Package Insert: Information for the User

Telmisartan/Hydrochlorothiazide Viatris 80 mg/25 mg Tablets EFG

Read this package insert carefully before you start taking this medication, as it contains important information for you.

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

1. Contents of the package and additional information

Telmisartán/Hidroclorotiazida Viatris is a combination of two active ingredients, telmisartán and hidroclorotiazida in a tablet. Both active ingredients help control high blood pressure.

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

Telmisartán blocks the effect of angiotensin II, causing blood vessels to relax and reducing blood pressure.

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

High blood pressure, if left untreated, can damage blood vessels in various organs, which in some cases can cause a heart attack, heart 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 is used for the treatment of high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlledwith telmisartan/hidroclorotiazida 80 mg/12.5 mg or in patients who have previously been stabilizedwith telmisartán and hidroclorotiazida separately.

Do not take Telmisartán/Hidroclorotiazida Viatris

- if you are allergic to telmisartán or any of the other ingredients of this medicine (listed in section 6).

- if you are allergic to hidroclorotiazida or other sulfonamide-derived medicines.

- if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also at the beginning of your pregnancy - see Pregnancy section).

- if you have severe liver problems such as cholestasis or biliary obstruction (liver and gallbladder drainage problems) 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 blood pressure-lowering medicine containing aliskirén.

If any of the above mentioned occur, 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 a deficiency of salts due to diuretic treatment, low-sodium diet, diarrhea, vomiting, or hemodialysis.
  • Kidney disease or kidney transplant.
  • Renal artery stenosis (narrowing of the blood vessels of one or both kidneys).
  • Liver disease.
  • Heart problems.
  • Diabetes.
  • Gout.
  • Elevated aldosterone levels (retention of water and salt in the body along with imbalance of several minerals in the blood).
  • Systemic lupus erythematosus (also called "lupus" or "LES") a disease in which the body's immune system attacks the body itself.
• The active ingredient hidroclorotiazida may cause a rare reaction, leading to a decrease in vision and eye pain. These symptoms may be indicative of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in your eye and may appear between hours and weeks after taking Telmisartán/Hidroclorotiazida. If left untreated, it may lead to permanent vision loss.
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly its 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 exposure and UV rays while taking Telmisartán/Hidroclorotiazida.

Consult your doctor before starting to take telmisartán/hidroclorotiazida:

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

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

Your doctor may monitor your renal function, blood pressure, and 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 digoxina.

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 be pregnant, or if you plan to become pregnant, 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 hidroclorotiazida may cause an electrolyte imbalance in your body. Typical symptoms of a fluid or 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 should also inform your doctor if you experience increased skin sensitivity to the sun with sunburn symptoms (such as redness, itching, swelling, and blistering) that appear more quickly than usual.

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

Telmisartán/Hidroclorotiazida may be less effective in reducing 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 medicines and Telmisartán/Hidroclorotiazida Viatris

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

• Medicines containing lithium for the treatment of certain types of depression.
• Medicines associated with low potassium levels in the blood (hypokalemia) such as, for example, other diuretics, laxatives (e.g. ricin oil), corticosteroids (e.g. prednisone), ACTH (adrenocorticotropic hormone), amphotericin (antifungal medicine), carbenoxolone (used in the treatment of mouth ulcers), penicillin G sodium (an antibiotic), and aspirin and derivatives.
• Medicines 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 medicines such as heparin sodium (anticoagulant).
• Medicines that are affected by changes in potassium levels in the blood such as heart medicines (e.g. digoxina) or medicines to control your heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol), medicines used to treat mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine), and other medicines such as some antibiotics (e.g. ciprofloxacin, pentamidine) or some 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 to reduce cholesterol levels in the blood.
• 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 anesthesia) such as atropine and biperiden.
• Amantadine (medicine used to treat Parkinson's disease and also to treat or prevent certain diseases caused by viruses).
• Other medicines used to treat high blood pressure, corticosteroids, analgesics (such as nonsteroidal anti-inflammatory drugs [NSAIDs]), medicines for cancer treatment, gout, or arthritis.
• If you are taking an ACE inhibitor or aliskirén (see also the information under the headings "Do not take Telmisartán/Hidroclorotiazida Viatris" and "Warnings and precautions").
• Digoxina

Telmisartán/Hidroclorotiazida may increase the effect of other medicines to lower blood pressure or medicines 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 medicines while taking Telmisartán/Hidroclorotiazida.

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

Taking telmisartán/hidroclorotiazida Viatris with food and alcohol

You can take Telmisartán/Hidroclorotiazida with or without food.

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

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant. 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 medicine 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 onwards.

Lactation

Inform your doctor if you plan to breastfeed or are breastfeeding because Telmisartán/Hidroclorotiazida is not recommended for use 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. If in 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. There have also been reports of slow heartbeats, dizziness, vomiting, and reduced kidney function, including kidney failure. 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 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/Hidroclorotiazida Viatris

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, 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, this medicine can cause side effects, although not everyone will experience them.

Some side effects can 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"), is a severe infection that involves a systemic inflammatory reaction, rapid swelling of the skin and mucous membranes (angioedema),formation of blisters and peeling on the superficial layer of the skin (toxic epidermal necrolysis);these side effects are rare (can 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 with telmisartan alone has been observed; however, it cannot be ruled out for Telmisartan/Hidroclorotiazida.

Possible side effects of Telmisartán/Hidroclorotiazida Viatris:

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

Dizziness.

Infrequent side effects(can 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(can 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), liver function disturbances (Japanese patients 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 limb pain, 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, although they have not been observed in clinical trials with this product.

Telmisartán

Additionally, the following side effects have been described in patients taking telmisartan alone:

Infrequent side effects(can 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), cough, kidney function disturbances including acute renal failure, weakness.

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

Low platelet count (thrombocytopenia), increased eosinophils, severe allergic reactions (e.g. hypersensitivity, anaphylactic reactions, drug eruptions), low blood sugar levels (in diabetic patients), stomach discomfort, eczema (a skin disorder), arthritis, tendon inflammation, decreased hemoglobin (a blood protein), drowsiness.

Very rare side effects(can 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 telmisartan use. However, it is unknown if telmisartan was the cause.

Hidroclorotiazida

Additionally, the following side effects have been described in patients taking hidroclorotiazida alone:

Frequent side effects(can affect up to 1in10people)

Nausea, low magnesium levels in the blood.

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

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

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

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

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 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 vascular layer of the eye [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,lip, eye, or mouth blistering, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney inflammation or function disturbances, glucose in the urine (glucosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, increased glucose levels in the blood, 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 the 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 blisters

This medication does not require special storage conditions.

For Al/PVC/PVDC blisters

Do not store at a temperature above 30°C.

Medications should not be thrown into the drains or trash. Dispose of the containers and medications you no longer need at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Telmisartan/Hydrochlorothiazide Viatris Composition

• The active principles 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, carboxymethylmethylcellulose sodium (type A) (from potato) and mannitol (E421).

Product appearance and packaging contents

Telmisartan Hydrochlorothiazide Viatris 80 mg/25 mg tablets are oval and concave tablets of 9.0 x 17.0 mm with "TH" engraved on one face and "25" on the other 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 manufacturer

Marketing authorization holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible manufacturer

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)http://www.aemps.gob.es/