PACKAGE LEAFLET: INFORMATION FOR THE USER

IRBESARTAN DOC Generici 75 mg tablets, 150 mg tablets, 300 mg tablets

Equivalent 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 or pharmacist.
This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What IRBESARTAN DOC Generici is and what it is used for
What you need to know before taking IRBESARTAN DOC Generici
How to take IRBESARTAN DOC Generici
Possible side effects
How to store IRBESARTAN DOC Generici
Contents of the pack and other information

1. WHAT IRBESARTAN DOC Generici IS AND WHAT IT IS USED FOR

IRBESARTAN DOC Generici 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 increased blood pressure.
IRBESARTAN DOC Generici prevents angiotensin-II from binding to these receptors, allowing blood vessels to dilate and thereby reducing blood pressure. IRBESARTAN DOC Generici slows the decline in renal function in patients with high blood pressure and type 2 diabetes.
IRBESARTAN DOC Generici is used to treat high blood pressure ( essential arterial hypertension ) and to protect the kidneys in hypertensive patients with elevated blood pressure, type 2 diabetes, and evidence of kidney dysfunction shown by laboratory tests.

2. WHAT YOU NEED TO KNOW BEFORE TAKING IRBESARTAN DOC Generici

Do not take IRBESARTAN DOC Generici:

if you are allergic (hypersensitive) 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 better to avoid taking IRBESARTAN DOC Generici even in the early stages of 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 DOC Generici

if you have excessive vomiting or diarrhoea
if you have kidney problems
if you have heart problems
if you are taking IRBESARTAN DOC Generici for diabetic kidney disorders. In this case, your doctor may prescribe regular blood tests, especially to monitor serum potassium levels in case of poor kidney function
if you are due to undergo surgery or receive anaesthetics, you must inform your doctor
you must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). IRBESARTAN DOC Generici is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section Pregnancy)
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 monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the information under the heading “Do not take IRBESARTAN DOC Generici”.
Children and adolescents
This medicine should not be used in children and adolescents, as efficacy and safety have not yet been fully established.
Other medicines and IRBESARTAN DOC Generici
Inform 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 information under “Do not take IRBESARTAN DOC Generici” and “Warnings and precautions”).
IRBESARTAN DOC Generici usually does not interact with other medicines.
Special precautionary measures (e.g. blood tests) may be advisable if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines (such as certain diuretics), or lithium-containing medicines.
Like other medicines that lower blood pressure, the effect of irbesartan may be reduced when you take non-steroidal anti-inflammatory drugs (NSAIDs).

IRBESARTAN DOC Generici with food and drink
IRBESARTAN DOC Generici can be taken before, during, or after meals. The tablets should be swallowed with a glass of water.
Pregnancy and breast-feeding
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking IRBESARTAN DOC Generici before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of IRBESARTAN DOC Generici. IRBESARTAN DOC Generici is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. IRBESARTAN DOC Generici is not recommended for women who are breast-feeding. If you wish to breast-feed, your doctor may choose an alternative treatment, especially if your baby is newborn or was born prematurely.
Driving and using machines
No studies on the ability to drive or use machines have been conducted.
It is unlikely that IRBESARTAN DOC Generici will affect your ability to drive or use machines. However, occasionally, during treatment for high blood pressure, dizziness or fatigue may occur. If this happens, talk to your doctor before driving or operating machinery.
IRBESARTAN DOC Generici contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. HOW TO TAKE IRBESARTAN DOC Generici

Take this medicine exactly as prescribed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is 150 mg once daily. The dose may subsequently be increased to 300 mg
once daily, depending on the reduction in blood pressure levels. Maximum antihypertensive effect
should be achieved within 4–6 weeks after starting treatment.
In patients with high blood pressure and type 2 diabetes, the indicated maintenance dose is 300 mg
once daily for the treatment of associated kidney disease.
Your doctor may decide to use lower doses, especially at the beginning of treatment, in certain
patients such as those undergoing haemodialysis, or in patients over 75 years of age.
IRBESARTAN DOC Generici is for oral use and may be taken before, during or after meals. Swallow
the tablets with a glass of water. Try to take the medicine at approximately the same time each day.
It is important that you continue taking IRBESARTAN DOC Generici unless your doctor tells you
otherwise.
IRBESARTAN DOC Generici must not be given to children (under 18 years of age).
If you take more IRBESARTAN DOC Generici than you should
If you accidentally take too many tablets, or if a child swallows any, contact your doctor immediately.
An overdose may cause dizziness, fainting, rapid heartbeat or palpitations.
If you forget to take IRBESARTAN DOC Generici
If you accidentally miss a dose, continue your treatment as usual. Do not take a double dose to
make up for the missed dose.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
Some effects may be serious and may require medical attention.
As with other similar medicines, rare cases of skin allergic reactions (rash, urticaria) as well as localized swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you experience any of these symptoms or shortness of breath, stop taking this medicine and contact your doctor immediately.

The frequency of the adverse reactions listed below is defined according to the following convention:
Very common: affects at least 1 in 10 people or more
Common: affects at least 1 in 100 and less than 1 in 10 people
Uncommon: affects at least 1 in 1,000 and less than 1 in 100 people

The adverse reactions reported during clinical studies in patients treated with irbesartan were the following:

Very common: if you have high blood pressure and type II diabetes with kidney disease, blood tests may show increased potassium levels
Common: dizziness, feeling unwell/nausea, fatigue, and increased levels of an enzyme that measures muscle and heart function (creatine kinase enzyme), as shown by blood tests. In patients with high blood pressure and type 2 diabetes with kidney disease, the following have also been reported: dizziness upon standing up from lying or sitting position, low blood pressure when standing up from lying or sitting position, joint or muscle pain, and decreased levels of a protein found in red blood cells (haemoglobin)
Uncommon: increased heart rate, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain

Some adverse reactions have been reported after the marketing of irbesartan. Adverse reactions for which frequency is not known include: feeling of instability, headache, taste disturbances, tinnitus (ringing in the ears), muscle cramps, joint and muscle pain, reduced platelet count, abnormal liver function, increased potassium levels in the blood, reduced kidney function, and inflammation of the small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis). Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE IRBESARTAN DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp.
The expiry date refers to the last day of that month.
Store in the original packaging to protect from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What IRBESARTAN DOC Generici contains

The active substance is irbesartan. Each tablet contains 75/150/300 mg of irbesartan.
The other components are: microcrystalline cellulose (E460), sodium croscarmellose (E468), lactose monohydrate, magnesium stearate (E470b), anhydrous colloidal silica (E551), maize starch, povidone K-29/32 (E-1201) and hydrogenated castor oil.

Description of the appearance of IRBESARTAN DOC Generici and pack contents
IRBESARTAN DOC Generici 75 mg tablets are white, cylindrical, biconvex.
IRBESARTAN DOC Generici 150 mg tablets are white, cylindrical, biconvex, with a breakline on one side.
The breakline on the tablet is intended to facilitate breaking the tablet for easier swallowing and does not indicate division into equal doses.
IRBESARTAN DOC Generici 300 mg tablets are white, oblong, biconvex, with a breakline on one side. The breakline on the tablet is intended to facilitate breaking the tablet for easier swallowing and does not indicate division into equal doses.
IRBESARTAN DOC Generici 75 mg/150 mg/300 mg tablets are available in packs of 14, 28, 56 or 98 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

Manufacturer:
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
NL: Irbesartan Focus 75 mg/150 mg/300 mg tabletten
IT: IRBESARTAN DOC Generici 75 mg/150 mg/300 mg compresse