Package Insert: Information for the Patient

Telmisartán Viatris 20 mg Tablets EFG

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

-Keep this package insert, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms of the disease, 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.What is Telmisartán Viatris and how is it used

2.What you need to know before starting to take Telmisartán Viatris

3.How to take Telmisartán Viatris

4.Possible adverse effects

5.Storage of Telmisartán Viatris

6.Contents of the package and additional information

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

Telmisartán 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 blood vessels in some organs, which can eventually lead to a heart attack, heart failure, or renal failure, strokes, or blindness. Generally, there are no symptoms of high blood pressure before damage occurs. Therefore, it is essential to measure blood pressure regularly to verify if it is within the normal range.

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

Do not take Telmisartán Viatris:

• If you are allergic to telmisartan or any of the other ingredients of this medication (listed in section 6).
• If your pregnancy has exceeded 3 months of gestation(it is better to avoid taking Telmisartán Viatris also in the first months of pregnancy – see Pregnancy section).
• 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 medication to lower blood pressure that contains aliskiren.

Inform your doctor or pharmacist before taking Telmisartán Viatris if any of the above applies to you.

Warnings and precautions

Inform your doctor if you are experiencing or have ever experienced any of the following diseases or disorders:

• If you have kidney disease or have undergone a kidney transplant.
• If you have a 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 usually occurs if you experience excessive water loss from the body (dehydration) or have low levels of salts because you take diuretics, follow a low-salt diet, or have diarrhea or vomiting.
• If you have water and salt retention in the body accompanied by an imbalance of various minerals in the blood (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 medications 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.

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 electrolyte levels in the blood (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Telmisartán Viatris”.

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

Inform your doctor if you think you might be (or intend to become) pregnant. Telmisartán 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 you use it at that time (see Pregnancy section).

Inform your doctor if you are to undergo surgery or receive anesthesia, as you are taking Telmisartán Viatris.

Children and adolescents

Telmisartán Viatris is not recommended for use in children and adolescents under 18 years.

Taking Telmisartán Viatris with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, 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 need to stop taking one of the medications. This applies especially to the medications listed below when taken at the same time as Telmisartán 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, nonsteroidal 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 Telmisartán Viatris, may cause excessive water loss from the body and lower blood pressure (hypotension).

• As with other blood pressure medications, the effect of Telmisartán Viatris may be reduced by taking NSAIDs (e.g., aspirin or ibuprofen) or corticosteroids.
• Other medications for treating high blood pressure, analgesics, barbiturates (for epilepsy),baclofen (used for 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 oraliskiren(see also the information under the headings “Do not take Telmisartán Viatris” and “Warnings and precautions”).
• Digoxin.

Telmisartán Viatris may increase the anti-hypertensive effect of other medications used to treat high blood pressure.

Telmisartán Viatris with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you might be (or intend to become) pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor will usually 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. Telmisartán should not be taken after the third month of pregnancy, as it may cause serious harm to your baby if you use it at that time.

Breastfeeding

Inform your doctor if you are to start or are breastfeeding. Telmisartán is not recommended for mothers who breastfeed their babies; your doctor may choose another treatment if you want to breastfeed your baby, especially if your baby is newborn or premature.

Driving and operating machinery

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; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of Telmisartán Viatris will depend on why you are taking this medication. 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 elevated blood pressure for a period of 24 hours. 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 association with diuretics such as hydrochlorothiazide, as they have demonstrated an additive effect in reducing blood pressure when taken with telmisartán.

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

If you feel that the effect of Telmisartán 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 old should not take Telmisartán Viatris.

Administration form

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

You can take Telmisartán Viatris with or without food.

Patients with liver problems

If your liver does not function 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 an initial dose lower than 20 mg daily.

If you take more Telmisartán Viatris than you should

The 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication 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, take your normal dose the next day. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Telmisartán Viatris

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

If you have any other doubts 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, as they may be fatal if not treated:

• Sepsis* (also known as "blood infection," it is a severe infection that involves a systemic inflammatory reaction).
• Severe allergic reaction with symptoms such as skin rash, itching, difficulty breathing, wheezing, facial swelling, or decreased blood pressure (anaphylactic reaction).
• Fast swelling of the skin, face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema).
• Severe skin reactions, which may include blisters and skin peeling (toxic skin reaction).
• Fluid retention causing fatigue, discomfort, shortness of breath, and swelling of the legs, ankles, or feet (renal insufficiency including renal failure).
• Difficulty breathing with dry 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 to reduce cardiovascular events, such as heart attack or stroke.

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

• Upper respiratory tract infection (e.g. sore throat, common cold, inflamed and swollen nasal passages that cause pain, fever, and tenderness).
• Urinary tract infection, including inflammation of the bladder surface.
• Anemia, which may cause pale skin and weakness and shortness of breath.
• Elevated potassium levels, observable in blood tests.
• Feeling sad (depression).
• Difficulty falling asleep.
• Sensation of spinning (vertigo).
• Fainting (syncope).
• Dizziness or mild dizziness, especially when standing up (orthostatic hypotension).
• Slowed heart rate (bradycardia).
• Low blood pressure (hypotension) in users 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 level of a substance called creatinine in the blood, observable in blood tests.

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

• Reduced platelet count in the blood, with an increased risk of bleeding or bruising.
• Increased certain white blood cells (eosinophilia), observable in blood tests.
• Anxiety.
• Vision disorder (alteration of vision).
• Accelerated heart rate (tachycardia).
• Dry mouth.
• Alteration of taste (dysgeusia).
• Liver function anomalies**.
• Skin inflammation, characterized by itching and skin rash and often including blisters (eczema), redness of the skin, rashes (urticaria).

• Joint pain (arthralgia), pain in the extremities 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), observable in blood tests.
• Low blood sugar (in diabetic patients).
• Decreased hemoglobin (a protein in the blood), 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: intestinal inflammation has been reported, with symptoms such as abdominal pain, nausea, vomiting, and diarrhea after 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 coincidental or may be related to an unknown mechanism.

**The majority of cases of liver function anomalies and liver-related disorders from post-marketing experience with telmisartan occurred in Japanese patients. Japanese patients are more prone to this adverse effect.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse 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 blister pack, the box, and the 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 drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

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).

Appearance of the product and contents of the package

White or off-white, round, flat, beveled-edge tablets, marked with “TN20” on one side, and “M” on the other.

Telmisartan Viatris is available in packages containingblister packs of14, 28, 30, 56, 60, 84, 90, 98, or 100 tablets, calendar blister pack of28 tabletsor in plastic bottles with a plastic stopper containingalgodón absorbent and desiccant (do not eat the desiccant) containing56, 60, 84, 90, 98, 280, 500, or 1,000 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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 with the following names:

GermanyTelmisartan Mylan 20 mg Tabletten

BelgiumTelmisartan Mylan 20 mg tabletten

DenmarkTelmisartan Mylan 20 mg tablets

SpainTelmisartán Viatris 20 mg comprimidos EFG

GreeceTelmisartan Mylan Tablets 20 mg

HungaryTelmisartan Mylan 20 mg tabletta

IrelandTelmisartan Mylan 20 mg

LuxembourgTelmisartan Mylan 20 mg CPR

NetherlandsTelmisartan Mylan 20 mg tabletten

PolandTelmisartan Mylan

PortugalTelmisartan Mylan

United KingdomTelmisartán Mylan 20 mg Tablets

RomaniaTelmisartan Mylan 20 mg Comprimate

Last review date of this leaflet:January 2025

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/