Irbesartan Accord

Package leaflet: Information for the user

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

Generic medicine
Please read all of 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to 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 taking 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 Irbesartan Accord is 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 increased blood pressure. Irbesartan Accord prevents angiotensin II from binding
to these receptors, allowing blood vessels to relax and thereby lowering 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 shown by laboratory tests.

2. What you should know before taking Irbesartan Accord

Do not take Irbesartan Accord:
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. (Irbesartan Accord is best avoided even in early pregnancy – see Pregnancy section).
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
Irbesartan Accord must 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 if any of the following apply to you:
if you are experiencing excessive vomiting or diarrhoea.
if you have kidney problems.
if you have heart problems.
if you are receiving Irbesartan Accord for diabetic kidney disease. In this case, your doctor may carry out periodic blood tests, particularly to monitor potassium levels in the blood if kidney function is reduced.
if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or pallor, numbness, rapid and pounding heartbeat), especially if you are being treated for diabetes.
if you are scheduled for surgery or need to take anaesthetics.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant).
Irbesartan Accord is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the unborn baby if taken during this period (see Pregnancy section).
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.

• Talk to your doctor if, after taking Irbesartan Accord, you experience abdominal pain, nausea, vomiting or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Irbesartan Accord on your own.

Your doctor may wish to monitor your kidney function, blood pressure and blood electrolyte levels (e.g. potassium) at regular intervals.
See also information under 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 yet 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 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 Accord" and "Warnings and precautions").

You may need to have regular blood tests if you are taking:

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

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

Irbesartan Accord with food and drink
Irbesartan Accord may 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 Irbesartan Accord before starting pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine.
Irbesartan Accord is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the unborn baby if taken beyond the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Irbesartan Accord is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or was born prematurely.

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

Irbesartan Accord contains lactose (as lactose monohydrate)
Irbesartan Accord contains lactose (as lactose monohydrate). If your doctor has diagnosed you with an intolerance to certain 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 exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Method of administration
Irbesartan Accord is for oral use. Swallow the tablets with a sufficient amount of fluid (for example: a glass of water). You may take Irbesartan Accord 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 dose may later be increased to 300 mg once daily, depending on the blood pressure response.
• 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 for treating associated kidney disease is 300 mg once daily.

Your doctor may recommend a lower dose, particularly at the beginning of treatment, in certain patients such as those on haemodialysis or those over 75 years of age.
Maximum antihypertensive effect should be achieved within 4–6 weeks after starting therapy.
Use in children and adolescents
Irbesartan Accord must not be given to children under 18 years of age. If a child takes any tablets, contact your doctor immediately.
If you take more Irbesartan Accord than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan Accord
If you accidentally miss a daily dose, simply take the next dose as usual. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Irbesartan Accord can cause side effects, although not everyone experiences them.
Some of these side effects can be serious and may require medical attention.
As with 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 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 in patients treated with Irbesartan Accord were:

Very common (may affect more than 1 in 10 people)

• If you have high blood pressure, type 2 diabetes and kidney disease, blood tests may show elevated potassium levels.

Common (may affect up to 1 in 10 people)

• Dizziness
• Feeling unwell/nausea and fatigue
• 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 from a lying or sitting position, low blood pressure upon standing from a 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
• Hot flushes
• Cough
• Diarrhoea
• Indigestion/heartburn
• Sexual dysfunction (problems with 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.

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

• Reduced number of platelets
• Sensation of dizziness
• Headache
• Taste disturbances
• Ringing in the ears (tinnitus)
• Muscle cramps
• Joint and muscle pain
• 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)
• Decreased number of red blood cells (anaemia – symptoms may include tiredness, headache, shortness of breath during physical activity, dizziness and pale appearance)
• 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, including those not listed in this leaflet, talk to your doctor or pharmacist.

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 Italian Medicines Agency (AIFA) website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects 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 stated on the carton and blister after 'Exp.'. The expiry date refers to the last day of that month.
• No special storage conditions are required.
• Do not remove the tablets from the blister pack until it is time to take the medicine.
• 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 Irbesartan Accord contains
The active substance is irbesartan. Each 75 mg, 150 mg and 300 mg film-coated tablet contains
75 mg, 150 mg and 300 mg of irbesartan, respectively.
The other components in the tablet core are monohydrate lactose, croscarmellose sodium (E468), microcrystalline
cellulose (E460), hypromellose E5 (E464), colloidal anhydrous silica (E551) and magnesium stearate (E572).
The other components in the tablet coating are hypromellose E5 (E464), macrogol 400, monohydrate lactose and
titanium dioxide (E 171).
Description of the appearance of Irbesartan Accord 75, 150, 300 mg and contents of the pack
Irbesartan Accord 75 mg tablets are film-coated, biconvex, oval-shaped tablets, white to off-white in colour, with 'I 75' engraved on one side and smooth on the other side.
Irbesartan Accord 150 mg tablets are film-coated, biconvex, oval-shaped tablets, white to off-white in colour, with 'I 150' engraved on one side and smooth on the other side.
Irbesartan Accord 300 mg tablets are film-coated, biconvex, oval-shaped tablets, white to off-white in colour, with 'I 300' engraved on one side and smooth on the other side.
Irbesartan Accord 75 mg, 150 mg and 300 mg tablets are supplied in blister packs containing 8, 14, 28, 30, 56,
64, 90 and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorization 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,
The Netherlands
This medicinal product is authorized in the European Economic Area countries and in the United Kingdom (Northern Ireland)
under the following names: