IRBETENS 150 mg Tabletki Powlekane

Treść ulotki

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

IRBETENS 150 mg film-coated tablets
IRBETENS 300 mg film-coated tablets
Irbesartan

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others. It may be harmful to people even if their symptoms are the same as yours.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is IRBETENS and what is it used for

IRBETENS 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 blood vessels, causing them to constrict. This results in an increase in blood pressure. IRBETENS prevents angiotensin-II from binding to these receptors, allowing blood vessels to dilate and blood pressure to decrease. IRBETENS slows the decline of kidney function in patients with high blood pressure and type 2 diabetes. IRBETENS is used in adult patients

• to treat high blood pressure ( essential arterial hypertension);
• to protect the kidney in hypertensive patients with high blood pressure, type 2 diabetes and evidence of kidney dysfunction in laboratory tests.

2. What you need to know before taking IRBETENS

Do not take IRBETENS:

• if you are allergicto irbesartan or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant for more than 3 months. (it is best to avoid taking IRBETENS even

in the early stages of pregnancy - see section Pregnancy)

• if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren

Warnings and precautions
Talk to your doctor or pharmacist before taking IRBETENS if you are in any of the following
conditions:

• excessive vomiting or diarrhoea;
• if you suffer from kidney problems;
• if you suffer from heart problems;
• if you are taking IRBETENS for diabetic kidney disorders. In this case, your doctor may prescribe you regular blood tests, especially to measure serum potassium levels in case of poor kidney function;
• if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or paleness, numbness, fast and pounding heartbeat), especially if you are being treated for diabetes;
• if you are to undergo surgeryor receive anaesthetics;
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor” (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren

Talk to your doctor if, after taking Irbetens, you experience abdominal pain, nausea, vomiting or
diarrhoea. The doctor will decide on whether to continue treatment. Do not stop taking
Irbetens on your own.
The doctor may check your kidney function, blood pressure, and the amount of electrolytes
(e.g. potassium) in your blood at regular intervals.
See also what is stated under "Do not take IRBETENS"
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). IRBETENS is not recommended in the early stages of pregnancy and must not be
taken if you are pregnant for more than 3 months, as it can cause serious harm to the baby if
taken during this period (see section Pregnancy).

Children and adolescents
This medicine should not be used in children and adolescents as safety and
efficacy have not been fully established.

Other medicines and IRBETENS
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Your doctor may need to adjust the dose and/or take other precautions:

• If you are taking an ACE inhibitor or aliskiren (see also what is stated under: "Do not take IRBETENS” and "Warnings and precautions”).

You may need blood tests if you are using:

• potassium supplements;
• salt substitutes containing potassium;
• potassium-sparing medicines (like some diuretics);
• medicines containing lithium.
• repaglinide (medicine used to lower blood sugar levels).

If you take some painkillers, called non-steroidal anti-inflammatory drugs,
the effectiveness of irbesartan may be reduced.

IRBETENS with food and drink
IRBETENS can be taken with or without food.

Pregnancy, breastfeeding
Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy); your doctor will usually advise you to stop taking IRBETENS before
starting a pregnancy or as soon as you find out you are pregnant and will
advise you to take another medicine instead of IRBETENS. IRBETENS is not recommended
in the early stages of pregnancy and must not be taken if you are pregnant for more than 3 months
as it can cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. IRBETENS is not recommended
for women who are breastfeeding and your doctor may choose another treatment if you
wish to breastfeed, especially if the baby is newborn or premature.

Driving and using machines
It is unlikely that IRBETENS will affect your ability to drive or operate machinery. However,
dizziness or fatigue may occasionally occur during treatment for high blood pressure.
If this happens, talk to your doctor before driving or using machines.

IRBETENS contains lactose. If you have been diagnosed with intolerance to some sugars, contact
your doctor before taking this medicine.

IRBETENS contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per
tablet, i.e. essentially “sodium-free”.

3. How to take IRBETENS

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.

Method of administration
IRBETENS is for oral use. Swallow the tablets with a sufficient amount of fluids (e.g., a
glass of water). You can take IRBETENS with or without food. Try to take the medicine every
day at the same time. The treatment should be continued as long as your doctor deems it necessary.

• Patients with high blood pressureThe usual dose is 150 mg once a day. The dosage may then be increased to 300 mg (two tablets a day) once a day depending on the reduction of blood pressure levels.
• Patients with high blood pressure and type 2 diabetes with kidney diseaseIn patients with high blood pressure and type 2 diabetes, the indicated maintenance dose is 300 mg (two tablets a day) once a day for the treatment of associated kidney disease.

The doctor may decide to use lower doses, especially at the beginning of treatment, in
particular patients such as those in hemodialysis, or in patients over 75 years of age.
The maximum antihypertensive effect should be achieved 4-6 weeks after the start of therapy.

Use in children and adolescents.
IRBETENS should not be given to children under 18 years of age. If a child swallows some
tablets, contact your doctor immediately.

If you take more IRBETENS than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take IRBETENS
If you accidentally forget to take a dose, continue with the therapy normally. Do not
take a double dose to compensate for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, IRBETENS can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.
As with similar medicines, rare cases of allergic skin reactions (redness, hives) and 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 IRBETENS and contact your doctor immediately.
The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
The side effects reported in clinical studies for patients treated with IRBETENS were:

• Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show high levels of potassium.
• Common (may affect up to 1 in 10 people): dizziness, feeling unwell/vomiting, fatigue and blood tests may show an increase in the levels of an enzyme that measures muscle and heart function (creatine kinase). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, joint or muscle pain, and a decrease in the levels of a protein in red blood cells (hemoglobin) have also been reported.
• Uncommon (may affect up to 1 in 100 people): increased heart rate, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.

Some side effects have been reported since IRBETENS was marketed.
The side effects with rare frequency (may affect up to 1 in 1,000):
intestinal angioedema (swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting and diarrhea).
The side effects with frequency not known: feeling of dizziness, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, reduced number of platelets, abnormal liver function, increased potassium levels in the blood, decreased number of red blood cells (anemia – symptoms may include fatigue, headache, shortness of breath during physical activity, dizziness and paleness) kidney function disorders, inflammation of small blood vessels mainly affecting the skin (condition known as leucocytoclastic vasculitis), severe allergic reactions (anaphylactic shock). Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store IRBETENS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and blister after
Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What IRBETENS contains

• The active ingredient is irbesartan.
• Each IRBETENS 150 mg tablet contains 150 mg of irbesartan.
• Each IRBETENS 300 mg tablet contains 300 mg of irbesartan.

The excipients are:
Tablet core: Lactose monohydrate, anhydrous colloidal silica, microcrystalline cellulose,
sodium croscarmellose, hypromellose, pregelatinized starch, magnesium stearate.
Coating: Lactose monohydrate, hypromellose, titanium dioxide, macrogol 4000. See section 2
“IRBETENS contains lactose”.

Description of the appearance of IRBETENSand contents of the pack
Pack of 28 tablets of 150 mg contained in blisters
Pack of 28 tablets of 300 mg contained in blisters

Marketing Authorisation Holder:
LANOVA Farmaceutici S.r.l. - Via Conca D’oro, 212 – 00141 Roma

Manufacturer:
Genetic S.p.A.