TELMISARTAN AUROVITAS 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan Aurovitas 20 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 which causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, so that the blood vessels relax and your blood pressure is reduced.

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 not treated, can damage blood vessels in various organs, which could lead in some cases to heart attacks, heart or kidney failure, strokes, or blindness. Usually, high blood pressure does not produce symptoms before damage occurs. Therefore, it is important to regularly measure blood pressure to verify 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 tell you if you are at high risk of having 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 more than 3 months pregnant (in any case, it is better to avoid taking this medicine also at the start 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 gall bladder) or any other serious liver disease.
• If you have diabetes or kidney insufficiency and are being treated with a blood pressure medicine containing aliskiren.

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

Warnings and precautions

Consult your doctor before starting treatment with 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 treatment with diuretics, low-salt diet, diarrhea, or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Consult your doctor before starting treatment with 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 associated with 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 have a baby, tell your doctor. The use of telmisartan is not recommended at the start of pregnancy (first 3 months) and is contraindicated during the second and third trimesters of pregnancy because 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

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

Other medicines andTelmisartanAurovitas

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 some 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 medicines (e.g., aspirin or ibuprofen), heparin, immunosuppressants (e.g., cyclosporin 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 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 lower blood pressure (e.g., baclofen, amifostine).

Additionally, the decrease in blood pressure may be increased 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 tell your doctor if you think you may be pregnant or are planning to have a baby. 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.

Do not take telmisartan if you are more than 3 months pregnant. It is also better to avoid telmisartan in early pregnancy - see section Pregnancy.

Breastfeeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. It is not recommended to take telmisartan while breast-feeding, and your doctor may choose a different treatment for you, especially if you are feeding a newborn or premature baby.

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 sodium (23 mg) per tablet, which 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 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 cardiovascular prevention, the recommended dose of telmisartan is one 80 mg tablet once daily. When initiating telmisartan 80 mg preventive treatment, blood pressure should be frequently monitored.

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

If you take moreTelmisartanAurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicological 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 then 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 a forgotten dose.

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 contact your doctor immediately:

Sepsis* (often referred to as “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 contact 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 prevention.

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 spasms, 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 referred to as “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, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, drowsiness, vision disturbance, increased 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), pain in the limbs, 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 using similar products.

• This may have been a chance finding 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 Medicines Agency's website for the pharmacovigilance of human medicines: 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 20 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, uncoated tablets, round, with a flat face and beveled edges, with the mark “N20” on one face and smooth on the other (size: 7 mm, approximately).

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.

Avenida 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 20 mg Tabletten

Spain: Telmisartán Aurovitas 20 mg comprimidos EFG

Netherlands: Telmisartan Aurobindo 20 mg, tabletten

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/).