TELMISARTAN AUROVITAS 40 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan Aurovitas 40 mg 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

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

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

Telmisartan belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body that causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, causing the blood vessels to relax and your blood pressure to decrease.

Telmisartan is used to treat 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 untreated, can damage blood vessels in various organs, which can lead, in some cases, to heart attacks, heart failure, or kidney failure, strokes, or blindness. Usually, there are no symptoms of high blood pressure before damage occurs. Therefore, it is important to regularly measure your blood pressure to check if it is 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 they have had a stroke or have a high risk of suffering from diabetes. Your doctor will inform you if you have a high risk of suffering from these events.

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

Do not takeTelmisartanAurovitas

• If you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant for more than 3 months (in any case, it is better to avoid taking this medicine also at the beginning of your pregnancy - see section Pregnancy).
• If you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of bile 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.

If your case is any of the above, inform your doctor or pharmacist before taking telmisartan.

Warnings and precautions

Consult your doctor before starting to take telmisartan if you are suffering or have ever suffered from any of the following disorders or diseases:

• Kidney disease or kidney transplant.
• Stenosis of the renal artery (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 a salt deficiency due to treatment with diuretics, a low-salt diet, diarrhea, or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Consult 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 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 heading "Do not take Telmisartan Aurovitas".

• If you are taking digoxin.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. Telmisartan is not recommended during the first trimester of pregnancy (first 3 months) and should not be taken after the third month 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 lowering 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

Telmisartan is not recommended for use in children and adolescents up to 18 years.

Other medicines andTelmisartanAurovitas

Inform 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 at the same time as telmisartan:

• Medicines that contain lithium 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 antagonists, non-steroidal anti-inflammatory medicines (e.g., aspirin 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 lower blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Telmisartan Aurovitas" and "Warnings and precautions").
• Digoxin.

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

Telmisartan may increase the blood-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 think you may be pregnant or are planning to become 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 to treat your high blood pressure. Telmisartan is not recommended during the first trimester of pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are about to start or are already breastfeeding, as telmisartan is not recommended for use during this period. Your doctor may decide to give you a different treatment that is more suitable if you want to breastfeed, especially to newborns or premature babies.

Driving and using machines

Some people feel dizzy or tired when taking telmisartan. If you feel dizzy or tired, do not drive or use machines.

Telmisartan 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

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

The recommended dose 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 telmisartan 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 a 24-hour period. 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. When starting preventive treatment with 80 mg of telmisartan, 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 moreTelmisartanAurovitas than you should

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

If you forget to takeTelmisartanAurovitas

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

If you have any further questions on 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 called "blood infection", a serious infection that involves an inflammatory reaction of the whole body), rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are 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, drug rash (skin reaction to medicines), back pain, muscle cramps, muscle pain (myalgia), kidney failure including acute kidney failure, chest pain, and symptoms of weakness and high creatinine levels in the blood.

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

Sepsis* (often called "blood infection", a serious infection that involves an inflammatory reaction of the whole body and can cause death), increased 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, fast heart rate (tachycardia), dry mouth, stomach upset, taste disturbance (dysgeusia), abnormal liver function (Japanese patients show a greater 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), skin redness, hives (urticaria), severe drug rash, joint pain (arthralgia), limb pain, tendon pain, flu-like illness, decrease in hemoglobin (a blood protein), increase in blood uric acid levels, increase in liver enzymes or creatine phosphokinase in the blood.

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

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

Frequency not known (frequency 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 use of similar products.

• This may have been a chance finding or may be related to a mechanism that is currently not known.

** 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 to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: www.notificaram.es. By reporting side 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 which is stated on the carton or blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition ofTelmisartanAurovitas

• The active substance is telmisartan. Each tablet contains 40 mg of telmisartan.
• The other ingredients are: mannitol, meglumine, povidone (K-25), sodium hydroxide, colloidal anhydrous silica, and sodium stearyl fumarate (see section 2).

Appearance of the product and packaging

White or almost white, elongated, biconvex tablets with the marks "N" and "40" on each side of the score line on one face and smooth on the other (size: 13 × 5.9 mm, approximately).

The tablet can be divided into equal doses.

Telmisartan Aurovitas tablets are available in blister packs.

Pack sizes:

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

Not all 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Telmisartan PUREN 40 mg Tablets

Spain: Telmisartán Aurovitas 40 mg tablets EFG

France: Telmisartan Arrow 40 mg, scored tablet

Netherlands: Telmisartan Aurobindo 40 mg, tablets

Poland: Telmisartan Aurovitas

Portugal: Telmisartan Generis Phar

Date of last revision of this leaflet: January 2025

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