Telmisartan aurovitas

Package leaflet: Information for the user

Telmisartan Aurovitas, 40 mg, tablets
Telmisartan Aurovitas, 80 mg, tablets
Telmisartanum
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Telmisartan Aurovitas is and what it is 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 pack and other information

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

Telmisartan Aurovitas belongs to a group of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance produced by the body that causes blood vessels to narrow, leading to increased blood pressure. Telmisartan Aurovitas works by blocking the effects of angiotensin II, allowing blood vessels to relax and blood pressure to decrease.

Telmisartan Aurovitas is used to treat essential (primary) hypertension (high blood pressure) in adults. The term "essential" means that the high blood pressure is not caused by another disease.

Untreated high blood pressure may damage blood vessels in various organs and, in some cases, may lead to heart attack, heart or kidney failure, stroke, or loss of vision. Often, there are no symptoms of high blood pressure before these complications occur. Therefore, it is important to have your blood pressure checked regularly to ensure it remains within normal limits.

Telmisartan Aurovitas is also used to reduce the risk of cardiovascular events (such as heart attack or stroke) in adult patients at high risk, including those with reduced blood flow to the heart or legs, those who have had a stroke, or those with diabetes. Your doctor will inform you whether you belong to such a high-risk group.

2. Important information before using Telmisartan Aurovitas

When not to use 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 more than 3 months pregnant. (Telmisartan Aurovitas should also be avoided during early pregnancy – see section “Pregnancy”).
• If the patient has 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 the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren. If any of the above situations apply, inform the doctor or pharmacist before taking Telmisartan Aurovitas.

Warnings and precautions
Before starting treatment with Telmisartan Aurovitas, discuss with the doctor if the patient has or has had any of the following conditions or diseases:

• Kidney disease or history of kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys).
• Liver disease.
• Heart problems.
• Elevated aldosterone levels (retention of water and salt in the body, accompanied by imbalances in various blood minerals).
• Low blood pressure (hypotension), especially if the patient is dehydrated (excessive loss of body water) or has salt deficiency, for example due to diuretic (water tablet) treatment, low-salt diet, diarrhoea or vomiting.
• High blood potassium levels.
• Diabetes.

Before starting treatment with Telmisartan Aurovitas, discuss with the doctor:

• If the patient is taking any of the following medicines used to treat high blood pressure:
  • ACE inhibitors (e.g. enalapril, lisinopril, ramipril), particularly if the patient has kidney problems related to diabetes.
  • Aliskiren. The doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading “When not to use Telmisartan Aurovitas”.
• If the patient is taking digoxin.

If the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Telmisartan Aurovitas, discuss this with the doctor. The doctor will decide whether treatment should continue. Do not stop taking Telmisartan Aurovitas without consulting the doctor.
Inform the doctor if the patient suspects she is (or might be) pregnant. Use of Telmisartan Aurovitas is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child (see section “Pregnancy”).
If undergoing planned surgery or anaesthesia, inform the doctor about taking Telmisartan Aurovitas.
Telmisartan Aurovitas may be less effective in lowering blood pressure in people of black race.

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

Telmisartan Aurovitas and other medicines
Tell the doctor or pharmacist about all medicines currently or recently taken, or those the patient plans to take. The doctor may need to adjust the dose of these medicines or take other precautions. In some cases, one of the medicines may need to be discontinued. This particularly applies to concomitant use with the following medicines:

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

The effect of Telmisartan Aurovitas may be reduced when taken with NSAIDs (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 low blood pressure (e.g. baclofen, amifostine).
In addition, low blood pressure may be intensified by: alcohol, barbiturates, narcotics or antidepressants. Symptoms include dizziness upon standing. If dose adjustment of another medicine taken during treatment with Telmisartan Aurovitas is needed, consult the doctor.

Pregnancy and breastfeeding
Pregnancy
Inform the doctor if the patient suspects she is (or might be) pregnant. Usually, the doctor will advise stopping Telmisartan Aurovitas before planning pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Use of Telmisartan Aurovitas is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if used beyond 3 months of pregnancy.

Breastfeeding
Inform the doctor if breastfeeding or planning to breastfeed. Telmisartan Aurovitas is not recommended during breastfeeding. The doctor may choose an alternative treatment during breastfeeding, especially when feeding newborns or premature infants.

Driving and operating machinery
In some patients taking Telmisartan Aurovitas, adverse effects such as fainting or dizziness (vertigo) may occur. If the patient experiences these adverse effects, driving or operating machinery should be avoided.

Telmisartan Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Telmisartan Aurovitas

Telmisartan Aurovitas must always be taken as directed by your doctor. If you have any
doubts, consult your doctor or pharmacist.
The recommended dose of Telmisartan Aurovitas is one tablet per day. Try to take the tablet at the
same time each day.
Telmisartan Aurovitas may be taken with or without food. Swallow the tablets with water or another
non-alcoholic drink. It is important to take Telmisartan Aurovitas every day, unless your doctor
advises otherwise. If you feel the effect of Telmisartan Aurovitas is too strong or too weak, consult
your doctor or pharmacist.

20 mg
In the treatment of essential hypertension, the usual dose of Telmisartan Aurovitas for most patients
is one 40 mg tablet once daily, providing 24-hour blood pressure control. Your doctor may prescribe
a lower dose of one 20 mg tablet per day. Telmisartan Aurovitas may also be used in combination
with a diuretic (water tablet), such as hydrochlorothiazide, which enhances the blood pressure-lowering
effect of Telmisartan Aurovitas.

40 mg and 80 mg
In the treatment of essential hypertension, the usual dose of Telmisartan Aurovitas for most patients
is one 40 mg tablet once daily, providing 24-hour blood pressure control. However, your doctor may
sometimes prescribe a lower dose of 20 mg or a higher dose of 80 mg. Telmisartan Aurovitas may
also be used in combination with a diuretic (water tablet), such as hydrochlorothiazide, which enhances
the blood pressure-lowering effect of Telmisartan Aurovitas.

For reducing the risk of cardiovascular events, the usual dose of Telmisartan Aurovitas is one 80 mg
tablet once daily. Blood pressure should be monitored frequently at the beginning of treatment.

In patients with impaired liver function, the usual dose must not exceed 40 mg once daily.

Taking more Telmisartan Aurovitas than prescribed
If you accidentally take too many tablets, contact your doctor or pharmacist immediately, or go to the
nearest hospital emergency department.

If you miss a dose of Telmisartan Aurovitas
If you forget to take a dose, take it as soon as you remember, then continue with your regular dosing
schedule. If the missed tablet is not taken during the same day, take your usual dose the next day.
Do not take a double dose to make up for a missed tablet.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some adverse effects may be serious and require immediate medical attention.
If any of the following symptoms occur, contact your doctor immediately:
Sepsis* (commonly known as "blood poisoning", a severe infection causing systemic inflammatory response), sudden swelling of the skin and mucous membranes (angioedema). These adverse effects are rare (may occur in 1 out of 1,000 people), but are very serious. In such cases, treatment with the medicine must be discontinued immediately and medical advice sought without delay. If left untreated, these symptoms may result in death.

Possible adverse effects of Telmisartan Aurovitas:

Common adverse effects (may occur in up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated to reduce the frequency of cardiovascular events.

Uncommon adverse effects (may occur in 1 in 100 people):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), reduced number of red blood cells (anaemia), high potassium levels in plasma, difficulty falling asleep, low mood (depression), fainting, sensation of spinning (peripheral vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness upon standing (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, indigestion, bloating, vomiting, itching, excessive sweating, drug rash, back pain, muscle cramps, muscle pain, kidney function disorders, including acute kidney failure, chest pain, feeling of weakness, and increased blood creatinine levels.

Rare adverse effects (may occur in 1 in 1,000 people):
Sepsis* (commonly known as "blood poisoning", a severe infection with systemic inflammatory response, which may lead to death), increased number of certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reactions (e.g. rash, itching, breathing difficulties, wheezing, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients), feeling of restlessness, drowsiness, visual disturbances, rapid heart rate (tachycardia), dryness of the oral mucosa, abdominal discomfort, taste disturbances, liver function disorders (more frequent in patients of Japanese origin), sudden swelling of the skin and mucous membranes, which may also lead to death (angioedema, including fatal cases), skin eruption (skin disease), redness of the skin, urticaria, severe drug rash, joint pain, limb pain, tendon pain, influenza-like symptoms, decreased haemoglobin concentration (a protein in blood), increased uric acid levels, increased activity of liver enzymes or creatine kinase in blood, low sodium levels.

Very rare adverse effects (may occur in 1 in 10,000 people):
Progressive fibrosis of lung tissue (interstitial lung disease)**.

Frequency not known (frequency cannot be estimated from available data):
Angioedema of the intestine – with similar medicines, intestinal swelling has occurred with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

* The event may be coincidental or related to a currently unknown mechanism.
** Cases of progressive fibrosis of lung tissue have been reported during treatment with telmisartan. It is not known whether telmisartan is the cause.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.
Adverse effects can also be reported to the marketing authorisation holder.

5. How to store 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 carton or blister after: EXP.
The expiry date refers to the last day of the specified month.
No special temperature storage instructions are required.
Store in the original packaging in order 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. This will help protect the environment.

6. Contents of the pack and other information

What Telmisartan Aurovitas contains

• The active substance 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, elongated, biconvex, uncoated tablets, with engraved markings "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, elongated, biconvex, uncoated tablets, with engraved markings "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 blister packs.
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 Authorisation Holder and Manufacturer/Importer
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names:
France: Telmisartan Arrow 40 mg/ 80 mg, comprimé sécable
Germany: Telmisartan PUREN 20 mg/ 40 mg/ 80 mg Tabletten
Netherlands: Telmisartan Aurobindo 20 mg/ 40 mg/ 80 mg, tabletten
Poland: Telmisartan Aurovitas
Portugal: Telmisartan Generis Phar
Spain: Telmisartán Aurovitas 20 mg/ 40 mg/ 80 mg comprimidos EFG