TELMISARTAN VIATRIS 80 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Telmisartan Viatris 80 mg Film-Coated Tablets

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Telmisartan Viatris and what is it used for
2. What you need to know before you take Telmisartan Viatris
3. How to take Telmisartan Viatris
4. Possible side effects
5. Storage of Telmisartan Viatris
6. Contents of the pack and other information

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

Telmisartan Viatris contains telmisartan, which belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced by your body that causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan Viatris blocks the effect of angiotensin II, causing the blood vessels to relax and your blood pressure to decrease.

Telmisartan Viatris is used to treat essential hypertension (high blood pressure) in adults. "Essential" means that the high blood pressure is not caused by any other condition.

If high blood pressure is not treated, it can damage the blood vessels of some organs, which can eventually 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 measure your blood pressure to check if it is within the normal range.

Telmisartan Viatris is also used to reduce the risk of heart attack or stroke in adults at risk, due to a reduction or blockage of blood flow to the heart or legs, have had a stroke in the past, or suffer from organ damage caused by diabetes. Your doctor may indicate if you have a high risk of suffering such events.

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

Do not take Telmisartan Viatris:

• If you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant (it is also better to avoid taking Telmisartan Viatris during the first few months of pregnancy – see section Pregnancy).
• If you have severe liver problems, such as cholestasis or biliary obstruction (problems with the drainage of bile secreted by the liver and gallbladder) or any other serious liver disease.
• If you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medicine that contains aliskiren.

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

Warnings and precautions

Tell your doctor if you are suffering or have ever suffered from any of the following diseases or disorders:

• If you have kidney disease or have had a kidney transplant.
• If you have narrowing of the blood vessels to one or both kidneys (renal artery stenosis).
• If you have any other liver disease.
• If you have heart problems.
• If you have low blood pressure (hypotension), which can occur if you lose too much body water (dehydration) or have low levels of salts because you are taking diuretics, are on a low-salt diet, or have had diarrhea or vomiting.
• If you have water and salt retention in the body, accompanied by an imbalance of various minerals in the blood (high levels of aldosterone).
• If you have very high levels of potassium in your blood.
• If you are diabetic.

Consult your doctor or pharmacist before starting to take Telmisartan Viatris:

• If you are taking digoxin.
• If you are taking any of the following medicines used to treat high blood pressure:
• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• Aliskiren.

Consult 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.

Your doctor may 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 Viatris".

If you are black; as with any other angiotensin II receptor antagonist, the effectiveness of Telmisartan Viatris in lowering blood pressure may be lower in black patients.

You should tell your doctor if you think you might be pregnant or are planning to become pregnant. Telmisartan Viatris is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy (see section Pregnancy).

If you are going to have surgery or receive anesthesia, you should tell your doctor that you are taking Telmisartan Viatris.

Children and adolescents

Telmisartan Viatris is not recommended for children and adolescents under 18 years.

Taking Telmisartan Viatris with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Your doctor may need to change your dose and/or take other precautions. In some cases, you may be required to stop taking one of the medicines. This is especially true for the medicines listed below when taken at the same time as Telmisartan Viatris:

• Lithium (for treating some types of depression).

• Medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin or ibuprofen), heparin, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, such as furosemide, hydrochlorothiazide, amiloride; especially when taken at high doses with Telmisartan Viatris, they may cause excessive water loss and reduce blood pressure (hypotension).

• As with other blood pressure medicines, the effect of Telmisartan Viatris may be reduced by the taking of NSAIDs (non-steroidal anti-inflammatory drugs, such as aspirin or ibuprofen) or corticosteroids.
• Other medicines for treating high blood pressure, powerful painkillers, barbiturates (for epilepsy), baclofen (used to treat cerebral palsy and multiple sclerosis), amifostine (used to prevent fever and infections in patients receiving chemotherapy or radiotherapy), or medicines for depression.
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Telmisartan Viatris" and "Warnings and precautions").
• Digoxin.

Telmisartan Viatris may increase the blood pressure-lowering effect of other medicines used to treat high blood pressure.

Telmisartan Viatris with alcohol

The blood pressure-lowering effect of Telmisartan Viatris may be increased if you take it with alcohol, which may make you feel dizzy or faint, and weak, especially when standing up after sitting or lying down.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Your doctor will normally advise you to stop taking telmisartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead. Telmisartan must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken after this point.

Breastfeeding

Tell your doctor if you are about to start or are already breastfeeding. Telmisartan is not recommended for women who are breastfeeding, and your doctor may choose another treatment if you want to breastfeed your baby, especially if your baby is a newborn or premature.

Driving and using machines

Some people may feel dizzy or tired when taking blood pressure-lowering medicines. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartan Viatris contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Telmisartan Viatris

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose of Telmisartan Viatris depends on what you are taking it for. You should take your dose once a day, at the same time each day.

For the treatment of high blood pressure, the recommended dose is 40 mg once daily to control high blood pressure over a 24-hour period. However, in some cases, your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. For some patients, 20 mg may be a sufficient dose. Telmisartan Viatris can also be used in combination with diuretics such as hydrochlorothiazide, as they have been shown to have an additive effect on lowering blood pressure when taken with telmisartan.

To reduce the risk of heart attack or stroke, the recommended dose is 80 mg daily. When starting treatment, it will be necessary to frequently check your blood pressure.

If you think that the effect of Telmisartan Viatris is too strong or too weak, talk to your doctor or pharmacist.

Your medicine is available in 3 strengths:

20 mg, 40 mg, and 80 mg.

Use in children and adolescents

Children and adolescents under 18 years should not take Telmisartan Viatris.

Method of administration

Swallow the tablets whole with water or another non-alcoholic drink.

You can take Telmisartan Viatris with or without food.

Patients with liver problems

If your liver is not working properly, the recommended dose should not exceed 40 mg once daily.

Patients with kidney problems

If you have kidney problems, please talk to your doctor. Your doctor may prescribe a lower dose of 20 mg daily.

If you take more Telmisartan Viatris than you should

Symptoms may include low blood pressure, dizziness, increased or decreased heart rate, and kidney problems.

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

If you forget to take Telmisartan Viatris

If you forget to take your tablets, do not worry. Take them as soon as you remember and then continue to take them as usual.

If you miss a dose, take your normal dose the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Telmisartan Viatris

If you want to stop taking this medicine, consult your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

If you experience any of the following symptoms, you should see your doctor, as they can be life-threatening if left untreated:

• Sepsis* (often referred to as "blood infection", a serious infection that involves an inflammatory response of the whole body).
• Severe allergic reaction with symptoms such as skin rash, itching, difficulty breathing, wheezing, swelling of the face or a drop in blood pressure (anaphylactic reaction).
• Rapid swelling of the skin, face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema).
• Severe skin reactions, which can include blistering and peeling of the skin (toxic skin reaction).
• Fluid retention causing tiredness, discomfort, shortness of breath, and swelling of the legs, ankles, or feet (renal failure, including kidney failure).
• Difficulty breathing with a dry cough or non-productive cough and weight loss, due to progressive scarring of lung tissue (interstitial lung disease) ***.

Other possible side effects:

Common (may affect up to 1 in 10 people):

• Low blood pressure (hypotension) in users treated for cardiovascular events, such as heart attack or stroke.

Uncommon (may affect up to 1 in 100 people):

• Upper respiratory tract infection (e.g., sore throat, common cold, inflamed and swollen nasal sinuses causing pain, fever, and pain on palpation).
• Urinary tract infection, including inflammation of the bladder surface.
• Low red blood cell count (anemia), which can cause pale skin and make you feel weak and tired.
• High potassium levels, seen in blood tests.
• Feeling sad (depression).
• Difficulty sleeping.
• Feeling that everything is spinning (vertigo).
• Fainting (syncope).
• Dizziness or mild dizziness, especially when standing up (orthostatic hypotension).
• Slow heart rate (bradycardia).
• Low blood pressure (hypotension) in users treated for high blood pressure.
• Difficulty breathing and chest pain.
• Cough.
• Stomach pain, diarrhea, indigestion, bloating, or vomiting.
• Skin rash, itching.
• Increased sweating.
• Back pain, muscle pain (myalgia), muscle spasms.
• Weakness.
• Increased levels of a substance called creatinine in the blood, seen in blood tests.

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

• Low platelet count in the blood, with an increased risk of bleeding or bruising.
• Increased levels of certain white blood cells (eosinophilia), seen in blood tests.
• Anxiety.
• Vision problems (vision disturbance).
• Fast heart rate (tachycardia).
• Dry mouth.
• Taste disturbances (dysgeusia).
• Liver function abnormalities**.
• Skin inflammation, characterized by itching and skin rash, often including blisters (eczema), skin redness, hives (urticaria).

• Joint pain (arthralgia), pain in the limbs, or pain in the tendons.

• Flu-like symptoms (influenza-like illness).
• Increased levels of certain enzymes in the blood (such as liver enzymes or creatine phosphokinase), seen in blood tests.
• Low blood sugar levels (in diabetic patients).
• Decreased hemoglobin (a blood protein), seen in blood tests.
• Increased levels of uric acid, seen in blood tests.
• Drowsiness.
• Stomach upset.

Frequency not known (cannot be estimated from the available data):

• Intestinal angioedema: inflammation in the intestine has been reported with symptoms such as abdominal pain, nausea, vomiting, and diarrhea after the use of similar products.

• In a long-term study involving over 20,000 patients, the number of patients treated with telmisartan who experienced septicemia exceeded that of patients who did not receive telmisartan. The event may be casual or may be related to a currently unknown mechanism.

** Most cases of liver function abnormalities and liver disorders derived from post-marketing experience with telmisartan occurred in Japanese patients. Japanese patients are more likely to experience this side effect.

*** Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is not known whether telmisartan was the cause.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Telmisartan Viatris

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

Do not use this medicine after the expiry date which is stated on the blister, carton, and bottle after EXP. The expiry date refers to the last day of the month shown.

Store in the original package to protect from light.

Do not use this medicine if you notice discoloration of the tablets.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents in Additional Formation

Composition of Telmisartan Viatris

• The active ingredient is telmisartan.
• Each tablet contains 80 mg of telmisartan.
• The other components are magnesium stearate (E-470b), povidone, meglumine, sodium hydroxide, and mannitol (E-421).

Appearance of the Product and Container Contents

White or almost white tablets, with curved sides, oblong, marked with "TN80" on one face, and "M" on the other.

Telmisartan Viatris is available in packs containing blisters of 14, 28, 30, 56, 60, 84, 90, 98, or 100 tablets, calendar blister pack of 28 tablets, or plastic bottles with a plastic cap containing absorbent cotton and desiccant (do not eat the desiccant) containing 56, 60, 84, 90, 98, 280, 500, or 1,000 tablets.

Telmisartan Viatris 80 mg is also available in a multiple blister pack of 98, which consists of 2 cardboard boxes with 49 tablets each.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

McDermott Laboratories Limited trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

Or

Mylan Hungary Kft

H-2900, Komárom, Mylan útca 1

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany Telmisartan Mylan 80 mg Tabletten

Belgium Telmisartan Mylan 80 mg tabletten

Cyprus Telmisartan Mylan

Denmark Telmisartan Mylan 80 mg tablets

Slovakia Telmisartan Mylan 80 mg

Spain Telmisartán Viatris 80 mg comprimidos EFG

France TELMISARTAN MYLAN 80 mg comprimé

Greece Telmisartan Mylan Tablets 80 mg

Hungary Telmisartan Mylan 80 mg tabletta

Ireland Telmisartan Mylan 80 mg

Luxembourg Telmisartan Mylan 80 mg CPR

Netherlands Telmisartan Mylan 80 mg tabletten

Poland Telmisartan Mylan

Portugal Telmisartan Mylan

United Kingdom Telmisartan Mylan 80 mg Tablets

Czech Republic Telmisartan Mylan 80 mg tablety

Romania Telmisartan Mylan 80 mg Comprimate

Date of the last revision of this prospectus:January 2025

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