Irbesartan BMS
irbesartan
irbesartan
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 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:
What Irbesartan BMS is and what it is used for
Before you take Irbesartan BMS
How to take Irbesartan BMS
Possible side effects
How to store Irbesartan BMS
Further information
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Irbesartan BMS 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 BMS prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan BMS slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan BMS 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.
if you are allergic (hypersensitive) to irbesartan or any other ingredients of Irbesartan BMS
if you are more than 3 months pregnant. (It is also better to avoid Irbesartan BMS in early pregnancy – see pregnancy section)
Irbesartan BMS should not be given to children and adolescents (under 18 years).
if you get excessive vomiting or diarrhoea
if you suffer from kidney problems
if you suffer from heart problems
if you receive Irbesartan BMS 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
You must tell your doctor if you think you are (or might become) pregnant. Irbesartan BMS 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).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Irbesartan BMS does not usually interact with other medicines.
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 may be reduced.
Irbesartan BMS can be taken with or without food.
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan BMS before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan BMS. Irbesartan BMS 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.
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Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan BMS 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 BMS 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.
Always take Irbesartan BMS exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Irbesartan BMS is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan BMS 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 BMS until your doctor tells
you otherwise.
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.
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 accidentally take too many tablets, contact your doctor immediately.
Irbesartan BMS should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.
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.
Medicinal product no longer authorised
Like all medicines, Irbesartan BMS 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 BMS and contact your doctor immediately.
The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more
Common: at least 1 in 100 and less than 1 in 10 patients
Uncommon: at least 1 in 1000 and less than 1 in 100 patients
Side effects reported in clinical studies for patients treated with Irbesartan BMS 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.
Uncommon: 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 BMS 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.
Keep out of the reach and sight of children.
Do not use Irbesartan BMS 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.
Do not store above 30°C.
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.
The active substance is irbesartan. Each tablet of Irbesartan BMS 75 mg contains 75 mg irbesartan.
The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose
Medicinal product no longer authorised
monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188.
Irbesartan BMS 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Irbesartan BMS 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.
Not all pack sizes may be marketed.
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