75 mg film-coated tablets
irbesartan
1. What Aprovel is and what it is used for
Aprovel belongs to a group of medicines called angiotensin -II receptor antagonists. Angiotensin -II is a substance, which is produced in the body, and which binds to certain structures ( receptors ) in the blood vessels and causes them to contract. This leads to increased blood pressure. Aprovel prevents the binding of angiotensin II to these receptors, which causes the blood vessels to relax and the blood pressure to drop. Aprovel delays the deterioration of kidney function in patients with high blood pressure and type 2 diabetes.
Aprovel is used in adult patients
- in the treatment of hypertension ( essential hypertension )
- to protect the kidneys of patients with high blood pressure, type 2 diabetes, and renal impairment detected in laboratory tests.
2. What you need to know before you take Aprovel
Do not take Aprovel
- if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6)
- Pregnant women should not use Aprovel during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Aprovel, see Pregnancy and breast-feeding).
- if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren
Warnings and cautions
Talk to your doctor before taking Aprovel and if any of the following apply to you :
- if you experience severe vomiting or diarrhea
- if you suffer from kidney problems
- if you suffer from heart problems
- if you are receiving Aprovel for diabetes-related kidney disease. Then your doctor may take regular blood tests, especially to measure the level of potassium in the blood in case of poor kidney function.
- if you are going to have surgery or get anesthesia.
- if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (eg enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems.
- aliskiren.
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.
See also the information under the heading “Do not take Aprovel”.
If you think you may be pregnant or become pregnant during treatment, consult your doctor. Aprovel is not recommended during early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects, see Pregnancy and breast-feeding.
Children and young people
This medicine should not be used by children and adolescents as the safety and efficacy of the medicine have not been fully evaluated.
Other medicines and Aprovel
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may need to change your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Aprovel” and “Warnings and precautions”).
You may need to take blood samples if you use:
- potassium supplement
- potassium-containing salt substitutes
- potassium-sparing medicines (eg certain diuretics )
- medicines containing lithium.
If you use certain painkillers, so-called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.
Aprovel with food and drink
Aprovel can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
If you think you may be pregnant or become pregnant during treatment, consult your doctor. Usually, your doctor will suggest that you stop taking Aprovel before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Aprovel should not be used during early pregnancy and should not be used during the last 6 months of pregnancy, as it may cause birth defects.
Breast-feeding
Tell your doctor if you are breast-feeding or planning to start breast-feeding. Aprovel is not recommended for breastfeeding and your doctor may choose another treatment for you if you want to breast-feed your baby, especially if your baby is a newborn or born prematurely.
Driving and using machines
Aprovel is unlikely to affect your ability to drive or use machines. Occasionally, however, dizziness or fatigue may occur during the treatment of high blood pressure. If you experience this, talk to your doctor before driving or using machines.
Aprovel contains lactose
If you have been told by your doctor that you have an intolerance to some sugars (eg lactose ), contact your doctor before taking this medicine.
3. How to take Aprovel
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Method of administration Aprovel is taken orally. Swallow the tablets with a sufficient amount of drink (eg a glass of water). You can take Aprovel 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 Aprovel until your doctor tells you otherwise.
- Patients with high blood pressure The usual dose is 150 mg once daily (two tablets daily). The dose can then be increased to 300 mg (four tablets daily) once daily depending on the effect on blood pressure.
- Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets daily) once daily is preferred as the maintenance dose.
The doctor may, especially when starting treatment, prescribe a lower dose to certain patients e.g. those treated with hemodialysis, or those older than 75 years.
Maximum reduction in blood pressure is obtained 4-6 weeks after starting treatment.
Use for children and adolescents
Aprovel should not be given to children under 18 years of age. If a child swallows any tablets, contact a doctor immediately.
If you take more Aprovel than you should
If you accidentally take too many tablets, contact a doctor immediately.
If you forget to take Aprovel
If you accidentally skip a daily dose, just take the next dose normally. Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and may require medical attention.
As with similar medications, rare cases of allergic skin reactions (skin rash, hives ), as well as local swelling of the face, lips, and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or if you have difficulty breathing, stop taking Aprovel, and contact a doctor immediately.
The frequency of side effects listed below is defined according to the following convention:
Very common: may affect more than 1 in 10 patients
Common: may affect up to 1 in 10 patients
Uncommon: may affect up to 1 in 100 patients
In clinical trials, the following adverse reactions were reported in patients treated with Aprovel:
- Very common (may affect more than 1 in 10 people): if you have 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, nausea/vomiting, fatigue, and blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase). Patients with high blood pressure and type 2 diabetes with kidney disease also reported dizziness when getting up from a supine or sitting position, low blood pressure when getting up from a lying or sitting position, and joint or muscle pain and decreased levels of a protein in the red blood cells ( hemoglobin ).
- Uncommon (may affect up to 1 in 100 people): palpitations, flushing, cough, diarrhea, indigestion/heartburn, impaired sexual ability, and chest pain.
Some side effects have been reported since Aprovel came on the market. Side effects without known frequency are dizziness, headache, taste changes, ringing in the ears, muscle cramps, joint and muscle pain, decreased number of platelets, liver effects, the increased potassium level in the blood, impaired kidney function, inflammation of fine blood vessels especially in the skin (a condition called leukocytoclastic vasculitis ) and severe allergic reactions (anaphylactic shock ). Jaundice (yellowing of the skin and/or whites of the eyes) has, as a less common side effect, also been reported.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Aprovel
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified 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.
6. Contents of the packaging and other information
Content declaration
- The active substance is irbesartan. Each tablet of Aprovel 75 mg contains 75 mg of irbesartan.
- The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silica, magnesium stearate, titanium dioxide, macrogol 3000, and carnauba wax. See section 2 “Aprovel contains lactose”.
What the medicine looks like and the contents of the pack
Aprovel 75 mg film-coated tablets are white to off-white, biconvex, and oval with a heart imprinted on one side and number 2871 on the other side.
Aprovel 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90, and 98 tablets. Single-dose packs (pressure packs) of 56 x 1 film-coated tablets are also available for hospital use.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
sanofi-aventis groupe
54, rue La Boétie
F-75008 Paris France
Manufacturer:
SANOFI WINTHROP INDUSTRIE
1, rue de la Vierge
Ambarès & Lagrave
F 33565 Carbon Blanc Cedex France
SANOFI WINTHROP INDUSTRY
30-36 Avenue Gustave Eiffel, BP 7166
F-37071 Tours Cedex 2 – France
Further information on this medicine can be obtained from the representative of the marketing authorization holder:
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