TELMISARTAN VIR 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

TelmisartanVir80 mg film-coated 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 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Telmisartan Vir and what is it used for
2. What you need to know before you take Telmisartan Vir
3. How to take Telmisartan Vir
4. Possible side effects
5. Storage of Telmisartan Vir

1. Contents of the pack and further information

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

Telmisartan Vir belongs to a class of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan VIR blocks the effect of angiotensin II, so that the blood vessels relax and your blood pressure is reduced.

TelmisartanViris used totreat essential hypertension (high blood pressure) in adults. “Essential” means that the high blood pressure is not caused by any other condition.

High blood pressure, if left uncontrolled, can lead to serious cardiovascular diseases, such as stroke, heart attack, or kidney failure. Usually, there are no symptoms of high blood pressure before damage occurs. Therefore, it is important to regularly check your blood pressure to make sure it is within the normal range.

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

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

Do not take Telmisartan Vir

• 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. (In any case, it is recommended to avoid taking telmisartan also at the start of pregnancy - see section Pregnancy)
• 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 impairment and are treated with a blood pressure lowering medicine containing aliskiren.

If any of these apply to you, tell your doctor or pharmacist before taking telmisartan.

Warnings and precautions

Tell your doctor before taking telmisartan if you have or have had 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.
• High levels of aldosterone (water and salt retention in the body along with an 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 salt deficiency due to, for example, treatment with diuretics, low-salt diet, diarrhea, or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Consult your doctor before taking Telmisartan 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), especially if you have kidney problems related to diabetes.
  • aliskiren

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 headings “Do not take Telmisartan Vir” and “Warnings and precautions”.

• if you are taking digoxin.

You should inform your doctor if you think you are (or might become) pregnant. The use of this medicine is not recommended during the first trimester of pregnancy and should not be used during the second and third trimesters of pregnancy, as it may cause serious harm to your baby (see section Pregnancy).

In case of surgery or anesthesia, inform your doctor that you are taking telmisartan.

Telmisartan 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 telmisartan. Your doctor will decide whether to continue treatment. Do not stop taking telmisartan on your own.

Children and adolescents

The use of telmisartan is not recommended in children and adolescents up to 18 years.

Use of Telmisartan Vir 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 the dose of these medicines or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially true for the following medicines when taken with telmisartan:

• Medicines containing lithium for treating certain types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken in high doses with telmisartan, may cause excessive loss of water from the body and low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Telmisartan Vir” and “Warnings and precautions”).
• Digoxin.

The effect of telmisartan may be reduced when you use NSAIDs (non-steroidal anti-inflammatory drugs, e.g., aspirin or ibuprofen) or corticosteroids.

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

Additionally, the decrease in blood pressure may be enhanced 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 taking telmisartan.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant or think you might be pregnant. 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. The use of telmisartan is not recommended during the first trimester of pregnancy and should not be used during the second and third trimesters of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

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

Driving and using machines

Some people may experience side effects such as fainting or dizziness when taking telmisartan. If you experience these side effects, do not drive or use machines.

Telmisartan Vir contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Telmisartan Vir contains sodium

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

3. How to take Telmisartan Vir

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

The recommended dose of telmisartan is one tablet per day. Try to take the tablet at the same time each day. You can take telmisartan with or without food. The tablets should be swallowed with a little water or another non-alcoholic drink. It is important that you take this medicine every day until your doctor tells you to stop. If you think that the effect of telmisartan is too strong or too weak, talk to your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of telmisartan 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. Telmisartan can also be used in combination with diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure-lowering effect with telmisartan.

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

If your liver is not working properly, the usual dose should not exceed 40 mg once a day.

If you take more Telmisartan Vir than you should

In case of overdose or accidental intake, contact your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, or go to the emergency department of the nearest hospital.

If you forget to take Telmisartan Vir

If you forget to take a dose, do not worry. Take it as soon as you remember and then continue as before. If you do not take your tablet one day, take your normal dose the next day. Do nottake a double dose to make up for forgotten doses.

If you stop taking Telmisartan Vir

Do not stop taking this medicine without consulting your doctor.

You may need to take blood pressure-lowering medicines for the rest of your life. If you stop taking telmisartan, your blood pressure will return to the level it was before treatment within a few days.

If you have any other questions about 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 immediately:

Sepsis* (often referred to as “blood infection”, a severe infection that involves an inflammatory reaction of the whole body), rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare but extremely serious and patients should stop taking the medicine and see their doctor immediately. If these side effects are not treated, they can be fatal.

Possible side effects of telmisartan:

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

Low blood pressure (hypotension) in users treated for cardiovascular event reduction.

Uncommon 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), high potassium levels, difficulty falling asleep (insomnia), feeling sad (depression), fainting (syncope), feeling of losing balance (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness when standing up (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhea, abdominal discomfort, abdominal distension, vomiting, itching, increased sweating, itching, drug rash (reaction of the skin to medicines), back pain, muscle cramps, muscle pain (myalgia), kidney failure (including acute kidney failure), chest pain, symptoms of weakness, and high creatinine levels in the blood.

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

Sepsis* (often referred to as “blood infection”, a severe infection that involves an inflammatory reaction of the whole body 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 anxious, drowsiness, vision disturbance, increased heart rate (tachycardia), dry mouth, abdominal discomfort, taste disturbance (dysgeusia), abnormal liver function (Japanese patients show a higher tendency to experience this side effect), sudden swelling of the skin and mucous membranes that can cause death (angioedema, including fatal outcome), eczema (a skin disorder), redness of the skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in the limbs, tendon pain, pseudoinfluenza syndrome, decrease in hemoglobin (a blood protein), increased uric acid levels, increased liver enzymes, or creatine phosphokinase in the blood, low sodium levels.

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

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

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

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

• This may have been a coincidental event or related to a currently unknown mechanism.

** 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 leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Telmisartan Vir

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 carton, after “EXP”. The expiry date refers to the last day of the month shown.

No special storage conditions are required.

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. Contents of the pack and further information

Composition of TelmisartanVir

The active substance is telmisartan. Each tablet contains 80 mg of telmisartan.

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

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

Appearance of the product and contents of the pack

Telmisartan Vir 80 mg are yellow, film-coated, capsule-shaped tablets with “80” engraved on one side and “T” on the other.

Telmisartan Vir 80 mg is available in blister packs containing 14, 15, 28, 30, 56, 60, 84, 90, or 98 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Industria Química Y Farmaceutica Vir, S.A.

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

28923 Alcorcón (Madrid)

Manufacturer

Glenmark Pharmaceuticals s.r.o.

City Tower, Hvezdova 1716/2b,

Prague 4, CZ-140 78

Czech Republic

Date of last revision of this leaflet: February 2025.

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