").
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. Gisartan is not recommended during breastfeeding. Your doctor may choose a different treatment during breastfeeding.

Driving and using machines

Some patients taking Gisartan may experience dizziness or fatigue. In this case, do not drive or operate machinery.

Gisartan contains sodium

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

3. How to take Gisartan

Always take Gisartan exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Gisartan is one tablet per day. Try to take your tablet at the same time each day. Gisartan can be taken with or without food.
Swallow the tablets with water or a non-alcoholic drink. It is important to take Gisartan every day until your doctor tells you to stop.
If you have liver problems, the usual dose should not exceed 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide per day.

Taking more Gisartan than prescribed

If you accidentally take too many tablets, you may experience low blood pressure and rapid heartbeat. There have also been reports of slow heartbeat, dizziness, vomiting, worsening kidney function, including kidney failure. Due to the hydrochlorothiazide content, you may also experience very low blood pressure and low potassium levels in the blood, which can lead to nausea, drowsiness, and muscle cramps, and irregular heartbeat associated with the concurrent use of medicines such as digitalis glycosides and certain antiarrhythmic medicines. Contact your doctor or pharmacist immediately or go to the nearest hospital emergency department.

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 you experience any of the following symptoms, contact your doctor immediately:
Septicaemia (blood poisoning) is a serious infection with an inflammatory response throughout the body, sudden swelling of the skin and mucous membranes (angioedema), blistering and peeling of the outer layer of the skin (toxic epidermal necrolysis).
These side effects are rare (may affect up to 1 in 1,000 people) or have an unknown frequency (in the case of toxic epidermal necrolysis), but they are extremely serious, and you should stop taking the medicine and contact your doctor immediately. If left untreated, they may be fatal.
The increased incidence of sepsis has been observed in patients taking telmisartan monotherapy, but it cannot be ruled out in the case of Gisartan therapy.

Side effects of Gisartan:

Common side effects (may affect up to 1 in 10 people):
Dizziness
Uncommon side effects (may affect up to 1 in 100 people):
Low potassium levels in the blood, anxiety, fainting, tingling or numbness (paresthesia), spinning sensation (vertigo), rapid heartbeat (tachycardia), irregular heartbeat, low blood pressure, sudden drop in blood pressure when standing up, shortness of breath (dyspnea), diarrhea, dry 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 affect up to 1 in 1,000 people):
Pneumonia (inflammation of the lungs), worsening of systemic lupus erythematosus (a disease in which the immune system attacks the body), sore throat, sinusitis, depression, insomnia, vision disturbances, breathing difficulties, abdominal pain, constipation, bloating (indigestion), nausea (vomiting), gastritis, abnormal liver function (more common in Japanese patients), skin redness (rash), allergic reactions, such as itching or hives, increased sweating, hives, 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 when taking 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 affect up to 1 in 100 people):
Upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), urinary tract infections, low red blood cell count (anemia), high potassium levels in the blood, slow heartbeat (bradycardia), kidney problems, including acute kidney failure, weakness, cough.
Rare side effects (may affect up to 1 in 1,000 people):
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 diabetic patients), gastritis, skin rash, joint degeneration, tendonitis, decreased hemoglobin levels (a protein in the blood), drowsiness.
Very rare side effects (may affect up to 1 in 10,000 people):
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 affect up to 1 in 10 people):
Nausea, low magnesium levels in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
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 affect up to 1 in 10,000 people):
Increased pH (disturbed acid-base balance) due to low chloride levels in the blood.
Side effects with unknown frequency (frequency cannot be estimated from the available data):
Parotitis (inflammation of the salivary glands), malignant tumors of the skin and lips (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, restricted vision and eye pain (possibly symptoms of fluid accumulation in the vascular layer surrounding the eye or acute glaucoma), vasculitis (inflammation of blood vessels), pancreatitis, gastritis, jaundice (yellowing of the skin and eyes), systemic lupus erythematosus-like syndrome (a disease that mimics lupus), skin disorders, such as vasculitis, increased sensitivity to sunlight, rash, redness of the skin, blistering of the lips, eyes, and mouth, peeling of the skin, fever (possibly 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 known diabetes.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, 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, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gisartan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, blister, or label on the bottle after "EXP". The expiry date refers to the last day of the month stated.
Aluminum/Aluminum blisters and HDPE container
No special storage precautions are required.
PVC/PVDC/Aluminum blisters
Do not store above 30°C.
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 packaging and other information

What Gisartan contains

• The active substances 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.
Pack 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
tel.: (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:December 2020

4. Possible Adverse Reactions

Like all medications, this medication can cause adverse reactions, although they do not occur in everyone.

Some Adverse Reactions May Be Severe and Require Immediate Medical Attention:

In the event of any of the following symptoms, one should immediately contact a doctor: Septicemia* (often referred to as blood poisoning) being a severe infection, with an inflammatory reaction of the entire body, sudden swelling of the skin and mucous membranes (angioedema), blistering and peeling of the outer skin layer (toxic epidermal necrolysis). The above adverse reactions 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 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 frequency of septicemia has been observed in individuals taking telmisartan in monotherapy, but it cannot be ruled out in the case of therapy with Gisartan.

Possible Adverse Reactions of Gisartan:

Common adverse reactions (may occur in up to 1 in 10 patients): Dizziness. Uncommon adverse reactions (may occur in up to 1 in 100 patients): Decreased potassium levels in the blood, anxiety, fainting, tingling and numbness (paresthesia), feeling of spinning, 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 spasms, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, increased uric acid levels in the blood. Rare adverse reactions (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, feeling of sadness (depression), difficulty sleeping (insomnia), vision disturbances, breathing difficulties, 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 spasms, flu-like symptoms, pain, low sodium levels, increased creatinine levels, increased liver enzyme activity or creatine phosphokinase in the blood. Adverse reactions reported for one of the components may also occur during therapy with Gisartan, even if they were not observed during clinical trials of the product.

Telmisartan

In patients taking only telmisartan, the following additional adverse reactions have been observed: Uncommon adverse reactions (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 adverse reactions (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 adverse reactions (may occur in up to 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 temporal association with the use of telmisartan. However, a causal relationship has not been established.

Hydrochlorothiazide

In patients taking only hydrochlorothiazide, the following additional adverse reactions have been observed: Common adverse reactions (may occur in up to 1 in 10 patients): Nausea, low magnesium levels in the blood. Rare adverse reactions (may occur in up to 1 in 1,000 patients): Decreased 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 adverse reactions (may occur in up to 1 in 10,000 patients): Increased pH (disturbed acid-base balance) due to low chloride levels in the blood. Adverse reactions with an unknown frequency of occurrence (frequency impossible to estimate based on available data): Salivary gland inflammation, 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 (probably 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 (necrotizing vasculitis), pancreatitis, gastritis, jaundice (yellowing of the skin or eyes), lupus-like syndrome (a disease mimicking systemic lupus erythematosus, in which the body is attacked by its own immune system), skin disorders, such as vasculitis of the skin, 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 (glycosuria), fever, electrolyte imbalance disorders, high cholesterol levels in the blood, decreased blood volume, increased blood glucose levels, difficulty controlling blood glucose levels/urine in patients with diagnosed diabetes or fat in the blood.

Reporting Adverse Reactions

If any adverse reactions occur, including any adverse reactions not listed in the leaflet, one should inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Adverse Reaction Monitoring 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. Adverse reactions can also be reported to the marketing authorization holder. By reporting adverse reactions, more information can be gathered 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 storage precautions. PVC/PVDC/Aluminum blisters: Do not store above 30°C. Medications should not be disposed of in wastewater or household waste containers. One should ask a pharmacist how to dispose of unused medications. 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.
• The other ingredients are: magnesium stearate (E 470b), potassium hydroxide, meglumine, povidone, sodium carboxymethyl cellulose (type A), microcrystalline cellulose, mannitol (E 421).

Appearance of Gisartan and Package Contents

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 package 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 leaflet update:December 2020