75 mg, 150 mg, 300 mg film-coated tablets
irbesartan
What Irbesartan Accord is and what it is used for
Irbesartan Accord belongs to a group of medicines called angiotensin -II receptor antagonists.
Angiotensin -II is a substance, which is produced in the body, and which binds to certain structures ( receptors ) in the blood vessels and causes them to constrict. This leads to increased blood pressure. Irbesartan Accord prevents the binding of angiotensin II to these receptors, which causes the blood vessels to relax and the blood pressure to drop. Irbesartan Accord delays the deterioration of renal function in patients with high blood pressure and type 2 diabetes.
Irbesartan Accord is used in adults
- in the treatment of hypertension ( essential hypertension )
- to protect the kidneys in patients with high blood pressure , type 2 diabetes and renal impairment detected in laboratory tests.
Irbesartan contained in the Irbesartan Accord may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Irbesartan Accord
Do not take Irbesartan Accord
- If you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6).
- If you are pregnant later than the third month. (It is also good to avoid Irbesartan Accord during the previous pregnancy, see Pregnancy and breast-feeding).
- If you have diabetes or kidney problems and are being treated with a blood pressure lowering medicine containing aliskiren
Irbesartan Accord should not be used in children and adolescents under 18 years of age.
Warnings and cautions
Talk to your doctor or pharmacist before taking Irbesartan Accord if any of the following apply to you:
- you get severe vomiting or diarrhea
- you suffer from kidney problems
- you suffer from heart problems
- you get Irbesartan Accord for diabetes-related kidney disease. Then the doctor may take regular blood tests, especially to measure the level of potassium in the blood in case of poor kidney function.
- you need surgery or anesthesia.
- You must tell your doctor if you think you are (or might become) pregnant. Irbesartan Accord is not recommended during early pregnancy and should not be taken if you are pregnant for more than three months as it may cause birth defects (see section on pregnancy).
- if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (eg enalapril , lisinopril, ramipril), especially if you have diabetes-related kidney problems.
- aliskiren.
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.
See also the information under the heading “Do not take Irbesartan Accord”.
Children and young people
This product should not be used by children and adolescents as the safety and efficacy of the drug have not been fully evaluated.
Other medicines and Irbesartan Accord
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 take other precautions:
- If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Irbesartan Accord” and “Warnings and precautions”).
You may need to take blood samples if you use:
- potassium supplement
- potassium-containing salt substitutes
- potassium-sparing medicines (eg certain diuretics )
- medicines containing lithium.
If you use certain painkillers, so-called non-steroidal anti-inflammatory drugs, the effect of Irbesartan may be reduced.
Irbesartan Accord with food and drink
Irbesartan Accord can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will usually suggest that you stop taking Irbesartan Accord before pregnancy or as soon as you know you are pregnant and instead recommend a medicine other than Irbesartan Accord to you. Irbesartan Accord is not recommended during early pregnancy and should not be taken if you are pregnant later than the third month as it may cause serious birth defects if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breastfeeding or planning to start breastfeeding. Irbesartan Accord is not recommended for women who are breastfeeding and your doctor may choose another treatment for you if you want to breastfeed your baby, especially if your baby is newborn or born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Irbesartan Accord is unlikely to affect your ability to drive or use machines. Occasionally, however, dizziness or fatigue may occur during treatment of high blood pressure. If you experience this, talk to your doctor before driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Irbesartan Accord contains lactose (as lactose monohydrate)
Irbesartan Accord contains lactose (as 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. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
3. How to take Irbesartan Accord
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Method of administration
Irbesartan Accord is taken by mouth. Swallow the tablets with a sufficient amount of drink (eg a glass of water). You can take Irbesartan Accord 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 Accord until your doctor tells you otherwise.
- Patients with high blood pressure The usual dose is 150 mg once a day. Dose a can then be increased to 300 mg once daily depending on blood pressure et
- Patients with high blood pressure and type 2 diabetes with kidney diseaseIn patients with high blood pressure and type 2 diabetes with kidney disease, 300 mg once daily is preferable as a maintenance dose.
The doctor may, especially when starting treatment, recommend a lower dose to some patients e.g. those treated with hemodialysis, or those older than 75 years.
Maximum reduction in blood pressure is obtained 4-6 weeks after starting treatment.
Use for children and adolescents
Irbesartan Accord should not be given to children under 18 years of age. If a child swallows any tablets, contact a doctor immediately.
If you take more Irbesartan Accord than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you accidentally take too many tablets, contact a doctor immediately.
If you forget to take Irbesartan Accord
If you accidentally skip a daily dose , just take the next dose normally. 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, this medicine can cause side effects, although not everybody gets them. Some side effects can be serious and may require medical attention.
As with similar medicines, rare cases of allergic skin reactions (skin rash, hives ), as well as local swelling of the face, lips and / or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or if you have difficulty breathing, stop taking this medicine and contact a doctor immediately .
The frequency of side effects listed below is defined according to the following convention:
Very common (may affect more than 1 user in 10)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Adverse reactions reported in clinical trials in patients treated with irbesartan tablets:
Very common (may affect more than 1 user in 10):
- If you have high blood pressure and type 2 diabetes with kidney disease, blood tests can show an increased level of potassium .
Common (may affect up to 1 in 10 people):
- dizziness
- nausea / vomiting, fatigue
- blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase)
- In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness was reported when getting up from a supine or sitting position, low blood pressure when getting up from a lying or sitting position, and joint or muscle pain and decreased levels of a protein in the red blood cells ( hemoglobin ).
Uncommon (may affect up to 1 in 100 people):
- palpitation
- redness
- cough
- diarrhea
- indigestion / heartburn
- impaired sexual ability
- chest pain.
Some side effects have been reported since the introduction of the Irbesartan Accord. Adverse reactions that have been reported (occurring in an unknown number of users) are:
- decreased platelet count
- spinning feeling
- headache
- taste changes
- ringing in the ears
- muscle cramps
- joint and muscle pain
- abnormal liver function test
- increased potassium levels in the blood
- renal impairment
- inflammation of fine blood vessels especially in the skin (a condition called leukocytoclastic vasculitis ).
Jaundice (yellowing of the skin and / or whites of the eyes) has, as a less common side effect , also been reported.
If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Irbesartan Accord
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions are recommended.
Do not remove the tablets from the blister card until it is time for you to take the medicine.
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 packaging and other information
Content declaration
- The active substance is irbesartan. Each film-coated tablet Irbesartan 75 mg, 150 mg, 300 mg contains 75 mg, 150 mg and 300 mg irbesartan, respectively.
- The other ingredients in the tablet core are lactose monohydrate , croscarmellose sodium (E468), microcrystalline cellulose (E460), hypromellose E5 (E464), colloidal anhydrous silica (E551), magnesium stearate (E572).
- The other ingredients in the tablet coating are hypromellose E5 (E464), macrogol 400, lactose monohydrate and titanium dioxide (E171).
What the medicine looks like and contents of the pack
Irbesartan Accord 75 mg film-coated tablet is white to off-white, oval, biconvex, marked I 75 ‘on one side and smooth on the other side.
Irbesartan Accord 150 mg film-coated tablet is white to off-white, oval, biconvex, marked I 150 ‘on one side and smooth on the other side.
Irbesartan Accord 300 mg film-coated tablet is white to off-white, oval, biconvex marked I 300 ‘on one side and smooth on the other side.
Irbesartan Accord 75 mg, 150 mg and 300 mg tablets are supplied in blister packs of 8, 14, 28, 30, 56, 64, 90 and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht
Netherlands
Manufacturer:
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, HA1 4HF
UK
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare BV,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands