aliskiren.<\/li><\/ul><\/li><\/ul>\n\n\n\nYour 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.<\/p>\n\n\n\n
Children and young people<\/h2>\n\n\n\n This medicine should not be used by children and adolescents as the safety and efficacy of the medicine have not been fully evaluated.<\/p>\n\n\n\n
Other medicines and Aprovel<\/h2>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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:<\/strong><\/p>\n\n\n\npotassium supplement<\/li> potassium-containing salt substitutes<\/li> potassium-sparing medicines (eg certain diuretics )<\/li> medicines containing lithium.<\/li><\/ul>\n\n\n\nIf you use certain painkillers, so-called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.<\/p>\n\n\n\n
Aprovel with food and drink<\/h2>\n\n\n\n Aprovel can be taken with or without food.<\/p>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n Pregnancy<\/strong> Breast-feeding<\/strong> Driving and using machines<\/h2>\n\n\n\n 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.<\/p>\n\n\n\n
Aprovel contains lactose<\/h2>\n\n\n\n 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<\/h2>\n\n\n\n Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
administration<\/strong> Aprovel is taken orally<\/strong>. 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 <\/strong>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.<\/li><\/ul>\n\n\n\nPatients with high blood pressure and type 2 diabetes with kidney disease<\/strong> The doctor may, especially when starting treatment, prescribe a lower dose to certain patients e.g. those treated with hemodialysis<\/strong>, or those older than 75 years<\/strong>.Maximum reduction in blood pressure is obtained 4-6 weeks after starting treatment.<\/p>\n\n\n\n
Use for children and adolescents<\/h2>\n\n\n\n Aprovel should not be given to children under 18 years of age. If a child swallows any tablets, contact a doctor immediately.<\/p>\n\n\n\n
If you take more Aprovel than you should<\/h2>\n\n\n\n If you accidentally take too many tablets, contact a doctor immediately.<\/p>\n\n\n\n
If you forget to take Aprovel<\/h2>\n\n\n\n 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.<\/p>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them.
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<\/strong>.The frequency of side effects listed below is defined according to the following convention:
In clinical trials, the following adverse reactions were reported in patients treated with Aprovel:<\/p>\n\n\n\n
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.<\/li><\/ul>\n\n\n\nSome 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<\/em><\/p>\n\n\n\nIf 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. <\/p>\n\n\n\n
5. How to store Aprovel<\/h2>\n\n\n\n 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 \u00b0 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.<\/p>\n\n\n\n
6. Contents of the packaging and other information<\/h2>\n\n\n\nContent declaration<\/h2>\n\n\n\nThe active substance is irbesartan. Each tablet of Aprovel 75 mg contains 75 mg of irbesartan.<\/li> 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”.<\/li><\/ul>\n\n\n\nWhat the medicine looks like and the contents of the pack<\/h2>\n\n\n\n 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.<\/p>\n\n\n\n
Marketing Authorisation Holder:<\/h2>\n\n\n\n sanofi-aventis groupe
Manufacturer:<\/strong> SANOFI WINTHROP INDUSTRY
Further information on this medicine can be obtained from the representative of the marketing authorization holder:Belgium \/ Belgique \/ Belgien<\/strong>Sanofi BelgiumTel: +32 (0) 2 710 54 00<\/td>Lithuania<\/strong>UAB sanofi-aventis LietuvaTel. +370 5 2755224<\/td><\/tr>Bulgaria<\/strong>Sanofi Bulgaria EOODTel: +359 (0) 2 970 53 00<\/td>Luxembourg \/ Luxemburg<\/strong>Sanofi BelgiumPhone: +32 (0) 2 710 54 00 (Belgium \/ Belgium)<\/td><\/tr>Czech Republic<\/strong>sanofi-aventis, sroTel: +420 233 086 111<\/td>Hungary<\/strong>SANOFI-AVENTIS Zrt.Tel .: +36 1 505 0050<\/td><\/tr>Denmark<\/strong>Sanofi A \/ STel: +45 45 16 70 00<\/td>Malta<\/strong>Sanofi SpATel: +39 02 39394275<\/td><\/tr>Germany<\/strong>Sanofi-Aventis Deutschland GmbHTel: 0800 52 52 010Tel. from abroad: +49 69 305 131<\/td>The Netherlands<\/strong>sanofi-aventis Netherlands BVTel: +31 20 245 4000<\/td><\/tr>Eesti<\/strong>sanofi-aventis Estonia O\u00dcTel: +372 627 34 88<\/td>Norway<\/strong>sanofi-aventis Norge ASTel: +47 67 10 71 00<\/td><\/tr>Greece<\/strong>sanofi-aventis \u0391\u0395BE:\u0397\u03bb: +30 210 900 16 00<\/td>Austria<\/strong>sanofi-aventis GmbHTel: +43 1 80 185 – 0<\/td><\/tr>Spain<\/strong>sanofi-aventis, SATel: +34 93 485 94 00<\/td>Poland<\/strong>sanofi-aventis Sp. z ooTel .: +48 22 280 00 00<\/td><\/tr>France<\/strong>sanofi-aventis FranceTel: 0 800 222 555Call from abroad: +33 1 57 63 23 23<\/td>Portugal<\/strong>Sanofi – Pharmaceutical Products, LdaTel: +351 21 35 89 400<\/td><\/tr>Croatia<\/strong>sanofi-aventis Croatia dooTel: +385 1 600 34 00<\/td>Romania<\/strong>Sanofi Romania SRLTel: +40 (0) 21 317 31 36<\/td><\/tr>Ireland<\/strong>sanofi-aventis Ireland Ltd. T \/ A SANOFITel: +353 (0) 1 403 56 00<\/td>Slovenia<\/strong>sanofi-aventis dooTel: + 386 1 560 48 00<\/td><\/tr>Iceland<\/strong>Vistor hf.Phone: +354 535 7000<\/td>Slovak Republic<\/strong>sanofi-aventis Pharma Slovakia sroTel: + 421 2 33 100 100<\/td><\/tr>Italy<\/strong>Sanofi SpATel: 800.536389<\/td>Finland \/ Finland<\/strong>Sanofi OyPuh \/ Tel: +358 (0) 201 200 300<\/td><\/tr>\u039a\u03cd\u03c0\u03c1\u03bf\u03c2<\/strong>sanofi-aventis Cyprus Ltd.:\u0397\u03bb: +357 22 871600<\/td><\/td><\/tr> Latvia<\/strong>sanofi-aventis Latvia SIATel: +371 67 33 24 51<\/td>United Kingdom<\/strong>SanofiTel: +44 (0) 845 372 7101<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"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.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2201,2200],"tags":[10175,10178,6850,10172,10179,10174,10177,10173,10176,6853],"class_list":["post-5531","post","type-post","status-publish","format-standard","hentry","category-a","category-medicines","tag-approve","tag-approve-tablet","tag-irbesartan","tag-irbesartan-tablet","tag-side-effects-of-approve","tag-side-effects-of-irbesartan","tag-what-approve-is-used-for","tag-what-irbesartan-is-used-for","tag-what-is-approve","tag-what-is-irbesartan"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5531","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=5531"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5531\/revisions"}],"predecessor-version":[{"id":12531,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5531\/revisions\/12531"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=5531"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=5531"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=5531"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}