Telmisartan Aurovitas 80 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Telmisartán Aurovitas 80 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Telmisartán Aurovitas is and what it is used for
2. What you need to know before taking Telmisartán Aurovitas
3. How to take Telmisartán Aurovitas
4. Possible adverse effects
5. How to store Telmisartán Aurovitas
6. Contents of the pack and other information

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

Telmisartan 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. Telmisartan blocks the effect of angiotensin II, allowing blood vessels to relax and thereby reducing your blood pressure.

Telmisartan 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 produce symptoms until damage has occurred. Therefore, it is important to measure your blood pressure regularly to ensure it remains within the normal range.

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

2. What you need to know before taking Telmisartán Aurovitas

Do not take Telmisartán Aurovitas

• 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 this medicine 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 renal insufficiency 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 taking telmisartan.

Warnings and precautions

Talk to your doctor before starting to take telmisartan if you are suffering or have previously 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.
• 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.

Talk to your doctor before starting to take telmisartan:

• 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 Aurovitas”.

• If you are taking digoxin.

Talk to 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.

You must inform your doctor if you think you are (or could become) pregnant. Use of telmisartan is not recommended during early pregnancy (first 3 months), and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby (see Pregnancy section).

If you are undergoing surgery or anaesthesia, inform your doctor that you are taking telmisartan.

Telmisartan may be less effective in lowering blood pressure in patients of black origin.

Children and adolescents

Use of telmisartan is not recommended in children and adolescents under 18 years of age.

Other medicines and Telmisartán Aurovitas

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 other 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 potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, NSAIDs (non-steroidal anti-inflammatory drugs, e.g., aspirin or ibuprofen), heparin, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken at high doses together with telmisartan, may cause excessive loss of body water 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 Aurovitas” 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 reduce blood pressure (e.g., baclofen, amifostine).

In addition, the blood pressure-lowering effect may be increased by alcohol, barbiturates, narcotics, or antidepressants. You may notice this as dizziness when standing up. You should consult your doctor if dose adjustments of your other medicines are needed while taking telmisartan.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you suspect you may be (or could become) pregnant. Your doctor will usually advise you to stop taking telmisartan before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative antihypertensive medicine. Telmisartan is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that stage.

Breastfeeding

Inform your doctor if you are planning to start or are currently breastfeeding, as telmisartan is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable if you intend to breastfeed, especially if the infant is a 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 Aurovitas 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 Aurovitas

Follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet daily. Try to take the tablet at the same time each day.

Telmisartan may be taken with or without food. The tablets should be swallowed with a little water or another non-alcoholic drink. It is important that you take telmisartan every day until your doctor tells you otherwise. If you think that the effect of telmisartan is too strong or too weak, inform 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 exert 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 beginning of preventive treatment with 80 mg of telmisartan, 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 Telmisartan Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Telmisartan Aurovitas

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 a missed dose.

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 can cause adverse effects, although not everyone experiences 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); rapid swelling of the skin and mucous membranes (angioedema). These adverse effects are rare (may affect up to 1 in 1,000 people) but are extremely serious, and patients must stop taking the medicine and see their doctor immediately. If these adverse effects are not treated, they may be fatal.

Possible adverse effects of telmisartan

Frequent 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 (anemia), elevated potassium levels, difficulty sleeping (insomnia), feeling of sadness (depression), fainting (syncope), sensation of loss of balance (vertigo), 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, diarrhea, stomach pain, abdominal distension, vomiting, itching, increased sweating, drug rash (skin reaction to medicines), back pain, muscle cramps, muscle pain (myalgia), renal failure (including acute renal failure), chest pain, weakness symptoms, 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 that 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, vision disturbances, increased heart rate (tachycardia), dry mouth, abdominal discomfort, taste disturbances (dysgeusia), abnormal liver function (Japanese patients show a higher tendency to experience this adverse effect), sudden swelling of the skin and mucous membranes that 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 hemoglobin (a blood protein), increased blood levels of uric acid, increased liver enzymes or creatine phosphokinase in blood, low sodium levels.

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

Progressive fibrosis of lung tissue (interstitial lung disease) **.

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

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

• This may have been an incidental finding or related to a mechanism currently unknown.

** Cases of progressive fibrosis of lung tissue 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 a possible adverse effect not listed in this leaflet. You can also report them directly via 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 Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging or blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Telmisartan Aurovitas

• The active substance is telmisartan. Each tablet contains 80 mg of telmisartan.
• The other components are: mannitol, meglumine, povidone (K-25), sodium hydroxide, anhydrous colloidal silica, and sodium stearyl fumarate (see section 2).

Appearance of the product and contents of the pack

Uncoated white or almost white, elongated, biconvex tablets, marked with “N” and “80” on either side of the score line on one side and smooth on the other (size: approximately 16.2 × 7.8 mm).

Telmisartan Aurovitas tablets are available in blister packs.

Pack sizes:
14, 28, 30, 50, 56, 84, 90, 98 and 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Or
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

Or
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Germany: Telmisartan PUREN 80 mg Tabletten
Spain: Telmisartán Aurovitas 80 mg comprimidos EFG
France: Telmisartan Arrow 80 mg, comprimé sécable
Netherlands: Telmisartan Aurobindo 80 mg, tabletten
Poland: Telmisartan Aurovitas
Portugal: Telmisartan Generis Phar

Date of the most recent review of this leaflet: October 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).