Irbesartan 75mg Film-Coated Tablet
Out of date information, search anotherRead all of this leaflet carefully
before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you haveanyfurtherquestions, 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Irbesartan Tablets are and what they are used for
2. Before you take Irbesartan Tablets
3. How to take Irbesartan Tablets
4. Possible side effects
5. How to store Irbesartan Tablets
6. Further information
1. WHAT IRBESARTAN TABLETS ARE AND WHAT THEY ARE USED FOR
Irbesartan Tablets belong to a group of medicines known as angiotensin-ll receptor antagonists. Angiotensin-ll 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 Tablets prevent the binding of angiotensin-ll to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan Tablets slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Tablets are used
• to treat high blood pressure (essential hypertension)
• to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidneyfunction.
2. BEFORE YOU TAKE , IRBESARTAN TABLETS
Do not take Irbesartan Tablets
• if you are allergic (hypersensitive) to Irbesartan Tablets or any other ingredients of Irbesartan Tablets
• if you are more than 3 months pregnant. (It is also better to avoid Irbesartan Tablets in early pregnancy see pregnancy section.)
Irbesartan Tablets should not be given to children and adolescents (under 18 years).
Take special care with Irbesartan Tablets
Tell your doctor if any of the following apply to you:
• if you get excessive vomiting or diarrhoea
• if you sufferfrom kidney problems
• If you sufferfrom heart problems
• if you receive Irbesartan Tablets for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidneyfunction
• if you are going to have an operation (surgery) or be given anaesthetics
You must tell your doctor if you think that you are (or might become) pregnant. Irbesartan Tablets are 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).
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Irbesartan Tablets do not usually interact with other medicines.
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
If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of Irbesartan Tablets may be reduced.
Taking Irbesartan Tablets with food and drink
Irbesartan Tablets 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 Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of IrbesartanTablets. Irbesartan Tablets are 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 afterthe third month of pregnancy.
Breastfeeding
u Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan Tablets are 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 Tablets are 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, talk to your doctor before attempting to drive or use machines.
Important information about some of the ingredients of Irbesartan Tablets Irbesartan Tablets contain lactose. If
you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.
3. HOW TO TAKE IRBESARTAN TABLETS
Always take Irbesartan Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Other strengths are available.
Method of administration Irbesartan Tablets are for oral use.
Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan Tablets 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 Tablets 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 kidnev 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.
If you take more Irbesartan Tablets than you should
If you accidentally take too many tablets, contact your doctor immediately.
Children should not take Irebsartan Tablets
Irbesartan Tablets should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.
If you forget to take Irbesartan Tablets
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 product, ask your doctor or pharmacist.
• Uncommon: heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Some side effects have been reported since marketing of Irbesartan Tablets but the frequency for them to occur is not known. These side 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 leukocytoclasticvasculitis).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE IRBESARTAN TABLETS
4. POSSIBLE SIDE EFFECTS
Keep out of the reach and sight of children.
Do not use Irbesartan Tablets 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Like all medicines, Irbesartan Tablets 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 Tablets swelling of the face, lips and/or tongue have been reported in patients taking IrbesartanTablets. If you get any of these symptoms or get short of breath, stop taking Irbesartan Tablets and contact your doctor immediately.
The frequency of the side effects listed below is defined using the following convention:
Very common: affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
Frequency cannot be estimated from the available data
Side effects reported in clinical studies for patients treated with Irbesartan Tablets were:
• Very common: if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
• Common: dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). 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.
6. FURTHER INFORMATION
Common:
Uncommon:
Rare:
Very rare: Not known:
What Irbesartan Tablets contains
The active substance is irbesartan.
Each tablet contains 75 mg irbesartan.
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, colloidal anhydrous silica, magnesium stearate, titanium dioxide(E171)and macrogol 3350.
What Irbesartan Tablets looks like and contents of the pack
Irbesartan 75 mg film-coated tablets are white, oblong and convex.
Irbesartan 75 mg film-coated tablets are supplied in blister packs of 14,28,30,56 and 90 film-coated tablets.
Not all packsizesmay be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd 115 Narborough Road Leicester, LE3 0PA,
United Kingdom
Manufacturer
West Pharma Produgoes de Especialidades Farmaceuticas, S.A. Rua Joao de Deus, n.° 11, Venda Nova, 2700-486 Amadora, Portugal
Atlantic Pharma Produgoes Farmaceuticas, S.A.
Rua da Tapada Grande, n.° 2; Abrunheira, 2710-089 Sintra, Portugal
This leaflet was last approved in 04/2011