Patient Information Leaflet: Information for the patient

Rabesat 150 mg film-coated tablets, 300 mg film-coated tablets

Irbesartan
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. Do not give it to others. This medicine may be harmful to others, even if their symptoms are the same as yours.
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 Rabesat is and what it is used for
What you need to know before taking Rabesat
How to take Rabesat
Possible side effects
How to store Rabesat
Contents of the pack and other information

1. What Rabesat is and what it is used for

Rabesat 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. Rabesat prevents angiotensin-II from binding to these receptors, allowing the blood vessels to dilate and blood pressure to decrease. Rabesat slows down the decline in kidney function in patients with high blood pressure and type 2 diabetes.
Rabesat is used in adult patients

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

2. What you need to know before taking Rabesat

Do not take Rabesat:

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 better to avoid taking Rabesat 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 before taking Rabesat if you are in any of the following conditions:

excessive vomiting or diarrhoea
if you suffer from kidney disorders
if you suffer from heart disorders
if you are taking Rabesat for diabetic kidney problems. In this case, your doctor may prescribe regular blood tests, especially to monitor serum potassium levels in case of poor kidney function
if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid or pounding heartbeat), especially if you are being treated for diabetes
if you are scheduled for surgery or are receiving anaesthetics
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, or aliskiren

Talk to your doctor if, after taking Rabesat, you experience abdominal pain, nausea, vomiting or diarrhoea.
Your doctor will decide whether treatment should continue.
Do not stop taking Rabesat on your own.
Your doctor may monitor your kidney function, blood pressure, and blood levels of electrolytes
(e.g. potassium) at regular intervals.
See also information under the section "Do not take Rabesat".
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Rabesat 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).

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 Rabesat
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 Rabesat" and "Warnings and precautions").

You may need blood tests if you are taking:

potassium supplements
potassium-containing salt substitutes
potassium-sparing medicines (such as certain diuretics)
lithium-containing medicines
repaglinide (a medicine used to lower blood sugar levels)

If you are taking certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs), the effectiveness of irbesartan may be reduced.

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

Pregnancy and breastfeeding
Pregnancy
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 Rabesat before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Rabesat 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 beyond the third month of pregnancy.

Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Rabesat is not recommended for women who are breast-feeding. Your doctor may choose another treatment if you wish to breast-feed, especially if the baby is a newborn or was born prematurely.

Driving and using machines
It is unlikely that Rabesat affects the ability to drive or use machines. However, occasionally, dizziness or fatigue may occur during treatment for high blood pressure. If this happens, talk to your doctor before driving or operating machinery.

Rabesat contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

Rabesat contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially ‘sodium-free’.

3. How to take Rabesat

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Method of administration
Rabesat is for oral use. Swallow the tablets with a sufficient amount of fluid (for example: a glass of water). You may take Rabesat with or without food. Try to take the medicine at the same time each day. Treatment should be continued for as long as your doctor considers it necessary.

Patients with high blood pressure: The usual dose is 150 mg once daily. The dosage may be increased to 300 mg once daily depending on the reduction in blood pressure levels.
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 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.
Maximum antihypertensive effect should be achieved within 4–6 weeks after starting therapy.
Use in children and adolescents
Rabesat must not be given to children under 18 years of age. If a child swallows any tablets, contact your doctor immediately.
If you take more Rabesat than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Rabesat
If you accidentally miss a dose, continue with your next dose as normal. Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Some of these effects can be serious and may require medical intervention.
As with similar medicines, rare cases of skin allergic reactions (redness, urticaria) as well as 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
Rabesat 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
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people

The side effects reported in clinical studies for patients treated with Rabesat are:

Very common (may affect more than 1 in 10 people): if you have 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/nausea, fatigue, and blood tests may show increased 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 upon standing up from lying or sitting position, low blood pressure upon standing up from 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, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.
Rare (may affect up to 1 in 1,000 people): intestinal angioedema (swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea).

Additional side effects have been reported since Rabesat has been marketed. The side effects with unknown frequency are: sensation of dizziness, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, decreased number of red blood cells (anaemia - symptoms may include tiredness, headache, shortness of breath during physical activity, dizziness and pale appearance), reduced platelet count, abnormal liver function, increased potassium levels in the blood, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock), and low blood sugar levels.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

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 the following website: 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 Rabesat

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 the month.
Do not dispose of any medicine 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 Rabesat contains

The active substance is irbesartan.
Each Rabesat 150 mg tablet contains 150 mg of irbesartan.
Each Rabesat 300 mg tablet contains 300 mg of irbesartan.
The excipients are: microcrystalline cellulose, pregelatinized starch, lactose monohydrate, Poloxamer 188, sodium croscarmellose, magnesium stearate, hydroxypropylcellulose, hypromellose 6cp, titanium dioxide, talc. See section 2 "Rabesat contains lactose".

Description of the appearance of Rabesat and contents of the pack
Box containing 28 tablets of 150 mg in blisters
Box containing 28 tablets of 300 mg in blisters

Marketing Authorization Holder:
Genetic S.p.A., Via Della Monica n. 26, 84083 – Castel San Giorgio (SA)

Manufacturer:
Genetic S.p.A. – Contrada Canfora – Fisciano (SA) - Italy