Telmisartan/hydrochlorothiazide Viatris 80 mg/25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Telmisartan/Hydrochlorothiazide Viatris 80 mg/25 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Telmisartan/Hydrochlorothiazide Viatris is and what it is used for

2. What you need to know before taking Telmisartan/Hydrochlorothiazide Viatris

3. How to take Telmisartan/Hydrochlorothiazide Viatris

4. Possible side effects

5. How to store Telmisartan/Hydrochlorothiazide Viatris

6. Contents of the pack and other information

1. What Telmisartan/Hydrochlorothiazide Viatris is and what it is used for

Telmisartan/Hydrochlorothiazide Viatris is a combination of two active substances, telmisartan and hydrochlorothiazide, in a single tablet. Both active substances help control high blood pressure.

• Telmisartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body that causes your blood vessels to narrow, thereby increasing your blood pressure.

Telmisartan blocks the effect of angiotensin II, allowing blood vessels to relax and resulting in lower blood pressure.

• Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increase urine elimination, leading to a reduction in blood pressure.

If left untreated, high blood pressure can damage blood vessels in various organs and may eventually lead to heart attack, heart or kidney failure, stroke, or blindness. Often, there are no symptoms of high blood pressure before such damage occurs. Therefore, it is important to have your blood pressure checked regularly to ensure it remains within the normal range.

Telmisartan/Hydrochlorothiazide is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled with telmisartan/hydrochlorothiazide 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 Telmisartán/Hidroclorotiazida Viatris

Do not take Telmisartán/Hidroclorotiazida Viatris

• 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 to other sulfonamide-derived medicines.
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy – see Pregnancy section).
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder) or any other severe liver disease.
• if you have severe kidney disease.
• if your doctor finds that you have low blood potassium levels or high blood calcium levels that do not improve with treatment.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above apply to you, inform your doctor or pharmacist before taking Telmisartán/Hidroclorotiazida.

Warnings and precautions

Consult your doctor before starting to take Telmisartán/Hidroclorotiazida if you have or have 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 salt deficiency due to treatment with diuretics, a low-sodium 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.
  • High levels of aldosterone (fluid and salt retention in the body along with imbalance of several blood minerals).
  • Systemic lupus erythematosus (also called “lupus” or “SLE”), a disease in which the body's immune system attacks the body itself.

• The active ingredient hydrochlorothiazide may cause a rare reaction leading to vision loss and eye pain. These symptoms may indicate fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may appear from hours to weeks after taking Telmisartán/Hidroclorotiazida. If untreated, this may lead to permanent vision impairment.

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Telmisartán/Hidroclorotiazida.

Consult your doctor before starting to take telmisartan/hydrochlorothiazide:

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

• aliskiren

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Telmisartán/Hidroclorotiazida Viatris”.

• if you are taking digoxin.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking telmisartan. Your doctor will decide whether to continue treatment. Do not stop taking telmisartan on your own.

If you are pregnant, think you might be pregnant, or are planning to become pregnant, you must inform your doctor. Use of Telmisartán/Hidroclorotiazida is not recommended during early pregnancy (first three months) and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby – see Pregnancy section.

Treatment with hydrochlorothiazide may cause an electrolyte imbalance in your body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting, muscle fatigue, and abnormally rapid heartbeat (more than 100 beats per minute). If you experience any of these symptoms, inform your doctor.

You should also inform your doctor if you experience increased skin sensitivity to sunlight, with symptoms of sunburn (such as redness, itching, swelling, blistering) appearing more quickly than usual.

If you are due to undergo surgery or receive anaesthesia, you must inform your doctor that you are taking Telmisartán/Hidroclorotiazida.

Telmisartán/Hidroclorotiazida may be less effective in lowering blood pressure in patients of black race.

Children and adolescents

Telmisartán/Hidroclorotiazida is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Telmisartán/Hidroclorotiazida Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Your doctor may need to adjust the dose of these other medicines or take other precautions. In some cases, you may need to stop taking one of these medicines, especially if you are using any of the following medicines together with Telmisartán/Hidroclorotiazida:

• Medicines containing lithium used to treat certain types of depression.
• Medicines associated with low blood potassium levels (hypokalaemia), such as other diuretics, laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (adrenocorticotropic hormone), amphotericin (an antifungal medicine), carbenoxolone (used in the treatment of mouth ulcers), sodium penicillin G (an antibiotic), and acetylsalicylic acid and its derivatives.
• Medicines that may increase blood potassium levels, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant), and other medicines such as sodium heparin (an anticoagulant).
• Medicines affected by changes in blood potassium levels, such as heart medicines (e.g. digoxin) or medicines to control your 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 to treat allergic reactions (e.g. terfenadine).
• Medicines for the treatment of diabetes (insulins or oral agents such as metformin).
• Cholestyramine and colestipol, medicines used to reduce blood fat levels.
• Medicines to increase blood pressure, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Calcium and/or vitamin D supplements.
• Anticholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal spasms, urinary spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid to anaesthesia), such as atropine and biperiden.
• Amantadine (a medicine used to treat Parkinson’s disease and also to treat or prevent certain viral infections).
• Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), medicines for cancer, gout, or arthritis.
• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Telmisartán/Hidroclorotiazida Viatris” and “Warnings and precautions”).
• Digoxin

Telmisartán/Hidroclorotiazida may enhance the blood pressure-lowering effect of other medicines or of medicines that may potentially lower blood pressure (e.g. baclofen, amifostine).

In addition, the blood pressure-lowering effect may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may experience this effect as dizziness upon standing. Inform your doctor, as dose adjustments of your other medicines may be needed while you are taking Telmisartán/Hidroclorotiazida.

The effect of Telmisartán/Hidroclorotiazida may be reduced when used with NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen).

Taking telmisartan/hydrochlorothiazide Viatris with food and alcohol

You may take telmisartan/hydrochlorothiazide with or without food.

Avoid alcohol until you have spoken with your doctor. Alcohol may further lower your blood pressure and/or increase the risk of feeling dizzy or weak.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking telmisartan/hydrochlorothiazide before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative antihypertensive treatment. The use of telmisartan/hydrochlorothiazide is not recommended during pregnancy and must not be administered from the third month of pregnancy onward, as it may cause serious harm to your baby when used from that point.

Breastfeeding

Inform your doctor if you are planning to start or are currently breastfeeding, as telmisartan/hydrochlorothiazide is not recommended for women during this period. Your doctor may choose a treatment more suitable for you if you intend to breastfeed.

Driving and use of machines

Some patients may feel dizzy or tired when taking telmisartan/hydrochlorothiazide. If you experience dizziness or fatigue, do not drive or operate machinery.

3. How to take Telmisartan/Hydrochlorothiazide Viatris

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, please consult your doctor or pharmacist again.

The recommended dose of Telmisartan/Hydrochlorothiazide is one tablet per day. Try to take one tablet every day at the same time. You may take Telmisartan/Hydrochlorothiazide with or without food. The tablets should be swallowed with a little water or other non-alcoholic drink. It is important that you take Telmisartan/Hydrochlorothiazide every day until your doctor tells you otherwise.

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/Hydrochlorothiazide Viatris than you should

If you accidentally take too many tablets, you may experience symptoms such as low blood pressure and rapid heartbeat. Slow heartbeat, dizziness, vomiting, and reduced kidney function including kidney failure have also been reported. Due to the hydrochlorothiazide component, markedly low blood pressure and low potassium levels in the blood may also occur, which may lead to nausea, drowsiness, muscle cramps and/or irregular heartbeat, particularly when used concomitantly with medications such as digitalis or certain antiarrhythmic treatments. Contact your doctor or pharmacist immediately or go to the nearest hospital emergency department.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Telmisartan/Hydrochlorothiazide Viatris

If you forget to take your medicine, do not worry. Take the dose as soon as you remember and then continue as before. If you miss a day, take your normal dose the next day. Do not take a double dose to make up for forgotten doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

If you experience any of the following symptoms, you must see your doctor immediately:

Sepsis* (often called “blood infection”) is a serious infection involving a systemic inflammatory response, rapid swelling of the skin and mucous membranes (angioedema), and blistering and peeling of the outer layer of the skin (toxic epidermal necrolysis); these adverse 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 see their doctor immediately. If these adverse effects are not treated, they may be fatal. An increased incidence of sepsis has been observed with telmisartan alone; however, it cannot be ruled out for Telmisartan/Hydrochlorothiazide.

Possible adverse effects of Telmisartán/Hidroclorotiazida Viatris:

Frequent adverse effects (may affect up to 1 in 10 people):
Dizziness.

Uncommon adverse effects (may affect up to 1 in 100 people):
Decreased blood potassium levels, anxiety, fainting (syncope), tingling or prickling sensation (paresthesia), dizziness (vertigo), rapid heartbeat (tachycardia), irregular heart rhythm, low blood pressure, sudden drop in blood pressure upon standing, shortness of breath (dyspnea), diarrhea, dry mouth, flatulence, back pain, muscle spasms, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, and increased blood uric acid levels.

Rare adverse effects (may affect up to 1 in 1,000 people):
Lung inflammation (bronchitis), activation 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 sleeping (insomnia), vision disturbances, breathing difficulty, abdominal pain, constipation, abdominal bloating (dyspepsia), general malaise (vomiting), stomach inflammation (gastritis), liver function abnormalities (Japanese patients show a higher tendency to experience this adverse effect), skin redness (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia), limb pain, muscle cramps, flu-like illness, pain, low sodium levels, increased levels of creatinine, liver enzymes, or creatine phosphokinase in blood.

Adverse reactions reported for one of the individual components may also be potential adverse reactions of Telmisartan/Hydrochlorothiazide, even if they have not been observed in clinical trials with this product.

Telmisartan

The following additional adverse effects have been reported in patients taking telmisartan alone:

Uncommon adverse effects (may affect up to 1 in 100 people):
Upper respiratory tract infection (e.g., sore throat, sinusitis, common cold), urinary tract infections, deficiency of red blood cells (anemia), high potassium levels, slow heart rate (bradycardia), cough, kidney function impairment including acute kidney failure, weakness.

Rare adverse effects (may affect up to 1 in 1,000 people):
Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions, drug rash), low blood sugar levels (in diabetic patients), stomach discomfort, eczema (a skin disorder), osteoarthritis, tendon inflammation, decreased hemoglobin (a blood protein), drowsiness.

Very rare adverse effects (may affect up to 1 in 10,000 people):
Progressive fibrosis of lung tissue (interstitial lung disease) **

• This may have been an incidental finding or related to a currently unknown mechanism.

** Cases of progressive fibrosis of lung tissue have been reported during telmisartan use. However, it is unknown whether telmisartan was the cause.

Hydrochlorothiazide

The following additional adverse effects have been reported in patients taking hydrochlorothiazide alone:

Frequent adverse effects (may affect up to 1 in 10 people):
Nausea, low blood magnesium levels.

Rare adverse effects (may affect up to 1 in 1,000 people):
Decreased platelet count in blood, increasing the risk of bleeding and bruising (small purple-red spots on the skin or other tissues caused by bleeding), high blood calcium levels, headache.

Very rare adverse effects (may affect up to 1 in 10,000 people):
Increased pH (acid-base imbalance) due to low blood chloride levels.

Frequency not known (cannot be estimated from available data):
Intestinal angioedema: intestinal inflammation has been reported with similar products, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea. Salivary gland inflammation, skin and lip cancer (non-melanoma skin cancer), decreased number (or even absence) of blood cells, including low counts of red and white blood cells, severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), decreased or loss of appetite, restlessness, dizziness, blurred or yellowish vision, decreased vision and eye pain (possible signs of fluid accumulation in the vascular layer of the eye [choroidal effusion], acute myopia, or acute angle-closure glaucoma), inflammation of blood vessels (necrotizing vasculitis), pancreatitis, stomach discomfort, yellowing of the skin or eyes (jaundice), pseudolupus syndrome (a condition mimicking systemic lupus erythematosus, in which the body's immune system attacks its own tissues), skin disorders such as skin vessel inflammation, increased sensitivity to sunlight, skin rash, skin redness, blistering of lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney inflammation or impaired kidney function, glucose in urine (glucosuria), fever, electrolyte imbalance, high blood cholesterol levels, reduced blood volume, increased blood glucose levels, difficulty controlling blood/urine glucose levels in patients diagnosed with diabetes mellitus, or fat in the blood.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet.

You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Telmisartan/Hydrochlorothiazide Viatris

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after “EXP”. The expiry date is the last day of the month indicated.

For Al/Al blisters

This medicine does not require any special storage conditions.

For Al/PVC/PVDC blisters

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your usual pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Telmisartan/Hydrochlorothiazide Viatris

• The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.

• The other components are magnesium stearate, meglumine, microcrystalline cellulose, povidone, potassium hydroxide, sodium carboxymethylstarch (type A) (from potato), and mannitol (E421).

Appearance of the product and contents of the pack

Telmisartan Hydrochlorothiazide Viatris 80 mg/25 mg tablets are oval, biconcave tablets of 9.0 x 17.0 mm, with "TH" engraved on one side and "25" on the other.

Available in Al/PVC/PVDC blisters of 28 tablets and in calendar Al/Al blisters of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Actavis Ltd.

BLB016

Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Date of the most recent review of this leaflet: January 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/