Telmisartan/hydrochlorothiazide Viatris 80 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Telmisartan/Hydrochlorothiazide Viatris 80 mg/12.5 mg tablets EFG

Read the entire 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 effects not listed in this leaflet. See section 4.

Leaflet contents

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 Telmisartán/Hidroclorotiazida Viatris is and what it is used for

Telmisartán/Hidroclorotiazida Viatris is a combination of two active substances, telmisartan and hydrochlorothiazide, in one 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 reducing your blood pressure.

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

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

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

2. What you need to know before taking Telmisartán/Hidroclorotiazida Viatris

Do not take Telmisartán/Hidroclorotiazida Viatris

• 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 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 serious liver disease.
• If you have severe kidney disease.
• If your doctor finds that you have low levels of potassium or high levels of calcium in your blood 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/Hydrochlorothiazide.

Warnings and precautions

Talk to your doctor before taking Telmisartán/Hydrochlorothiazide 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, diarrhea, vomiting, or hemodialysis.
• 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 (retention of water and salt 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 substance 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 pressure in your eye and may appear from hours to weeks after taking Telmisartán/Hydrochlorothiazide. If left untreated, this may lead to permanent vision loss.
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking telmisartan/hydrochlorothiazide, seek medical attention immediately.

Talk to your doctor before starting 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

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially 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 exposure to sunlight and UV rays while taking telmisartan/hydrochlorothiazide.

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.

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

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. Use of Telmisartán/Hidroclorotiazida Viatris is not recommended during early pregnancy (first 3 months), and must not be used from the third month of pregnancy onward, 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 develop increased skin sensitivity to sunlight with symptoms of sunburn (such as redness, itching, swelling, blistering) that appear more quickly than usual.

If you are scheduled for surgery or anesthesia, you must inform your doctor that you are taking Telmisartán/Hydrochlorothiazide.

Telmisartán/Hydrochlorothiazide may be less effective in lowering blood pressure in black patients.

Children and adolescents

Use of Telmisartán/Hydrochlorothiazide is not recommended in children and adolescents under 18 years of age.

Other medicines and Telmisartán/Hidroclorotiazida Viatris with other medicines

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 together with Telmisartán/Hydrochlorothiazide:

• Medicines containing lithium used to treat certain types of depression.
• Medicines associated with low blood potassium levels (hypokalemia) such as other diuretics, laxatives (e.g., castor oil), corticosteroids (e.g., prednisone), ACTH (adrenocorticotropic hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat 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 used to treat allergic reactions (e.g., terfenadine).
• Medicines for 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 (used to treat various disorders such as gastrointestinal spasms, urinary spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid in anesthesia) such as atropine and biperiden.
• Amantadine (a medicine used to treat Parkinson’s disease and also 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]), and medicines for cancer, gout, or arthritis.
• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Telmisartán/Hidroclorotiazida Viatris” and “Warnings and precautions”).
• Digoxin

Telmisartán/Hydrochlorothiazide 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, blood pressure reduction may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness when standing up. Inform your doctor, as dose adjustments of your other medicines may be needed while using Telmisartán/Hydrochlorothiazide.

The effect of Telmisartán/Hydrochlorothiazide 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 taking 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 at any time from the third month of pregnancy onward, as it may cause serious harm to your baby when used from that stage.

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 decide to prescribe a treatment more suitable for use while breastfeeding.

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 given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The recommended dose of Telmisartan/Hydrochlorothiazide is one tablet daily. Try to take one tablet each day at the same time. You may take Telmisartan/Hydrochlorothiazide with or without food. Tablets should be swallowed with a little water or another 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 renal failure have also been reported. Due to the hydrochlorothiazide component, 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 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 telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Telmisartan/Hydrochlorothiazide Viatris

If you forget to take your dose, do not worry. Take the missed dose as soon as you remember, and then continue as before. If you miss a dose one 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, Telmisartan/Hydrochlorothiazide Viatris may cause adverse effects, although not everyone will experience 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* (commonly called “blood infection”) is a serious infection involving a systemic inflammatory response, rapid swelling of the skin and mucous membranes (angioedema), blistering and peeling of the outer layer of 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, this cannot be ruled out for Telmisartan/hydrochlorothiazide.

Possible adverse effects of Telmisartan/Hydrochlorothiazide Viatris:

Common adverse effects (may affect up to 1 in 10 people)

Dizziness.

Uncommon adverse effects (may affect up to 1 in 100 people)

Low blood potassium levels, anxiety, fainting (syncope), tingling sensation, numbness (paresthesia), dizziness (vertigo), rapid heartbeat (tachycardia), heart rhythm disturbances, 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, sinus inflammation, feeling of sadness (depression), difficulty sleeping (insomnia), vision disturbances, difficulty breathing, 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 creatinine, liver enzymes, or creatine phosphokinase levels in blood.

Adverse reactions reported for one of the individual components may be potential adverse reactions of Telmisartan/Hydrochlorothiazide, even if not 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, sinus inflammation, common cold), urinary tract infections, deficiency of red blood cells (anemia), high potassium levels, slow heart rate (bradycardia), cough, kidney function impairment including acute renal 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 a coincidental 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:

Common 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 chloride levels in blood.

Adverse effects of unknown frequency (cannot be estimated from available data)

Intestinal angioedema: intestinal inflammation has been reported, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea following use of similar products; salivary gland inflammation, skin and lip cancer (non-melanoma skin cancer), decreased number (or even absence) of blood cells, including low red and white blood cell counts, 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] or 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 a disease called systemic lupus erythematosus, in which the body's immune system attacks its own tissues), skin disorders such as inflammation of skin blood vessels, 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, decreased blood volume, increased blood glucose levels, difficulty controlling blood/urine glucose levels in patients diagnosed with diabetes mellitus, or fat in 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 may 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 refers to 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 must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be handed over to the SIGRE Point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps 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 12.5 mg of hydrochlorothiazide.
• The other components are magnesium stearate, meglumine, microcrystalline cellulose, povidone, potassium hydroxide, sodium carboxymethyl starch (type A) (from potato), and mannitol (E421).

Appearance of the product and contents of the pack

Telmisartan/Hydrochlorothiazide Viatris 80 mg/12.5 mg tablets are capsule-shaped tablets of 9.0 x 17.0 mm with "TH 12.5" engraved on both sides.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 revision of this leaflet: January 2025

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