Irbesartan Sandoz 300mg Film-Coated Tablets
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Irbesartan Sandoz 75 mg film-coated tablets Irbesartan Sandoz 150 mg film-coated tablets Irbesartan Sandoz 300 mg film-coated tablets
Irbesartan
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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.
What is in this leaflet:
1. What Irbesartan is and what it is used for
2. What you need to know before you take Irbesartan
3. How to take Irbesartan
4. Possible side effects
5. How to store Irbesartan
6. Contents of the pack and other information
Irbesartan belongs to a group of medicines known as angiotensin II receptor antagonists. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them. Irbesartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan tablets are used to treat:
• high blood pressure (hypertension).
• kidney disease in patients with hypertension and type 2 diabetes mellitus as part of a treatment of hypertension.
2 What you need to know before you take Irbesartan
Do NOT take Irbesartan if you:
• are allergic to irbesartan or to any of the ingredients in preparation (see section 6).
• are more than 3 months pregnant. (It is also better to avoid Irbesartan in early pregnancy - see pregnancy section).
If you think any of the above situations applies to you, consult your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Irbesartan if you:
• have kidney problems.
• have heart problems.
• have had a kidney transplant recently.
• are vomiting, have recently been vomiting or have diarrhoea.
• have diabetic kidney disease.
• have a disease of the adrenal gland (Conn’s disease -hyperaldosteronism).
Children and adolescents
Irbesartan should not be used in children and adolescents because the safety and efficacy have not yet been fully established.
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 if used at that stage (see pregnancy section).
Other medicines and Irbesartan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Irbesartan can affect the way some other medicines work and some medicines can have an effect on irbesartan.
If you are taking certain medicines, your doctor may need to do blood tests from time to time.
In particular, tell your doctor if you are taking any of the following medicines:
• to help lower your blood pressure, including ACE inhibitors.
• water tablets (diuretics).
They can have synergistic effect with Irbesartan.
• ibuprofen, naproxen or diclofenac, medicines that are known as non-steroidal anti-inflammatory drugs (NSAIDs).
• celecoxib or etoricoxib, medicines that are known as COX-2 inhibitors.
• acetylsalicylic acid (Aspirin), if you are taking more than 3 g each day.
• potassium supplements or salt substitutes containing potassium.
They can worsen your renal function, increase potassium in your blood and reduce the blood-lowering effect of Irbesartan.
• lithium (a medicine for treatment of mania or depression). Irbesartan may potentate effect of lithium.
Taking Irbesartan with food and drink
You can take Irbesartan with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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 of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan 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
This medicine does not affect your alertness but you may feel weak due to a decrease in your blood pressure which may occur, especially at the beginning of treatment or when increasing the dose. If this happens, your ability to drive or to operate machinery may be affected.
Irbesartan 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.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The following strengths are available: 75 mg, 150 mg and 300 mg.
Take your tablet(s) with a glass of water, preferably at the same time each day, with or without food.
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Use in high blood pressure only: The usual dose is 150 mg once daily. The dose can be increased to 300 mg, or other medicines used to treat high blood pressure, such as a water tablet, may be prescribed. Your doctor will adjust your dose according to your blood pressure response.
Use in high blood pressure with type 2 diabetes
Treatment should be started at 150 mg daily and increased up to 300 mg once daily.
Use in impaired kidney function
No dosage adjustment is necessary in patients with impaired kidney function. Your doctor may prescribe lower starting dose, 75 mg if you are undergoing haemodialysis.
Use in impaired liver function
Your doctor will decide the most appropriate dose for you if you have liver problems.
Use in the elderly (over 75 years)
Your doctor may prescribe a lower dose although most elderly patients can take the dose.
Use in patients of black origin
The effect of irbesartan may be reduced and therefore the dose will need to be adjusted. Additional medicines may be needed more frequently for blood pressure control in this population.
Use in children and adolescents
Irbesartan should not be given to children and
adolescents.
If you take more Irbesartan than you should
If you take too many tablets, contact your nearest hospital casualty department or tell your doctor immediately. If this happens, you may experience symptoms such as dizziness or faintness due to a drop in blood pressure. If this occurs, lying down with the legs raised can help.
If you forget to take Irbesartan
It is important to take your medicine every day. However, if you forget to take a dose, take it as soon as you remember and then continue with your normal schedule. Do not take a double dose to make up for a forgotten dose.
If you stop taking Irbesartan
Always consult your doctor, if you wish to stop taking this medicine. Even if you feel well, it may be necessary to continue taking this medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
• muscle cramps
• pain in joints and muscles
• worsening of your kidney function
• inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis)
• levels of creatinine kinase, haemoglobin (pigment in red blood cells) in your blood may increase.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Keep out of the reach and sight of children.
Do not use Irbesartan after the expiry date which is stated on the outer carton, the blister and bottle after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
After first opening the bottles: 3 months.
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 Contents of the pack and other information
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following side effects, stop taking the tablets and contact your doctor immediately:
• swelling of the face, lips, mouth, tongue eyes or throat
• difficulty in breathing.
These are symptoms of a serious allergic reaction which must be treated immediately, usually in a hospital.
Very common (occur in more than 1 user in 10):
• levels of potassium in your blood may increase.
Common (occur in 1 to 10 users in 100):
• dizziness
• nausea, vomiting
• orthostatic dizziness
• fatigue
• orthostatic hypotension
• muscle pain.
Uncommon (occur in 1 to 10 users in 1,000)
• faster heart rate (tachycardia)
• flushing
• cough
• problems with sexual performance
• chest pain
• diarrhoea
• indigestion, heartburn
• yellowing of the skin and/or eyes, also called jaundice.
Frequency is not known
• rash or allergic skin reaction
• headache
• feeling of spinning
• ringing in the ears (tinnitus)
• taste disturbance
• liver inflammation (hepatitis)
What Irbesartan contains
- The active substance is Irbesartan. Each tablet contains 75, 150 or 300 mg irbesartan.
- The other ingredients are:
Tablet core:
Microcrystalline cellulose, Lactose monohydrate, Croscarmellose sodium, Silica, colloidal anhydrous, Hypromellose, Magnesium stearate.
Tablet coating:
Hypromellose, Hydroxypropylcellulose, Macrogol 6000, Lactose monohydrate, Titanium dioxide (E 171), Talc.
What Irbesartan looks like and contents of the pack
Irbesartan 75 mg film-coated tablets are white, oval biconvex film-coated tablets, debossed with ‘75’ on one side and scored on the other side.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Irbesartan 150 mg film-coated tablets are white, oval biconvex film-coated tablets, debossed with ‘150’ on one side and scored on the other side.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Irbesartan 300 mg film-coated tablets are white, oval biconvex film-coated tablets, debossed with ‘300’ on one side and scored on the other side.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Irbesartan is available in blister (oPA/Al/PVC//Al or PVC/PVDC//Al) or in bottle (high density polyethylene (HDPE) container).
oPA/Al/PVC//Al or PVC/PVDC//Al blisters: 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 98, 100 film-coated tablets.
oPA/Al/PVC//Al or PVC/PVDC//Al unit dose blisters: 56 x 1, 100 x 1 film-coated tablets.
HDPE bottle: 100, 250 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Lek Pharmaceuticals d.d., Verovskova 57,1526 Ljubljana, Slovenia or Lek S.A., ul. Domaniewska 50 C, 02-672 Warsaw, Poland or Salutas Pharma GmbH, Otto-von-Guericke-Allee-1, 39179 Barleben, Germany or Salutas Pharma GmbH, Dieselstrasse 5, D-70839 Gerlingen, Germany or Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia.
This leaflet was last revised in 07/2012.
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