Package leaflet: Information for the patient

Gisartan, 80 mg + 12.5 mg, tablets
Telmisartan + Hydrochlorothiazide
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
Consult your doctor or pharmacist if you have any questions.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Gisartan is and what it is used for
Important information before taking Gisartan
How to take Gisartan
Possible side effects
How to store Gisartan
Contents of the pack and other information

1. What Gisartan is and what it is used for

Gisartan is a combination medicine containing two active substances, telmisartan and hydrochlorothiazide, in a single 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 narrow, thereby increasing 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 output, leading to a reduction in blood pressure.

Untreated high blood pressure may damage blood vessels in organs and, in some cases, may lead to complications such as heart attack, heart or kidney failure, stroke, or loss of vision. Often, there are no symptoms of high blood pressure before these complications occur. Therefore, it is important to regularly monitor blood pressure to ensure it remains within the normal range.
Gisartan is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled by telmisartan or hydrochlorothiazide taken 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 (Gisartan should also be avoided during early pregnancy – see section “Pregnancy”);
if the patient has severe liver disease, such as biliary obstruction or cholestasis (impaired bile flow from the liver and gallbladder), or any other severe liver disease;
if the patient has severe kidney disease;
if the doctor has diagnosed low blood potassium levels or high blood calcium levels 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, inform your doctor or pharmacist before taking Gisartan.

Warnings and precautions

Before starting Gisartan, inform your doctor if the patient has or has previously had any of the following conditions or diseases:

low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive loss of body water) or has a salt deficiency due to diuretic medicines (water tablets), a low-salt diet, diarrhoea, vomiting, or haemodialysis;
kidney disease or kidney transplant;
renal artery stenosis (narrowing of the blood vessels to one or both kidneys);
liver disease;
heart problems;
diabetes;
gout;
increased aldosterone levels (retention of water and salt in the body together with electrolyte imbalance);
systemic lupus erythematosus (also known as “lupus” or “SLE”), a disease in which the immune system attacks the body itself;
the active substance hydrochlorothiazide may cause rare reactions leading to vision disturbances and eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid buildup between the choroid and sclera) or increased intraocular pressure, which may occur within a few hours to several weeks after taking Gisartan. If left untreated, these may lead to permanent vision loss;
if the patient has previously had skin cancer or if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially at high doses over a long period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. During treatment with Gisartan, protect the skin from sunlight and UV radiation;
if the patient has previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If severe shortness of breath or breathing difficulties occur after taking Gisartan, seek immediate medical help.

Contact your doctor before taking Gisartan:

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

Inform your doctor if you suspect (or are planning) pregnancy. Use of Gisartan is not recommended during early pregnancy. Do not take it after the third month of pregnancy, as it may seriously harm the unborn child (see section “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, restlessness, muscle pain or cramps, nausea, vomiting, muscle fatigue, and abnormally rapid heartbeat (faster than 100 beats per minute). If any of these symptoms occur, inform your doctor.

Also inform your doctor if you experience skin hypersensitivity to sunlight, such as sunburn (e.g. redness, itching, swelling, blistering) occurring more quickly than usual.

If a surgical procedure or anaesthesia is planned, inform the doctor that the patient is taking Gisartan.

Gisartan may be less effective in lowering blood pressure in patients of Black race.

Children and adolescents

The use of Gisartan in children and adolescents under 18 years of age is not recommended.

Other medicines and Gisartan

Tell your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use. The doctor may decide to adjust the dose of these medicines or take other precautions. In some cases, discontinuation of one of the medicines may be necessary. This particularly applies to concomitant use of Gisartan with the following medicines:

lithium preparations, used to treat certain types of depression;
medicines associated with low blood potassium levels (hypokalaemia), such as: other diuretics (water tablets), laxatives (e.g. castor oil), corticosteroids (e.g. prednisolone), ACTH (adrenocorticotropic hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat oral ulcers), sodium salt of penicillin G (an antibiotic), salicylic acid and its derivatives;
medicines that may increase blood potassium levels, e.g. potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant), and other medicinal products such as sodium heparin (an anticoagulant);
medicines affected by changes in blood potassium levels, such as cardiac medicines (e.g. digoxin) or medicines used to control heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol), medicines used to treat psychiatric 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 in diabetes (insulin or oral medicines such as metformin);
cholestyramine and colestipol, medicines used to lower blood lipid levels;
medicines that raise blood pressure, such as noradrenaline;
muscle relaxants such as tubocurarine;
calcium supplements and (or) vitamin D;
anticholinergic medicines (used to treat various disorders such as gastrointestinal spasms, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as adjuncts in anaesthesia), such as atropine and biperiden;
amantadine (a medicine used in Parkinson’s disease and also in the treatment or prevention of certain viral infections);
other medicines used to treat hypertension, corticosteroids, painkillers (e.g. non-steroidal anti-inflammatory drugs, NSAIDs), medicines used to treat cancer, gout, or arthritis;
if the patient is taking an ACE inhibitor or aliskiren (see also information under the headings “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 potentially lower blood pressure (e.g. baclofen, amifostine). In addition, low blood pressure may be intensified by alcohol, barbiturates, narcotics, or antidepressants. The patient may experience this as dizziness upon standing.

Consult your doctor if dose adjustment of another medicine is needed during Gisartan treatment.

The effect of Gisartan may be reduced when taken concomitantly with NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen).

Taking Gisartan with food and alcohol

Gisartan may be taken with or without food.

Avoid alcohol until you have spoken with your 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, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.

Pregnancy

Inform your doctor if you suspect (or are planning) pregnancy. Usually, the doctor will recommend stopping Gisartan before a planned pregnancy or immediately after pregnancy is confirmed and will prescribe an alternative medicine. Gisartan is not recommended during pregnancy. Do not take it after the third month of pregnancy, as it may seriously harm the unborn child if used after 3 months of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or intend to breastfeed. Gisartan is not recommended during breastfeeding. The doctor may choose an alternative treatment during breastfeeding.

Driving and operating machinery

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

Gisartan contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered “sodium-free”.

3. How to use Gisartan

Gisartan should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose of Gisartan is one tablet per day. Try to take the tablet at the same time each day. Gisartan may be taken during or between meals.
Swallow the tablets with water or a non-alcoholic drink. It is important to take Gisartan every day unless your doctor advises otherwise.
If the patient has impaired liver function, the usual dose should not exceed 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide per day.

Taking more Gisartan than recommended
If too many tablets are taken by mistake, symptoms such as low blood pressure and rapid heartbeat may occur. Cases of slow heartbeat, dizziness, vomiting, and worsening kidney function, including kidney failure, have also been reported. Due to the presence of hydrochlorothiazide, markedly low blood pressure and low blood potassium levels may also occur, which could lead to nausea, drowsiness, muscle cramps, and/or irregular heartbeat, particularly when used concomitantly with drugs such as digitalis glycosides or certain antiarrhythmic medications. Seek immediate medical advice from your doctor, pharmacist, or the nearest hospital emergency department.

Missing a dose of Gisartan
If a patient forgets to take a dose, they should take it as soon as they remember, on the same day. If a tablet is missed on one day, take the usual dose the next day. Do not take a double dose to make up for the missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some adverse reactions may be serious and require immediate medical attention:
If any of the following symptoms occur, contact a doctor immediately:
Sepsis* (often referred to as blood poisoning), a severe infection causing a systemic inflammatory response; sudden swelling of the skin and mucous membranes (angioedema); blistering and peeling of the outer layer of skin (toxic epidermal necrolysis).
The above adverse reactions 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 serious. In such cases, treatment with the medicine must be discontinued immediately and medical advice sought without delay. If left untreated, these symptoms may result in death.
An increased incidence of sepsis has been observed in individuals receiving telmisartan monotherapy; however, it cannot be excluded in patients treated with Gisartan.
Very rare (may occur in no more than 1 in 10,000 patients): acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).

Possible adverse reactions of Gisartan:
Common adverse reactions (may occur in no more than 1 in 10 patients):
Dizziness

Uncommon adverse reactions (may occur in no more than 1 in 100 patients):
Decreased blood potassium levels, anxiety, fainting (syncope), tingling and numbness (paraesthesia), sensation of spinning (vertigo), rapid heartbeat (tachycardia), heart rhythm disorders, low blood pressure, sudden drop in blood pressure upon standing, shortness of breath (dyspnoea), diarrhoea, dryness of oral mucous membranes, bloating, back pain, muscle cramps, muscle pain, erectile dysfunction (inability to achieve or maintain erection), chest pain, increased blood uric acid levels.

Rare adverse reactions (may occur in no more than 1 in 1,000 patients):
Lung inflammation (bronchitis), onset or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks its own tissues, causing joint pain, skin rashes, and fever), sore throat, sinusitis, feeling of sadness (depression), difficulty falling asleep (insomnia), visual disturbances, abdominal pain, constipation, bloating (dyspepsia), nausea (vomiting), inflammation of the gastric mucosa, abnormal liver function (more frequently observed in patients of Japanese origin), skin redness (erythema), allergic reactions such as itching or rash, increased sweating, urticaria, joint pain and limb pain, muscle cramps, influenza-like symptoms, pain, low sodium levels, increased creatinine levels, increased liver enzyme activity or creatine phosphokinase levels in blood.

Adverse reactions 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 receiving telmisartan alone, the following additional adverse reactions have been observed:

Uncommon adverse reactions (may occur in no more than 1 in 100 patients):
Upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), urinary tract infections, low number of red blood cells (anaemia), high potassium levels, slow heart rate (bradycardia), kidney dysfunction, including acute kidney failure, fatigue, cough.

Rare adverse reactions (may occur in no more than 1 in 1,000 patients):
Low platelet count (thrombocytopenia), increased number 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, rash (skin disorder), joint degeneration, tendonitis, decreased haemoglobin levels (blood protein), somnolence.

Very rare adverse reactions (may occur in no more than 1 in 10,000 patients):
Progressive fibrosis of lung alveoli (interstitial lung disease)**

*This phenomenon may be coincidental or related to a mechanism not yet understood.
**Cases of interstitial lung disease have been reported in temporal association with telmisartan use. However, a causal relationship has not been established.

Hydrochlorothiazide
In patients receiving hydrochlorothiazide alone, the following additional adverse reactions have been observed:

Common adverse reactions (may occur in no more than 1 in 10 patients):
Nausea, low blood magnesium levels.

Rare adverse reactions (may occur in no more than 1 in 1,000 patients):
Reduced platelet count, increasing the risk of bleeding or bruising (small purple-red skin or tissue lesions caused by haemorrhage), high blood calcium levels, headache.

Very rare adverse reactions (may occur in no more than 1 in 10,000 patients):
Increased pH (disturbed acid-base balance) due to low chloride levels in blood.

Adverse reactions of unknown frequency (frequency cannot be estimated from available data):
Salivary gland inflammation, skin and lip malignancies (non-melanoma skin cancers), decreased blood cell counts, including low numbers of red and white blood cells, severe allergic reactions (e.g. hypersensitivity, anaphylactic reactions), decreased or loss of appetite, restlessness, feeling of emptiness in the head, blurred vision or yellow vision, visual field defects and eye pain (possibly symptoms of fluid accumulation in the uvea—the layer surrounding the eye—or excessive fluid accumulation between the choroid and sclera—or acute angle-closure glaucoma), vasculitis (necrotizing vasculitis), pancreatitis, gastritis, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking systemic lupus erythematosus, in which the body's immune system attacks its own tissues), skin disorders such as cutaneous vasculitis, increased sensitivity to sunlight, rash, skin redness, blistering of lips, eyes, and mouth, skin peeling, fever (possible symptoms of erythema multiforme), weakness, kidney inflammation or impaired kidney function, presence of glucose in urine (glucosuria), fever, electrolyte imbalance, elevated blood cholesterol levels, reduced blood volume, increased blood glucose levels, difficulty controlling blood/urine glucose or blood lipid levels in patients with diagnosed diabetes or hyperlipidaemia.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the 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 carton, blister
or label on the bottle after: "EXP". The expiry date refers to the last day of the stated month.
Aluminium/Aluminium blisters and HDPE container
No special storage conditions required.
PVC/PVDC/Aluminium blisters
Do not store above 30°C.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the package and other information

What Gisartan contains

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

What Gisartan looks like and contents of the pack
Gisartan tablets, 80 mg + 25 mg, are white or almost white, biconvex, oval-shaped tablets,
measuring 9.0 x 17 mm, marked with "TH" on one side and "25" on the other side.
Pack sizes
Blister packs: 14, 28, 56 tablets
Plastic container: 30, 90 and 250 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

Package leaflet: information for the patient

Gisartan, 80 mg + 25 mg, tablets
Telmisartan + Hydrochlorothiazide
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
Please consult your doctor or pharmacist if you have any doubts.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents

What Gisartan is and what it is used for
Important information before taking Gisartan
How to take Gisartan
Possible side effects
How to store Gisartan
Contents of the package and other information

1. What Gisartan is and what it is used for

Gisartan is a combination medicine containing two active substances, telmisartan and hydrochlorothiazide, in a single 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 narrow, thereby increasing 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 output, leading to a reduction in blood pressure.

Untreated high blood pressure may damage blood vessels in organs and, in some cases, may lead to complications such as heart attack, heart or kidney failure, stroke, or loss of vision. Often, there are no symptoms of high blood pressure before such complications occur. Therefore, it is important to regularly monitor blood pressure to ensure it remains within normal limits.
Gisartan is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by telmisartan or hydrochlorothiazide taken separately.

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 (you should also avoid using Gisartan in early pregnancy – see section "Pregnancy");
if you have severe liver disease, such as biliary obstruction or bile duct stenosis (impaired bile flow from the liver and gallbladder), or any other severe liver disease;
if you have severe kidney disease;
if your doctor has diagnosed low blood potassium levels or high blood calcium levels that do not improve with treatment;
if you have diabetes or kidney dysfunction and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to you, please inform your doctor or pharmacist before taking Gisartan.
Warnings and precautions
Before starting Gisartan, inform your doctor if you have or have had any of the following conditions or diseases:

low blood pressure (hypotension), which is more likely if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic use (water tablets), a low-salt diet, diarrhoea, vomiting, or haemodialysis;
kidney disease or kidney transplant;
renal artery stenosis (narrowing of the blood vessels to one or both kidneys);
liver disease;
heart problems;
diabetes;
gout;
increased aldosterone levels (water and salt retention together with electrolyte imbalance);
systemic lupus erythematosus (also called "lupus" or "SLE"), a disease in which the immune system attacks the body itself;
the active substance hydrochlorothiazide may cause rare reactions leading to vision impairment and eye pain. These may be symptoms of fluid accumulation in the uvea (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure, which may occur within hours to weeks after taking Gisartan. If untreated, these may lead to permanent vision loss;
if you have previously had skin cancer or if you develop unexpected skin changes during treatment. Treatment with hydrochlorothiazide, especially in high doses over a long period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Gisartan, protect your skin from sunlight and UV radiation;
if you have previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or breathing difficulties after taking Gisartan, seek immediate medical help.

Contact your doctor before taking Gisartan:

if you are taking any of the following medicines used to treat 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 kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals. See also information under the heading "When not to take Gisartan".
- if you are taking digoxin.

Inform your doctor if you suspect (or are planning) pregnancy. Gisartan is not recommended during early pregnancy. Do not take it after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy").
Treatment with hydrochlorothiazide may lead to electrolyte imbalance in the body.
Typical symptoms of fluid or electrolyte imbalance include dryness of the oral mucosa, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting, muscle fatigue, and abnormally rapid heartbeat (faster than 100 beats per minute). If any of these symptoms occur, inform your doctor.
You should also inform your doctor if you experience skin hypersensitivity to sunlight, such as sunburn (e.g., redness, itching, swelling, blistering) occurring more quickly than usual.
If you are scheduled for surgery or anaesthesia, inform your doctor that you are taking Gisartan.
Gisartan may be less effective in lowering blood pressure in black individuals.
Children and adolescents
The use of Gisartan in children and adolescents under 18 years of age is not recommended.
Other medicines and Gisartan
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. Your doctor may decide to adjust the dose of these medicines or take other precautions. In some cases, it may be necessary to discontinue one of the medicines. This particularly applies to concomitant use of Gisartan with the following medicines:

lithium preparations, used to treat certain types of depression;
medicines associated with low blood potassium levels (hypokalaemia), such as: other diuretics (water tablets), laxatives (e.g., castor oil), corticosteroids (e.g., prednisolone), ACTH (adrenocorticotropic hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat oral ulcers), sodium penicillin G (an antibiotic), salicylic acid and its derivatives;
medicines that may increase blood potassium levels, e.g., potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant), and other medicinal products, e.g., sodium heparin (an anticoagulant);
medicines affected by changes in blood potassium levels, such as cardiac medicines (e.g., digoxin) or medicines used to control heart rhythm (e.g., quinidine, disopyramide, amiodarone, sotalol), medicines used to treat psychiatric 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 for diabetes (insulin or oral medicines such as metformin);
cholestyramine and colestipol, medicines that lower blood lipid levels;
medicines that raise blood pressure, such as noradrenaline;
muscle relaxants such as tubocurarine;
calcium supplements and (or) vitamin D;
anticholinergic medicines (used to treat various disorders such as gastrointestinal spasms, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an adjunct in anaesthesia), such as atropine and biperiden;
amantadine (a medicine used in Parkinson's disease and also in the treatment or prevention of certain viral diseases);
other medicines used to treat hypertension, corticosteroids, painkillers (e.g., non-steroidal anti-inflammatory drugs, NSAIDs), medicines used to treat cancer, gout, or arthritis;
if you are taking an ACE inhibitor or aliskiren (see also information under the headings "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 potentially lower blood pressure (e.g., baclofen, amifostine). In addition, low blood pressure may be intensified by alcohol, barbiturates, narcotics, or antidepressants. You may experience this as dizziness upon standing.
Consult your doctor if dosage adjustment of another medicine is needed while taking Gisartan.
The effect of Gisartan may be reduced when taken concomitantly with NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen).
Taking Gisartan with food and alcohol
Gisartan can be taken with food or independently of meals.
Avoid alcohol until you have spoken with your doctor. Alcohol may further lower blood pressure and (or) increase the risk of dizziness or fainting.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor if you suspect (or are planning) pregnancy. Usually, your doctor will recommend discontinuing Gisartan before planned pregnancy or immediately after pregnancy is confirmed and will prescribe an alternative medicine. Gisartan is not recommended during pregnancy. Do not take it after the third month of pregnancy, as it may seriously harm the unborn child if used after 3 months of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Gisartan is not recommended during breastfeeding. Your doctor may choose an alternative treatment during breastfeeding.
Driving and using machines
Some patients taking Gisartan may experience dizziness or fatigue. In such cases, do not drive or operate machinery.
Gisartan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Gisartan

Always take Gisartan exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose of Gisartan is one tablet daily. Try to take the tablet at the same time each day. Gisartan can be taken with or between meals. Swallow the tablets with water or a non-alcoholic drink. It is important to take Gisartan every day unless your doctor advises otherwise.
If your liver is not functioning properly, 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, symptoms such as low blood pressure and rapid heartbeat may occur. Cases of slowed heartbeat, dizziness, vomiting, worsening kidney function, including kidney failure, have also been reported. Due to the presence of hydrochlorothiazide, markedly low blood pressure and low blood potassium levels may also occur, leading to nausea, drowsiness, muscle cramps, and (or) irregular heartbeat, especially when taken concomitantly with medicines such as cardiac glycosides and certain antiarrhythmics. Seek immediate medical help from your doctor, pharmacist, or the nearest hospital emergency department.
Missing a dose of Gisartan
If you forget to take a dose, take it as soon as you remember, on the same day. If a tablet is missed on one day, take the usual dose the next day. Do not take a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
Some side effects may be serious and require immediate medical attention:
If any of the following symptoms occur, contact your doctor immediately:
Sepsis* (often called blood poisoning), a severe infection with systemic inflammatory response, sudden swelling of the skin and mucous membranes (angioedema), blistering and peeling of the outer layer of skin (toxic epidermal necrolysis).
These adverse reactions 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 serious. In such cases, stop taking the medicine and contact your doctor immediately. If these symptoms are not treated, they may result in death.
An increased incidence of sepsis has been observed in patients taking telmisartan as monotherapy; however, it cannot be excluded in patients treated with Gisartan.
Very rarely (may occur in no more 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 no more than 1 in 10 patients):
Dizziness
Uncommon side effects (may occur in no more than 1 in 100 patients):
Low blood potassium levels, anxiety, fainting, tingling and numbness (paraesthesia), vertigo, rapid heartbeat (tachycardia), irregular heartbeat, low blood pressure, sudden drop in blood pressure upon standing, shortness of breath (dyspnoea), diarrhoea, dryness of the oral mucosa, bloating, back pain, muscle cramps, muscle pain, erectile dysfunction (inability to achieve or maintain erection), chest pain, increased blood uric acid levels.
Rare side effects (may occur in no more than 1 in 1,000 patients):
Lung inflammation (bronchitis), onset or worsening 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 falling asleep (insomnia), visual disturbances, abdominal pain, constipation, bloating (indigestion), nausea (vomiting), inflammation of the gastric mucosa, abnormal liver function (more common in patients of Japanese origin), skin redness (flushing), allergic reactions such as itching or rash, increased sweating, urticaria, joint pain and limb pain, muscle cramps, flu-like symptoms, pain, low sodium levels, increased creatinine levels, increased liver enzyme or creatine kinase activity in blood.
Adverse reactions reported for one of the components may also occur during treatment with Gisartan, even if they were not observed in clinical trials of the product.
Telmisartan
In patients taking telmisartan alone, the following additional adverse reactions have been observed:
Uncommon adverse reactions (may occur in no more than 1 in 100 patients):
Upper respiratory tract infection (e.g., sore throat, sinusitis, common cold), urinary tract infections, low red blood cell count (anaemia), high potassium levels, slow heart rate (bradycardia), kidney dysfunction, including acute kidney failure, weakness, cough.
Rare adverse reactions (may occur in no more than 1 in 1,000 patients):
Low platelet count (thrombocytopenia), increased number of certain white blood cells (eosinophilia), severe allergic reaction (e.g., hypersensitivity, anaphylactic reaction, drug rash), low blood glucose levels (in diabetic patients), gastritis, rash (skin disorder), osteoarthritis, tendonitis, decreased haemoglobin (blood protein), drowsiness.
Very rare adverse reactions (may occur in no more than 1 in 10,000 patients):
Progressive scarring of lung alveoli (interstitial lung disease)**
*This phenomenon may be coincidental or related to a mechanism not yet known.
**Cases of interstitial lung disease temporally associated with telmisartan use have been reported. However, a causal relationship has not been established.
Hydrochlorothiazide
In patients taking hydrochlorothiazide alone, the following additional adverse reactions have been observed:
Common adverse reactions (may occur in no more than 1 in 10 patients):
Nausea, low blood magnesium levels.
Rare adverse reactions (may occur in no more than 1 in 1,000 patients):
Reduced platelet count, increasing the risk of bleeding or bruising (small purple-red skin lesions or in other tissues caused by bleeding), high blood calcium levels, headache.
Very rare adverse reactions (may occur in no more than 1 in 10,000 patients):
Increased pH (disturbed acid-base balance) due to low blood chloride levels.
Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
Salivary gland inflammation, skin and lip cancer (non-melanoma skin cancer), reduced blood cell count, including low red and white blood cells, severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), decreased or loss of appetite, restlessness, feeling of emptiness in the head, blurred or yellow vision, vision impairment and eye pain (likely symptoms of fluid accumulation in the uvea – excessive fluid accumulation between choroid and sclera – or acute angle-closure glaucoma), vasculitis (necrotizing vasculitis), pancreatitis, gastritis, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a disease mimicking systemic lupus erythematosus, in which the body is attacked by its own immune system), skin disorders such as skin vasculitis, increased sensitivity to sunlight, rash, skin redness, blistering of lips, eyes, and mouth, skin peeling, fever (possible symptoms of erythema multiforme), weakness, kidney inflammation or kidney dysfunction, presence of glucose in urine (glucosuria), fever, electrolyte imbalance, high blood cholesterol levels, reduced blood volume, increased blood glucose levels, difficulty controlling blood glucose/urine glucose in diagnosed diabetic patients or blood lipids.
Reporting of adverse reactions
If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Gisartan

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle label after "EXP". The expiry date refers to the last day of the stated month.
Aluminium/Aluminium blisters and HDPE container
No special storage conditions required.
PVC/PVDC/Aluminium blisters
Do not store above 30°C.
Do not dispose of medicines via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. These measures help protect the environment.

6. Contents of the package and other information

What Gisartan contains

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

What Gisartan looks like and contents of the pack
Gisartan tablets, 80 mg + 25 mg, are white or almost white, biconvex, oval-shaped tablets,
measuring 9.0 x 17 mm, marked with "TH" on one side and "25" on the other side
Pack sizes
Blister packs: 14, 28, 56 tablets
Plastic container: 30, 90 and 250 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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