Label: Information for the User

Telmisartán/Hidroclorotiazida Viatris 40 mg/12.5 mg Tablets EFG

Read this label carefully before taking this medicine, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Telmisartán/Hidroclorotiazida Viatris is an association of two active principles, telmisartán and hidroclorotiazida in a tablet. Both active principles help to control high blood pressure.

• Telmisartán belongs to a group of medications known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to constrict, thereby increasing blood pressure.

Telmisartán blocks the effect of angiotensin II, so that blood vessels relax and blood pressure is reduced.

• Hidroclorotiazida belongs to a group of medications known as thiazide diuretics, which increase urine elimination, resulting in a decrease in blood pressure.

High blood pressure, if left untreated, can damage blood vessels of various organs, which in some cases can cause a heart attack, heart failure or kidney failure, stroke or blindness. There are usually no symptoms of high blood pressure before damage occurs. Therefore, it is essential to monitor blood pressure periodically to ensure it is within the normal range.

Telmisartán/Hidroclorotiazida Viatris is used for the treatment of high blood pressure (essential hypertension) in adults whose blood pressure is not controlled sufficiently when telmisartán is used alone.

Do not take Telmisartán/HidroclorotiazidaViatris

- If you are allergic to telmisartan or any of the other components of this medication (listed in section 6).

- If you are allergic to hydrochlorothiazide or other sulfonamide-derived medications.

- If you are more than 3 months pregnant. (In any case, it is best to avoid taking this medication also at the beginning of your 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 determines that you have low potassium levels or high calcium levels in your blood that do not improve with treatment.

- If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.

If any of the above occurs, inform your doctor or pharmacist before using 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:

Consult your doctor before starting to take telmisartán/hidroclorotiazida:

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

• An angiotensin-converting enzyme inhibitor (ACEI) (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. The treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking telmisartán/hidroclorotiazida.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in your blood (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 diarrhea after taking telmisartán. Your doctor will decide whether to continue treatment. Do not stop taking telmisartán on your own.

If you are pregnant, if you suspect you may beor if you plan to becomepregnant, you must inform your doctor. Telmisartán/Hidroclorotiazida is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered after the third month of pregnancy because it may cause serious harm to your baby, see Pregnancy section.

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

You must also inform your doctor if you experience increased skin sensitivity to the sun with symptoms of sunburn (such as redness, itching, swelling, and blistering) that appear more quickly than usual.

If you are to undergo surgery (surgery) or anesthesia, you must inform your doctor that you are taking Telmisartán/Hidroclorotiazida.

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

Children and adolescents

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

Other medications and Telmisartán/Hidroclorotiazida ViatrisViatris

Inform your doctor or pharmacist if you are taking, have takenrecently or may need to takeany other medication. Your doctor may need to adjust the dose of those other medications or take other precautions. In some cases, you may need to discontinue the use of one of these medications, especially if you are using it with Telmisartán/Hidroclorotiazida, one of the following medications:

• Medications containing lithium for the treatment of certain types of depression
• Medications associated with low potassium levels in the blood (hypokalemia) such asother diuretics, laxatives (e.g., castor oil), corticosteroids (e.g., prednisone), ACTH (adrenocorticotropic hormone), amphotericin (antifungal medication), carbenoxolone (used in the treatment of mouth ulcers), penicillin G sodium (an antibiotic), and aspirin and its derivatives.
• Medications that may increase potassium levels in the blood such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporine (immunosuppressant), and other medications such as heparin sodium (anticoagulant).

• Medicationsthat are affected by changes in potassium levels in the blood such as heart medications (e.g., digoxin) or medications to control heart rhythm (e.g., quinidine, disopyramide,amiodarone, sotalol), medications used totrat trastornos mentales (e.g., thioridazine, chlorpromazine, levomepromazine)and other medications such as some antibiotics (e.g., ciprofloxacin, pentamidine) or some medications for allergic reactions (e.g., terfenadine).

• Medications for the treatment of diabetes (insulins or oral agents such as metformin).
• Colestiramine and colestipol, medications to reduce cholesterol levels in the blood.
• Medications to increase blood pressure, such as norepinephrine.
• Relaxants, such as tubocurarine.
• Calcium and/or vitamin D supplements.
• Anticholinergic medications (medications used to treat a variety of conditions such as gastrointestinal spasms, urinary spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia) such as atropine and biperiden.
• Amantadine (medication used to treat Parkinson's disease and also to treat or prevent certain diseases caused by viruses).

• Other medications used to treat high blood pressure, corticosteroids, analgesics(such as nonsteroidal anti-inflammatory drugs [NSAIDs]), medications for cancer treatment, gout, or arthritis.
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Telmisartán/HidroclorotiazidaViatris” and “Warnings and precautions”).
• Digoxin.

Telmisartán/Hidroclorotiazida may increase the effect of other medications to lower blood pressureor of medications that may potentially lower blood pressure (e.g., baclofen, amifostine). Additionally, the decrease in blood pressure may be exacerbated by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness when standing up. Inform your doctor about the need to adjust the dose of your other medications while taking Telmisartán/Hidroclorotiazida.

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

Administration oftelmisartán/hidroclorotiazidaViatriswith food and alcohol

You can takeTelmisartán/Hidroclorotiazidawith 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 lactation

Pregnancy

You must inform your doctor if you are pregnant,if you suspect you may beor if you plan to becomepregnant. Your doctor will usually advise you to stop taking Telmisartán/Hidroclorotiazida before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Telmisartán/Hidroclorotiazida is not recommended for use during pregnancy and should not be administered after the third month of pregnancy because it may cause serious harm to your baby when administered from that point on.

Lactation

Inform your doctor if you plan to initiate or are in a lactation period since Telmisartán/Hidroclorotiazida is not recommended for administration to women during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed.

Driving and operating machinery

Some patients may feel dizzy or tired when taking Telmisartán/Hidroclorotiazida. If you feel dizzy or tired, do not drive or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of Telmisartán/Hidroclorotiazida is one tablet per day. Try to take one tablet every day at the same time. You can take Telmisartán/Hidroclorotiazida with or without food. The tablets should be swallowed with a little water or other non-alcoholic beverage. It is essential to take Telmisartán/Hidroclorotiazida every day until your doctor tells you otherwise.

If your liver does not function correctly, the usual dose should not exceed 40 mg/12.5 mg once a day.

If you take more Telmisartán/Hidroclorotiazida Viatris than you should

If you accidentally take too many tablets, you may experience symptoms such as low blood pressure and rapid heartbeats. Slow heartbeats, dizziness, vomiting, and reduced kidney function, including kidney failure, have also been described. Due to the hydrochlorothiazide component, you may also experience notably low blood pressure and low potassium levels in the blood, which can lead to nausea, drowsiness, and muscle cramps and/or irregular heartbeats associated with the concomitant use of medications such as digitalis or certain antiarrhythmic treatments. Contact your doctor or pharmacist immediately or the nearest hospital emergency service.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Telmisartán/HidroclorotiazidaViatris

If you forget to take the medication, do not worry. Take the dose as soon as you remember and continue as before. If you miss a dose one day, take your normal dose the next day.Do not take a double dose to compensate for the missed doses.

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

Like all medicines, Telmisartán/Hidroclorotiazida can cause side effects, although not everyone will experience them.

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

If you experience any of the following symptoms, you should visit your doctor immediately:

Sepsis* (also known as "blood infection," it is a severe infection that involves a systemic inflammatory reaction), rapid swelling of the skin and mucous membranes (angioedema), formation of blisters and peeling of the skin's surface (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 should stop taking the medicine and visit their doctor immediately. If these side effects are not treated, they can be fatal. An increased incidence of sepsis has been observed with telmisartán alone; however, it cannot be ruled out for Telmisartán/Hidroclorotiazida.

Possible side effects of Telmisartán/Hidroclorotiazida Viatris:

Frequent side effects(may affect up to 1 in 10 people):

Dizziness.

Infrequent side effects(may affect up to 1 in 100 people):

Decreased potassium levels in the blood, anxiety, fainting (syncope), tingling sensation, numbness (paresthesia), dizziness (vertigo), rapid heart rate (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 uric acid levels in the blood.

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

Pneumonia (bronchitis), activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks the body, causing joint pain, skin rashes, and fever), sore throat, sinusitis, feeling of sadness (depression), difficulty falling asleep (insomnia), vision disturbances, difficulty breathing, abdominal pain, constipation, indigestion (dyspepsia), general discomfort (vomiting), stomach inflammation (gastritis), alteration in liver function (patients in Japan are more prone to experiencing this side effect), skin redness (erythema), allergic reactions such as itching or rashes, increased sweating, hives (urticaria), joint pain (arthralgia), and pain in the extremities, muscle cramps, pseudogripal disease, pain, low sodium levels, increased creatinine, liver enzymes, or creatine phosphokinase in the blood.

The adverse reactions reported for one of the individual components may be potential adverse reactions of Telmisartán/Hidroclorotiazida Viatris, although they have not been observed in clinical trials with this product.

Telmisartán

The following additional side effects have been described in patients taking telmisartán alone:

Infrequent side effects(may affect up to 1 in 100 people):

Upper respiratory tract infection (e.g., sore throat, sinusitis, common cold), urinary tract infections, anemia, high potassium levels, slow heart rate (bradycardia), acute renal failure, and weakness.

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

Low platelet count (thrombocytopenia), eosinophilia (an increase in certain white blood cells), severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions, skin eruptions), low blood sugar levels (in diabetic patients), stomach discomfort, eczema (a skin disorder), arthritis, tendon inflammation, decreased hemoglobin (a protein in the blood), drowsiness.

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

Progressive fibrosis of lung tissue (interstitial lung disease)**

* This may have been a chance finding or related to an unknown mechanism.

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

Hidroclorotiazida

The following additional side effects have been described in patients taking hidroclorotiazida alone:

Frequent side effects(may affect up to 1 in 10 people):

Nausea, low magnesium levels in the blood.

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

Low platelet count, which increases the risk of bleeding and hematoma formation (small purple-red marks on the skin or in other tissues caused by bleeding), high calcium levels in the blood, headache.

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

Increased pH (alteration of acid-base balance) due to low chloride levels in the blood.

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

Intestinal angioedema: intestinal inflammation presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea after use of similar products, salivary gland inflammation, skin cancer 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 appetite, restlessness, dizziness, blurred or yellowish vision, decreased vision, and eye pain (possible signs of fluid accumulation in the eye's vascular layer [choroidal effusion] or acute myopia oracute angle-closure glaucoma), necrotizing vasculitis, pancreatitis, stomach discomfort, yellowing of the skin or eyes (jaundice), pseudolupus syndrome (a condition that mimics a disease called systemic lupus erythematosus in which the body's immune system attacks the body), skin disorders such as inflammation of blood vessels in the skin, increased sensitivity to sunlight, skin rash, redness of the skin, formation of blisters on the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney inflammation or alteration of its function, glucose in the urine (glucosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, increased blood glucose levels, difficulty controlling blood glucose levels/orine in patients with diabetes mellitus, or blood fat.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the carton after “CAD”. The expiration date is the last day of the month indicated.

For Al/Al Blister Packs

This medication does not require special storage conditions.

For Al/PVC/PVDC Blister Packs

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Telmisartan/Hydrochlorothiazide Viatris Composition

• The active principles are telmisartan and hydrochlorothiazide. Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
• The other components are magnesium stearate, meglumine, microcrystalline cellulose, povidone, potassium hydroxide, carboxymethylmethylcellulose sodium (type A) (from potato) and mannitol (E421).

Appearance of the product and content of the packaging

Telmisartan/Hydrochlorothiazide Viatris 40 mg/12.5 mg tablets are oval and concave tablets, 6.55 x 13.6 mm with TH engraved on one face.

It is available in Al/PVC/PVDC blisters of 28 tablets and in Al/Al calendar blisters of 28 tablets.

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for Manufacturing

Actavis Ltd.

BLB016
Bulebel Industrial Estate

Zejtun ZTN 3000 Malta

Last review date of this leaflet: January 2025

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