TELMISARTAN VIATRIS 20 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Telmisartan Viatris 20 mg Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as your illness, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are 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 taking Telmisartan Viatris
3. How to take Telmisartan Viatris
4. Possible side effects
5. Storage of Telmisartan Viatris
6. Contents of the pack and further information

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

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

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

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 or brain damage. Usually, there are no symptoms of high blood pressure before damage occurs. Therefore, it is essential to regularly check your blood pressure to verify that 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 reduced or blocked 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 taking Telmisartan Viatris

Do not take Telmisartan Viatris:

• If you are allergic to telmisartan or any of the other components of this medication (listed in section 6).
• If your pregnancy has exceeded 3 months of gestation (it is also best to avoid taking Telmisartan Viatris in the first months of pregnancy - see section Pregnancy).
• If you have serious liver problems, such as cholestasis or biliary obstruction (problems with the drainage of bile secreted by the liver and the gallbladder) or any other severe liver disease.
• If you have diabetes mellitus or kidney failure and are being treated with a blood pressure medication that contains aliskiren.

If any of the above applies to you, inform 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 often occurs if you suffer from excessive water loss (dehydration) or have low salt levels 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 aldosterone levels).
• If you have very high potassium levels in the 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 medications used to treat high blood pressure:
• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly 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 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 Telmisartan Viatris".

If you are of African descent; as with any other angiotensin II receptor antagonist, the efficacy of Telmisartan Viatris in reducing blood pressure may be lower in African patients.

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

If you are going to undergo surgery or receive anesthesia, you must inform your doctor that you are taking Telmisartan Viatris.

Children and adolescents

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

Taking Telmisartan Viatris with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

• Lithium (for treating certain types of depression).

• Medications that can increase potassium levels in the blood, such as potassium-based salt substitutes, 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 if taken at high doses with Telmisartan Viatris, may cause excessive water loss and reduce blood pressure (hypotension).

• As with other blood pressure medications, the effect of Telmisartan Viatris may be reduced by taking NSAIDs (non-steroidal anti-inflammatory drugs, such as aspirin or ibuprofen) or corticosteroids.
• Other medications for treating high blood pressure, potent analgesics, barbiturates (for epilepsy), baclofen (used to treat cerebral palsy and multiple sclerosis), amifostine (used to prevent fever and infections in patients receiving chemotherapy or radiation therapy), or medications 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 anti-hypertensive effect of other medications used to treat high blood pressure.

Telmisartan Viatris with alcohol

The hypotensive effect may increase if you take Telmisartan Viatris with alcohol, so you may feel dizzy or faint and weak, especially when standing up after sitting or lying down.

Pregnancy and breastfeeding

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

Pregnancy

Your doctor will normally advise you to stop taking telmisartan before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication. Telmisartan should not be taken from the third month of pregnancy onwards, as it may cause serious harm to your baby if taken from that time on.

Breastfeeding

Tell your doctor if you are about to start or are breastfeeding. Telmisartan is not recommended for breastfeeding mothers; your doctor may choose another treatment if you wish to breastfeed your child, especially if your baby is newborn or premature.

Driving and using machines

Some people may feel dizzy or tired when receiving treatment for high blood pressure. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartan Viatris contains sodium

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

3. How to take Telmisartan Viatris

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

The recommended dose of Telmisartan Viatris will depend on what you are taking this medication for. You should take your dose once a day and at the same time every day.

For the treatment of high blood pressure, the recommended dose is 40 mg once a day to control high 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. Telmisartan Viatris may also be used in combination with diuretics such as hydrochlorothiazide, as they have been shown to have an additive effect in reducing 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 monitor your blood pressure.

If you feel that the effect of Telmisartan Viatris is too strong or too weak, consult your doctor or pharmacist.

Your medication is available in 3 presentations:

20 mg, 40 mg, and 80 mg.

Use in children and adolescents

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

Method of administration

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

You can take Telmisartan Viatris with or without food.

Patients with liver problems

If your liver is not functioning correctly, the recommended dose should not exceed 40 mg once a day.

Patients with kidney problems

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

If you take more Telmisartan 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, phone 91 562 04 20, indicating the medication and the amount ingested.

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 continue taking them as usual.

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 stop taking Telmisartan Viatris

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

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

4. Possible side effects

Like all medications, this medication 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, as they can be life-threatening if left untreated:

• Sepsis* (often referred to as "blood infection", a severe infection that involves an inflammatory reaction of the entire body).
• Severe allergic reaction with symptoms such as skin rash, itching, difficulty breathing, wheezing, swelling of the face or decrease 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 blisters and peeling of the skin (toxic skin reaction).
• Fluid retention causing fatigue, discomfort, shortness of breath, and swelling of the legs, ankles, or feet (renal failure, including kidney failure).
• Difficulty breathing with dry cough or non-productive cough and weight loss, due to progressive fibrosis of lung tissue (interstitial lung disease) ***.

Other possible side effects:

Frequent (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 bladder inflammation.
• Anemia (low red blood cell count), which can cause pale skin and weakness and shortness of breath.
• High potassium levels, observable in blood tests.
• Feeling of sadness (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 creatinine levels in the blood, observable in blood tests.

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

• Reduced platelet count in the blood, with increased risk of bleeding or bruising.
• Increased levels of certain white blood cells (eosinophilia), observable in blood tests.
• Anxiety.
• Visual disturbance (vision changes).
• 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 tendon pain.

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

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

• Intestinal angioedema: inflammation in the intestine has been reported, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea after using 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 fibrosis of lung tissue have been reported during telmisartan treatment. However, it is unknown whether telmisartan was the cause.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Telmisartan Viatris

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the blister pack, carton, and bottle after CAD or EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Do not use this medication if you observe discoloration of the tablets.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content in Additional Formation

Telmisartan Viatris Composition

• The active ingredient is telmisartan.
• Each tablet contains 20 mg of telmisartan.
• The other components are magnesium stearate (E-470b), povidone, meglumine, sodium hydroxide, and mannitol (E-421).

Product Appearance and Packaging Content

White or almost white, round, flat tablets with a beveled edge, marked with "TN20" on one side and "M" on the other.

Telmisartan Viatris is available in packages containing blisters of 14, 28, 30, 56, 60, 84, 90, 98, or 100 tablets, a calendar blister 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.

Only some package 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 20 mg Tabletten

Belgium Telmisartan Mylan 20 mg tabletten

Denmark Telmisartan Mylan 20 mg tablets

Spain Telmisartán Viatris 20 mg EFG tablets

Greece Telmisartan Mylan Tablets 20 mg

Hungary Telmisartan Mylan 20 mg tabletta

Ireland Telmisartan Mylan 20 mg

Luxembourg Telmisartan Mylan 20 mg CPR

Netherlands Telmisartan Mylan 20 mg tabletten

Poland Telmisartan Mylan

Portugal Telmisartan Mylan

United Kingdom Telmisartan Mylan 20 mg Tablets

Romania Telmisartan Mylan 20 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/