Each tablet of: IRBEGEN 150 mg: The active substance is irbesartan. Each tablet contains 150 mg irbesartan.
IRBEGEN 300 mg: The active substance is irbesartan. Each tablet contains 300 mg irbesartan.
Excipients/Inactive Ingredients: All strengths contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, poloxamer 188, pregelatinised starch and magnesium stearate. The tablet coating contains Opadry white 20A28735 (which consists of: hydroxypropyl cellulose, hypromellose, titanium dioxide and talc).
Irbegen 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. Irbegen prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Irbegen slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Irbegen is used in adult patients: 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.
Always take this medicine exactly as the doctor has instructed. Check with the doctor or pharmacist if not sure.
Method of administration: Irbegen is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
Irbegen can be taken with or without food. Try to take daily dose at about the same time each day. It is important that the patient continues to take Irbegen until the doctor tells otherwise.
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.
Use in children and adolescents: Irbegen should not be given to children under 18 years of age. If a child swallows some tablets, contact the doctor immediately.
If the patient forgets to take Irbegen: If a daily dose is accidentally missed, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.
For any further questions on the use of this medicine, ask the doctor or pharmacist.
If the patient takes more Irbegen than necessary: If too many tablets were accidentally taken, contact the doctor immediately.
Do not take Irbegen: If the patient is allergic to irbesartan or any other ingredients of this medicine (listed in Description).
If the patient is more than 3 months pregnant. (It is also better to avoid Irbegen in early pregnancy - see Use in Pregnancy & Lactation).
If the patient has diabetes or impaired kidney function and is being treated with a blood pressure lowering medicine containing aliskiren.
The concomitant use of Irbegen with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR<60ml/min/1.73m2).
Dual blockade of the renin-angiotensin-aldosterone system (RAAS): There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended.
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Talk to the doctor before taking Irbegen and if any of the following applies: If the patient gets excessive vomiting or diarrhoea.
If the patient suffers from kidney problems.
If the patient suffers from heart problems.
If the patient receives Irbegen for diabetic kidney disease. In this case the doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function.
If the patient is going to have an operation (surgery) or be given anaesthetics.
If the patient is taking any of the following medicines used to treat high blood pressure: an ACE-inhibitor (for example enalapril, lisinopril, ramipril) in particular if having diabetes-related kidney problems; Aliskiren.
The doctor may check the kidney function, blood pressure, and the amount of electrolytes (e.g.potassium) in the blood at regular intervals.
See also information under Contraindications. The patient must tell the doctor if she thinks she is (or might become) pregnant. Irbegen is not recommended in early pregnancy, and must not be taken if the patient is more than 3 months pregnant, as it may cause serious harm to the baby if used at that stage (see Use in Pregnancy & Lactation).
Irbegen contains lactose: If the patient has an intolerance to some sugars (e.g. lactose), contact the doctor before taking this medicine.
Driving and using machines: No studies on the effects on the ability to drive and use machines have been performed. Irbegen is unlikely to affect the ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If any of these is experienced, talk to the doctor before attempting to drive or use machines.
Use in 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.
Pregnancy: Tell the doctor if the patient thinks she is (or might become) pregnant. The doctor will normally advise to stop taking Irbegen before becoming pregnant or as soon as the patient knows she is pregnant and will advise to take another medicine instead of Irbegen. Irbegen is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to the baby if used after the third month of pregnancy.
Breast-feeding: Tell the doctor if the patient is breast-feeding or about to start breast-feeding. Irbegen is not recommended for mothers who are breast-feeding, and the doctor may choose another treatment if the patient wishes to breast-feed, especially if the baby is newborn, or was born prematurely.
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 localized swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If the patient gets any of these symptoms or get short of breath, stop taking Irbegen and contact the doctor immediately.
The frequency of the side effects listed as follows 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.
Side effects reported in clinical studies for patients treated with Irbegen were: Very common (may affect more than 1 in 10 people): if suffering 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 Irbegen. Undesirable effects where the frequency is not known are: feeling of spinning, 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 the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not mentioned. The patient can also report side effects directly via the national reporting system. By reporting side affects the patient can help provide more information on the safety of this medicine.
Clinical trial data has shown that dual blockade of the RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent.
Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.
The doctor may need to change the dose and/or to take other precautions: If the patient is taking an ACE-inhibitor or aliskiren (see also information under Contraindications and Precautions).
The patient may need to have blood checks if taking: potassium supplements, salt substitutes containing potassium, potassium-sparing medicines (such as certain diuretics), medicines containing lithium.
If the patient is taking certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.
Irbegen with food and drink: Irbegen can be taken with or without food.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
C09CA04 - irbesartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
FC tab 150 mg (white to off-white, oblong, biconvex with scoreline and 'G' embossed on one side and plain on the other) x 2 x 15's. 300 mg (white to off-white, oblong, biconvex, with a scoreline) x 2 x 15's.