Irbesartan Teva
irbesartan
Irbesartan
Keep 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Irbesartan Teva is and what it is used for
What you need to know before you take Irbesartan Teva
How to take Irbesartan Teva
Possible side effects
How to store Irbesartan Teva
Contents of the pack and other information
Irbesartan Teva 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 Teva prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan Teva slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Teva 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.
If you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6).
If you are more than 3 months pregnant (it is also better to avoid Irbesartan Teva 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
Talk to your doctor before taking Irbesartan Teva 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 Teva 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 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 Teva”.
You must tell your doctor if you think that you are (or might become) pregnant. Irbesartan Teva 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).
This medicinal product should not be given to children under 18 years of age because the safety and efficacy have not yet been fully established. If a child swallows some tablets, contact your doctor
immediately.
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 Teva” and “Warnings and precautions”).
potassium supplements
salt substitutes containing potassium
potassium-sparing medicines (such as certain diuretics)
medicines containing lithium
If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.
You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will
normally advise you to stop taking Irbesartan Teva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan Teva. Irbesartan Teva 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.
Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan Teva 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.
Irbesartan Teva 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.
This medicine contains less than 1 mmol sodium (23 mg) per film-coated 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.
Irbesartan Teva is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan Teva 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 Teva until your doctor tells
you otherwise.
The usual dose is 150 mg once a day. The dose may later be increased to 300 mg once daily depending on blood pressure response.
In patients with high blood pressure and type 2 diabetes, 300 mg 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.
If you accidentally take too many tablets, contact your doctor immediately.
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 Teva and contact your doctor immediately.
List of side effects:
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 1in 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 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.
Not known (frequency cannot be estimated from the available data): feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, 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) and severe allergic reactions (anaphylactic shock). 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 that is stated on the outer carton or foil after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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.
The active substance is irbesartan.
Each Irbesartan Teva 75 mg film-coated tablet contains 75 mg irbesartan.
The other ingredients are:
Tablet core: povidone, pregelatinized starch (maize), poloxamer 188, microcrystalline cellulose, croscarmellose sodium, colloidal hydrated silica and magnesium stearate.
Tablet coating: polydextrose, titanium dioxide, hypromellose and macrogol 4000.
Irbesartan 75 mg film-coated tablets are white to off white capsule shaped, film coated tablet. One side of the tablet debossed with the number “93”. The other side of the tablet debossed with number
“7464”.
Irbesartan Teva is available in pack sizes of 7, 14, 28, 30, 56, 60, 80, 84, 90, 98 and 100 film-coated tablets in non-perforated blisters; pack sizes of 50 x 1 and 56 x 1 film-coated tablet in unit dose blisters and pack size of 28 film-coated tablets in non-perforated calendar blisters.
Not all pack sizes may be marketed.
Teva B.V.
Swensweg 5 2031GA Haarlem The Netherlands
Teva Operations Poland Sp.z.o.o ul. Mogilska 80
31-546 Kraków Poland
Teva Pharmaceutical Works Private Limited Company Pallagi út 13
Debrecen H-4042 Hungary
Pharmachemie B.V. Swensweg 5
2031 GA Haarlem The Netherlands
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien
Tél/Tel: +32 38207373
Тева Фарма ЕАД Teл: +359 24899585
Teva Gyógyszergyár Zrt. Tel: +36 12886400
Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111
Teva Pharmaceuticals Ireland L-Irlanda
Τel: +44 2075407117
Teva Denmark A/S Tlf: +45 44985511
Teva Nederland B.V. Tel: +31 8000228400
TEVA GmbH
Tel: +49 73140208
Teva Norway AS Tlf: +47 66775590
UAB Teva Baltics Eesti filiaal Tel: +372 6610801
ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
Specifar A.B.E.E.
Τηλ: +30 2118805000
Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
Teva Pharma, S.L.U. Tel: +34 913873280
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550
Teva Santé
Tél: +33 155917800
Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Pliva Hrvatska d.o.o Tel: +385 13720000
Teva Pharmaceuticals Ireland Tel: +44 2075407117
Pliva Ljubljana d.o.o. Tel: +386 15890390
TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911
Teva Finland Oy Finnland
Sími: +358 201805900
Teva Finland Oy
Puh/Tel: +358 201805900
Teva Italia S.r.l. Tel: +39 028917981
Teva Sweden AB Tel: +46 42121100
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000
Teva Pharmaceuticals Ireland Ireland
Tel: +44 2075407117
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666
UAB Teva Baltics Tel: +370 52660203
Detailed information on Irbesartan Teva is available on the European Medicines Agency web site: