Irbesartan 75mg Film-Coated Tablets
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Apt LI
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Irbesartan 75mg, 150mg & 300mg film-coated tablets
irbesartan
Read all of this leaflet carefully before you start taking this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• The full name of the medicinal product is Irbesartan 75mg, 150mg & 300mg film-coated tablets, but it will be referred as Irbesartan in the rest of the leaflet.
What is in this leaflet:
1. What Irbesartan is and what it is used for
2. What you need to know before you take Irbesartan
3. How to take Irbesartan
4. Possible side effects
5. How to store Irbesartan
6. Contents of the pack and other information
I.What Irbesartan is and what it is used for
Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan is used:
• in the treatment of high blood pressure (hypertension)
• to protect the kidney in patients with high blood pressure, type 2 diabetes and known impaired kidney function.
2.What you need to know before you take Irbesartan
Do not take Irbesartan
• if you are allergic to Irbesartan or any other ingredients of this medicine (listed in section 6)
• if you are more than 3 months pregnant. (It is also better to avoid Irbesartan in early pregnancy - see pregnancy section.)
• if you have diabetes mellitus or impaired kidney function and you are treated with aliskiren (another medicine to treat high blood pressure).
Warnings and precautions
Talk to your doctor before taking Irbesartan and if any of
the following to you:
• if you suffer from excessive vomiting or diarrhoea
• if you suffer from kidney problems
• if you suffer from heart problems
• if you receive Irbesartan for diabetic renal disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function
• if you are going to have an operation (surgery) or be given anaesthetics
• if you are taking aliskiren
You must tell your doctor if you think you are (or might become) pregnant. Irbesartan is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.
Other medicines and Irbesartan
Tell your doctor or pharmacist if you are taking,have recently taken or might take any other medicines.
Your doctor may need to change your dose and/or to take other precautions if you are taking aliskiren.
You may need to have blood checks if you take:
• potassium supplements
• salt substitutes containing potassium
• potassium-sparing medicines (such as certain diuretics)
• medicines containing lithium
The effect of Irbesartan may be reduced when you take non-steroidal anti-inflammatory drugs (certain pain killers).
Irbesartan with food and drink
Irbesartan can be taken with or without food.
Pregnancy and breast-feeding Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan. Irbesartan is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. Irbesartan is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, you should consult your doctor before attempting such activities.
3. How to take Irbesartan
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Method of administration
Irbesartan is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan until your doctor tells you otherwise.
• Patients with high blood pressure
The usual dose is 150 mg once a day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on 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, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.
Use in children and adolescents
Irbesartan 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 than you should
If you accidentally take too many tablets, contact your
doctor immediately.
If you forget to take Irbesartan
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on 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 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, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking Irbesartan. If you get any of these symptoms or get short of breath, stop taking Irbesartan and contact your doctor immediately.
Side effects reported in clinical studies for patients treated with Irbesartan 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 an increased level of potassium.
• Common (may affect up to 1 in 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme called creatine kinase that can indicate muscle damage. 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, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.
• Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Some undesirable effects have been reported since marketing of Irbesartan but the frequency for them to occur is not known. These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine
5. How to store Irbesartan
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 on the blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
If you would like more information on your disease or treatment, you should ask your doctor or pharmacist.
What Irbesartan contains
• The active substance is Irbesartan. Each tablet contains 75 mg, 150 mg or 300 mg of Irbesartan.
• The other ingredients are: croscarmellose sodium, microcrystalline cellulose, hypromellose, mannitol, magnesium stearate, silica, colloidal anhydrous, hydroxypropyl cellulose, polyethylene glycol, titanium dioxide
What Irbesartan looks like and contents of the pack
The 75 mg tablets are white, elliptical, biconvex, film-coated, with diameter of 5.2 x 10 mm, marked 'I' on one side and '75' on the other side.
The 150 mg tablets are white, elliptical, biconvex, film-coated, with diameter of 6.5 x 12.7 mm, marked 'I' on one side and '150' on the other side.
The 300 mg tablets are white, elliptical, biconvex, film-coated, with diameter of 8.2 x 16.0 mm, marked 'I' on one side and '300' on the other side.
Pack sizes:
Blisters: 14, 28, 30, 56, 84, 90, 98 film-coated tablets Tablet containers: 14, 28, 30, 56, 84, 90, 98 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aptil Pharma Limited 9th Floor, CP House 97-107 Uxbridge Road, Ealing London W5 5TL
Manufacturer:
Actavis hf.
Reykjavikurvegi 78 PO Box 420 IS-220 Hafnarfordur Iceland
This leaflet was last updated in 02/2014 LIRBXY-01