TELMISARTAN 40 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Telmisartan Aurovitas, 40 mg, tablets
3. Telmisartan Aurovitas, 80 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Telmisartan Aurovitas and what is it used for
5. Important information before taking Telmisartan Aurovitas
   1. When not to take Telmisartan Aurovitas
   2. Warnings and precautions
   3. Children and adolescents
   4. Telmisartan Aurovitas and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Telmisartan Aurovitas contains sodium
6. How to take Telmisartan Aurovitas
   1. Taking a higher dose of Telmisartan Aurovitas than recommended
   2. Missing a dose of Telmisartan Aurovitas
7. Possible side effects
   1. Some side effects may be serious and require immediate medical attention
   2. Possible side effects of Telmisartan Aurovitas:
   3. Reporting side effects
8. How to store Telmisartan Aurovitas
9. Contents of the packaging and other information
   1. What Telmisartan Aurovitas contains
   2. What Telmisartan Aurovitas looks like and contents of the pack
   3. Pack sizes:
   4. Marketing authorization holder and manufacturer/importer
   5. Marketing authorization holder:
   6. Manufacturer/Importer:
   7. This medicine is authorized in the Member States of the European Economic Area under the following names:
   8. Date of last revision of the leaflet: 01/2025

Leaflet accompanying the packaging: information for the user

Telmisartan Aurovitas, 40 mg, tablets

Telmisartan Aurovitas, 80 mg, tablets

Telmisartanum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Telmisartan Aurovitas and what is it used for
• 2. Important information before taking Telmisartan Aurovitas
• 3. How to take Telmisartan Aurovitas
• 4. Possible side effects
• 5. How to store Telmisartan Aurovitas
• 6. Contents of the packaging and other information

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

Telmisartan Aurovitas belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is a substance produced by the body that causes blood vessels to constrict, leading to an increase in blood pressure. Telmisartan Aurovitas blocks the action of angiotensin II, causing blood vessels to relax and blood pressure to decrease.
Telmisartan Aurovitas is used to treat essential hypertension (high blood pressure) in adults. Essential means that the high blood pressure is not caused by another disease.
Untreated high blood pressure can cause damage to blood vessels in various organs, which can lead to heart attack, heart failure, or kidney disease, stroke, or vision loss. Most of the time, there are no symptoms of high blood pressure before these complications occur.
Therefore, it is essential to regularly check blood pressure to ensure it is within the normal range.
Telmisartan Aurovitas is also used to reduce the risk of cardiovascular events (such as heart attack or stroke) in adults at risk, i.e., those with reduced blood flow to the heart or legs, who have had a stroke, or who have diabetes. The doctor will inform the patient if they are at risk of these events.

2. Important information before taking Telmisartan Aurovitas

When not to take Telmisartan Aurovitas

• If the patient is allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• If the patient is pregnant after the third month of pregnancy. (The patient should also avoid taking Telmisartan Aurovitas during early pregnancy - see "Pregnancy").
• If the patient has severe liver problems, such as cholestasis or biliary obstruction (problems with bile flow from the liver and gallbladder) or any other severe liver disease.
• If the patient has diabetes or kidney problems and is taking a blood pressure-lowering medicine containing aliskiren. If any of these situations apply to the patient, they should inform their doctor or pharmacist before taking Telmisartan Aurovitas.

Warnings and precautions

Before starting treatment with Telmisartan Aurovitas, the patient should discuss with their doctor if they have or have had any of the following conditions or diseases:

• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys).
• Liver disease.
• Heart problems.
• High aldosterone levels (water and salt retention in the body, accompanied by mineral imbalance in the blood).
• Low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive water loss from the body) or has low salt levels due to taking diuretics, a low-salt diet, diarrhea, or vomiting.
• High potassium levels in the blood.
• Diabetes.

Before starting treatment with Telmisartan Aurovitas, the patient should discuss with their doctor if they are taking any of the following blood pressure-lowering medicines:

• ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes.
• Aliskiren.

The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also the information under the heading "When not to take Telmisartan Aurovitas".

• If the patient is taking digoxin.

The patient should inform their doctor if they are pregnant or think they may be pregnant. It is not recommended to take Telmisartan Aurovitas during early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby (see "Pregnancy").
In case of planned surgery or anesthesia, the patient should inform their doctor about taking Telmisartan Aurovitas. Telmisartan Aurovitas may be less effective in lowering blood pressure in black patients.
If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Telmisartan Aurovitas, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Telmisartan Aurovitas on their own.

Children and adolescents

Telmisartan Aurovitas is not recommended for use in children and adolescents under 18 years of age.

Telmisartan Aurovitas and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The doctor may recommend changing the dose of these medicines or taking other precautions. In some cases, it may be necessary to stop taking one of the medicines. This is especially true for the following medicines taken with Telmisartan Aurovitas:

• Medicines containing lithium, used to treat certain types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressive agents (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken in high doses with Telmisartan Aurovitas, as they may lead to significant water loss and low blood pressure (hypotension).
• If the patient is taking an ACE inhibitor or aliskiren (see also the information under the heading "When not to take Telmisartan Aurovitas" and "Warnings and precautions").
• Digoxin.

The effect of Telmisartan Aurovitas may be reduced when taken with non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid or ibuprofen) or corticosteroids.
Telmisartan Aurovitas may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that may cause a decrease in blood pressure (e.g., baclofen, amifostine).
Additionally, low blood pressure may be exacerbated by: alcohol, barbiturates, narcotics, or antidepressants. The symptom is dizziness when standing up. If it is necessary to adjust the dose of another medicine taken by the patient while taking Telmisartan Aurovitas, the patient should consult their doctor.

Pregnancy and breastfeeding

Pregnancy
The patient should inform their doctor if they are pregnant or think they may be pregnant. The doctor will usually recommend stopping Telmisartan Aurovitas before planned pregnancy or as soon as pregnancy is detected and recommend another medicine instead of Telmisartan Aurovitas. It is not recommended to take Telmisartan Aurovitas during early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby if taken after 3 months of pregnancy.
Breastfeeding
The patient should tell their doctor if they are breastfeeding or plan to breastfeed. Telmisartan Aurovitas is not recommended during breastfeeding. The doctor may choose another treatment during breastfeeding, especially in the case of newborns and premature babies.

Driving and using machines

Some patients taking Telmisartan Aurovitas may experience dizziness or fatigue. In such cases, they should not drive or operate machines.

Telmisartan Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Telmisartan Aurovitas

Telmisartan Aurovitas should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose of Telmisartan Aurovitas is one tablet per day. The patient should try to take the tablet at the same time every day. Telmisartan Aurovitas can be taken with or without food. The tablets should be swallowed with water or another non-alcoholic drink.
It is essential to take Telmisartan Aurovitas every day, unless the doctor recommends otherwise.
If the patient feels that the effect of Telmisartan Aurovitas is too strong or too weak, they should consult their doctor or pharmacist.
In the treatment of high blood pressure, the usual dose of Telmisartan Aurovitas is one 40 mg tablet per day for most patients, which provides 24-hour blood pressure control. The doctor may recommend a lower dose of 20 mg per day or a higher dose of 80 mg per day. Telmisartan Aurovitas can also be given in combination with a diuretic, such as hydrochlorothiazide, which enhances the blood pressure-lowering effect of Telmisartan Aurovitas.
To reduce the risk of cardiovascular events, the usual dose of Telmisartan Aurovitas is one 80 mg tablet per day. Blood pressure should be monitored frequently at the start of treatment.
In patients with liver problems, the recommended dose should not exceed 40 mg per day.

Taking a higher dose of Telmisartan Aurovitas than recommended

If the patient accidentally takes too many tablets, they should immediately contact their doctor or pharmacist or the nearest hospital emergency department.

Missing a dose of Telmisartan Aurovitas

If the patient misses a dose, they should take it as soon as they remember, and then continue taking the medicine as scheduled. If the tablet is not taken within a day, the patient should take the usual dose the next day. The patient should not take a double dose to make up for the missed dose.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Telmisartan Aurovitas can cause side effects, although not everyone gets them.

Some side effects may be serious and require immediate medical attention

If the patient experiences any of the following symptoms, they should immediately contact their doctor:
Septicemia* (also known as blood poisoning, a severe infection with an inflammatory reaction throughout the body), sudden swelling of the skin and mucous membranes (angioedema); these side effects are rare (may occur in 1 in 1,000 people), but are very serious, and the patient should stop taking the medicine and contact their doctor immediately. If these symptoms are not treated, they can be fatal.

Possible side effects of Telmisartan Aurovitas:

Common side effects (may occur in up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated to reduce the risk of cardiovascular events.
Uncommon side effects (may occur in up to 1 in 100 people):
Urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), decreased red blood cell count (anemia), high potassium levels in the blood, difficulty sleeping, low mood (depression), fainting, spinning sensation (peripheral vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness when standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhea, abdominal discomfort, bloating, vomiting, itching, excessive sweating, rash, back pain, muscle spasms, muscle pain, flu-like symptoms, decreased hemoglobin levels (a protein in the blood), increased uric acid levels, increased liver enzyme activity or creatine phosphokinase in the blood.
Rare side effects (may occur in up to 1 in 1,000 people):
Progressive scarring of lung tissue (interstitial lung disease)**
Frequency not known (frequency cannot be estimated from the available data):
Angioedema of the intestine - after taking similar medicines, angioedema of the intestine has occurred with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
* The event may be coincidental or related to an unknown mechanism.
** Cases of progressive scarring of lung tissue have been reported with telmisartan. It is not known whether telmisartan is the cause.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Telmisartan Aurovitas

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after EXP.
The expiry date refers to the last day of that month.
There are no special storage instructions for the medicine.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Telmisartan Aurovitas contains

• The active substance of the medicine is telmisartan.

Each tablet contains 40 mg of telmisartan.
Each tablet contains 80 mg of telmisartan.

• The other ingredients are: mannitol, meglumine, povidone (K 25), sodium hydroxide, colloidal anhydrous silica, and sodium stearyl fumarate (see section 2).

What Telmisartan Aurovitas looks like and contents of the pack

Tablet.
Telmisartan Aurovitas, 40 mg, tablets:[Size: approximately 13 x 5.9 mm]
White or almost white, oblong, biconvex tablets without coating, with engraved "N" and "40" on both sides of the break line on one side and smooth on the other side.
The tablet can be divided into equal doses.
Telmisartan Aurovitas, 80 mg, tablets:[Size: approximately 16.2 x 7.8 mm]
White or almost white, oblong, biconvex tablets without coating, with engraved "N" and "80" on both sides of the break line on one side and smooth on the other side.
The tablet can be divided into equal doses.
Telmisartan Aurovitas tablets are available in blisters.

Pack sizes:

Telmisartan Aurovitas, tablets, 40 mg, 80 mg: 14, 28, 30, 50, 56, 84, 90, 98, and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João De Deus 19, Venda Nova
2700-487 Amadora
Portugal
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:

France:
Telmisartan Arrow 40 mg/ 80mg, comprimé sécable
Germany:
Telmisartan PUREN 20 mg/ 40 mg/ 80 mg Tabletten
Netherlands:
Telmisartan Aurobindo 20mg/ 40 mg/ 80 mg, tabletten
Poland:
Telmisartan Aurovitas
Portugal:
Telmisartan Generis Phar
Spain:
Telmisartán Aurovitas 20 mg/ 40 mg/ 80 mg comprimidos EFG

Date of last revision of the leaflet: 01/2025