Irbesartan 75 Mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Irbesartan 75 mg
tablets
Irbesartan 150 mg
tablets
Irbesartan 300 mg
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 doctoror 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 becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Irbesartan is and what it is used for
2. Beforeyoutake Irbesartan
3. Howto take Irbesartan
4. Possible side effects
5. Howto store Irbesartan
6. Further information
1. WHAT IRBESARTAN IS AND WHAT IT IS USEDFOR
Irbesartan belongs to a group of medicines known asangiotensin-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 prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax andthe blood pressureto lower. Irbesartan slows the decrease of kidney
function in patients with high blood pressure andtype 2 diabetes.
Irbesartan 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
Do not take Irbesartan
- if you are allergic (hypersensitive) to irbesartan or any other ingredients of Irbesartan tablets
- if you are more than 3 months pregnant. (It is also better to avoid Irbesartan in early pregnancy - see pregnancy section)
Irbesartan should not be given to children and adolescents (under 18 years).
Take special care with Irbesartan
Tell your doctor if any of the following apply to you:
- if you get excessive vomitingor diarrhoea;
- if you sufferfrom kidney problems;
- if you sufferfrom heart problems;
- if you receive irbesartan 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.
You must tell your doctor if you think you are (or might become) pregnant. Irbesartan 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 at that stage (see pregnancy section).
Takingother medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained withouta prescription.
Irbesartan 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 nonsteroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.
Taking Irbesartan with food and drink
Irbesartan can betaken with orwithoutfood.
Pregnancyand 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 before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan. Irbesartan 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 ofpregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan is not recommended for mothers who are breastfeeding, 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 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
Irbesartan contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOWTOTAKEIRBESARTAN
Always take irbesartan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Method ofadministration
Irbesartan is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass
of water). You can take irbesartan 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 until your doctor tellsyou 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 theageof75years.
The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.
If you take more Irbesartan than you should
If you accidentally take too many tablets, contact your doctor immediately.
Children should nottake Irbesartan
Irbesartan should not be given to children under 18 years of age. If a child swallows some tablets, contactyourdoctor immediately.
If you forget to take Irbesartan
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for aforgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLESIDEEFFECTS
Like all medicines, irbesartan 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 and contact your doctor immediately.
The frequency ofthe side effects listed below is definedusing the following convention:
Very common: at least 1 in 10 patients or more Common:atleast1 in100andlessthan1 in 10 patients
Uncommon: at least 1 in 1000 and less than 1 in 100 patients
Side effects reported in clinical studies for patientstreatedwithirbesartanwere:
♦ Verycommon: ifyou suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level ofpotassium.
♦ Common: dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heartfunction (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizzinesswhen 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: increased heart rate, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chestpain.
Some undesirable effects have been reported since marketing of Irbesartan butthefrequency 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 leukocytoclasticvasculitis).
If any of the side effects becomes severe, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOWTOSTOREIRBESARTAN
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not use irbesartan after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day
ofthatmonth.
No 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. FURTHERINFORMATION
What Irbesartan contains
- The active substance is irbesartan.
Each Irbesartan 75 mg tablet contains 75 mg irbesartan.
Each Irbesartan 150 mg tablet contains 150 mg irbesartan.
Each Irbesartan 300 mg tablet contains 300 mg irbesartan.
- The other ingredients are lactose monohydrate, colloidal anhydrous silica, microcrystalline cellulose, croscarmellose sodium, hypromellose, pregelatinized starch, magnesium stearate, titanium dioxide (E171) and macrogol 4000.
What Irbesartan looks like and contents of the pack
- Irbesartan 75 mg tablets are white to off-white, oval shaped, tablets debossed with “J” on one side and “75” on the other.
- Irbesartan 150 mg tablets are white to off-white, oval shaped, tablets debossed with “J” on one side and “150” on the other.
- Irbesartan 300 mg tablets are white to off-white, oval shaped, tablets debossed with “J” on one side and “300” on the other.
Irbesartan film-coated tablets are supplied in blisterpacks of28,56,84or98tablets.
Notallpacksizesmaybemarketed.
Marketing Authorisation Holder:
Waymade Plc
Trading as: Sovereign Medical
Sovereign House
MilesGrayRoad
Basildon
Essex
SS143FR
United Kingdom
Manufacturer:
PSI supplynv Axxes Business Park Guldensporenpark22 - BlockC
9820 Merelbeke Belgium
Waymade Plc
Sovereign House
MilesGrayRoad
Basildon
Essex
SS143FR
United Kingdom