TELMISARTAN/HYDROCHLOROTHIAZIDE VIATRIS 80 mg/25 mg TABLETS

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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Telmisartan/Hydrochlorothiazide Viatris and what is it used for
2. What you need to know before you take Telmisartan/Hydrochlorothiazide Viatris
3. How to take Telmisartan/Hydrochlorothiazide Viatris
4. Possible side effects
5. Storage of Telmisartan/Hydrochlorothiazide Viatris

1. Contents of the pack and other information

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

Telmisartan/Hydrochlorothiazide Viatris is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet. Both active substances help to 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 makes your blood vessels narrow, thus increasing your blood pressure.

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

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

High blood pressure, if left untreated, can damage the blood vessels of various organs, which in some cases can lead to a heart attack, heart failure or kidney failure, stroke or blindness. Usually, there are no symptoms of high blood pressure before damage occurs. Therefore, it is important to regularly check your blood pressure to ensure it is 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 with telmisartan and hydrochlorothiazide separately.

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

Do not take Telmisartan/Hydrochlorothiazide 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 medicines of the sulfonamide type.
• 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 section Pregnancy).
• 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 determines that you have low potassium or high calcium levels in your blood that do not improve with treatment.
• if you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskiren.

If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan/Hydrochlorothiazide.

Warnings and precautions

Consult your doctor before starting to take Telmisartan/Hydrochlorothiazide if you suffer from or have suffered from any of the following disorders or diseases:

• • Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body water) or have low levels of salts due to treatment with diuretics, 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.
  • High levels of aldosterone (water and salt retention in the body along with imbalance of various minerals in the blood).
  • 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 decreased vision and eye pain. These symptoms can be indicative of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye and may appear between hours and weeks after taking Telmisartan/Hydrochlorothiazide. If left untreated, it can lead to permanent vision loss.
• 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 exposure and UV rays while taking Telmisartan/Hydrochlorothiazide.

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 need to check 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 Telmisartan/Hydrochlorothiazide Viatris".

• if you are taking digoxin.

Tell 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, think you may be pregnant, or are planning to become pregnant, tell your doctor. Telmisartan/Hydrochlorothiazide is not recommended during pregnancy (first 3 months) and should not be taken after the third month of pregnancy as it may cause serious harm to your baby, see section Pregnancy.

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

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

If you are going to have surgery (including dental surgery) or anesthesia, tell your doctor that you are taking Telmisartan/Hydrochlorothiazide.

Telmisartan/Hydrochlorothiazide may be less effective in reducing blood pressure in black patients.

Children and adolescents

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

Other medicines and Telmisartan/Hydrochlorothiazide Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may need to change the dose of those other medicines or take other precautions. In some cases, it may be necessary to stop taking some of these medicines, especially if you are taking any of the following medicines with Telmisartan/Hydrochlorothiazide:

• Medicines containing lithium for the treatment of certain types of depression.
• Medicines associated with low potassium levels in the blood (hypokalemia) 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), penicillin G sodium (an antibiotic), and acetylsalicylic acid and derivatives.
• Medicines that can increase potassium levels in the blood such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporine (an immunosuppressive medicine), and other medicines such as heparin sodium (an anticoagulant).
• Medicines affected by changes in potassium levels in the blood such as heart medicines (e.g., digoxin) or medicines to control your heart rate (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 for treating allergic reactions (e.g., terfenadine).
• Medicines for the treatment of diabetes (insulins or oral agents such as metformin).
• Colestyramine and colestipol, medicines 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 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)), medicines for treating cancer, gout, or arthritis.
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Telmisartan/Hydrochlorothiazide Viatris" and "Warnings and precautions").
• Digoxin

Telmisartan/Hydrochlorothiazide may increase the ability of other medicines to lower blood pressure or of medicines that may potentially lower blood pressure (e.g., baclofen, amifostine).

Additionally, the decrease in blood pressure may be enhanced by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness when standing up. You should tell your doctor about the need to adjust the dose of your other medicines while taking Telmisartan/Hydrochlorothiazide.

The effect of Telmisartan/Hydrochlorothiazide may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g., aspirin or ibuprofen).

Taking Telmisartan/Hydrochlorothiazide Viatris with food and alcohol

You can take Telmisartan/Hydrochlorothiazide with or without food.

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

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking Telmisartan/Hydrochlorothiazide before you become pregnant or as soon as you find out you are pregnant, and will recommend that you take another blood pressure medicine instead. Telmisartan/Hydrochlorothiazide is not recommended during pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are about to start or are already breastfeeding, as Telmisartan/Hydrochlorothiazide is not recommended for use during breastfeeding. Your doctor may decide to give you a different treatment that is more suitable if you want to breastfeed.

Driving and using machines

Some patients feel dizzy or tired when taking Telmisartan/Hydrochlorothiazide. If you feel dizzy or tired, do not drive or use machines.

3. How to take Telmisartan/Hydrochlorothiazide Viatris

Follow exactly the instructions of administration of this medicine given to you by your doctor. If you are not sure, ask your doctor or pharmacist again.

The recommended dose of Telmisartan/Hydrochlorothiazide is one tablet per day. Try to take one tablet each day at the same time. You can 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 to stop.

If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day.

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 fast heart rate. Slow heart rate, dizziness, vomiting, and reduced kidney function including kidney failure have also been reported. Due to the hydrochlorothiazide component, you may also experience very low blood pressure and low potassium levels in the blood, which can lead to nausea, somnolence, and muscle cramps and/or irregular heartbeats associated with concomitant use of medicines such as digitalis or certain antiarrhythmic treatments. Contact your doctor or pharmacist or the nearest hospital emergency department immediately.

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

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 continue as before. If you do not take your tablet 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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

Sepsis* (often called "blood infection"), is a serious infection that involves an inflammatory reaction of the entire body, rapid swelling of the skin and mucous membranes (angioedema), 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 should stop taking the medicine and visit their doctor immediately. If these adverse effects are not treated, they can be fatal. An increase in the incidence of sepsis with telmisartan alone has been observed; however, it 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):

Decrease in potassium levels in the blood, anxiety, fainting (syncope), tingling sensation, numbness (paresthesia), dizziness (vertigo), rapid heartbeats (tachycardia), heart rhythm disorders, low blood pressure, sudden drop in blood pressure when standing up, shortness of breath (dyspnea), diarrhea, dry mouth, flatulence, back pain, muscle spasms, muscle pain, erectile dysfunction (inability to have or maintain an erection), chest pain, and increased uric acid levels in the blood.

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

Inflammation of the lungs (bronchitis), activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks the body itself, causing joint pain, skin rashes, and fever), sore throat, inflammation of the paranasal sinuses, feeling of sadness (depression), difficulty falling asleep (insomnia), vision disturbance, breathing difficulties, abdominal pain, constipation, abdominal distension (dyspepsia), general malaise (vomiting), stomach inflammation (gastritis), alteration in liver function (Japanese patients show a greater tendency to experience this adverse effect), redness of the skin (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia), and pain in the limbs, muscle cramps, pseudoinfluenza syndrome, pain, low sodium levels, increased creatinine, liver enzymes, or creatine phosphokinase levels in the blood.

Adverse reactions reported for one of the individual components may 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 described 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, red blood cell deficiency (anemia), high potassium levels, slow heart rate (bradycardia), cough, alteration in kidney function including acute kidney failure, weakness.

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

Low platelet count (thrombocytopenia), increased white blood cell count (eosinophilia), severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions, drug rash), low blood sugar levels (in diabetic patients), stomach upset, 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 casual finding or be related to a currently unknown mechanism.

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

Hydrochlorothiazide

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

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

Nausea, low magnesium level in the blood.

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

Decrease in platelet count in the blood, which increases the risk of bleeding and bruising (small purple-red spots on the skin or other tissues caused by bleeding), high calcium level in the blood, headache.

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

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

Frequency not known (cannot be estimated from available data)

Intestinal angioedema: inflammation in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea after use of similar products, salivary gland inflammation, skin and lip cancer (non-melanoma skin cancer), decrease in blood cell count, including low red and white blood cell count, severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), decreased or lost 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 angle-closure glaucoma), blood vessel inflammation (necrotizing vasculitis), pancreatitis, stomach upset, 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 itself), skin disorders such as blood vessel inflammation of the skin, increased sensitivity to sunlight, skin rash, skin redness, blistering of the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney inflammation or altered function, glucose in the urine (glucosuria), fever, altered electrolyte balance, high cholesterol levels in the blood, decreased blood volume, increased glucose levels in the blood, difficulty controlling glucose levels in the blood/urine in patients with a diagnosis of 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 it is a possible adverse effect that does not appear in this leaflet.

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

5. Storage of Telmisartan/Hydrochlorothiazide Viatris

Keep this medicine out of sight and reach of children.

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

For Al/Al blisters

This medicine does not require 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. Deposit the packaging and medicines you no longer need at the SIGRE point in your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Telmisartan/Hydrochlorothiazide Viatris

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

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

Appearance of the Product and Package Contents

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

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Actavis Ltd.

BLB016

Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Date of the Last Revision 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/