Irbesartan 300 Mg Film-Coated Tablets
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Irbesartan 75 mg film-coated tablets Irbesartan 150mg film-coated tablets Irbesartan 300mg film-coated tablets
Irbesartan
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4
What is in this leaflet:
1. What Irbesartan is and what it is used for
2. What do 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 further information
1. 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:
• 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 kidney function.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IRBESARTAN Do not take Irbesartan:
• If you are allergic (hypersensitive) 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 or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
Irbesartan should not be given to children and adolescents (under 18 years).
Talk to your doctor or pharmacist before taking Irbesartan
• if you get excessive vomiting or diarrhoea
• if you suffer from kidney problems
• if you suffer from heart problems
• if you receive Irbesartan for diabetic kidney 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 think that 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).
• if you are taking any of the following medicines used to treat high blood pressure:
- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
- aliskiren
See also information under the heading “Do not take Irbesartan”.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
Children and adolescents
Irbesartan is not recommended for use in children and adolescents under 18 years of age.
Other medicines and Irbesartan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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
Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan” and “warnings and precautions”)
If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.
Irbesartan with food and drink
Irbesartan can be taken with or without food.
Pregnancy, breast-feeding and fertility
You must tell your doctor if you think that 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.
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.
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, talk to your doctor before attempting to drive or use machines.
Irbesartan contains lactose
This medicine contains lactose (a milk sugar). 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
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
• Patients with high blood pressure
The usual dose is 150 mg once a day. The dose may later be increased to 300 mg 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 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. 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 your medicine 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 your medicine until your doctor tells you otherwise.
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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Irbesartan 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.
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
Rare: may affect up to1in
1,000 people
Very rare: may affect up to 1 in 10,000
people
Not known: frequency cannot be estimated from the available data
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 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.
• 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).
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at 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 Irbesartan 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 medicine 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 What Irbesartan contains
• Irbesartan 75 mg: Each tablet contains 75 mg irbesartan which is the active substance.
• Irbesartan 150mg: Each tablet contains 150mg irbesartan which is the active substance.
• Irbesartan 300mg: Each tablet contains 300mg irbesartan which is the active substance.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, poloxamer 188, pregelatinised maize starch and magnesium stearate.
The tablet coating contains Opadry white 20A28735 (which consists of: hydroxypropyl cellulose, hypromellose, titanium dioxide and talc).
What Irbesartan looks like and contents of the pack
• Irbesartan 75 mg: white to off-white, oblong, biconvex, film-coated tablets, embossed with 'BL' on one side and '75' on the other.
• Irbesartan 150 mg: white to off-white, oblong, biconvex, film-coated tablets embossed with 'B' and 'L' on either side of the score line and '150' on the other. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses
• Irbesartan 300 mg: white to off-white, oblong, biconvex, film-coated tablets embossed with 'B' and 'L' on either side of the score line and '300' on the other. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses
Irbesartan is supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
BRISTOL LABORATORIES LTD
Unit 3, Canalside, Northbridge Road,
Berkhmastead, Hertfordshire,
HP4 1EG United Kingdom Telephone :0044(0)1442200922 Fax : 0044(0)1442873717 Email : info@bristol-labs.co.uk
Manufacturer:
GENEPHARM S.A.
18 Km Marathon Avenue 15351 Pallini,
GREECE
This leaflet was last approved in: {06/2015}
To request the copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.