1. What Irovel is and what it is used for

Irovel 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. Irovel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irovel slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Irovel is used:

- To treat high blood pressure (essential hypertension).

- To protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function.

2. Before you take Irovel

Do not take Irovel

- If you are allergic (hypersensitive) to irbesartan or any other ingredients of Irovel.

- If you are more than 3 months pregnant. (It is also better to avoid Irovel in early pregnancy).

Irovel should not be given to children and adolescents (under 18 years).

Take special care with Irovel

Tell your doctor if any of the following apply to you:

-  If you suffer from excessive vomiting or diarrhea.

-  If you suffer from kidney problems.

-  If you suffer from heart problems.

- If you receive Irovel 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 anesthetics.

- You must tell your doctor if you think that you are (or might become) pregnant. Irovel 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.

Taking 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.

Irovel does 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 Irovel may be reduced.

Taking Irovel with food and drink

Irovel can be taken with or without food. The tablets should be swallowed with a drink of water.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. 

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irovel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irovel. Irovel 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.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Irovel 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. 

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Irovel 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 such activities.

Important information about some of the ingredients of Irovel

Irovel contains lactose. If you have been told by your  doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.  How to take Irovel

Always take Irovel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Method of administration

Irovel is for oral use and is taken with or without food. The tablets should be swallowed with a drink of water. You should try to take your daily dose at about the same time each day. It is important that you continue to take Irovel until your doctor tells you 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 hemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment. 

Children should not take Irovel Irovel

should not be given to children (<18 years).

If you take more Irovel than you should

If you accidentally take too many tablets, or a child swallows some, contact your doctor immediately. Symptoms of overdose can be hypotension and tachycardia; bradycardia.

If you forget to take Irovel

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, Irovel 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 you get any of these symptoms or get short of breath, stop taking Irovel 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.

Common: Affects 1 to 10 users in 100.

Uncommon: Affects 1 to 10 users in 1,000.

Rare: Affects 1 to 10 users in 10,000.

Very rare: Affects less than 1 user in 10,000.

Not known: Frequency cannot be estimated from the available data.

Side effects reported in clinical studies for patients treated with irbesartan 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 (hemoglobin) were also reported.

Uncommon: Heart rate increased, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

Some side effects have been reported since marketing of irbesartan 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 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.

5. How to store Irovel

Keep out of reach of children.

Store below 30°C.

Do not use beyond the expiry date or if the product shows any sign of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.

These measures will help protect the environment.