Irbegen Plus Special Precautions

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).