RABESAT 150 mg Film-Coated Tablets

Зміст інструкції

1. Rabesat 150 mg film-coated tablets, 300 mg film-coated tablets
   1. What is Rabesat and what is it used for
   2. What you need to know before taking Rabesat
   3. How to take Rabesat
   4. Possible side effects
   5. How to store Rabesat
   6. Contents of the pack and other information

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

Irbesartan
Generic medicine

Read this leaflet carefully before you start 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 pass it on to others. It may be harmful for people other than you, 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 Rabesat is and what it is used for
• 2. What you need to know before you take Rabesat
• 3. How to take Rabesat
• 4. Possible side effects
• 5. How to store Rabesat
• 6. Contents of the pack and other information

1. What is Rabesat and what is it 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 blood
vessels causing them to constrict. This results in an increase in blood pressure.
Rabesat prevents angiotensin-II from binding to these receptors, allowing blood
vessels to dilate and blood pressure to decrease. Rabesat slows the decline of kidney function in
patients with high blood pressure and type 2 diabetes.
Rabesat 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 with evidence of renal dysfunction in laboratory tests.

2. What you need to know before taking Rabesat

Do not take Rabesat:

• 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 Rabesat 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 before taking Rabesat 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 take Rabesat for diabetic kidney disorders. In this case, your doctor may prescribe 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 or pounding heartbeat), especially if you are being treated for diabetes
• if you are to undergo surgery(surgical) or receive anaesthetics
• if you are taking one of the following medicines used to treat high blood pressure: or an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes or aliskiren

Talk to your doctor if, after taking Rabesat, you experience abdominal pain, nausea, vomiting or diarrhoea.
The doctor will decide on the continuation of treatment. Do not stop taking Rabesat
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 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 in early pregnancy and should 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 yet been fully established.

Other medicines and Rabesat
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The 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
Rabesat” and "Warnings and precautions”).

You may need blood tests if you are using:

• potassium supplements
• salt substitutes containing potassium
• potassium-sparing medicines (such as 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.

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

Pregnancy and breastfeeding
Pregnancy
Tell 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 you find out you are pregnant and will advise
you to take another medicine instead of Rabesat. Rabesat is not recommended in early
pregnancy and should 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. Rabesat 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 Rabesat will affect your ability to drive or operate machinery. However,
occasionally, dizziness or fatigue may occur during treatment for high blood pressure.
If this happens, talk to your doctor before driving or using machinery.

Rabesat contains lactose. If you have been diagnosed with intolerance to some sugars, contact
your doctor 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 following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.

Method of administration
Rabesat is for oral use. Swallow the tablets with a sufficient amount of fluids (e.g., a glass
of water). You can take Rabesat 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 necessary.

• Patients with high blood pressureThe usual dose is 150 mg once a day. The dosage may be increased to 300 mg once a day depending on the reduction in 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 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 reached 4-6 weeks after the start of therapy.

Use in children and adolescents
Rabesat 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 Rabesat than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Rabesat
If you accidentally forget to take a dose, continue normally with the therapy. Do not take
a double dose to compensate for the missed dose.
If you have any doubts about the use of 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 may be serious and may require medical attention.
As with similar medicines, rare cases of allergic skin reactions (redness, hives) 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 if you 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 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/nausea, 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 upon standing up from a lying or sitting position, low blood pressure upon standing 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.
• Rare (may affect up to 1 in 1,000 people): intestinal angioedema (swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea).

Since the marketing of Rabesat, some side effects have been reported. Side effects with unknown frequency are: feeling of dizziness, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, decreased
number of red blood cells (anemia - symptoms may include fatigue, headache, shortness of breath during physical activity, dizziness, and paleness), reduced number of platelets, 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 leucocytoclastic vasculitis), severe allergic reactions (anaphylactic shock), and low blood sugar levels.
Cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported uncommonly.

Reporting of side effects
Please inform 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 Rabesat

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 carton and blister after Exp.
The expiry date refers to the last day of the 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 Rabesat contains

• The active ingredient 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
Pack of 28 tablets of 150 mg contained in blisters
Pack of 28 tablets of 300 mg contained in blisters

Marketing Authorisation 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