Irbegen Plus

Irbesartan, hydrochlorothiazide.

IRBEGEN PLUS TABLETS 150MG/12.5MG are light pink, oblong, and biconvex.
Each tablet of IRBEGEN PLUS TABLETS 150MG/12.5MG contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
IRBEGEN PLUS TABLETS 300MG/12.5MG are light pink, oblong, and biconvex.
Each tablet of IRBEGEN PLUS TABLETS 300MG/12.5MG contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
IRBEGEN PLUS TABLETS 300MG/25MG are red-brick, oblong, biconvex, and with a scoreline.
Each tablet of IRBEGEN PLUS TABLETS 300MG/25MG contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Excipients/Inactive Ingredients: The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, poloxamer 188, pregelatinised starch and magnesium stearate. Furthermore, the tablet coating of IRBEGEN PLUS TABLETS 150MG/12.5MG and IRBEGEN PLUS TABLETS 300MG/12.5MG also contains Opadry pink 03A34089 (which consists of hypromellose, stearic acid, titanium dioxide, microcrystalline cellulose, iron oxide yellow and iron oxide red). The tablet coating of IRBEGEN PLUS TABLETS 300MG/25MG also contains Opadry pink 03A36005 (which consists of hypromellose, stearic acid, titanium dioxide, microcrystalline cellulose, iron oxide black and iron oxide red).

Irbegen Plus is a combination of two active substances, irbesartan and hydrochlorothiazide.
Irbesartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Hydrochlorothiazide is a thiazide diuretic that causes increased urine output and so causes a lowering of blood pressure.
The two active ingredients in Irbegen Plus work together to lower blood pressure further than if either was given alone.

Irbegen Plus is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of blood pressure.

Patients should always take this medicine exactly as prescribed. Patients should be advised if they are unsure.
Dosage: The recommended dose of Irbegen Plus is one tablet a day. Irbegen Plus will usually be prescribed when previous treatment did not reduce the blood pressure enough. Patients will be instructed how to switch from the previous treatment to Irbegen Plus.
Method of administration: Irbegen Plus is for oral use. The tablets should be swallowed with a sufficient amount of fluid (e.g. one glass of water). Irbegen Plus can be taken with or without food. The daily dose should be taken at about the same time each day. It is important to continue taking Irbegen Plus until instructed otherwise.
The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment.
Children should not take Irbegen Plus: Irbegen Plus should not be given to children under 18 years of age. Immediate medical attention is needed if a child swallows some tablets.
Forgotten intake of Irbegen Plus: If a daily dose is accidentally missed, the next dose should be taken as normal. A double dose should not be taken to make up for a forgotten dose.

Immediate medical attention is needed if too many tablets are accidentally taken.

Irbegen Plus should not be taken in case of: allergy to irbesartan or any of the other ingredients of this medicine (listed in Description); allergy to hydrochlorothiazide or any other sulfonamide-derived medicines; pregnancy of more than 3 months (Irbegen Plus should be avoided in early pregnancy, see Use in Pregnancy & Lactation); severe liver or kidney problems; difficulty in producing urine; persistently high calcium or low potassium levels in the blood; diabetes or impaired kidney function and treatment with a blood pressure lowering medicine containing aliskiren.
The concomitant use of Irbegen Plus with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²).

Kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in the blood should be checked at regular intervals.
Use with caution in patients: on a low-salt diet; who have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heartbeat which may indicate an excessive effect of hydrochlorothiazide; who experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal; who are going to have an operation (surgery) or be given anaesthetics.
The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.
Patients should exercise caution before taking Irbegen Plus and if any of the following is applicable: excessive vomiting or diarrhea; suffering from kidney problems, or with a kidney transplant; suffering from heart problems; suffering from liver problems; suffering from diabetes; low blood sugar levels develop (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat), particularly if being treated for diabetes; suffering from lupus erythematosus (also known as lupus or SLE); suffering from primary aldosteronism; taking an ACE inhibitor (for example enalapril, lisinopril, ramipril) in particular if with diabetes-related kidney problems; taking aliskiren; history of skin cancer, or an unexpected skin lesion developed during treatment; breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past.
Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). The skin should be protected from sun exposure and UV rays while taking Irbegen Plus.
If patients develop any severe shortness of breath or difficulty breathing after taking Irbegen Plus, immediate medical attention should be sought.
Non-melanoma skin cancer: An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry. Photosensitizing actions of hydrochlorothiazide could act as a possible mechanism of NMSC.
Patients taking hydrochlorothiazide should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions. Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients in order to minimize the risk of skin cancer. Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies. The use of hydrochlorothiazide may also need to be reconsidered in patients who have experienced previous NMSC.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS): There is evidence that the concomitant use of ACE inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended.
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Choroidal effusion, secondary acute angle-closure glaucoma and/or acute myopia: Sulfonamide or sulfonamide derivative drugs can cause an idiosyncratic reaction, which may result in choroidal effusion, secondary acute angle-closure glaucoma and/or acute transient myopia. Symptoms include acute onset of decreased visual acuity, blurred vision or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
Irbegen Plus contains lactose: Before taking this medicinal product, patients should be informed if they have an intolerance to some sugars (e.g. lactose).
Driving and using machines: Irbegen Plus is unlikely to affect the ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If patients experience these, they should be advised before attempting to drive or use machines.
Use in Pregnancy: Irbegen Plus is not recommended in early pregnancy, and must not be taken by patients who are more than 3 months pregnant, as it may cause serious harm to the baby if used at that stage (see Use in Pregnancy & Lactation).
Use in Children: Irbegen Plus should not be used in children and adolescents (under 18 years).

Pregnancy: Patients will be normally advised to stop taking Irbegen Plus before becoming pregnant or as soon as pregnancy is confirmed and will be advised to take another medicine instead of Irbegen Plus. Irbegen Plus is not recommended in early pregnancy and must not be taken when more than 3 months pregnant, as it may cause serious harm to the baby if used after the third month of pregnancy.
Breast-feeding: Irbegen Plus is not recommended for mothers who are breast-feeding. Another treatment may be chosen if breast-feeding is to be continued, especially if the baby is newborn, or was born prematurely.

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.

Other medicines and Irbegen Plus: Patients should exercise caution if they are taking, have recently taken or might take any other medicines.
Diuretic agents such as the hydrochlorothiazide contained in Irbegen Plus may have an effect on other medicines. Preparations containing lithium should not be taken with Irbegen Plus without close medical supervision.
The dose may need to be changed and/or other precautions may need to be taken if an ACE inhibitor or aliskiren is being taken (see also Contraindications and Precautions).
Clinical trial data has shown that dual blockade of RAAS through the combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal functions (including acute renal failure) compared to the use of a single RAAS-acting agent.
Blood checks may be needed if the following are being taken: potassium supplements; salt substitutes containing potassium; potassium-sparing medicines or other diuretics; some laxatives; antigout medicines; therapeutic vitamin D supplements; medicines to control heart rhythm; antidiabetic medicines (oral agents as repaglinide or insulins); carbamazepine.
It is also important to know if the following are being taken: other antihypertensive medicines, steroids, anticancer medicines, painkillers, arthritis medicines, or cholestyramine and colestipol resins.
Irbegen Plus with food and drink: Irbegen Plus can be taken with or without food.
Due to the hydrochlorothiazide contained in Irbegen Plus, if alcohol is consumed while on treatment with this medicine, an increased feeling of dizziness may occur on standing up, especially when getting up from a sitting position.

Medicines should not be thrown away via wastewater or household waste. Patients should be advised how to throw away medicines no longer used. These measures will help protect the environment.

Store at temperature below 25°C.
Store in the original package in order to protect from moisture.

Angiotensin II Antagonists / Diuretics

C09DA04 - irbesartan and diuretics ; Belongs to the class of angiotensin II receptor blockers (ARBs) in combination with diuretics. Used in the treatment of cardiovascular disease.

P₁S₁S₃