150 mg film-coated tablets
irbesartan

What Irbesartan Sandoz is and what it is used for

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

Irbesartan Sandoz tablets are 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 Sandoz may also be approved for the treatment of other conditions not mentioned in this 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 Sandoz

Take NOT Irbesartan Sandoz

  • if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6)
  • if you are pregnant and the pregnancy has lasted longer than 3 months . (It is best to avoid Irbesartan Sandoz during early pregnancy as well – see the section 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 Sandoz 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 Sandoz for diabetes-related kidney disease. Then your doctor may take regular blood tests, especially to measure potassium levels 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 Sandoz”.

If you think you may be pregnant or become pregnant during treatment, consult your doctor. Irbesartan Sandoz is not recommended in early pregnancy and should not be used if the pregnancy has lasted more than 3 months, as it may cause birth defects (see Pregnancy and breast-feeding).

Children and young people

This medicine should not be used by children and adolescents (under 18 years of age) as the safety and efficacy of the medicine have not been fully evaluated.

Other medicines and Irbesartan Sandoz

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 Sandoz” 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 Sandoz with food and drink

Irbesartan Sandoz can be taken with or without food.

Pregnancy and breastfeeding

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 Sandoz before pregnancy or as soon as you know you are pregnant and will recommend another medicine to you instead. Irbesartan Sandoz should not be used in early pregnancy and should not be taken if the pregnancy has lasted more than 3 months, as it may cause birth defects.

Breast-feeding

Tell your doctor if you are breastfeeding or planning to start breastfeeding. Irbesartan Sandoz 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 born prematurely.

Driving and using machines

Irbesartan Sandoz 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 vigilance. 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 Sandoz contains excipients

Irbesartan Sandoz contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Irbesartan Sandoz contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free.

3. How to take Irbesartan Sandoz

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

Method of administration

Irbesartan Sandoz is taken  by mouth . Swallow the tablets with a sufficient amount of drink (eg a glass of water). The breaker is not for dividing the tablet into equal doses but only for easier swallowing. You can take Irbesartan Sandoz 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 Sandoz until your doctor tells you otherwise.

  • Patients with high blood pressureThe 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 diseaseIn patients with high blood pressure and type 2 diabetes , 300 mg once daily is preferred as the maintenance dose for the treatment of concomitant kidney disease.

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.

Use for children and adolescents

Irbesartan Sandoz should not be given to children and adolescents under 18 years of age. If a child swallows any tablets, contact a doctor immediately.

If you take more Irbesartan Sandoz than you should

If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Irbesartan Sandoz

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 Irbesartan Sandoz and contact your doctor immediately.

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

  • 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 may show an increased level of potassium .
  • Common (may affect up to 1 in 10 people):dizziness, nausea / vomiting, fatigue and blood tests that may show increased levels of an enzyme that measures muscle and heart function (creatinine 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 Sandoz. Side effects without known frequency are decreased a number of platelets, dizziness, headache, taste changes, ringing in the ears, muscle cramps, joint and muscle pain, 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 ), and severe allergic reactions (anaphylactic shock ). 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

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 Sandoz

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

Do not store above 30 ° C.

After the jar has been opened for the first time, it must be used within 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 packaging and other information

Content declaration

  • The active substance is irbesartan.Each tablet contains 150 mg irbesartan.
  • The other ingredients are microcrystalline cellulose, microcrystalline cellulose (silica), lactose monohydrate , croscarmellose sodium , anhydrous silica ( colloidal ), hypromellose, magnesium stearate, hydroxypropylcellulose, macrogol 6000, titanium dioxide (E 171) and talc

What the medicine looks like and contents of the pack

Irbesartan Sandoz film-coated tablets: White, oval, biconvex coated tablets with the imprint “150” on one side and a break notch on the other side.

The tablets are packaged in OPA / Alu / PVC // Alu or PVC / PVDC // Alu-blister and stored in a carton, or packaged in an HDPE jar with a PP screw cap.

Blister packs: 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets.

Perforated unit dose blisters: 56 x 1 or 100 x 1 film-coated tablets.

Jar: 100 or 250 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz A / S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Muhammad Nadeem

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