1. What Irovel Plus is and what it is used for 
Irovel Plus is a combination of two active substances, irbesartan and hydrochlorothiazide. 
Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that 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. 
Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure. 
The two active ingredients in Irovel Plus work together to lower blood pressure further than if either was given alone. 
Irovel Plus is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.

2. Before you take Irovel Plus
Do not take Irovel Plus 
-    If you are allergic to irbesartan or any of the other ingredients of this medicine.
-    If you are allergic to hydrochlorothiazide or any other sulfonamide-derived medicines. 
-    If you are more than 3 months pregnant. (It is also better to avoid Irovel Plus in early pregnancy). 
-    If you have severe liver or kidney problems. 
-    If you have difficulty in producing urine. 
-    If your doctor determines that you have persistently high calcium or low potassium levels in your blood.
-    If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
Children and adolescents 
Irovel Plus should not be given to children and adolescents (under 18 years).   
Take special care with Irovel Plus
Talk to your doctor before taking Irovel Plus and if any of the following apply to you: 
-    If you get excessive vomiting or diarrhea. 
-    If you suffer from kidney problems or have a kidney transplant. 
-    If you suffer from heart problems. 
-    If you suffer from liver problems.
-    If you suffer from diabetes. 
-    If you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart beat), particularly if you are being treated for diabetes.
-    If you suffer from lupus erythematosus (also known as lupus or SLE). 
-    If you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure). 
-    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.
-    If you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irovel Plus.
-    If you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Irovel Plus, seek medical attention immediately.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
You must tell your doctor if you think you are (or might become) pregnant. 
Irovel Plus 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.
You should also tell your doctor: 
-    If you are on a low-salt diet. 
-    If you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Irovel Plus). 
-    If you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal. 
-    If you are going to have an operation (surgery) or be given anaesthetics. 
-    If you have decrease in your vision or pain in one or both of your eyes while taking Irovel Plus. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye (glaucoma) and can happen within hours to a week of taking irbesartan and hydrochlorothiazide. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this. You should discontinue Irovel Plus treatment and seek prompt medical attention. 
The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test. 
Children and adolescents
Irovel Plus should not be given to children and adolescents (under 18 years).
Taking other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Diuretic agents such as the hydrochlorothiazide contained in Irovel Plus may have an effect on other medicines. Preparations containing lithium should not be taken with Irovel Plus without close supervision by your doctor. 
Your doctor may need to change your dose and/or to take other precautions: If you are taking an ACE-inhibitor or aliskiren.

You may need to have blood checks if you take: 
-  Potassium supplements. 
-  Salt substitutes containing potassium. 
-  Potassium sparing medicines or other diuretics (water tablets). 
-  Some laxatives.
-  Medicines for the treatment of gout. 
-  Therapeutic vitamin D supplements. 
-  Medicines to control heart rhythm. 
-  Medicines for diabetes (oral agents as repaglinide or insulins). 
-  Carbamazepine (a medicine for the treatment of epilepsy). 
It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers, arthritis medicines, or colestyramine and colestipol resins for lowering blood cholesterol.
Taking Irovel Plus with food and drink 
Irovel Plus can be taken with or without food. 
Due to the hydrochlorothiazide contained in Irovel Plus, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, specially when getting up from a sitting position. 
Pregnancy, breast-feeding and fertility 
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 Plus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irovel Plus. Irovel Plus 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 Plus 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 
Irovel Plus 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. 
Important information about some of the ingredients of Irovel Plus
Irovel Plus contains lactose. 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.
Irovel Plus contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Irovel Plus
Always take Irovel Plus exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. 
Dosage 
The recommended dose of Irovel Plus is one or two tablets a day. Irovel Plus will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough. Your doctor will instruct you how to switch from the previous treatment to Irovel Plus. 
Method of administration 
Irovel Plus is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irovel Plus 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 Irovel Plus until your doctor tells you otherwise. 
The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment. 
If you take more Irovel Plus than you should 
If you accidentally take too many tablets, contact your doctor immediately. 
Children should not take Irovel Plus 
Irovel Plus should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.
If you forget to take Irovel Plus
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 medicine, ask your doctor or pharmacist.

4. Possible side effects 
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. 
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 the above symptoms or get short of breath, stop taking Irovel Plus and contact your doctor immediately. 
Side effects reported in clinical studies for patients treated with Irovel Plus were: 
Common side effects (affect 1 to 10 users in 100) 
-  Nausea/vomiting. 
-  Abnormal urination. 
-  Fatigue.
- Dizziness (including when getting up from a lying or sitting position). 
- Blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine). 
If any of these side effects causes you problems, talk to your doctor. 
Uncommon side effects (affect 1 to 10 users in 1,000) 
-  Diarrhea. 
-  Low blood pressure. 
-  Fainting.
-  Heart rate increased. 
-  Flushing. 
-  Swelling. 
-  Sexual dysfunction (problems with sexual performance). 
-  Blood tests may show lowered levels of potassium and sodium in your blood. 
-  Dyspnea.

If any of these side effects causes you problems, talk to your doctor. 
Side effects reported since the launch of Irovel Plus 
Some undesirable effects have been reported since marketing of Irovel Plus. Undesirable effects where the frequency is not known are: Headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired kidney function, increased level of potassium in your blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported. 
As for any combination of two active substances, side effects associated with each individual component cannot be excluded. 
Side effects associated with irbesartan alone 
In addition to the side effects listed above, chest pain has also been reported. 

Side effects associated with hydrochlorothiazide alone 
Loss of appetite, stomach irritation, stomach cramps, constipation, jaundice (yellowing of the skin and/or whites of the eyes), inflammation of the pancreas characterised by severe upper stomach pain; often with nausea and vomiting, sleep disorders, depression, blurred vision, lack of white blood cells; which can result in frequent infections, fever, decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anemia) characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale, kidney disease, lung problems including pneumonia or build-up of fluid in the lungs, increased sensitivity of the skin to the sun, inflammation of blood vessels, a skin disease characterized by the peeling of the skin all over the body, cutaneous lupus erythematosus; which is identified by a rash that may appear on the face, neck, and scalp, allergic reactions, weakness and muscle spasm, altered heart rate, reduced blood pressure after a change in body position, swelling of the salivary glands, high sugar levels in the blood, sugar in the urine, increases in some kinds of blood fat, high uric acid levels in the blood; which may cause gout.
Eye disorders: choroidal effusion; cases of choroidal effusion with visual field defect have been reported after the use of thiazide and thiazide-like diuretics (Frequency is Unknown). 
It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Irovel Plus
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 the medicines you no longer use. These measures will help to protect environment.