75 mg film-coated tablets 
irbesartan

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Aprovel is and what it is used for 
2. What you need to know before you take Aprovel 
3. How to take Aprovel 
4. Possible side effects 
5. How to store Aprovel 
6. Contents of the packaging and other information 

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:

Belgium / Belgique / BelgienSanofi BelgiumTel: +32 (0) 2 710 54 00 LithuaniaUAB sanofi-aventis LietuvaTel. +370 5 2755224
BulgariaSanofi Bulgaria EOODTel: +359 (0) 2 970 53 00 Luxembourg / LuxemburgSanofi BelgiumPhone: +32 (0) 2 710 54 00 (Belgium / Belgium)
Czech Republicsanofi-aventis, sroTel: +420 233 086 111 HungarySANOFI-AVENTIS Zrt.Tel .: +36 1 505 0050
DenmarkSanofi A / STel: +45 45 16 70 00 MaltaSanofi SpATel: +39 02 39394275
GermanySanofi-Aventis Deutschland GmbHTel: 0800 52 52 010Tel. from abroad: +49 69 305 131 The Netherlandssanofi-aventis Netherlands BVTel: +31 20 245 4000
Eestisanofi-aventis Estonia OÜTel: +372 627 34 88 Norwaysanofi-aventis Norge ASTel: +47 67 10 71 00
Greecesanofi-aventis ΑΕBE:Ηλ: +30 210 900 16 00 Austriasanofi-aventis GmbHTel: +43 1 80 185 – 0
Spainsanofi-aventis, SATel: +34 93 485 94 00 Polandsanofi-aventis Sp. z ooTel .: +48 22 280 00 00
Francesanofi-aventis FranceTel: 0 800 222 555Call from abroad: +33 1 57 63 23 23 PortugalSanofi – Pharmaceutical Products, LdaTel: +351 21 35 89 400
Croatiasanofi-aventis Croatia dooTel: +385 1 600 34 00 RomaniaSanofi Romania SRLTel: +40 (0) 21 317 31 36
Irelandsanofi-aventis Ireland Ltd. T / A SANOFITel: +353 (0) 1 403 56 00 Sloveniasanofi-aventis dooTel: + 386 1 560 48 00
IcelandVistor hf.Phone: +354 535 7000 Slovak Republicsanofi-aventis Pharma Slovakia sroTel: + 421 2 33 100 100
ItalySanofi SpATel: 800.536389 Finland / FinlandSanofi OyPuh / Tel: +358 (0) 201 200 300
Κύπροςsanofi-aventis Cyprus Ltd.:Ηλ: +357 22 871600
Latviasanofi-aventis Latvia SIATel: +371 67 33 24 51 United KingdomSanofiTel: +44 (0) 845 372 7101

Muhammad Nadeem

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