75 mg film-coated tablets
irbesartan

What Irbesartan STADA is and what it is used for

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

Irbesartan Stada is used

  • 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 Stada 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 use Irbesartan STADA

Do not take Irbesartan STADA

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Irbesartan Stada 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 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 (such as potassium ) in your blood at regular intervals.

See also more information under the heading “Do not take Irbesartan Stada”.

Tell your doctor if you think you may be pregnant or become pregnant during treatment, contact your doctor. Irbesartan Stada 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 breast-feeding).

Children and young people

This medicine should not be used by children and adolescents as the safety and efficacy of the medicine have not been fully evaluated.

Other medicines and Irbesartan STADA

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 ask you to take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan Stada” and “Warnings and precautions”).

You may need to take blood samples if you use:

  • potassium supplement
  • potassium-containing salt substitutes
  • potassium-sparing drugs (eg certain diuretics )
  • drugs containing lithium.

If you use certain painkillers, so-called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Irbesatan STADA with food and drink

Irbesartan Stada can be taken with or without food.

Pregnancy and breastfeeding

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.

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 Stada before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Irbesartan Stada 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 Stada 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

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

Irbesartan STADA contains lactose and sodium

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

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free. next to “sodium-free”.

How to use Irbesartan STADA

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

Method of administration

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

  • Patients with high blood pressure

The recommended dose is 150 mg once daily (two tablets daily). The dose can then be increased to 300 mg (four tablets daily) 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 (four tablets daily) is recommended once daily as a maintenance dose for the treatment of related 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.

If you take more Irbesartan STADA 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.

Irbesartan Stada should not be given to children

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

If you forget to take Irbesartan STADA

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 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 Stada and contact your doctor immediately.

Irbesartan Stada can cause the following side effects:

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 and blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase). Patients with high blood pressure and type 2 diabetes with kidney disease also reported dizziness 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, yellowing of the skin and / or whites of the eyes caused by problems with the liver or blood (jaundice).

Has been reported ( occurs in an unknown number of users):

  • headache, taste changes, ringing in the ears, a feeling of dizziness or vertigo ( vertigo ), muscle cramps, joint and muscle pain, liver effects, increased potassium level in the blood, impaired kidney function, inflammation of fine blood vessels especially in the skin (a condition called leukocytoclastic vasculitis ) , severe allergic reactions (anaphylactic shock ) and decreased platelet count, which increases the risk of bleeding or bruising ( thrombocytopenia ).

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 STADA

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 and blister after 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 Irbesartan Stada 75 mg film-coated tablet contains 75 mg irbesartan.

The other ingredients in the tablet core are:

  • lactose monohydrate
  • pregelatinized corn starch
  • kopovidon
  • croscarmellose (E468)
  • anhydrous colloidal silica (E551)
  • magnesium stearate (E470b)

Other content topics in the film coating are:

  • hypromellos (E464)
  • macrogol 400
  • titanium dioxide (E171)

What the medicine looks like and contents of the pack

Irbesartan Stada 75 mg film-coated tablets are white, biconvex, oval and approximately 10 mm long.

Pack sizes: 10, 14, 28, 30, 50, 56, 60, 90 and 98 tablets in blister packs of PVC / PVDC / Al.

Pack sizes: 10 x 1, 14 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1, 90 x 1 and 98 x 1 tablets in PVC / PVDC / Aluminum perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

PharmaCoDane ApS

Marielundvej 46A, 2730 Herlev

Denmark

Centrafarm Services BV

Nieuwe Donk 9, 4871 AC Etten-Leur

Netherlands

NV Eurogenerics SA

Heizel Esplanade B22, 1020 Brussels

Belgium

STADA Arzneimittel GmbH

Muthgasse 36, 1190 Vienna

Austria

Clonmel Healthcare Ltd.

Waterford Road, Clonmel, Co. Tipperary

Ireland

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark 

Muhammad Nadeem

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