Leaflet: information for the user

Telmisartán Aurovitas 80 mg tablets EFG

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to take Telmisartán Aurovitas

3.How to take Telmisartán Aurovitas

4.Possible side effects

5.Storage of Telmisartán Aurovitas

6.Contents of the pack and additional information

Telmisartánbelongs to a class of medications known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to constrict, thereby increasing blood pressure.Telmisartánblocks the effect of angiotensin II, causing blood vessels to relax and reducing blood pressure.

Telmisartánis used to treat essential hypertension (high blood pressure) in adults. “Essential” means that the high blood pressure is not due to any other cause.

Untreated high blood pressure can damage blood vessels in various organs, which can lead, in some cases, to heart attacks, heart failure, or renal failure, strokes, or blindness. Generally, there are no symptoms of high blood pressure before damage occurs. Therefore, it is essential to measure blood pressure regularly to verify if it is within the normal range.

Telmisartánis 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 developing diabetes. Your doctor will inform you if you have an elevated risk of experiencing these events.

Do not takeTelmisartánAurovitas

•If you are allergic to telmisartán or any of the other components of this medication (listed in section 6).

•If you are more than 3 months pregnant (in any case, it is better to avoid taking this medication also at the beginning of your 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 insufficiency and are being treated with a medication to lower blood pressure that contains aliskireno.

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

Warnings and precautions

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

•Kidney disease or kidney transplant.

•Renal artery stenosis (narrowing of blood vessels to one or both kidneys).

•Liver disease.

•Heart problems.

•Elevated aldosterone levels (water and salt retention in the body along with imbalance of several 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 diuretic treatment, low-salt diet, diarrhea, or vomiting.

•Elevated potassium levels in the blood.

•Diabetes.

Consult your doctor before starting to taketelmisartán:

•If you are taking any of the following medications used to treat high blood pressure (hypertension):

-An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

-Aliskireno.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals. See also the information under the heading “Do not take Telmisartán Aurovitas”.

•If you are taking digoxina.

If you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant, inform your doctor. Telmisartán is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered after the third month of pregnancy because it may cause severe harm to your baby (see Pregnancy section).

Inform your doctor if you are undergoing surgery or anesthesia that you are takingtelmisartán.

Telmisartánmay be less effective in lowering blood pressure in black patients.

Children and adolescents

Telmisartánis not recommended for use in children and adolescents under 18 years.

Other medications andTelmisartánAurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Your doctor may need to adjust the dose of these medications or take other precautions. In some cases, you may need to stop taking one of the medications. This applies especially to the following medications when taken withtelmisartán:

•Medications containing lithium for treating certain types of depression.

•Medications that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (e.g., aspirin or ibuprofen), heparin, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimetoprim.

•Diuretics, especially if taken in high doses withtelmisartán, may cause excessive loss of water from the body and lower blood pressure (hypotension).

•If you are taking an ACE inhibitor or aliskireno (see also the information under the headings “Do not take Telmisartán Aurovitas” and “Warnings and precautions”).

•Digoxina.

The effect oftelmisartánmay be reduced when you use NSAIDs (e.g., aspirin or ibuprofen) or corticosteroids.

Telmisartánmay increase the hypotensive effect of other medications used to treat high blood pressure or medications that may potentially lower blood pressure (e.g., baclofen, amifostine).

Additionally, the decrease in blood pressure may be exacerbated 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 medications while takingtelmisartán.

Pregnancy and lactation

Pregnancy

You should inform your doctor if you suspect you may be (or may become) pregnant. Your doctor will usually advise you to stop takingtelmisartánbefore becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Telmisartán is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered after the third month of pregnancy because it may cause severe harm to your baby when administered from that point on.

Lactation

Inform your doctor if you plan to initiate or are in the lactation period becausetelmisartánis not recommended for administration to women during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially to newborns or premature babies.

Driving and operating machinery

Some people may feel dizzy or tired when taking telmisartán. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartán Aurovitas contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day. Try to take the tablet at the same time every day.

You can take telmisartán with or without food. The tablets should be swallowed with a little water or other non-alcoholic beverage. It is essential to take telmisartán every day until your doctor tells you otherwise. If you estimate that the effect of telmisartán is too strong or too weak, inform your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of telmisartán 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, 20 mg, or a higher dose, 80 mg. Telmisartán can also be used in association with diuretics such as hydrochlorothiazide, which has been shown to have an additional blood pressure-reducing effect with telmisartán.

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

If your liver does not function correctly, the usual dose should not exceed 40 mg per day.

If you take more Telmisartán Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Telmisartán 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 day, take your regular dose the next day. Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some side effects may be serious and require immediate medical attention

If you experience any of the following symptoms, you should visit your doctor immediately:

Sepsis* (often called "blood infection," it is a severe infection that involves a systemic inflammatory reaction), 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 visit their doctor immediately. If these side effects are not treated, they can be fatal.

Telmisartan side effects

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

Low blood pressure (hypotension) in patients treated for cardiovascular events.

Infrequent 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), elevated potassium levels, difficulty falling asleep (insomnia), feeling of sadness (depression), fainting (syncope), feeling of loss of balance (dizziness), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness when standing (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhea, abdominal discomfort, bloating, vomiting, itching, increased sweating, drug rash (skin reaction to medications), back pain, muscle cramps, muscle pain (myalgia), renal insufficiency including acute renal failure, chest pain, symptoms of weakness, and elevated blood creatinine levels.

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

Sepsis* (often called "blood infection," it is a severe infection that involves a systemic inflammatory reaction and may 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 of anxiety, drowsiness, vision alteration, increased heart rate (tachycardia), dry mouth, stomach discomfort, taste alteration (dysgeusia), abnormal liver function (Japanese patients are more prone to experience this side effect), sudden swelling of the skin and mucous membranes that may cause death (angioedema including fatal outcome), eczema (skin alteration), skin redness, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in the extremities, tendon pain, pseudogripal disease, decreased hemoglobin (a blood protein), elevated blood uric acid levels, elevated liver enzymes or creatine phosphokinase in the blood.

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

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

* This may have been a chance finding or related to an unknown mechanism currently.

** Cases of progressive fibrosis of lung tissue have been reported during telmisartan treatment. However, it is unknown if telmisartan was the cause.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the carton or blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofTelmisartanAurovitas

-The active ingredient is telmisartan. Each tablet contains 80 mg of telmisartan.

-The other components are: mannitol, meglumine, povidone (K-25), sodium hydroxide, anhydrous colloidal silica, and stearate and sodium fumarate (see section 2).

Appearance of the product and contents of the package

White or off-white, uncoated, elongated, biconvex tablets with the marks “N” and “80” on each side of the groove on one face and smooth on the other (size: 16.2 × 7.8 mm, approximately).

Telmisartan Aurovitastabletsare available in blister packs.

Pack sizes:

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

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Manufacturer responsible

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany:Telmisartan PUREN 80 mg Tabletten

Spain:Telmisartán Aurovitas 80 mg tablets EFG

France:Telmisartan Arrow 80 mg, scored tablet

Netherlands:Telmisartan Aurobindo 80 mg, tablets

Poland:Telmisartan Aurovitas

Portugal:Telmisartan Generis

Czech Republic:Telmisartan Aurovitas

Romania:Telmisartan Aurobindo 80 mg tablets

Last review date of this leaflet: January 2022

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).