Aprovel (irbesartan) - 300 mg - film-coated tablets - …

1 PPLLEEAASSEE RREEAADD AALLLLOOFFTTHHEE LLEEAAFFLLEETT CCAARREEFFUULLLLYYBBEEFFOORREE TTAAKKIINNGG TTHHIISS Keep this leaflet you may need to read it If you have any other questions or doubts, ask yourdoctor or pharmacist for further This medicine has been prescribed personally foryou. Do not give it to anybody else, even if he/shehas identical symptoms since it might cause harm active substance in Aprovel tablets is tablet contains 300 mg irbesartan . The tabletscontain the following excipients: microcrystallinecellulose, croscarmellose sodium, lactosemonohydrate, hypromellose, silicon dioxide,magnesium stearate, titanium dioxide (E 171),macrogol, carnauba wax. Aprovel 300 mg film-coatedtablets are supplied in blister packs of 14, 28, 56 or98.

2 Unidose blister packs of 56 tablets for delivery inhospitals are also available. Not all pack sizes may OOFF MMEEDDIICCIINNEEA provel belongs to a group of medicines known asangiotensin-II receptor antagonists. Angiotensin-II is asubstance produced in the body which binds toreceptors in blood vessels causing them to results in an increase in blood pressure. Aprovelprevents the binding of angiotensin-II to thesereceptors, causing the blood vessels to relax and theblood pressure to slows the decrease of kidney function inpatients with high blood pressure and type AAUUTTHHOORRIISSAATTIIOONN HHOOLLDDEERRSANOFI PHARMA BRISTOL-MYERS SQUIBB SNC174 avenue de France, F-75013 Paris - FranceMMAANNUUFFAACCTTUURREERRS anofi Winthrop Industrie - 1 rue de la ViergeAmbar s et Lagrave - 33565 Carbon Blanc Cedex -FranceWWHHEENN SSHHOOUULLDD AApprroovveell BBEE UUSSEEDD?

3 ? Aprovel is used in the treatment of high bloodpressure (hypertension) and for the protection of thekidney in hypertensive type 2 diabetic patients withlaboratory evidence of impaired renal doctor measured your blood pressure and foundit to be above the normal range for your age. Highblood pressure, if not treated, can damage bloodvessels in several organs such as the heart, thekidneys, the brain and the eyes. In some instancesthis may lead to heart attacks, heart or kidney failure,strokes, or blindness. There are usually no symptomsof high blood pressure before damages occur. Thusmeasurement of the blood pressure is necessary toverify if it is in the normal range or not. High bloodpressure can be treated and controlled withmedicines such as Aprovel .

4 Your doctor may alsohave recommended that you adjust your lifestyle tohelp to lower your high blood pressure (losing weight,avoiding smoking, reducing alcohol consumption andrestricting the amount of salt in the diet). He may alsohave encouraged the practice of regular, mild (notstrenuous) exercise such as walking and addition to blood sugar control and blood pressurecontrol that may need other concomitant medicines, Aprovel is used for the treatment of kidney disease inpatients with high blood pressure and type SSHHOOUULLDD AApprroovveell NNOOTT BBEE UUSSEEDD??Do not take Aprovel if:- you are in the second or third trimester ofpregnancy,- you are breast-feeding or- if you are allergic to any of the ingredients (see"Composition").

5 OOTTHHEERR IIMMPPOORRTTAANNTT IINNFFOORRMMAATTIIOONN BBEEFFOORREETTAAKKIINNGG AApprroovveellThere are certain conditions which you may have, orhave had, which require special care before or whiletaking Aprovel . Therefore, before taking this medicine,you should have told your doctor if you suffer from:- excessive vomiting or diarrhea,- kidney problems,- heart you are to undergo any surgery or receiveanaesthetics, you should make sure the doctor knowsthat you are taking Aprovel tablets . CCAANN YYOOUU TTAAKKEE AApprroovveell WWIITTHH OOTTHHEERR MMEEDDIICCIINNEESS??You should have informed your doctor of anymedicines you are taking. These include medicinesobtained without prescription. Aprovel does notusually interact with other medicines.

6 Specialprecautionary measures ( blood tests) may beappropriate if you take potassium supplements,1196785V2 - 13/03/2007 English/UrduSt phanie GENELOTA mbar s170 mm x 210 mm DCLaetus code 62682 Eurostile6 points mini Assembly Card Not Technical Card NOT RL - DC 45 g Technical Constraints NOT. SPOT. COD. ech 1 Leaflet Aprovel RM 300 mg 28 tabletsPakistanPantone 296 CVC (from 100 to 65%), Pantone Process Magenta CVCfilm-coated tabletspotassium-containing salt substitutes, potassium -sparing medicines (such as certain diuretics) orlithium-containing with other blood pressure lowering drugs, theeffect of irbesartan may be reduced when you takenon-steroidal anti-inflammatory AApprroovveell BBEE UUSSEEDD DDUURRIINNGG PPRREEGGNNAANNCCYY OORRBBRREEAASSTT--FFEEEEDDIINNGG?

7 ?Tell your doctor before taking Aprovel if you arepregnant, think you may be pregnant, are planning to bepregnant or if you are breast-feeding. It is preferable notto use Aprovel in the first trimester of pregnancy. If youbecome pregnant while on Aprovel treatment, refer toyour doctor without delay. Aprovel should not be takenduring the second or third trimester of pregnancy, orwhile breast-feeding (see when should Aprovel not beused ? ). A switch to a suitable alternative treatmentshould be carried out in advance of a II DDRRIIVVEE OORR OOPPEERRAATTEE MMAACCHHIINNEERRYY WWHHIILLEETTAAKKIINNGG AApprroovveell?? Aprovel is unlikely to affect your ability to drive or usemachines. However, occasionally dizziness orweariness may occur during treatment of high bloodpressure.

8 If you experience these, consult your doctorbefore attempting such SSHHOOUULLDD YYOOUU TTAAKKEE AApprroovveell??The tablets should be taken regularly as directed byyour doctor. Treatment usually starts with 150 mgonce a day. The dose may later be increased to 300mg once daily depending on blood pressure maximal blood pressure lowering effect should bereached 4-6 weeks after beginning youhave the impression that the effect of Aprovel is toostrong or too weak, talk to your doctor or pharmacist. In patients with high blood pressure and type 2diabetes, 300 mg once daily is the preferredmaintenance dose for the treatment of associatedkidney doctor may advise a lower dose, especially whenstarting treatment in certain patients such as thoseon haemodialysis, or those over the age of 75 years.

9 Aprovel can be taken with or without food. The tabletsshould be swallowed with a drink of water. You shouldtry to take your daily dose at about the same timeeach day. It is important that you continue to takeAprovel until your doctor tells you otherwise. Aprovelshould not be given to children (<18 years).MMIISSSSIINNGG AA DDOOSSEEIf you accidentally miss a daily dose, just take the nextdose as normal. Do not take a double dose to make upfor the missed dose. OOVVEERRDDOOSSEEIf you accidentally take too many tablets , or a child swallowssome, contact your doctor TTHHEERREE UUNNDDEESSIIRRAABBLLEE EEFFFFEECCTTSS WWHHEENNTTAAKKIINNGG AApprroovveell??All medicines may cause some undesirable effects. Ifany undesirable effects occur, they are likely to be mildand temporary.

10 However, some effects may beserious and require medical following side effects have been commonlyreported in patients with high blood pressure in clinicalstudies: dizziness, feeling sick/vomiting, fatigue andincreased plasma creatine kinase level. The followingless common side effects have also been reported:fast heart beat, flushing, cough, diarrhea, indigestion,problems with sexual performance and chest patients with high blood pressure and type 2diabetes with renal disease, the following additionalcommon side effects have been reported in clinicalstudies: low blood pressure and dizziness (especiallywhen getting up from a lying or sitting position), pain inbones and muscles as well as decrease inhaemoglobin (pigment in red blood cells).