Aprovel 75 mg/150 mg/300 mg Tablets

APROVEL belongs to a group of medicines known as angiotensin II receptor blockers (ARB's). APROVEL is used in the treatment of high blood pressure (hypertension) and for the protection of the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired renal function.

Do not take APROVEL:

• if you are hypersensitive (allergic) to irbesartan or any of the other ingredients of APROVEL (see “ WHAT APROVEL CONTAINS ”)
• if you have a history of angioedema (swelling around your face, throat or tongue) related to previous therapy with ARBs or to angiotensin converting enzyme inhibitors (ACEIs): You must never again be given these medicines
• if you have hereditary angioedema (swelling around your face, throat or tongue)
• if you have heart disease characterised by obstruction of blood flow and thickening of heart tissue (hypertrophic obstructive cardiomyopathy)
• if you have kidney problems where the blood supply to your kidney is reduced (renal artery stenosis) or a transplanted kidney
• If you have kidney problems and are taking fluoroquinolones (used to treat bacterial infections) at the same time (see “Taking other medicines with APROVEL”).
• if you have a decrease in blood supply flow through the aortic artery (aortic stenosis)
• if you have porphyria
• if you do not urinate or you have severe kidney problems
• if you are taking potassium-sparing diuretics (such as spironolactone, triamterene, amiloride)
• if you are taking a medicine containing lithium
• if you are pregnant or breastfeeding. If you are pregnant or breastfeeding your baby while taking APROVEL, please consult your doctor, pharmacist or other healthcare professional for advice. You should not breastfeed your baby if you are taking APROVEL. You must tell your doctor if you think you are (or might become) pregnant. APROVEL should not be used during pregnancy as it may cause serious harm to your baby. APROVEL should not be given to children.

Do not share the APROVEL prescribed for you with others. Always take APROVEL exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure.

The usual dose of APROVEL is 150 mg once a day. The dose may later be increased to 300 mg once daily, depending on your blood pressure response. If you have high blood pressure and type 2 diabetes with kidney disease your doctor will take this into account. If you have the impression that the effect of APROVEL is too strong or too weak, tell your doctor or pharmacist. Children should not take APROVEL. APROVEL should not be given to children under 18 years of age. If a child swallows some APROVEL tablets, contact your doctor immediately. If you take more APROVEL than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. If you forget to take APROVEL: If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for forgotten individual doses.

APROVEL can have side effects. 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 APROVEL. If you think you are developing such a reaction or get short of breath, stop taking APROVEL and seek immediate medical attention. Do not take another dose of APROVEL to see if the same reaction will happen again. If you have high blood pressure, you may experience the following side effects:

Frequent: Dizziness, feeling sick/vomiting and fatigue, headache

Less frequent: Fast heartbeat, cough, diarrhoea, indigestion, problems with sexual performance and chest pain

Frequency not specified: Oedema

If you have high blood pressure and type 2 diabetes with renal problems, you may also experience the following side effects:

Frequent: Increased blood potassium levels. Low blood pressure and dizziness (especially when getting up from a lying or sitting position)

Some undesirable effects reported since marketing of APROVEL are: Headache, liver function disorders, increased blood potassium levels, vertigo (lightheadedness) or a feeling you are about to fall, pain in joints and muscles, impaired kidney function, hypersensitive reactions (allergic)

Not all side effects reported for APROVEL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking APROVEL, please consult your doctor, pharmacist or other healthcare professional for advice. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of the reach of children. APROVEL tablets should be stored in a dry place, at or below 25 °C. Store in the original package. Do not use after the expiry date stated on the carton and on the blister. Do not remove the tablets from the blister pack until you are ready to take the medicine. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).