Irbesartan Mylan: detailed information

Patient Information Leaflet: Information for the User

Irbesartan Mylan 75 mg tablets, 150 mg tablets, 300 mg tablets

Irbesartan
Generic medicine
Please read this leaflet carefully before using 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, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Irbesartan Mylan is and what it is used for
What you need to know before taking Irbesartan Mylan
How to take Irbesartan Mylan
Possible side effects
How to store Irbesartan Mylan
Contents of the pack and other information

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

Irbesartan Mylan 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.
Irbesartan prevents angiotensin-II from binding to these receptors, allowing blood vessels to dilate and blood pressure to decrease. Irbesartan also slows the decline in kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Mylan is used in adults:
to treat high blood pressure (essential arterial hypertension)
to protect the kidneys 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 IRBESARTAN MYLAN

Do not take Irbesartan Mylan:
if you are allergic to Irbesartan Mylan or to any of the other ingredients of this
medicinal product (listed in section 6).
if you are more than 3 months pregnant (It is also advisable to avoid Irbesartan Mylan
in early pregnancy – see also the section “Pregnancy and breastfeeding”)
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 or pharmacist before taking Irbesartan Mylan if you are in any of the
following situations:
if you have had, or are experiencing during treatment, excessive vomiting or diarrhoea
if you are taking diuretics or are on a low-sodium diet
if you have kidney problems, including narrowing of the renal arteries, or have had a
kidney transplant
if you have heart problems, including narrowing of heart valves,
thickening of the heart muscle or weakness of the heart muscle (heart failure)
if you have narrowing of the heart blood vessels, which may cause chest pain, e.g. angina

if you are taking irbesartan for diabetic kidney disorders. In this case, your doctor may prescribe regular blood tests, especially to monitor serum potassium levels in case of impaired kidney function
if you have primary hyperaldosteronism (a condition associated with excessive production of the hormone aldosterone, causing sodium retention and consequently increased blood pressure)
if you are of Afro-Caribbean origin, as irbesartan may be less effective in lowering your blood pressure when taking one of the following medicines used to treat high blood pressure: or an ACE-inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes or aliskiren

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the information provided in the section “Do not take Irbesartan Mylan”.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Irbesartan Mylan is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause severe harm to the unborn baby if taken during this period (see section “Pregnancy”).

During treatment
You must inform your doctor

if you are due to undergo surgery or receive anaesthetics

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 Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those not requiring a prescription.
Your doctor may consider it necessary to adjust your dose and/or take other precautions:

if you are taking an ACE-inhibitor or a medicine containing aliskiren (see also “Do not take Irbesartan Mylan” and “Warnings and precautions”).

You may need blood tests if you are taking:
potassium supplements
potassium-containing salt substitutes
potassium-sparing (diuretic) medicines or other medicines that may increase potassium levels in the blood, e.g. heparin
medicines containing lithium (used to treat mental health conditions)
If you take certain painkillers, known as non-steroidal anti-inflammatory drugs (NSAIDs), or COX-2 inhibitors, e.g. celecoxib and acetylsalicylic acid, the effectiveness of irbesartan may be reduced.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop taking irbesartan before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of irbesartan. Irbesartan 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 after the third month of pregnancy.

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

Driving and using machines
No studies on the ability to drive or use machines have been conducted.
It is unlikely that irbesartan 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.

IRBESARTAN MYLAN contains lactose. If your doctor has informed you that you have an intolerance to certain sugars (e.g. lactose), contact him/her before taking this medicine.

3. How to take IRBESARTAN MYLAN

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Method of administration
Irbesartan Mylan is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g., a glass of water). You may take Irbesartan Mylan with or without food. Try to take the medicine at the same time each day. Treatment should be continued as long as your doctor considers it necessary.
Patients with high blood pressure
The recommended 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, if you are undergoing haemodialysis or are over 75 years of age.
Maximum antihypertensive effect should be achieved within 4–6 weeks after starting therapy.
Use in children and adolescents
Irbesartan Mylan must not be given to children under 18 years of age. If a child ingests any tablets, contact a doctor immediately.
If you take more Irbesartan Mylan than you should
If you accidentally take too many tablets, contact your doctor immediately.
You may experience dizziness and/or a faster or slower heartbeat.
If you forget to take Irbesartan Mylan
If you accidentally miss a dose, continue your treatment 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, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these side effects may be serious and may require medical attention. If you
experience any of the following side effects, stop taking the medicine and contact your
doctor immediately or go to the nearest emergency room:
Not known (frequency cannot be estimated from the available data)

red, itchy rash with swelling of the face, lips and/or tongue, and difficulty breathing
yellowing of the skin and whites of the eyes, severe pain in the upper stomach, and feeling unwell, which may be due to liver problems
skin rash with raised purple spots and flat red areas caused by inflammation of small blood vessels (vasculitis)
need to urinate more frequently, in larger amounts, and with pale-coloured urine, or difficulty or inability to urinate, or less frequent urination with darker-coloured urine, possibly even bloody urine. This may be due to kidney problems.

Other possible side effects
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 (vomiting)
feeling tired (fatigue)
blood tests may show increased levels of an enzyme that indicates how well muscles and heart are functioning (creatine kinase)
in patients with high blood pressure and type 2 diabetes with kidney disease, the following have also been reported:
dizziness when standing up from lying or sitting position
low blood pressure when standing up from lying or sitting position
joint or muscle pain
blood tests may indicate reduced levels of a protein in red blood cells (haemoglobin).

Uncommon (may affect up to 1 in 100 people)

awareness of heartbeat (increased heart rate)
flushing
cough
diarrhoea
indigestion/heartburn
sexual dysfunction (problems related to sexual performance)
chest pain.

Not known (frequency cannot be estimated from the available data)

more frequent bleeding or bruising, possibly due to a reduced number of platelets (blood cells involved in clotting)
sensation of spinning (dizziness)
headache
taste disturbances
ringing in the ears
muscle cramps
joint and muscle pain
blood tests may indicate impaired liver function
blood tests may indicate increased levels of potassium in the blood.

Reporting of side effects
If you get any side effects, 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:
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store IRBESARTAN MYLAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container, label, or blister after EXP. The expiry date refers to the last day of that month. The in-use shelf life of the product stored in plastic bottles is 90 days after opening.
This medicine does not require any special storage conditions.
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 Mylan contains
The active substance is Irbesartan.

Each 75 mg tablet contains 75 mg of irbesartan.
Each 150 mg tablet contains 150 mg of irbesartan.
Each 300 mg tablet contains 300 mg of irbesartan.

The other components are monohydrate lactose (see section 2 “IRBESARTAN MYLAN contains lactose” of this leaflet), povidone, microcrystalline cellulose, sodium croscarmellose, magnesium stearate and anhydrous colloidal silica.

Description of the appearance of Irbesartan Mylan and pack contents
75 mg tablets: white to off-white, round, with bevelled edges, biconvex, engraved with “M” on one side and “IN1” on the other.
150 mg tablets: white to off-white, round, biconvex, with bevelled edges, engraved with “M” on one side and “IN2” on the other.
300 mg tablets: white to off-white, oval, biconvex, with bevelled edges, engraved with “M” on one side and “IN3” on the other.

Irbesartan Mylan is available in blister packs containing 10, 14, 28, 30, 56, 57, 58, 60, 84, 90, 98 and 100 tablets; calendar blister packs containing 14, 28, 56, 84 and 98 tablets; and plastic bottles with polypropylene (PP) caps containing 500 and 1000 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A
Via Vittor Pisani 20
20124 Milan, Italy

Manufacturers responsible for batch release
McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft,
H-2900 Komarom,
Mylan utca 1,
Hungary
Generics [UK] Limited,
Station Close, Potters Bar,
Hertfordshire, EN6 1TL,
United Kingdom

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Irbesartan Jenson Pharmaceutical Services 75 mg, 150 mg & 300 mg tabletten
Belgium: Irbesartan Mylan 75 mg, 150 mg & 300 mg tabletten
Czech Republic: Irbesartan Mylan 150 mg & 300 mg tablety
Denmark: Irbesartan Mylan 75 mg, 150 mg & 300 mg tabletter
France: Irbesartan Mylan 75 mg, 150 mg & 300 mg comprimés
Germany: Irbesartan Mylan 75 mg, 150 mg & 300 mg tabletten
Greece: Irbesartan Generics 75 mg, 150 mg & 300 mg δισκία
Hungary: Irbesartan Mylan 75 mg, 150 mg & 300 mg tabletta
Iceland: Irbesartan Mylan 75 mg, 150 mg & 300 mg töflur
Ireland: Irbesartan Mylan 75 mg, 150 mg & 300 mg tablets
Italy: Irbesartan Mylan 75 mg, 150 mg & 300 mg compressa
Luxembourg: Irbesartan Jenson Pharmaceutical Services 75 mg, 150 mg & 300 mg comprimés
Norway: Irbesartan Jenson Pharmaceutical Services 75 mg, 150 mg & 300 mg tabletter
Portugal: Irbesartan Anova 75 mg, 150 mg & 300 mg comprimidos
Romania: Irbesartan Mylan 75 mg, 150 mg & 300 mg comprimate
Slovakia: Irbesartan Mylan 150 mg & 300 mg tablety
Slovenia: Irbesartan Mylan 150 mg & 300 mg tableta
Spain: Irbesartan Mylan 75 mg, 150 mg & 300 mg comprimidos
Sweden: Irbesartan Jenson Pharmaceutical Services 75 mg, 150 mg & 300 mg tabletter
Netherlands: Irbesartan Mylan 75 mg, 150 mg & 300 mg tabletten
United Kingdom: Irbesartan 75 mg, 150 mg & 300 mg tablets