Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - irbesartan

Document Subject

Generated Narrative: MedicinalProductDefinition mp0c9e6c673a48a176c2c1114fdf6885b8

identifier: http://ema.europa.eu/identifier/EU/1/06/376/001-005

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Irbesartan Zentiva 75 mg tablets.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-0c9e6c673a48a176c2c1114fdf6885b8

identifier: http://ema.europa.eu/identifier/EU/1/06/376/001-005

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - irbesartan

Attesters

What is in this leaflet

1. What Irbesartan Zentiva is and what it is used for
2. What you need to know before you take Irbesartan Zentiva
3. How to take Irbesartan Zentiva
4. Possible side effects
5. How to store Irbesartan Zentiva
6. Contents of the pack and other information

Irbesartan Zentiva belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan Zentiva prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan Zentiva slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartan Zentiva is used in adult patients

to treat high blood pressure (essential hypertension)

to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take Irbesartan Zentiva

if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)

if you are more than 3 months pregnant. (It is also better to avoid Irbesartan Zentiva in early pregnancy see pregnancy section)

if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warning and precautions Talk to your doctor before taking Irbesartan Zentiva and if any of the following apply to you:

if you get excessive vomiting or diarrhoea

if you suffer from kidney problems

if you suffer from heart problems

if you receive Irbesartan Zentiva for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function

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 are going to have an operation (surgery) or be given anaesthetics

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 Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading Do not take Irbesartan Zentiva .

You must tell your doctor if you think you are (or might become) pregnant. Irbesartan Zentiva 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 (see pregnancy section).

Children and adolescents This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Other medicines and Irbesartan Zentiva 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 to take other precautions. If you are taking an ACE-inhibitor or aliskiren (see also information under the headings Do not take Irbesartan Zentiva and Warnings and precautions ).

You may need to have blood checks if you take:

potassium supplements

salt substitutes containing potassium

potassium-sparing medicines (such as certain diuretics)

medicines containing lithium

repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Irbesartan Zentiva with food and drink Irbesartan Zentiva can be taken with or without food.

Pregnancy and breast-feeding Pregnancy You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan Zentiva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan Zentiva. Irbesartan Zentiva 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. Irbesartan Zentiva 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 Irbesartan Zentiva 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.

Irbesartan Zentiva contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Irbesartan Zentiva contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free .

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration Irbesartan Zentiva is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan Zentiva 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 Irbesartan Zentiva until your doctor tells you otherwise.

Patients with high blood pressure The usual dose is 150 mg once a day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.

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 a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

Use in children and adolescents Irbesartan Zentiva should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Irbesartan Zentiva than you should If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Irbesartan Zentiva 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.

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.

As with similar medicines, 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 these symptoms or get short of breath, stop taking Irbesartan Zentiva and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention: Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with Irbesartan Zentiva were:

Very common (may affect more than 1 in 10 people): if you suffer from 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, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

Some undesirable effects have been reported since marketing of Irbesartan Zentiva. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30 C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Irbesartan Zentiva contains

The active substance is irbesartan. Each tablet of Irbesartan Zentiva 75 mg contains 75 mg irbesartan.

The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188. Please see section 2 Irbesartan Zentiva contains lactose .

What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.

Irbesartan Zentiva 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder: Zentiva k.s.
U kabelovny 102 37 Prague Czech Republic

Manufacturer: Sanofi Winthrop Industrie 1 Rue de la vierge Ambar s et Lagrave 33 565 Carbon Blanc cedex France

Sanofi Winthrop Industrie 30-36 Avenue Gustave Eiffel 37 100 Tours
France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Belgi /Belgique/Belgien Zentiva, k.s. T l/Tel: +32 280 86 PV-Belgium@zentiva.com

Lietuva Zentiva, k.s. Tel: +370 52152PV-Lithuania@zentiva.com

Zentiva, k.s. : +35924417PV-Bulgaria@zentiva.com

Luxembourg/Luxemburg Zentiva, k.s. T l/Tel: +352 208 82PV-Luxembourg@zentiva.com esk republika Zentiva, k.s. Tel: +420 267 241 PV-Czech-Republic@zentiva.com Magyarorsz g Zentiva Pharma Kft. Tel.: +36 1 299 1PV-Hungary@zentiva.com Danmark Zentiva Denmark ApS Tlf: +45 787 68 PV-Denmark@zentiva.com

Malta Zentiva, k.s. Tel: +356 277 82 PV-Malta@zentiva.com Deutschland Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 PV-Germany@zentiva.com

Nederland Zentiva, k.s. Tel: +31 202 253 PV-Netherlands@zentiva.com

Eesti Zentiva, k.s. Tel: +372 52 70PV-Estonia@zentiva.com

Norge Zentiva Denmark ApS Tlf: +47 219 66 PV-Norway@zentiva.com

Zentiva, k.s. : +30 211 198 7PV-Greece@zentiva.com

sterreich Zentiva, k.s. Tel: +43 720 778 PV-Austria@zentiva.com Espa a Zentiva, k.s. Tel: +34 931 815 PV-Spain@zentiva.com

Polska Zentiva Polska Sp. z o.o. Tel: + 48 22 375 92 PV-Poland@zentiva.com France Zentiva France T l: +33 (0) 800 089 PV-France@zentiva.com

Portugal Zentiva Portugal, Lda Tel: +351210601PV-Portugal@zentiva.com Hrvatska Zentiva d.o.o. Tel: +385 1 6641 PV-Croatia@zentiva.com

Ireland Zentiva, k.s. Tel: +353 766 803 PV-Ireland@zentiva.com

Rom nia ZENTIVA S.A. Tel: +4 021 304 7PV-Romania@zentiva.com

Slovenija Zentiva, k.s. Tel: +386 360 00 PV-Slovenia@zentiva.com sland Zentiva Denmark ApS S mi: +354 539 0PV-Iceland@zentiva.com

Slovensk republika Zentiva, a.s. Tel: +421 2 3918 3PV-Slovakia@zentiva.com Italia Zentiva Italia S.r.l. Tel: +39-02-38598PV-Italy@zentiva.com Suomi/Finland Zentiva Denmark ApS Puh/Tel: +358 942 598 PV-Finland@zentiva.com

Zentiva, k.s. : +357 240 30 PV-Cyprus@zentiva.com

Sverige Zentiva Denmark ApS Tel: +46 840 838 PV-Sweden@zentiva.com Latvija Zentiva, k.s. Tel: +371 67893PV-Latvia@zentiva.com United Kingdom (Northern Ireland) Zentiva, k.s. Tel: +44 (0) 800 090 2PV-United-Kingdom@zentiva.com

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: