Telmisartan and hydrochlorothiazide Zentiva: detailed information

PATIENT INFORMATION LEAFLET

Telmisartan and Hydrochlorothiazide Zentiva 40 mg/12.5 mg tablets, 80 mg/12.5 mg tablets, 80 mg/25 mg tablets

Generic medicine
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.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA is and what it is used for
What you need to know before taking TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA
How to take TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA
Possible side effects
How to store TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA
Contents of the pack and other information

1. What is TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA and what is it used for?

TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA is a combination of two active substances,
telmisartan and hydrochlorothiazide, in a single tablet. Both of these 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 effect of angiotensin II, allowing blood vessels to relax and blood pressure to decrease.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which increase urine flow, leading to a reduction in blood pressure.

If left untreated, high blood pressure can damage blood vessels in various organs and may sometimes lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms before damage occurs. Therefore, it is important to have your blood pressure measured regularly to ensure it remains within the normal range.

TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA 40 mg/12.5 mg and TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA 80 mg/12.5 mg:
TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled with telmisartan alone.

TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA 80 mg/25 mg: TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled with TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA 80 mg/12.5 mg, or in patients who have previously been stabilized on telmisartan and hydrochlorothiazide taken separately.

2. What you need to know before taking TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA

Do not take TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA

If you are allergic to telmisartan or to any of the other ingredients of this medicine (listed in section 6).
If you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicine.
If you are more than three months pregnant. (It is better to avoid TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA even in the early stages of pregnancy – see section on Pregnancy.)
If you have severe liver problems such as cholestasis or biliary obstruction (conditions affecting bile flow from the gallbladder) or any other serious liver disease.
If you have severe kidney disease.
If your doctor has determined that you have low potassium or high calcium levels in the blood that do not improve with treatment.
If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions apply to you, inform your doctor or pharmacist before taking TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA.
Warnings and precautions
Talk to your doctor or pharmacist before taking TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA.
Talk to your doctor or pharmacist if you have or have ever had any of the following conditions or diseases:

Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body water) or have a salt deficiency due to diuretic therapy, low-salt diet, diarrhoea, vomiting, or if you are undergoing haemodialysis;
Kidney disease or kidney transplant;
Renal artery stenosis (narrowing of the blood vessels to one or both kidneys);
Liver disease;
Heart disorders;
Diabetes;
Gout;
Elevated aldosterone levels (water and salt retention in the body with disturbance of mineral balance in the blood);
Systemic lupus erythematosus (also known as “lupus” or “SLE”), a disease in which the immune system attacks the body.
If you have previously had skin cancer or are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV rays while taking TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA;
If you experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours or weeks after taking Telmisartan and Hydrochlorothiazide Zentiva. This condition can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this reaction.

Talk to your doctor or pharmacist before taking TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA:

If you are taking digoxin.
If you are taking any of the following medicines used to treat high blood pressure:
an "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
aliskiren.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals.
See also the information under the heading "Do not take TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA".
You must inform your doctor if you think you are pregnant (or could become pregnant). TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to your baby if used at this stage of pregnancy (see section on Pregnancy).
Treatment with hydrochlorothiazide may cause electrolyte imbalances in the body. Characteristic symptoms of altered electrolyte or fluid balance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea (feeling unwell), vomiting, muscle fatigue, unusually rapid heartbeat (faster than 100 beats per minute). If you experience any of these symptoms, inform your doctor.
You should also inform your doctor if you develop increased skin sensitivity to sunlight with symptoms of sunburn (such as redness, itching, swelling, blisters) that appear more quickly than usual.
If you are undergoing surgery or anaesthesia, inform your doctor that you are taking TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA.
TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA may be less effective in lowering blood pressure in Black patients.
Children and adolescents
The use of TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA is not recommended in children and adolescents under 18 years of age.
For those engaged in sports: using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Other medicines and TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may need to adjust the dose and/or take other precautions. In some cases, it may be necessary to discontinue one of these medicines. This is particularly relevant when the following medicines are taken concurrently with TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA:

Medicines containing lithium used to treat certain types of depression.
Medicines associated with low potassium levels in the blood (hypokalaemia), such as other diuretics, laxatives (e.g., castor oil), corticosteroids (e.g., prednisone), ACTH (a hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (an antibiotic), and 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 immunosuppressant medicine), and other medicines such as sodium heparin (an anticoagulant).
Medicines that alter potassium levels in the blood, such as heart medicines (e.g., digoxin) or medicines to control heart rhythm (e.g., quinidine, disopyramide, amiodarone, sotalol), medicines used for 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 for the treatment of diabetes (insulin or oral agents such as metformin).
Cholestyramine and colestipol, medicines used to lower blood lipid levels.
Medicines that increase blood pressure, such as noradrenaline.
Muscle relaxants such as tubocurarine.
Calcium and/or vitamin D supplements.
Anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as anaesthetic adjuvants), such as atropine and biperiden.
Amantadine (a medicine used to treat Parkinson’s disease and also used to treat or prevent certain viral diseases).
Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as 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 in the sections "Do not take Telmisartan and Hydrochlorothiazide Zentiva" and "Warnings and precautions").
Digoxin.

TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA may enhance the effect of other medicines used to lower blood pressure or medicines that may potentially reduce blood pressure (e.g., baclofen, amifostine). In addition, blood pressure reduction may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may experience this drop in blood pressure as dizziness upon standing. You should consult your doctor if dose adjustments of other medicines taken with TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA are needed.
The effect of TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA may be reduced when taken with NSAIDs (non-steroidal anti-inflammatory drugs, e.g., aspirin or ibuprofen).
TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA with food and alcohol
You may take TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA with or without food.
Avoid alcohol consumption until your doctor advises otherwise. Alcohol may further lower blood pressure and/or increase the risk of dizziness or feeling faint.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
Pregnancy:
Inform your doctor if you are pregnant (or could become pregnant). Your doctor will usually advise you to stop taking TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.
TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA is not recommended during pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breastfeeding:
Inform your doctor if you are breastfeeding or planning to breastfeed. TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.
Driving and using machines
Some patients may experience dizziness or fatigue when taking TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA. If you feel dizzy or fatigued, do not drive or operate machinery.
TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA contains sorbitol (E420) and sodium.
Telmisartan and Hydrochlorothiazide Zentiva 40 mg/12.5 mg tablets: each tablet contains 174.15 mg of sorbitol and 1.95 mg of sodium.
Telmisartan and Hydrochlorothiazide Zentiva 80 mg/12.5 mg tablets: each tablet contains 348.3 mg of sorbitol and 3.91 mg of sodium.
Telmisartan and Hydrochlorothiazide Zentiva 80 mg/25 mg tablets: each tablet contains 348.3 mg of sorbitol and 3.91 mg of sodium.
Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which people cannot digest fructose, talk to your doctor before taking or receiving this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially considered "sodium-free".

3. How to take TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose of TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA is one tablet daily. Try to take the tablet at the same time every day. You may take TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA with or without food. Swallow the tablets with water or another non-alcoholic drink. It is important that you take TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA every day unless otherwise instructed by your doctor. If your liver is not functioning properly, the usual dose should not exceed 40 mg/12.5 mg once daily.

If you take more TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA than you should
If you accidentally take too many tablets, symptoms such as low blood pressure and rapid heartbeat may occur. Slow heartbeat, dizziness, vomiting, and reduced kidney function, including renal failure, have also been reported. Due to the hydrochlorothiazide component, a marked drop in blood pressure and low blood potassium levels may occur, which can cause nausea, drowsiness, muscle cramps, and/or irregular heartbeat, especially when used concomitantly with medicines such as digitalis or certain anti-arrhythmic drugs.
Contact your doctor or pharmacist, or go immediately to the nearest hospital emergency department.

If you forget to take TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA
If you forget to take a dose, do not worry. Take it as soon as you remember, then continue as before. If you miss a tablet one day, take your usual dose the next day. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Some side effects can be serious and require immediate medical attention:
You must contact your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood infection", a severe infection with widespread inflammatory response throughout the body), rapid swelling of the skin and mucous membranes (angioedema), blistering and shedding of the top layer of skin (toxic epidermal necrolysis); these side effects are rare (may affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis), but are extremely serious, and patients must stop taking the medicine and seek immediate medical attention. If these effects are not treated, they may be fatal.
An increased incidence of sepsis has been observed with telmisartan alone; however, this cannot be excluded for TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA.
Possible side effects of TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA:
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 (syncope).
Tingling sensation.
Pricking sensation (paresthesia).
Feeling of spinning (vertigo).
Rapid heartbeat (tachycardia).
Heart rhythm disturbances.
Low blood pressure.
Sudden drop in blood pressure when standing up.
Shortness of breath (dyspnea).
Diarrhea.
Dry mouth.
Flatulence.
Back pain.
Muscle spasm.
Muscle pain.
Erectile dysfunction (inability to achieve or maintain an erection).
Chest pain.
Increased levels of uric acid in the blood.

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

Inflammation of the lung (bronchitis).
Activation or worsening of systemic lupus erythematosus (a disease in which the immune system attacks the body, causing joint pain, rash, and fever).
Sore throat.
Sinusitis.
Feeling sad (depression).
Difficulty falling asleep (insomnia).
Altered vision.
Breathing difficulties.
Abdominal pain.
Constipation.
Bloating (dyspepsia).
Feeling unwell (nausea).
Inflammation of the stomach (gastritis).
Abnormal liver function (this side effect may occur more frequently in Japanese patients).
Skin redness (erythema).
Allergic reactions such as itching or rash.
Increased sweating.
Urticaria.
Joint pain (arthralgia) and limb pain.
Muscle cramps.
Influenza-like syndrome.
Pain.
Low sodium levels.
Increased levels of creatinine, liver enzymes, or creatine phosphokinase in the blood.

Adverse reactions reported with one of the components may be potential adverse reactions with TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA, even if they have not been observed in clinical studies with this medicine.
Telmisartan
The following side effects have been reported in patients taking telmisartan alone:
Uncommon side effects (may affect up to 1 in 100 people):

Upper respiratory tract infections (such as sore throat, sinusitis, cold).
Urinary tract infections.
Deficiency of red blood cells (anemia).
High potassium levels.
Slow heart rate (bradycardia).
Kidney damage including acute renal failure.
Weakness.
Cough.

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

Low platelet count (thrombocytopenia).
Increase in certain types of white blood cells (eosinophilia).
Severe allergic reactions (such as hypersensitivity, anaphylactic reaction, drug rash).
Low blood sugar levels (in diabetic patients).
Stomach disturbances.
Eczema (a skin disorder).
Osteoarthritis.
Inflammation of tendons.
Decreased hemoglobin (a blood protein).
Drowsiness.

Very rare side effects (may affect up to 1 in 10,000 people):

Progressive scarring of lung tissue (interstitial lung disease) **.

*The event may have occurred by chance or could be related to a currently unknown mechanism.
**Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is not known whether telmisartan was the cause.
Hydrochlorothiazide
The following additional side effects have been reported in patients taking hydrochlorothiazide alone:
Common side effects (may affect up to 1 in 10 people):

Malaise (nausea).
Low magnesium levels in the blood.

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

Reduction in platelets, increasing the risk of bleeding or bruising (small purple-red spots on the skin or 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):

Increase in pH (altered acid-base balance) due to low chloride levels in the blood.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

Inflammation of the salivary gland.
Skin and lip cancer (non-melanoma skin cancer).
Decrease in number (or even absence) of blood cells, including low counts of red and white blood cells.
Severe allergic reactions (such as hypersensitivity, anaphylactic reaction).
Decreased or loss of appetite.
Restlessness.
Light-headedness.
Blurred or yellow vision.
Decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
Decreased vision and eye pain (possible signs of acute myopia or acute angle-closure glaucoma).
Inflammation of blood vessels (necrotizing vasculitis).
Inflammation of the pancreas.
Stomach disturbances.
Yellowing of the skin or eyes (jaundice).
Lupus-like syndrome (a condition resembling systemic lupus erythematosus, in which the immune system attacks the body).
Skin changes such as inflamed skin blood vessels, increased sensitivity of the skin to light.
Skin rash, skin redness, blistering on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme).
Weakness.
Inflammation of the kidneys or impaired kidney function.
Glucose in urine (glycosuria).
Fever.
Electrolyte imbalance.
High cholesterol levels in the blood.
Decreased blood volume.
Increased blood glucose levels, difficulty controlling blood/urine glucose levels in patients with a diagnosis of diabetes mellitus, or fats in the blood.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Store below 25°C.
Keep in the original packaging to protect from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA contains
The active substances are telmisartan and hydrochlorothiazide.
Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.
The other components are sorbitol (E420), sodium hydroxide, povidone 25 and magnesium stearate.

Description of the appearance of TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA and
packaging contents
TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA 40 mg/12.5 mg: tablets of white to yellowish colour, elongated biconvex tablets with "41" engraved on one side, 12 mm long and 6 mm wide.
TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA 80 mg/12.5 mg: tablets of white to yellowish colour, elongated biconvex tablets with "81" engraved on one side, 16.5 mm long and 8.3 mm wide.
TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA 80 mg/25 mg: tablets of white to yellowish colour, elongated biconvex tablets with "82" engraved on one side, 16 mm long and 8 mm wide.

Packaging contents:
OPA/Aluminium/PVC-Aluminium blisters in a cardboard box.
Pack sizes: 14, 28, 30, 56, 84, 90, 98 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Zentiva Italia S.r.l.
Viale Bodio 37/B
20158 Milan, Italy

Manufacturers
ZENTIVA, k.s.
U Kabelovny 130
102 37 Prague 10
Czech Republic

S.C. ZENTIVA S.A.
B-dul. Theodor Pallady nr.50, sector 3
Bucharest, code 032266
Romania

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Telmisartan/Hydrochlorothiazid Zentiva 40 mg/12.5 mg 80 mg/12.5 mg 80 mg/25 mg, tablety
France: TELMISARTAN HYDROCHLOROTHIAZIDE ZENTIVA 40/12.5 mg, 80/12.5 mg 80/25 mg comprimé
Germany: Telmisartan/Hydrochlorothiazid Zentiva 40 mg /12.5 mg (40 mg /12.5 mg, 40 mg /12.5 mg) Tabletten
Italy: TELMISARTAN AND HYDROCHLOROTHIAZIDE ZENTIVA
Portugal: Telmisartan/Hidroclorotiazida Zentiva
Spain: Telmisartan/Hidroclorotiazida Zentiva 40 mg/12,5 mg 80 mg/12,5 mg 80 mg/25 mg comprimidos EFG