Irbesartan 300 Mg Film-Coated Tablets
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER
Irbesartan Medipha Sante 75 mg film-coated tablets Irbesartan Medipha Sante 150 mg film-coated tablets Irbesartan Medipha Sante 300 mg film-coated tablets
Irbesartan
Read all of this leaflet carefully before you start taking this medicine.
• 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 leaflet:
1. What Irbesartan Medipha Sante is and what it is used for
2. Before you take Irbesartan Medipha Sante
3. How to take Irbesartan Medipha Sante
4. Possible side effects
5. How to store Irbesartan Medipha Sante
6. Further information
1. WHAT Irbesartan Medipha Sante IS AND WHAT IT IS USED FOR
Irbesartan Medipha Sante 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 Medipha Sante prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Irbesartan Medipha Sante slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Medipha Sante is used:
• 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.
2. BEFORE YOU TAKE Irbesartan Medipha Sante Do not take Irbesartan Medipha Sante:
• If you are allergic (hypersensitive) to irbesartan or any other ingredients of Irbesartan Medipha Sante
• If you are more than 3 months pregnant. (It is also better to avoid Irbesartan Medipha Sante in early pregnancy - see pregnancy section)
Irbesartan Medipha Sante should not be given to children and adolescents (under 18 years).
Take special care with Irbesartan Medipha Sante Tell your doctor if any of the following apply to you if:
• You get excessive vomiting or diarrhoea
• You suffer from kidney problems
• You suffer from heart problems
• You receive Irbesartan Medipha Sante 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
• You are going to have an operation (surgery) or be given anaesthetics
You must tell your doctor if you think that you are (or might become) pregnant. Irbesartan Medipha Sante 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).
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Irbesartan Medipha Sante does not usually interact with other medicines.
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
If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.
Taking Irbesartan Medipha Sante with food and drink
Irbesartan Medipha Sante can be taken with or without food.
Pregnancy and breast-feeding Pregnancy
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 Medipha Sante before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan Medipha Sante. Irbesartan Medipha Sante 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 Medipha Sante 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
No studies on the effects on the ability to drive and use machines have been performed.
Irbesartan Medipha Sante 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.
Important information about some of the ingredients of Irbesartan Medipha Sante
This medicine contains lactose (a milk sugar). If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.
3. HOW TO TAKE Irbesartan Medipha Sante
Always take Irbesartan Medipha Sante exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Method of administration
Irbesartan Medipha Sante is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take your medicine 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 your medicine until your doctor tells you otherwise.
• Patients with high blood pressure
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.
• Patients with high blood pressure and type 2 diabetes with kidney disease
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 take more Irbesartan Medipha Sante than you should:
If you accidentally take too many tablets, contact your doctor immediately.
Children should not take Irbesartan Medipha Sante
Irbesartan Medipha Sante should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.
If you forget to take Irbesartan Medipha Sante:
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Irbesartan Medipha Sante 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 Medipha Sante and contact your doctor immediately.
The frequency of the side effects listed below is defined using the following convention: Very common: affects more than 1 user in 10 Common: affects 1 to 10 users in 100
Uncommon:
Rare:
Very rare: Not known:
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated from the available data
Side effects reported in clinical studies for patients treated with Irbesartan Medipha Sante 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 undesirable effects have been reported since marketing of Irbesartan Medipha Sante but the frequency for them to occur is not known. These undesirable effects are: 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).
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.
5. HOW TO STORE Irbesartan Medipha Sante
Keep out of the reach and sight of children.
Do not use Irbesartan Medipha Sante 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.
6. FURTHER INFORMATION
What Irbesartan Medipha Sante contains
• Irbesartan Medipha Sante 75 mg: Each tablet contains 75 mg irbesartan which is the active substance.
• Irbesartan Medipha Sante 150 mg: Each tablet contains 150 mg irbesartan which is the active substance.
• Irbesartan Medipha Sante 300 mg: Each tablet contains 300 mg irbesartan which is the active substance.
• The other ingredients are : lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, poloxamer 188, pregelatinised maize starch and magnesium stearate. The tablet coating contains Opadry white 20A28735 (which consists of: hydroxypropyl cellulose, hypromellose, titanium dioxide and talc).
What Irbesartan Medipha Sante looks like and contents of the pack
• Irbesartan Medipha Sante 75 mg: white to off-white, oblong, biconvex, film-coated tablets.
• Irbesartan Medipha Sante 150 mg: white to off-white, oblong, biconvex, film-coated tablets with a score line, with ‘G’ embossed on one side and plain on the other. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses
• Irbesartan Medipha Sante 300 mg: white to off-white, oblong, biconvex, film-coated tablets with a score line. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses
Irbesartan Medipha Sante film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
MEDIPHA SANTE Les Fjords - Immeuble Oslo 19 avenue de Norvege 91953 Courtaboeuf Cedex FRANCE
Manufacturer:
Genepharm S.A., 18 Km Marathon Avenue, 15351 Pallini, Greece