Telmisartan EG

Italy
Brand name Telmisartan EG
Form tablets, film-coated
Active substance / Dosage
TELMISARTAN
Prescription type Prescription only
ATC code
C09CA07
Registration number 041183
Manufacturer EG S.P.A.

Table of Contents

Package leaflet: Information for the user

Telmisartan EG 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Telmisartan EG belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body that causes blood vessels to narrow, thereby increasing blood pressure. Telmisartan EG blocks the effect of angiotensin II, causing blood vessels to relax and thus reducing blood pressure.
Telmisartan EG is used to treat essential hypertension (high blood pressure).
"Essential" means that the high blood pressure is not caused by other conditions.
If left untreated, high blood pressure can damage blood vessels in many organs, which may sometimes lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms until such damage occurs. Therefore, it is important to have your blood pressure checked regularly to ensure it is within the normal range.
Telmisartan EG is also used to reduce cardiovascular events (e.g., heart attack or stroke) in patients who are at risk because of reduced or blocked blood flow to the heart or legs, or who have previously had a stroke, or who have high-risk diabetes. Your doctor can determine whether you are at high risk for these events.

2. What you should know before taking Telmisartan EG

Do not take Telmisartan EG
if you are allergic to telmisartan or to any of the other ingredients of this medicine (listed in
section 6).
if you are more than 3 months pregnant (it is better to avoid taking Telmisartan EG even in the
early stages of pregnancy – see section on Pregnancy).
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 impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
If any of these conditions apply to you, inform your doctor before taking Telmisartan EG.

Warnings and precautions
Tell your doctor if you have or have ever 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 diseases.
Heart problems.
Increased levels of aldosterone (water and salt retention in the body with imbalance of various minerals in the blood).
Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive loss of water from the body) or have salt deficiency due to diuretic therapy (“diuretics”), a low-salt diet, diarrhoea or vomiting.
High potassium levels in the blood.
Diabetes.

Talk to your doctor, pharmacist, or nurse before taking Telmisartan EG
If you are taking any of the following medicines used to treat high blood pressure:
an ACE inhibitor (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
aliskiren.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the information under the section "Do not take Telmisartan EG".
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Telmisartan EG is not recommended during early pregnancy and must not be taken after the third month of pregnancy as it may cause serious harm to the unborn baby if taken during this period (see the Pregnancy section).
If you are undergoing surgery or receiving anaesthetics, you must inform your doctor that you are taking Telmisartan EG.

Children and adolescents
The use of Telmisartan EG in children and adolescents up to 18 years of age is not recommended.
Like all other angiotensin II receptor antagonists, Telmisartan EG may be less effective in reducing blood pressure in black patients.

Other medicines and Telmisartan EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may decide to adjust the dose of these other medicines or take other precautions. In some cases, it may be necessary to stop taking one of these medicines. This particularly applies to the following medicines when taken together with Telmisartan EG:
Medicines containing lithium used 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, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin, immunosuppressants (e.g. cyclosporine or tacrolimus), and the antibiotic trimethoprim.
Diuretics, especially when taken at high doses together with Telmisartan EG, may cause excessive loss of body water and low blood pressure (hypotension).
If you are taking an ACE inhibitor or aliskiren (see also the sections "Do not take Telmisartan EG" and "Warnings and precautions").
As with other medicines that lower blood pressure, the effect of Telmisartan EG may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids.
Telmisartan EG may enhance the effect of other medicines used to lower blood pressure.

Telmisartan EG and food
Telmisartan EG can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Your doctor will normally advise you to stop taking Telmisartan EG before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Telmisartan EG. Telmisartan EG is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken during this period.

Breast-feeding
Telmisartan EG is not recommended during breast-feeding. Your doctor may choose an alternative treatment if you wish to breast-feed, especially if your baby is newborn or was born prematurely.

Driving and using machines
There is no information available on the effect of Telmisartan EG on the ability to drive or use machines. Some patients may experience dizziness or drowsiness during antihypertensive treatment. If you experience these effects, do not drive or operate machinery.

Telmisartan EG contains lactose
If your doctor has informed you of an intolerance to certain sugars, please consult them before taking this medicine.

3. How to take Telmisartan EG

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Telmisartan EG is one tablet daily. Try to take the tablet at the same time each day. You may take Telmisartan EG with or without food. Swallow the tablets with a glass of water or other non-alcoholic beverage. It is important to take Telmisartan EG every day unless your doctor tells you otherwise. If you feel that the effect of Telmisartan EG is too strong or too weak, talk to your doctor or pharmacist.

For the treatment of high blood pressure, the recommended dose of Telmisartan EG for most patients is one 40 mg tablet daily 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.

Alternatively, Telmisartan EG may also be used in combination with diuretics (tablets that increase urine production), such as hydrochlorothiazide. This combination has been shown to have an additive effect in lowering blood pressure.

For the reduction of cardiovascular events, the recommended dose of Telmisartan EG is one 80 mg tablet once daily. At the start of preventive treatment with Telmisartan EG 80 mg, blood pressure should be monitored frequently.

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

If you take more Telmisartan EG than you should
If you accidentally take too many tablets, contact your doctor, pharmacist, or go to the nearest emergency room immediately.

If you forget to take Telmisartan EG
If you forget to take a dose, do not worry. Take it as soon as you remember, then continue as usual. If you skip a day’s dose, take your normal dose the next day. Do not take a double dose to make up for the missed dose.

If you stop taking Telmisartan EG
Do not stop treatment with Telmisartan EG without first consulting your doctor.
You may need to take blood pressure medicines for the rest of your life. If you stop taking Telmisartan EG, your blood pressure will return to pre-treatment levels within a few days.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone may experience them.
Some adverse reactions can be serious and require immediate medical treatment:
Seek immediate medical attention if you experience any of the following symptoms:
Sepsis* (often called "blood poisoning", a severe infection causing a systemic inflammatory response), rapid swelling of the skin and mucous membranes (severe angioedema), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. skin rash, itching, breathing difficulties, shortness of breath, facial swelling or low blood pressure); these adverse reactions are rare (may affect up to 1 in 1,000 people) but are extremely serious, and patients must stop taking the medicine immediately and contact their doctor. If left untreated, these effects may be fatal.
Possible adverse reactions of Telmisartan EG
Common adverse reactions (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated for cardiovascular events.
Uncommon adverse reactions (may affect up to 1 in 100 people):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), deficiency of red blood cells (anaemia), high potassium levels, difficulty sleeping, feeling of sadness (depression), fainting (syncope), sensation of dizziness (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for hypertension, dizziness upon standing (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, abdominal discomfort, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), impaired renal function including acute renal failure, chest pain, feeling of weakness, increased blood creatinine levels.
Rare adverse reactions (may affect up to 1 in 1,000 people):
Increased levels of certain types of white blood cells (eosinophilia), low platelet count (thrombocytopenia), low blood sugar levels (in diabetic patients), anxiety, drowsiness, visual disturbances, fast heart rate (tachycardia), dry mouth, stomach discomfort, abnormal liver function (Japanese patients have a higher likelihood of experiencing these adverse reactions), eczema (a skin disorder), skin redness, urticaria, severe drug-induced skin rash, joint pain (arthralgia), limb pain, tendon pain, influenza-like illness, decreased haemoglobin (a blood protein), increased uric acid levels, increased liver enzymes or creatine phosphokinase in the blood.
Very rare adverse reactions (may affect up to 1 in 10,000 people):
Progressive scarring of lung tissue (interstitial lung disease)**
* The event may occur by chance or may be 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 is the cause.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You may also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Telmisartan EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the word "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Telmisartan EG contains

  • The active substance is telmisartan. Each tablet contains 20 mg/40 mg/80 mg of telmisartan.
  • The other components are: Sodium hydroxide, Povidone (K-25), Meglumine, Lactose monohydrate, Crospovidone, Yellow iron oxide (E172), Magnesium stearate.

The tablet coating contains:
Hypromellose
Titanium dioxide (E171)
Macrogol-400
Talc
Yellow iron oxide (E172)

Description of the appearance of Telmisartan EG and contents of the pack

Telmisartan EG is available as yellow, film-coated, round tablets with "20" imprinted on one side and "T" on the other.
Telmisartan EG is available as yellow, film-coated, capsule-shaped tablets with "40" imprinted on one side and "T" on the other.
Telmisartan EG is available as yellow, film-coated, capsule-shaped tablets with "80" imprinted on one side and "T" on the other.

Telmisartan EG 20 mg is supplied in blister packs containing 7, 10, 14, 15, 28, 30, 56, 60, 84, 90, 98, 112, 126, 140, 154, 168 or 182 tablets.
Telmisartan EG 40 mg is supplied in blister packs containing 7, 10, 14, 15, 28, 30, 50, 56, 60, 84, 90, 98, 112, 126, 140, 154, 168 or 182 tablets.
Telmisartan EG 80 mg is supplied in blister packs containing 7, 10, 14, 15, 28, 30, 50, 56, 60, 84, 90, 98, 112, 126, 140, 154, 168 or 182 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 – 20136 Milan, Italy

Manufacturers
Glenmark Pharmaceuticals s.ro., Fibíchova 143, 56617 Vysoké Mýto (Czech Republic)
Tillomed Laboratories Ltd., 3 Howard Road, Easton Socon, St. Neots, Cambridgeshire, PE19 8ET (United Kingdom)
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel (Germany)
STADA Arzneimittel GmbH, Muthgasse 36, 1190 Wien (Austria)
Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary (Ireland)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
UK Telmisartan Glenmark Generics 20/40/80 mg film-coated tablets
AT Telmisartan STADA 20/40/80 mg Filmtabletten
BE Telmisartan EG 20/40/80 mg filmomhulde tabletten
LU Telmisartan EG 20/40/80 mg comprimés pelliculés
BG Telmisartan STADA 20/40/80 mg Филмирана таблетка
DE Telmisartan STADA 20/40/80 mg Filmtabletten
DK Telmisartan STADA
ES Telmisartán STADA 20/40/80 mg comprimidos recubiertos con película EFG
FI Telmisartan STADA 20/40/80 mg Tabletti, kalvopäällysteinen
FR Telmisartan EG 20/40/80 mg comprimé pelliculé
IE Telmisartan Clonmel 20/40/80 mg film-coated tablets
IT Telmisartan EG 20/40/80 mg compresse rivestite con film
NL Telmisartan CF 20/40/80 mg filmomhulde tabletten
PT Telmisartan Ciclum
SE Telmisartan STADA 20/40/80 mg Filmdragerad tabletter