75 mg, 150 mg, 300 mg tablets
Irbesartan

What Irbesartan Aurobindo is and what it is used for

Irbesartan Aurobindo 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 Aurobindo prevents the binding of angiotensin -II to these receptors, which causes the blood vessels to relax and the blood pressure to drop. Irbesartan Aurobindo delays the deterioration of renal function in patients with high blood pressure and type 2 diabetes.

Irbesartan Aurobindo is used in adult patients

  • 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 Irbesartan Aurobindo may also be approved for the treatment of other conditions not mentioned in this product information. 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 you take Irbesartan Aurobindo

Do not take Irbesartan Aurobindo

  • If you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6).
  • Pregnant women should not use Irbesartan Aurobindo during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Irbesartan Aurobindo, see Pregnancy and breast-feeding).
  • if you have diabetes or renal impairment and are being treated with a blood pressure lowering medicine containing aliskiren

Warnings and cautions

Talk to your doctor before taking Irbesartan Aurobindo and if any of the following apply to you:

  • if you experience severe vomiting or diarrhea
  • if you suffer from kidney problems
  • if you suffer from heart problems
  • if you are receiving Irbesartan Aurobindo for diabetes-related kidney disease . Then your doctor may take regular blood tests, especially to measure the level of potassium in the blood in case of poor kidney function.
  • if you are going to have surgery or get anesthesia .
  • 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 Aurobindo”.

If you think you may be pregnant or become pregnant during treatment, consult your doctor. Irbesartan Aurobindo is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects, see Pregnancy and breastfeeding.

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 Aurobindo

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 Aurobindo” 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 Aurobindo with food and drink

Irbesartan Aurobindo can be taken with or without food.

Pregnancy, breastfeeding and fertility

Pregnancy
If you think you may be pregnant or become pregnant during treatment, consult your doctor. Your doctor will usually suggest that you stop taking Irbesartan Aurobindo before pregnancy or as soon as you know you are pregnant and then recommend another medicine to you. Irbesartan Aurobindo should not be used in early pregnancy and should not be used during the last 6 months of pregnancy, as it may cause birth defects.

Breast-feeding
Tell your doctor if you are breastfeeding or planning to start breastfeeding. Irbesartan Aurobindo is not recommended for breastfeeding and your doctor may choose another treatment for you if you want to breastfeed your baby, especially if your baby is newborn or prematurely born.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No studies have been performed on the ability to drive or use machines. Irbesartan Aurobindo 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 sharpened 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.

How to take Irbesartan Aurobindo

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.


Method of administration Irbesartan Aurobindo is taken by mouth. Swallow the tablets with a sufficient amount of drink (eg a glass of water). You can take Irbesartan Aurobindo with or without food. Try to take your daily dose at about the same time each day. You must continue to take Irbesartan Aurobindo until your doctor tells you otherwise.

  • Patients with high blood pressure The
    usual dose is 150 mg once a day. The dose can then be increased to 300 mg once daily depending on the effect on blood pressure .
  • 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 preferred as the maintenance dose.

The doctor may, especially when starting treatment, prescribe a lower dose to certain 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.

If you take more Irbesartan Aurobindo than you should

If you accidentally take too many tablets, contact a doctor immediately.
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.

Use for children and adolescents

Irbesartan Aurobindo should not be used in children below 18 years of age. If a child swallows any tablets, contact a doctor immediately.

If you forget to take Irbesartan Aurobindo

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 tablet.

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 medications, 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 Irbesartan Aurobindo and contact your doctor immediately.

The frequency of side effects listed below is defined according to the following convention:
Very common: may affect more than 1 in 10 patients
Common: may affect up to 1 in 10 patients
Uncommon: may affect up to 1 in 100 patients

In clinical trials, the following adverse reactions were reported in patients treated with Irbesartan Aurobindo:

  • Very common (may affect more than 1 in 10 people): if you have high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium .
  • Common (may affect up to 1 in 10 people): dizziness, nausea / vomiting, fatigue and 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 lying 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): palpitations, redness , cough, diarrhea, indigestion / heartburn, impaired sexual ability and chest pain.

Some side effects have been reported since the launch of Irbesartan Aurobindo. Side effects without known frequency are dizziness, headache, taste changes, ringing in the ears, muscle cramps, joint and muscle pain, decreased number of platelets, liver effects, increased potassium levels in the blood, impaired kidney function, and 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.

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly via the Medical Products Agency

Box 26

751 03 Uppsala

By reporting side effects, you can help increase drug safety 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 Aurobindo

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 label after EXP. date. respectively EXP. The expiration date is the last day of the specified month.

No special storage instructions.

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 tablet contains 75 mg irbesartan.
    Each tablet contains 150 mg irbesartan.
    Each tablet contains 300 mg irbesartan.

The other ingredients are Microcrystalline cellulose101, calcium hydrogen phosphate dihydrate, sodium starch glycolate (Type A), hypromellose (5cp), polysorbate 80, talc, colloidal, anhydrous silica, sodium stearyl fumarate.

What the medicine looks like and contents of the pack

Tablet.

Irbesartan Aurobindo 75 mg tablets
White to off-white, biconvex, oval uncoated tablets with “H 28” debossed on one side and smooth on the other.

Irbesartan Aurobindo 150 mg tablets
White to off-white, biconvex, oval uncoated tablets with “H 29” debossed on one side and smooth on the other.

Irbesartan Aurobindo 300 mg tablets
White to off-white, biconvex, oval uncoated tablets with “H 30” debossed on one side and smooth on the other.

Irbesartan Aurobindo tablets are available in PVC / PVdC-Aluminum blister packs and HDPE cans with polypropylene lids.

Pack sizes:
Blister: 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 98 and 100 tablets
HDPE cans: 30 and 500 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Aurobindo Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana FRN 1913
Malta

Manufacturer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Muhammad Nadeem

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