Chartoreg Plus 40/12.5 mg 28 tablets
Utopia Pharmaceutical Company
Utopia Pharmaceutical Company
Composition
Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
Description
Combined antihypertensive agent. It contains two active ingredients with complementary mechanisms of action to control blood pressure:
Telmisartan: Belongs to the class of angiotensin II receptor antagonists (ARBs). It blocks the vasoconstrictor effects of the hormone angiotensin II.
Hydrochlorothiazide: Belongs to the thiazide diuretic class. It increases the excretion of water and sodium from the body, reducing blood volume.
Therapeutic indications
Treatment of essential hypertension.
Chartoreg Plus 40 mg/12.5 mg and 80 mg/12.5 mg are indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.
Posology and method of administration
Dosage: The tablet is taken once daily. The specific strength (40/12.5; 80/12.5; or 80/25) is determined by the physician based on achieved blood pressure control.
Method of administration: For oral use. The tablets should be taken with liquid, with or without food.
Contraindications
- Hypersensitivity to telmisartan, hydrochlorothiazide, other sulfonamide-derived substances, or any excipients.
- Pregnancy (second and third trimesters). Must be discontinued as soon as pregnancy is detected.
- Cholestasis, biliary obstructive disorders, severe hepatic impairment.
- Severe renal impairment (creatinine clearance < 30 ml/min).
- Refractory hypokalaemia, hypercalcaemia.
- Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment.
Special warnings and precautions for use
- Renal impairment: Periodic monitoring of renal function is advised. Contraindicated in severe impairment.
- Hepatic impairment: Use with caution. Contraindicated in severe impairment.
- Renovascular hypertension: Increased risk of severe hypotension and renal insufficiency in patients with bilateral renal artery stenosis.
- Electrolyte imbalance: Can cause fluid or electrolyte imbalance (e.g., hypokalaemia, hyponatraemia, hypomagnesaemia, hypercalcaemia). Periodic monitoring is recommended.
- Other conditions: Use with caution in patients with aortic/mitral stenosis, obstructive hypertrophic cardiomyopathy, systemic lupus erythematosus, gout, diabetes, ischaemic heart disease.
- Photosensitivity: Photosensitivity reactions may occur. Sun protection is recommended.
- Non-melanoma skin cancer (NMSC): Risk of basal cell and squamous cell carcinoma may be increased. Regular skin examination is advised.
- Acute myopia and angle-closure glaucoma: A rare idiosyncratic reaction can occur. Discontinue treatment if symptoms occur.
Undesirable effects
Possible side effects listed by frequency
Common (≥1/100 to <1/10): Nausea, hypokalaemia.
Uncommon (≥1/1,000 to <1/100): Dizziness, asthenia (weakness), haemoglobin decreased.
Rare (≥1/10,000 to <1/1,000): Thrombocytopenia, headache, hypercalcaemia, hypomagnesaemia.
Very rare (<1/10,000): Hypochloraemic alkalosis, acute respiratory distress syndrome (ARDS).
Frequency not known: Anaphylactic reactions, hypersensitivity, hepatic function abnormal, jaundice, pancreatitis, diabetes mellitus, photosensitivity, lupus-like syndrome, acute angle-closure glaucoma, acute myopia, choroidal effusion, renal dysfunction, aplastic anaemia, leukopenia, neutropenia, non-melanoma skin cancer.
Pregnancy
Contraindicated in the second and third trimester. Exposure during these trimesters can cause fetal injury and death. Discontinue therapy as soon as pregnancy is detected.
Lactation
Not recommended. It is unknown if telmisartan is excreted in human milk. Hydrochlorothiazide is excreted in milk. A decision must be made to discontinue nursing or discontinue the drug.
Storage
Store at temperatures not exceeding 30°C in a dry place.
Package
A carton box containing 28 Film-coated tablets in blisters.