IRBESARTAN 75 mg Film-Coated Tablets

Зміст інструкції

1. IRBESARTAN ACCORD 75 mg, 150 e 300 mg FILM-COATED TABLETS
   1. What is Irbesartan Accord and what it is used for
   2. What you need to know before taking Irbesartan Accord
   3. How to take Irbesartan Accord
   4. Possible side effects
   5. How to store Irbesartan Accord
   6. Package contents and other information

IRBESARTAN ACCORD 75 mg, 150 e 300 mg FILM-COATED TABLETS

Generic medicine
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, even if their symptoms are the same as yours, as it could be harmful.
• 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 Irbesartan Accord is and what it is used for
• 2. What you need to know before you take Irbesartan Accord
• 3. How to take Irbesartan Accord
• 4. Possible side effects
• 5. How to store Irbesartan Accord
• 6. Contents of the pack and other information

1. What is Irbesartan Accord and what it is used for

Irbesartan Accord belongs to a group of medicines known as angiotensin II receptor antagonists.
Angiotensin II is a substance produced in the body that binds to receptors in blood vessels, causing them to
constrict. This results in an increase in blood pressure. Irbesartan Accord prevents the binding
of angiotensin II to these receptors, causing blood vessels to relax and reducing blood pressure. Irbesartan
Accord slows the decline in kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Accord is used in adult patients

• for the treatment of high blood pressure (essential hypertension)
• to protect the kidneys in patients with high blood pressure, type 2 diabetes and impaired kidney function as evidenced by laboratory tests.

2. What you need to know before taking Irbesartan Accord

Do not take Irbesartan Accord:
if you are allergic to 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 Irbesartan Accord even in the early stages of
pregnancy – see section on pregnancy).
if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine
that lowers your blood pressure, containing aliskiren.
Irbesartan Accord should not be given to children and adolescents under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Irbesartan Accord and if any of the following conditions
apply to you:
if you suffer from excessive vomiting or diarrhoea.
if you have kidney problems.
if you have heart problems.
if you receive Irbesartan Accord for diabetic kidney disease. In this case, your doctor may perform periodic blood tests, particularly to measure potassium levels in the blood if your kidney function is
reduced.
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 going to have surgery (surgical) or need to receive anaesthetics.
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant).
Irbesartan Accord 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 the section
Pregnancy).
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 have kidney problems related to diabetes.
• aliskiren.
• If you experience abdominal pain, nausea, vomiting or diarrhoea after taking Irbesartan Accord, contact your doctor. The doctor will decide on the continuation of treatment. Do not stop taking Irbesartan Accord.

Your doctor may want to 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 in the section "Do not take Irbesartan Accord".

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 Irbesartan Accord:
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 the sections "Do not take Irbesartan Accord" and "Warnings and precautions”).

You will probably need to undergo blood tests if you take:

• 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 effect of irbesartan may be reduced.

Irbesartan Accord with food and drink
Irbesartan Accord can be taken with or without food.

Pregnancy and breastfeeding:
Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Usually your doctor will advise you to stop taking Irbesartan Accord before becoming
pregnant or as soon as you find out you are pregnant and will advise you to take another
medicine instead of Irbesartan Accord.
Irbesartan Accord is not recommended in early pregnancy, and should not be taken if you are pregnant for
more than three 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. Irbesartan Accord is not recommended for mothers
who are breastfeeding and your doctor may choose another treatment if you wish to breastfeed, especially if your
baby is newly born or premature.

Driving and using machines:
It is unlikely that Irbesartan Accord will affect your ability to drive or operate machinery. However,
during treatment for high blood pressure, you may occasionally experience dizziness or fatigue. If you
experience these effects, consult your doctor before engaging in activities such as driving or using machinery.

Irbesartan Accord contains lactose (as lactose monohydrate)
Irbesartan Accord contains lactose (as lactose monohydrate). If you have been diagnosed with an intolerance to
some sugars, contact your doctor before taking this medicine.

Irbesartan Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Irbesartan Accord

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

Method of administration
Irbesartan Accord is for oral use. Swallow the tablets with a sufficient amount of fluids (e.g.: a
glass of water). You can take Irbesartan Accord 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 dose may be subsequently increased to 300 mg once a day, depending on the response of the blood pressure.
• Patients with high blood pressure and type 2 diabetes with kidney diseaseIn patients with high blood pressure and type 2 diabetes, the preferred maintenance dose for the treatment of associated kidney disease is 300 mg once a day.

The doctor may recommend a lower dose, particularly at the beginning of treatment in some patients, such as those
undergoing hemodialysis or those 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
Irbesartan Accord 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 Irbesartan Accord than you should
If you accidentally take too many tablets, seek immediate medical attention.

If you forget to take Irbesartan Accord
If you accidentally forget a daily dose, simply take the next dose as usual. Do not
take a double dose to compensate for a 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, Irbesartan Accord 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
(rash, 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 have difficulty breathing, stop taking this medicine 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
Adverse events observed in clinical studies on patients treated with Irbesartan Accord 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 and fatigue
• 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, and joint or muscle pain and decreased 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
• Hot flushes
• Cough
• Diarrhea
• Indigestion/heartburn
• Sexual dysfunction (problems with sexual performance)
• Chest pain

Rare (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.
Some side effects have been reported after the marketing of Irbesartan Accord. Side effects with
unknown frequency are:

• Reduced number of platelets
• Feeling of spinning
• Headache
• Altered taste
• Tinnitus (ringing in the ears)
• Muscle cramps
• Joint and muscle pain
• Abnormal liver function
• Increased levels of potassium in the blood
• Impaired kidney function
• Inflammation of small blood vessels, predominantly affecting the skin (a condition known as leucocytoclastic vasculitis)
• Decreased number of red blood cells (anemia - symptoms may include fatigue, headache, shortness of breath during physical activity, dizziness and paleness)
• 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.
If you experience any side effect, even those not listed in this leaflet, tell your doctor or
pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or
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 Irbesartan Accord

• 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 box and blister after ‘Exp.’. The expiry date refers to the last day of that month.
• No particular storage conditions are recommended.
• Do not remove the tablets from the blister until you are ready to take the medicine.
• 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. Package contents and other information

What Irbesartan Accord contains
The active ingredient is irbesartan. Each film-coated irbesartan tablet of 75 mg, 150 mg, 300 mg contains
75 mg, 150 mg and 300 mg of irbesartan.
The other ingredients in the tablet core are lactose monohydrate, sodium croscarmellose (E468), microcrystalline cellulose (E460), hypromellose E5 (E464), anhydrous colloidal silica (E551) and magnesium stearate (E572).
The other ingredients in the tablet coating are hypromellose E5 (E464), macrogol 400, lactose monohydrate and
titanium dioxide (E 171).

Description of the appearance of Irbesartan Accord 75, 150, 300 mg and package contents
Irbesartan Accord 75 mg tablets are film-coated, biconvex tablets, of a colour ranging from white to
off-white, oval in shape, with ‘I 75’ imprinted on one side and smooth on the other side .
Irbesartan Accord 150 mg tablets are film-coated, biconvex tablets, of a colour ranging from white to
off-white, oval in shape, with ‘I 150’ imprinted on one side and smooth on the other side.
Irbesartan Accord 300 mg tablets are film-coated, biconvex tablets, of a colour ranging from white to
off-white, oval in shape, with ‘I 300’ imprinted on one side and smooth on the other side .
Irbesartan Accord 75 mg, 150mg and 300 mg tablets are supplied in packs with blisters of 8, 14, 28, 30, 56,
64, 90 and 98 tablets .
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est, 6 Planta
08039 Barcelona
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern
Ireland) under the following designations: