Telmisartan Vir 40 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Telmisartan Vir 40 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 and must not be given to other people, even if they have the same symptoms as you. It may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Contents of this leaflet:
- What Telmisartan Vir is and what it is used for
- What you need to know before taking Telmisartan Vir
- How to take Telmisartan Vir
- Possible side effects
- How to store Telmisartan Vir
- Contents of the pack and other information
1. What Telmisartán Vir is and what it is used for
Telmisartán Vir belongs to a class of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance produced in your body that causes your blood vessels to narrow, thereby increasing your blood pressure. Telmisartán Vir blocks the effect of angiotensin II, allowing your blood vessels to relax and thereby reducing your blood pressure.
Telmisartán Vir is used to treat essential hypertension (high blood pressure) in adults. "Essential" means that the high blood pressure is not due to any other identifiable cause.
If left untreated, high blood pressure can damage blood vessels in various organs, which may lead, in some cases, to heart attacks, heart or kidney failure, strokes, or blindness. High blood pressure generally does not cause symptoms before such damage occurs. Therefore, it is important to measure your blood pressure regularly to ensure it remains within the normal range.
Telmisartán Vir is also used to reduce cardiovascular events (e.g., heart attacks or strokes) in adults who are at risk because their blood supply to the heart or legs is reduced or blocked, or who have had a stroke, or who have a high risk of developing diabetes. Your doctor will inform you if you are at high risk of such events.
2. What you need to know before taking Telmisartán Vir
Do not take Telmisartán Vir
- 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. (In any case, it is better to avoid taking telmisartan also during early 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 containing aliskiren.
If any of the above apply to you, inform your doctor or pharmacist before starting telmisartan.
Warnings and precautions
Tell your doctor before starting telmisartan if you are suffering from or have ever 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 imbalance of several blood minerals).
- Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body water) or have salt depletion due to, for example, diuretic treatment, low-salt diet, diarrhoea or vomiting.
- High levels of potassium in the blood.
- Diabetes.
Consult your doctor before taking Telmisartán Vir:
- if you are taking any of the following medicines used to treat high blood pressure (hypertension):
- an angiotensin-converting enzyme (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 blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading “Do not take Telmisartán Vir”.
- if you are taking digoxin.
You must inform your doctor if you think you are (or might become) pregnant. Use of this medicine is not recommended during early pregnancy and must not be used after the third month of pregnancy because it may cause serious harm to your baby if used at this stage (see Pregnancy section).
If you are undergoing surgery or anaesthesia, 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 diarrhoea 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 under 18 years of age.
Taking Telmisartán Vir with other medicines
Tell 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 the dose of these medicines 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 together with telmisartan:
- Medicines containing lithium used to treat certain types of depression.
- Medicines that may increase blood potassium levels such as potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen), heparin, immunosuppressants (e.g. cyclosporine or tacrolimus), and the antibiotic trimethoprim.
- Diuretics, especially when taken in high doses together with telmisartan, may cause excessive fluid loss and lower blood pressure (hypotension).
- If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Telmisartán Vir” and “Warnings and precautions”).
- Digoxin.
The effect of telmisartan may be reduced when you take NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids.
Telmisartan may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or of medicines that may potentially lower blood pressure (e.g. baclofen, amifostine).
In addition, blood pressure reduction may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness upon standing. Consult your doctor if you need dose adjustments of your other medicines while taking telmisartan.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you are (or might become) pregnant. 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 antihypertensive medicine. Telmisartan is not recommended during early pregnancy and must not be administered after the third month of pregnancy as it may cause serious harm to your baby when used from this stage onward.
Breastfeeding
Inform your doctor if you plan to breastfeed or are currently breastfeeding. Telmisartan is not recommended for breastfeeding mothers and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.
Driving and using machines
Some people may experience adverse effects such as fainting or dizziness (vertigo) when taking telmisartan. If you experience these adverse effects, do not drive or operate machinery.
Telmisartán Vir contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
Telmisartán 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 Telmisartán Vir
Follow exactly the instructions for use of this medicine as given by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of telmisartan is one tablet daily. Try to take the tablet at the same time each day. You may 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 unless your doctor tells you otherwise. If you think that the effect of telmisartan is too strong or too weak, tell 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 daily 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 may 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 monitored frequently.
If your liver is not functioning properly, the normal dose should not exceed 40 mg once daily.
If you take more Telmisartán Vir than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, call the Poison Information Service at telephone number: 91 562 04 20, or go to the nearest hospital emergency department.
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 dose one day, take your normal dose the next day. Do not take a double dose to make up for missed doses.
If you stop taking Telmisartán Vir
Do not stop taking this medicine without consulting your doctor.
You may need to take medicines for high blood pressure for the rest of your life. If you stop taking telmisartan, your blood pressure will return to the level it was at before treatment within a few days.
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 may 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 must see your doctor immediately:
Sepsis* (commonly called “blood infection”) – a serious infection involving a systemic inflammatory response throughout the body; rapid swelling of the skin and mucous membranes (angioedema). These adverse effects are rare but extremely serious, and patients must stop taking the medicine and seek immediate medical attention. If these adverse effects are not treated, they may be fatal.
Possible adverse effects of telmisartan:
Common adverse effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated for reduction of cardiovascular events.
Uncommon adverse effects (may affect up to 1 in 100 people):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), reduced red blood cells (anaemia), elevated potassium levels, difficulty sleeping (insomnia), feeling of sadness (depression), fainting (syncope), sensation of loss of balance (dizziness), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness upon standing (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhoea, abdominal discomfort, abdominal distension, vomiting, itching, increased sweating, itching, drug rash (skin reaction to medicines), back pain, muscle cramps, muscle pain (myalgia), renal failure (including acute renal failure), chest pain, symptoms of weakness, and elevated blood creatinine levels.
Rare adverse effects (may affect up to 1 in 1,000 people):
Sepsis* (commonly called “blood infection”) – a serious infection involving a systemic inflammatory response throughout the body, which may be fatal; increase in 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, visual disturbances, increased heart rate (tachycardia), dry mouth, abdominal discomfort, taste disturbances (dysgeusia), abnormal liver function (patients of Japanese origin appear to be more prone to this adverse effect), sudden swelling of the skin and mucous membranes which may be fatal (angioedema, including fatal outcome), eczema (a skin disorder), redness of the skin, hives (urticaria), severe drug rash, joint pain (arthralgia), limb pain, tendon pain, flu-like illness, decreased haemoglobin (a blood protein), increased uric acid levels, increased liver enzymes or increased creatine phosphokinase in blood, low sodium levels.
Very rare adverse 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 available data):
Intestinal angioedema: swelling of the intestine associated with symptoms such as abdominal pain, nausea, vomiting and diarrhoea has been reported with similar products.
- This may have been coincidental or related to a mechanism currently unknown.
** Cases of progressive pulmonary fibrosis 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 an effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 stated on the packaging, following "EXP". The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Telmisartan Vir
The active substance is telmisartan. Each tablet contains 40 mg of telmisartan.
The other components 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 40 mg are yellow, film-coated, capsule-shaped tablets, marked with "40" on one side and "T" on the other.
Telmisartan Vir 40 mg is available in blister packs containing 14, 15, 28, 30, 56, 60, 84, 90 or 98 tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Industria Química y Farmacéutica Vir, S.A.
C/Laguna 66-68-70, Polígono Industrial Urtinsa II
28923 Alcorcón (Madrid), Spain
Manufacturer
Glenmark Pharmaceuticals s.r.o.
City Tower, Hvezdova 1716/2b
Prague 4, CZ-140 78
Czech Republic
Date of the most recent revision of this leaflet: February 2025
“Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): www.aemps.gob.es ”