Irbegen Plus

Irbegen Plus Side Effects

irbesartan + hydrochlorothiazide

Manufacturer:

Genepharm

Distributor:

SB Pharma
Full Prescribing Info
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.
Rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan.
Irbegen Plus should be discontinued if any of these symptoms or shortness of breath occur.
Side effects reported in clinical studies for patients treated with irbesartan/hydrochlorothiazide: Common side effects (may affect up to 1 in 10 people): nausea/vomiting; abnormal urination; fatigue; dizziness (including when getting up from a lying or sitting position); raised levels of creatine kinase, blood urea nitrogen, creatinine.
Uncommon side effects (may affect up to 1 in 100 people): diarrhoea; low blood pressure; fainting; heart rate increased; flushing; swelling; sexual dysfunction; lowered levels of potassium and sodium in the blood.
Side effects reported since the launch of irbesartan/hydrochlorothiazide: Some undesirable effects have been reported since marketing of irbesartan/hydrochlorothiazide. Undesirable effects where the frequency is not known are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired kidney function, increased level of potassium in the blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat. Uncommon cases of jaundice have also been reported.
As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
Side effects associated with irbesartan alone: In addition to the side effects previously listed, chest pain, severe allergic reactions (anaphylactic shock), anaemia (symptoms may include tiredness, headaches, shortness of breath when exercising, dizziness and looking pale) and decrease in the number of platelets and low blood sugar levels have also been reported.
Side effects associated with hydrochlorothiazide alone: Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice; inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which can result in frequent infections, fever; decrease in the number of platelets; anaemia (characterised by tiredness, headaches, shortness of breath when exercising, dizziness and looking pale); kidney disease; lung problems including pneumonia or build-up of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin all over the body; cutaneous lupus erythematosus; allergic reactions; weakness and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of blood fat; high uric acid levels in the blood.
Very rare side effects (may affect up to 1 in 10,000 people): Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).
Not known (frequency cannot be estimated from the available data): skin and lip cancer (non-melanoma skin cancer), eye disorders (secondary acute angle-closure glaucoma, acute myopia and choroidal effusion).
It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.
Reporting of side effects: Side effects should be reported. This includes any possible side effects not previously listed. By reporting side effects, patients can help provide more information on the safety of this medicine.
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