Telmisartan Viatris 80 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Telmisartan Viatris 80 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Telmisartán Viatris contains telmisartan, which belongs to a class of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance produced by 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 thereby lowering blood pressure.

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

If high blood pressure is not treated, it can damage the blood vessels of certain organs, eventually leading to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure generally does not cause symptoms until damage has occurred. Therefore, it is important to measure your blood pressure regularly to ensure it remains within the normal range.

Telmisartan is also used to reduce the risk of heart attack or stroke in adults who are at risk due to reduced or blocked blood flow to the heart or legs, who have previously had a stroke, or who have organ damage caused by diabetes. Your doctor can determine whether you are at high risk for such events.

2. What you need to know before taking Telmisartán Viatris

Do not take Telmisartán Viatris:

• If you are allergic to telmisartan or to any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant (it is better to avoid taking Telmisartán Viatris during the first months of pregnancy as well – see Pregnancy section).
• If you have severe liver problems, such as cholestasis or biliary obstruction (problems with the drainage of bile produced by the liver and gallbladder) or any other serious liver disease.
• If you have diabetes mellitus or renal insufficiency 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 Viatris.

Warnings and precautions

Tell your doctor if you are suffering or have ever suffered from any of the following conditions 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 may occur if you have excessive loss of body water (dehydration) or low salt levels due to diuretic use, a low-salt diet, or episodes of diarrhoea or vomiting.
• If you have fluid and salt retention in the body accompanied by an imbalance of various blood minerals (elevated aldosterone levels).
• If you have very high levels of potassium in the blood.
• If you are diabetic.

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

• If you are taking digoxin.
• 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.

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

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 Viatris”.

If you are of Black origin; as with any other angiotensin II receptor antagonist, the effectiveness of Telmisartán Viatris in lowering blood pressure may be reduced in Black patients.

You must inform your doctor if you think you may be (or intend to become) pregnant. Telmisartán Viatris is not recommended during the first months of pregnancy and must not be taken after the third month of gestation, as it may cause serious harm to your unborn child if used at that stage (see Pregnancy section).

If you are scheduled for surgery or will receive anaesthesia, inform your doctor that you are taking Telmisartán Viatris.

Children and adolescents

The use of Telmisartán Viatris is not recommended in children and adolescents under 18 years of age.

Taking Telmisartán 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 your dose and/or take other precautions. In some cases, you may need to stop taking one of the medicines. This particularly applies to the following medicines when taken concurrently with Telmisartán Viatris:

• Lithium (used to treat certain types of depression).

• Medicines that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, e.g., aspirin or ibuprofen), heparin, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.

• Diuretics such as furosemide, hydrochlorothiazide, amiloride; especially if taken at high doses together with Telmisartán Viatris, may cause excessive loss of body water and lead to low blood pressure (hypotension).

• As with other antihypertensive medicines, the effect of Telmisartán Viatris may be reduced by taking NSAIDs (non-steroidal anti-inflammatory drugs such as aspirin or ibuprofen) or corticosteroids.

• Other medicines for treating high blood pressure, strong 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 angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Telmisartán Viatris” and “Warnings and precautions”).

• Digoxin.

Telmisartán Viatris may enhance the antihypertensive effect of other medicines used to treat high blood pressure.

Telmisartán Viatris and alcohol

The blood pressure-lowering effect may be increased if Telmisartán Viatris is taken with alcohol, which may cause dizziness, lightheadedness, or weakness, especially when standing up after sitting or lying down.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Your doctor will usually advise you to stop taking telmisartan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Telmisartan must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken from that point onward.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding. Telmisartan is not recommended for breastfeeding mothers; your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Some people may experience adverse effects such as fainting or dizziness (vertigo) when receiving treatment for high blood pressure. If you experience these adverse effects, do not drive or operate machinery.

Telmisartán Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Telmisartán Viatris

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Telmisartán Viatris depends on why you are taking this medicine. You should take your dose once daily at the same time each day.

For the treatment of high blood pressure, the recommended dose is 40 mg once daily to control elevated blood pressure over a 24-hour period. However, in certain 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 sufficiently high dose. Telmisartán Viatris may also be used in combination with diuretics such as hydrochlorothiazide, as they have been shown to have an additive effect in 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, your blood pressure will need to be monitored frequently.

If you feel that the effect of Telmisartán Viatris is too strong or too weak, consult 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 of age must not take Telmisartán Viatris.

Method of administration

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

You may take Telmisartán Viatris with or without food.

Patients with liver problems

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

Patients with kidney problems

If you have kidney problems, please speak with your doctor. Your doctor may prescribe an initial dose lower than 20 mg daily.

If you take more Telmisartán Viatris than you should

Symptoms may include hypotension, 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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Telmisartán Viatris

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

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 stop taking Telmisartán Viatris

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

If you have any further questions about 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 everyone will experience them.

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

If you experience any of the following symptoms, you should see your doctor, as they may be fatal if left untreated:

• Sepsis* (commonly known as “blood infection”, a serious infection causing a systemic inflammatory response).
• Severe allergic reaction with symptoms such as rash, itching, difficulty breathing, wheezing, facial swelling, or low blood pressure (anaphylactic reaction).
• Rapid swelling of the skin, face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema).
• Serious skin reactions, which may include blisters and peeling of the skin (toxic skin reaction).
• Fluid retention causing fatigue, malaise, shortness of breath, and swelling of the legs, ankles, or feet (renal impairment including kidney failure).
• Difficulty breathing with dry or non-productive cough and weight loss due to progressive fibrosis of lung tissue (interstitial lung disease) ***.

Other possible adverse effects:

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

• Low blood pressure (hypotension) in patients treated to reduce cardiovascular events, e.g., 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 sinuses causing pain, fever, and tenderness on palpation).
• Urinary tract infection, including inflammation of the bladder lining.
• Reduction in red blood cells (anemia), which may cause pale skin, weakness, and breathlessness.
• Elevated potassium levels, detectable in blood tests.
• Feeling of sadness (depression).
• Difficulty falling asleep.
• Sensation of spinning (dizziness).
• Fainting (syncope).
• Dizziness.
• Dizziness or mild lightheadedness, especially when standing up (orthostatic hypotension).
• Slowing of the heartbeat (bradycardia).
• Low blood pressure (hypotension) in patients treated for hypertension.
• 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, detectable in blood tests.

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

• Decreased platelet count in blood, increasing the risk of bleeding or bruising.

• Increase in certain white blood cells (eosinophilia), detectable in blood tests.

• Anxiety.

• Visual disturbance (vision abnormalities).

• Increased heart rate (tachycardia).

• Dry mouth.

• Taste disturbances (dysgeusia).

• Liver function abnormalities**.

• Skin inflammation characterized by itching and rash, often including blisters (eczema), skin redness, hives (urticaria).

• Joint pain (arthralgia), limb pain, or tendon pain.

• Flu-like symptoms (influenza-like illness).

• Increased levels of certain enzymes in the blood (such as liver enzymes or creatine phosphokinase), detectable in blood tests.

• Low blood sugar levels (in diabetic patients).

• Decreased hemoglobin (a blood protein), detectable in blood tests.

• Increased uric acid levels, detectable in blood tests.

• Drowsiness.

• Stomach discomfort.

• Low sodium levels.

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

• Intestinal angioedema: intestinal inflammation has been reported with similar products, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

• In a long-term study involving more than 20,000 patients, the number of patients treated with telmisartan who developed septicemia was higher than in patients not receiving telmisartan. This event could be coincidental or related to a currently unknown mechanism.

** Most cases of liver function abnormalities and hepatic disorders reported during post-marketing experience with telmisartan occurred in Japanese patients. Japanese patients appear to be more susceptible to this adverse effect.

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 pack, carton, and bottle after EXP or CAD. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Telmisartan Viatris

• The active substance 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 contents of the pack

White or almost white, biconvex, oblong tablets, marked with “TN80” on one side and “M” on the other.

Telmisartan Viatris is available in packs containing 14, 28, 30, 56, 60, 84, 90, 98 or 100 tablets in blister packs, calendar blister packs of 28 tablets, or in plastic bottles with plastic caps 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 tablets, consisting of 2 cardboard boxes containing 49 tablets each.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

For more information about this medicine, contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorised in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) 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
(Northern Ireland)
Czech Republic Telmisartan Mylan 80 mg tablety
Romania Telmisartan Mylan 80 mg Comprimate

Date of the most recent revision of this leaflet: April 2026

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