Candalkan 8 mg 14 tablets

Candalkan 8 mg 14 tablets

Composition:
Each tablet contains: Candesartan cilexetil  8 mg.
Inactive ingredients: lactose monohydrate, microcrystalline cellulose, HPMC-E 5, croscarmellose sodium, maize starch, magnesium stearate, red iron oxide.
Product Description:
Candalkan is a selective angiotensin II receptor antagonist (AT1) used to lower blood pressure in hypertension and treat heart failure.
It reduces systemic vascular resistance, increases renal blood flow, and decreases cardiac load without significant reflex increase in heart rate.
Indications for Use:
Treatment of essential hypertension in adults and children aged 6–18 years.
Treatment of heart failure in adults with left ventricular systolic dysfunction (LVEF ≤ 40%) when ACE inhibitors are not tolerated, or as add-on therapy with ACE inhibitors in symptomatic heart failure.
Method of Administration and Dosage:
Hypertension (adults): initial dose - 8 mg once daily; may increase to 16 mg, maximum 32 mg once daily.
Hypertension (children 6–<18 years): initial dose - 4 mg once daily; for weight ≥50 kg - may increase to 8 mg, if needed to 16 mg; maximum 32 mg.
Heart failure (adults): initial dose - 4 mg once daily, titrate to tolerated dose up to 32 mg.
Oral administration, with or without food.
Contraindications:
Hypersensitivity to candesartan or excipients.
Pregnancy and breastfeeding.
Severe hepatic impairment and/or cholestasis.
Children under 1 year.
Concomitant use with aliskiren-containing products in patients with diabetes or renal impairment (GFR < 60 ml/min/1.73 m²).
Precautions:
Monitor renal function and electrolytes in renal impairment.
Caution in hypovolemia, diuretic use, elderly patients.
Avoid concomitant ACE inhibitor use in diabetic nephropathy.
Careful supervision in children with possible hypovolemia.
Caution in renal artery stenosis or kidney transplant patients.
Contains lactose - not for patients with rare hereditary galactose metabolism disorders.
Adverse Reactions (Side Effects):
Hypertension:
Common: headache, dizziness, respiratory infections.
Rare: hyperkalemia, hyponatremia, cough, liver disorders, skin reactions, back/muscle pain, renal impairment.
Heart Failure:
Most common: hyperkalemia, hypotension, renal impairment.
More pronounced in patients >70 years, diabetics, or with concomitant RAAS-influencing drugs.
Pregnancy and Lactation:
Contraindicated in pregnancy (especially 2nd and 3rd trimesters - risk of fetotoxicity).
Not recommended during breastfeeding - unknown effects on infants.
Storage Conditions:
Store below 30 °C in a dry place, protected from light.
Keep away from the reach of children.
Packaging:
Cardboard box containing 2 blisters of 7 tablets and insert leaflet.