Package Insert: Information for the User

TelmisartánVIR20 mg Film-Coated Tablets

Read this package insert carefully before starting to take the medication because 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 as you, 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

Contents of the package and additional information

TelmisartánVIRbelongs to a class of medications known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to constrict, thereby increasing blood pressure. TelmisartánVIRblocks the effect of angiotensin II, causing blood vessels to relax and reducing blood pressure.

TelmisartánVIRis used totreat essential hypertension (high blood pressure)in adults. “Essential” means that the high blood pressure is not due to any other cause.

High blood pressure, if left untreated, can damage blood vessels in various organs, which can lead, in some cases, to heart attacks, 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.

TelmisartánVIRis also used toreduce cardiovascular events (e.g., heart attacks or strokes) in adults with a high risk because their blood supply to the heart or legs is reduced or blocked, or they have had a stroke or have a high risk of developing diabetes. Your doctor will inform you if you have a high risk of experiencing these events.

Do not take Telmisartán VIR

• if you are allergic to telmisartán or any of the other ingredients of this medicine (listed in section 6)
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking Telmisartán VIR also at the beginning of your pregnancy - see Pregnancy section)
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder) or any other severe liver disease.
• if you have diabetes or kidney failure and are being treated with a blood pressure lowering medicine that contains aliskiren.

Inform your doctor or pharmacist before taking Telmisartán VIR if your case is any of the above.

Warnings and precautions

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

• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
• Liver disease.
• Heart problems.
• Elevated aldosterone levels (water and salt retention in the body along with imbalance of various minerals in the blood).
• Low blood pressure (hypotension) that may occur if you are dehydrated (excessive loss of water from the body) or have a salt deficiency due to diuretic treatment, low-salt diet, diarrhea, or vomiting.
• Elevated potassium levels in the blood.
• Diabetes.

Consult your doctor before takingTelmisartán VIR:

• 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 monitor your kidney function, blood pressure, and electrolyte levels (e.g. potassium) at regular intervals. See also the information under the heading “Do not take Telmisartán VIR”.

• if you are taking digoxina.

If you are pregnant (or suspect you may be) inform your doctor. Telmisartán VIR is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy because it may cause serious harm to your baby (see Pregnancy section).

Inform your doctor if you are undergoing surgery or anesthesia that you are taking Telmisartán VIR.

Telmisartán VIR may be less effective in reducing blood pressure in black patients.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking telmisartán. Your doctor will decide whether to continue treatment. Do not stop taking telmisartán in monotherapy.

Children and adolescents

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

Use of Telmisartán VIR with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may take other medicines.Your doctor may need to change the dose of these medicines or take other precautions. In some cases, you may need to stop taking one of the medicines.This applies especially to the following medicines when taken with Telmisartán VIR:

• Medicines containing lithium for treating some 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 (e.g. aspirin or ibuprofen), heparin, immunosuppressants (e.g. ciclosporin or tacrolimus), and the antibiotic trimetoprim.
• Diuretics, especially if taken in high doses with Telmisartán VIR, may cause excessive loss of water from the body and lower blood pressure (hypotension).
• ACE inhibitors or aliskiren (see also the information under the headings “Do not take Telmisartán VIR” and “Warnings and precautions”).
• Digoxina.

The effect of Telmisartán VIR may be reduced when you use NSAIDs (e.g. aspirin or ibuprofen) or corticosteroids.

Telmisartán VIR may increase the effect of other medicines used to treat high blood pressure or of medicines that may potentially lower blood pressure (e.g. baclofen, amifostine).

Additionally, the decrease in blood pressure may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness when standing up. You should consult your doctor if you need to adjust the dose of your other medicines while takingTelmisartán VIR.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, if you suspect you may be, or if you plan to become pregnant. Your doctor will usually advise you to stop taking Telmisartán VIR before becoming pregnant or as soon as you become pregnant, and will recommend taking another blood pressure lowering medicine instead. Telmisartán VIR is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy because it may cause serious harm to your baby when administered from that time.

Breastfeeding

Inform your doctor if you are planning to start or are breastfeeding. Telmisartán VIR is not recommended for use in breastfeeding women and your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially in newborns or premature babies.

Driving and operating machinery

Some people may feel dizzy or tired when taking Telmisartán VIR. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartán VIR contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking Telmisartán VIR.

Follow exactly the administration instructions for Telmisartán VIR as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The recommended dose of Telmisartán VIR is one tablet per day. Try to take the tablet at the same time every day. You can take Telmisartán VIR with or without food. The tablets should be swallowed with a little water or other non-alcoholic beverage. It is essential to take Telmisartán VIR every day until your doctor tells you otherwise. If you estimate that the effect of Telmisartán VIR is too strong or too weak, inform your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Telmisartán VIR for most patients is one 40 mg tablet once a day, to control blood pressure over 24 hours. However, your doctor may sometimes recommend a lower dose of 20 mg or a higher dose of 80 mg. Telmisartán VIR can also be used in association with diuretics such as hydrochlorothiazide, which has been shown to have an additional blood pressure-lowering effect with Telmisartán VIR.

For the reduction of cardiovascular events, the usual daily dose of Telmisartán VIR is one 80 mg tablet. At the beginning of preventive treatment with Telmisartán VIR 80 mg, blood pressure should be monitored frequently.

If your liver does not function correctly, the usual dose should not exceed 40 mg per day.

If you take more Telmisartán VIR than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, call the Toxicological Information Service, phone: 91 562 04 20, or go to the nearest hospital emergency department immediately.

If you forget to take Telmisartán VIR

If you forget to take a dose, do not worry. Take it as soon as you remember and continue as before. If you miss a day, take your usual dose the next day.Do nottake a double dose to compensate for the missed doses.

If you interrupt treatment with Telmisartán VIR

Do not stop taking Telmisartán VIR without consulting your doctor.

You may need to take blood pressure medication for the rest of your life. If you stop taking Telmisartán VIR, your blood pressure will return to the level it was before treatment in a few days.

If you have any other questions 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 severe and require immediate medical attention:

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

Sepsis* (often called "blood infection," it is a severe infection that involves a systemic inflammatory reaction), rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare but are extremely serious and patients should stop taking the medicine and visit their doctor immediately. If these side effects are not treated, they can be fatal.

Telmisartan VIR side effects:

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

Low blood pressure (hypotension) in patients treated for cardiovascular events.

Less frequent side effects(may affect up to 1 in 100 people):

Urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), decreased red blood cells (anemia), elevated potassium levels, difficulty falling asleep, feeling of sadness (depression), fainting (syncope), feeling of loss of balance (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness when standing (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhea, abdominal discomfort, vomiting, itching, increased sweating, itching, drug rash, back pain, muscle cramps, muscle pain (myalgia), renal insufficiency including acute renal failure, chest pain, symptoms of weakness, and elevated blood creatinine levels.

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

Sepsis* (often called "blood infection," it is a severe infection that involves a systemic inflammatory reaction and can cause death), increased certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients),feeling of anxiety, drowsiness, vision alteration, increased heart rate (tachycardia), stomach discomfort, dry mouth, taste alterations (dysgeusia), abnormal liver function(Japanese patients are more prone to experiencing these side effects), sudden swelling of the skin and mucous membranes that can cause death (angioedema including fatal outcome), eczema (a skin alteration), skin reddening, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in the extremities, tendon pain, pseudogripal disease, decreased hemoglobin (a blood protein), elevated blood uric acid levels, elevated liver enzymes or creatine phosphokinase in blood.

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

Progressive scarring of lung tissue (interstitial lung disease)**

* This may have been a coincidence or related to an unknown mechanism at present.

**There have been reported cases of progressive scarring of lung tissue during telmisartan use. However, it is unknown if telmisartan was the cause.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for human use:www.notificaRAM.es. By reporting side 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 packaging, after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Telmisartan Vir Composition

The active ingredient is telmisartan. Each tablet contains 20 mg of telmisartan.

The other components are sodium hydroxide, povidone (K25), meglumine, lactose monohydrate, crospovidone, yellow iron oxide (E172), magnesium stearate.

The coating contains: hypromellose, titanium dioxide (E171), macrogol-400, talc, and yellow iron oxide (E172).

Product appearance and container content

Telmisartan Vir 20 mg are film-coated, yellow, round tablets with “20” engraved on one face and “T” on the other.

Telmisartan Vir 20 mg is available in containers with blisters containing 14, 15, 28, 30, 56, 60, 84, 90, or 98 tablets.

Only some container sizes may be commercially marketed.

Marketing Authorization Holder

Industria Química y Farmaceutica Vir, S.A.

C/Laguna 66-68-70.Industrial Park Urtinsa II

28923 Alcorcón (Madrid)

Responsible for manufacturing

Glenmark Pharmaceuticals s.r.o.

City Tower, Hvezdova 1716/2b,

Prague 4, CZ-140 78

Czech Republic

Last review date of this leaflet: January 2025

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es”