Sabervel
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this le afle t:
What Sabervel is and what it is used for
Before you take Sabervel
How to take Sabervel
Possible side effects
How to store Sabervel
Further information
Medicinal product no longer authorised
Sabervel 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. Sabervel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Sabervel slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Sabervel 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 alle rgic (hypersensitive) to irbesartan or any other ingredients of Sabervel
if you are more than 3 months pre gnant. (It is also better to avoid Sabervel 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.
if you get e xcessive vomiting or diarrhoe a
if you suffer from kidne y proble ms
if you suffer from he art proble ms
if you receive Sabervel for diabe tic kidne y 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 ope ration (surgery) or be given anae sthetics.
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 Sabervel”.
You must tell your doctor if you think you are (or might become) pregnant. Sabervel 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 medicine should not be used in children and adolescents (under 18 years) because the safety and
efficacy have not yet been fully established.
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 Sabervel” and “Warnings and precautions”).
potassium supplements
salt substitutes containing potassium
potassium-sparing medicines (such as certain diuretics)
Medicinal product no longer authorised
medicines containing lithium
If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.
Sabervel can be taken with or without food.
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally
advise you to stop taking Sabervel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Sabervel. Sabervel 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. Sabervel 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.
No studies on the effects on the ability to drive and use machines have been performed. Sabervel 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.
sugars (e.g. lactose), contact your doctor before taking this medicine.
Always take Sabervel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Sabervel is for oral use . Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Sabervel 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 Sabervel 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 hae modialysis, or those ove r the age of 75 years.
The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.
Medicinal product no longer authorised
If you accidentally take too many tablets, contact your doctor immediately.
Sabervel should not be given to children under 18 years of age. If a child swallows some 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 product, ask your doctor or pharmacist.
Like all medicines, Sabervel 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 Sabe rvel and contact your doctor
The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more
Common: at least 1 in 100 and less than 1 in 10 patients
Uncommon: at least 1 in 1000 and less than 1 in 100 patientsSide effects reported in clinical studies for patients treated with Irbesartan were:
Very common : if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
Common : 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 : heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Some side effects have been reported since marketing of Irbesartan Side 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, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the sight and reach of children.
Medicinal product no longer authorised
Do not use Sabervel 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.
This medicinal product does not require any special storage conditions.
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.
The active substance is irbesartan. Each tablet of Sabervel 75 mg contains 75 mg irbesartan.
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silica colloidal anhydrous, hypromellose, magnesium stearate,
Film-coating: hypromellose, titanium dioxide (E171), macrogol 400
Sabervel 75 mg film-coated tablets are white, concave, round, film-coated tablets with 7 mm diameter.
Sabervel 75mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets. Not all pack sizes may be marketed.
Pharmathen S.A,
6 Dervenakion Str.,
15351 Pallini, Attiki, Greece
J. Uriach y Compañía, S.A. Av. Camí Reial, 51-57
08184 – Palau-solità i Plegamans, Barcelona, Spain
Pharmathen S.A,
6 Dervenakion Str.,
15351 Pallini, Attiki, Greece
Pharmathen International S.A. Industrial Park Sapes,
Rodopi Prefecture, Block No 5, Rodopi 69300, Greece
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Pharmathen S.A.
Tél/Tel: +30 210 66 65 067
Portfarma ehf.
Tel: +354 534 4030
Pharmathen S.A.
Teл.: +30 210 66 65 067
Portfarma ehf.
Tel: +354 534 4030
Medicinal product no longer authorised
Pharmathen S.A.
Tel: +30 210 66 65 067
Pharmathen S.A.
Tel.: +30 210 66 65 067
Portfarma ehf.
Tlf: +354 534 4030
Pharmathen S.A.
Tel: +30 210 66 65 067
Glenmark Arzneimittel GmbH
Tel: +49 8142 44392 0
Glenmark Generics B.V.
Tel: 0031 20 5226030
Portfarma ehf.
Tel: +354 534 4030
Pharmathen S.A.
Tlf: +30 210 66 65 067
Pharmathen Hellas S.A.
Τηλ: +30 210 66 04 300
Pharmathen S.A.
Tel: +30 210 66 65 067
Pharmathen S.A.
Tel: +30 210 66 65 067
Pharmathen S.A.
Tel.: +30 210 66 65 067
Pharmathen S.A.
Tél: +30 210 66 65 067
Pharmathen S.A.
Tel: +30 210 66 65 067
Pharmathen S.A.
Tel: +30 210 66 65 067
Pharmathen S.A.
Tel: +30 210 66 65 067
Aspire Pharma Limited
Tel: +44(0)1730 234527
Pharmathen S.A.
Tel: +30 210 66 65 067
Portfarma ehf.
Tel: +354 534 4030
Pharmathen S.A.
Tel: +30 210 66 65 067
Pharmathen S.A.
Tel: +30 210 66 65 067
Pharmathen S.A.
Puh/Tel: +30 210 66 65 067
C.V. MEDILINE LTD
Τηλ: +357 25761699
Pharmathen S.A.
Tel: +30 210 66 65 067
Portfarma ehf.
Tel: +354 534 4030
Medicinal product no longer authorised
Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa .eu/