Irbesartan EG
ItalyTable of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
IRBESARTAN EG 75 mg film-coated tablets, 150 mg film-coated tablets, 300 mg film-coated tablets
irbesartan
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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What IRBESARTAN EG is and what it is used for
- What you need to know before taking IRBESARTAN EG
- How to take IRBESARTAN EG
- Possible side effects
- How to store IRBESARTAN EG
- Contents of the pack and other information
1. What IRBESARTAN EG is and what it is used for
IRBESARTAN EG belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced by the body that binds to receptors in the blood vessels, causing them to constrict. This results in an increase in blood pressure. IRBESARTAN EG prevents angiotensin II from binding to these receptors, causing the blood vessels to relax and thereby lowering blood pressure. IRBESARTAN EG slows down the decline in kidney function in patients with high blood pressure and type 2 diabetes.
IRBESARTAN EG is used for:
- treating high blood pressure (essential hypertension)
- protecting the kidney in hypertensive patients with type 2 diabetes who show evidence of kidney dysfunction in laboratory tests.
2. What you need to know before taking IRBESARTAN EG
Do not take IRBESARTAN EG
- If you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6),
- If you are more than 3 months pregnant. (It is best to avoid using IRBESARTAN EG even during early pregnancy – see Pregnancy section)
- If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren
Warnings and precautions
Talk to your doctor or pharmacist before taking Irbesartan EG, or if any of the following conditions apply to you:
- If you have severe vomiting or diarrhoea
- If you have kidney problems
- If you have heart problems
- If you are due to undergo surgery or receive anaesthetics
- If you are taking any of the following medicines used to treat high blood pressure:
- an "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
- aliskiren
Your doctor may check your kidney function, blood pressure, and blood levels of electrolytes (such as potassium) at regular intervals. See also section "Do not take IRBESARTAN EG"
- Inform your doctor if you suspect (or are planning) pregnancy. Use of IRBESARTAN EG is not recommended during early pregnancy and the medicine must not be taken if you are more than 3 months pregnant, as it may seriously harm your unborn baby (see Pregnancy section).
Children and adolescents
This medicine must not be used in children and adolescents, as its safety and efficacy have not yet been fully established.
Other medicines and IRBESARTAN EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may consider it necessary to adjust your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also sections "Do not take IRBESARTAN EG" and "Warnings and precautions").
Blood tests may be required if you are taking:
- Potassium supplements
- Potassium-containing salt substitutes
- Potassium-sparing medicines (such as certain diuretics)
- Medicines containing lithium
The effectiveness of irbesartan may be reduced when taken with certain painkillers, known as non-steroidal anti-inflammatory drugs (NSAIDs).
IRBESARTAN EG with food and drink
IRBESARTAN EG can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor if you think you may have become (or are planning) pregnant. Your doctor will usually advise you to stop treatment with IRBESARTAN EG before you become pregnant or as soon as pregnancy is confirmed, and will prescribe an alternative medicine. Use of IRBESARTAN EG is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may seriously harm your unborn baby if taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or intend to breast-feed.
Mothers who breast-feed must not take IRBESARTAN EG. If you wish to continue breast-feeding, your doctor may decide to prescribe an alternative treatment, especially if your baby is newborn or was born prematurely.
Driving and using machines
No studies on the ability to drive and use machines have been conducted. It is unlikely that IRBESARTAN EG impairs your ability to drive or operate machinery. However, dizziness or fatigue may occasionally occur during treatment for high blood pressure. If you experience such effects, consult your doctor before driving or operating machinery.
IRBESARTAN EG contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars (e.g. lactose), contact your doctor before taking this medicine.
3. How to take IRBESARTAN EG
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Method of administration
IRBESARTAN EG is for oral use. The tablet should be swallowed with a sufficient amount of liquid (e.g. a glass of water). IRBESARTAN EG can be taken independently of food.
You should try to take your daily tablet at the same time each day. It is important that you continue taking IRBESARTAN EG for as long as your doctor has instructed.
- Patients with high blood pressure
The recommended dose is 150 mg once daily (two tablets per day). The dose may subsequently be increased to 300 mg (four tablets per day) once daily, depending on your blood pressure response.
IRBESARTAN EG 150 mg
The recommended dose is 150 mg once daily (one tablet per day). The dose may subsequently be increased to 300 mg (two tablets per day) once daily, depending on your blood pressure response.
IRBESARTAN EG 300 mg
The recommended dose is 150 mg once daily (for this dose, other formulations of IRBESARTAN EG are available). The dose may subsequently be increased to 300 mg (one tablet per day) once daily, depending on your blood pressure response.
- Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose is 300 mg (four tablets per day) once daily for the treatment of associated kidney disease.
IRBESARTAN EG 150 mg
In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose is 300 mg (two tablets per day) once daily for the treatment of associated kidney disease.
IRBESARTAN EG 300 mg
In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose is 300 mg (one tablet per day) once daily for the treatment of associated kidney disease.
Your doctor may decide to use lower doses, especially at the beginning of treatment, in particular patients such as those on haemodialysis, or in patients over 75 years of age.
The maximum blood pressure-lowering effect should be achieved within 4–6 weeks after starting treatment.
If you take more IRBESARTAN EG than you should
If you take too many tablets, contact your doctor immediately.
Children must not take IRBESARTAN EG
IRBESARTAN EG must not be given to children under 18 years of age. If a child swallows any tablets, contact your doctor immediately.
If you forget to take IRBESARTAN EG
If you accidentally miss a dose, take the next dose as usual. Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Some of these effects may be serious and may require medical attention.
As with similar medicines, rare cases of allergic skin reactions (rash, urticaria) and also localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you experience any of these symptoms or have difficulty breathing, stop taking IRBESARTAN EG and contact your doctor immediately.
IRBESARTAN EG may cause the following side effects:
Very common (may affect more than 1 in 10 people):
- if you have high blood pressure, type 2 diabetes and associated kidney disease, blood tests may show increased potassium levels.
Common (may affect up to 1 in 10 people):
- dizziness, feeling unwell/vomiting, fatigue. Blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase). In patients with high blood pressure, type 2 diabetes and kidney disease, dizziness when standing up from a lying or sitting position, low blood pressure upon standing from a lying or sitting position, joint or muscle pain, and decreased levels of a protein in red blood cells (haemoglobin) have also been reported.
Uncommon (may affect up to 1 in 100 people):
- increased heart rate, hot flushes, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain, yellowing of the skin or whites of the eyes due to liver or blood problems (jaundice).
Not known (frequency cannot be estimated from the available data):
- headache, altered taste sensation, ringing in the ears, sensation of dizziness (vertigo), muscle cramps, joint and muscle pain, abnormal liver function, increased potassium levels in the blood, kidney function disorders, and inflammation of the small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store IRBESARTAN 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 and blister after the words
"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 you no longer use. This will help protect the environment.
6. Package contents and other information
What IRBESARTAN EG contains
The active substance is irbesartan.
One 75 mg film-coated tablet of IRBESARTAN EG contains 75 mg of irbesartan.
One 150 mg film-coated tablet of IRBESARTAN EG contains 150 mg of irbesartan.
One 300 mg film-coated tablet of IRBESARTAN EG contains 300 mg of irbesartan.
The other components in the tablet core are:
- Monohydrate lactose
- Pregelatinized corn starch
- Copovidone
- Croscarmellose (E468)
- Anhydrous colloidal silica (E551)
- Magnesium stearate (E470b)
The other components in the tablet coating are:
- Hypromellose (E464)
- Macrogol 400
- Titanium dioxide (E171)
Description of the appearance of IRBESARTAN EG 75 mg, 150 mg and 300 mg film-coated tablets and
pack contents
The 75 mg film-coated tablets of IRBESARTAN EG are white, biconvex, ovaloid and approximately 10 mm long.
The 150 mg film-coated tablets of IRBESARTAN EG are white, biconvex, ovaloid and approximately 13 mm long.
The 300 mg film-coated tablets of IRBESARTAN EG are white, biconvex, ovaloid and approximately 16 mm long.
The 75 mg film-coated tablets of IRBESARTAN EG are packaged in PVC/PVDC/aluminum blisters. Packs containing 14, 28, 30, 50, 56 or 98 tablets are available.
The 150 mg film-coated tablets of IRBESARTAN EG are packaged in PVC/PVDC/aluminum blisters. Packs containing 14, 28, 30, 50, 56 or 98 tablets are available.
The 300 mg film-coated tablets of IRBESARTAN EG are packaged in PVC/PVDC/aluminum blisters. Packs containing 14, 28, 30, 50, 56 or 98 tablets are available.
Not all pack sizes may be marketed.
MARKETING AUTHORISATION HOLDER
EG S.p.A., Via Pavia 6, 20136 Milano, Italy
Manufacturers
Centrafarm Services B.V., Nieuwe Donk 9, NL-4879 Etten Leur (The Netherlands)
S.A. Eurogenerics N.V., Heizel Esplanade Heysel B 22, B-1020 Brussels (Belgium)
Stada Arzneimittel AG, Stadastr. 2-18, D-61118 Bad Vilbel (Germany)
This medicinal product is authorised in the EEA Member States under the following names:
DE: IRBESARTAN AL 75 mg/ 150 mg/ 300 mg Filmtabletten
IT: IRBESARTAN EG 75 mg/ 150 mg/ 300 mg compresse rivestite con film
NL: IRBESARTAN STADA 75 mg/ 150 mg/ 300 mg filmomhulde tabletten