Composition: Each film-coated tablet contains: Active ingredient: bempedoic acid — 180 mg. Excipients: microcrystalline cellulose (102), lactose monohydrate (fine), sodium starch glycolate (type A), hydroxypropyl cellulose (HPC-L), colloidal silicon dioxide (200), magnesium stearate, Opadry II 85G58977 White, Orange Lake (E110), purified water.
Form: Film-coated tablets.
Indications: To reduce the risk of myocardial infarction and coronary revascularisation in adults unable to take recommended statin therapy (including those not taking statins) who: • have cardiovascular disease (CVD); • are at high risk of a cardiovascular event but do not have established CVD. As an adjunct to diet, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering treatments, or as monotherapy when concomitant LDL-C lowering treatment is not possible, to reduce LDL-C in adults with primary hyperlipidaemia, including heterozygous familial hypercholesterolaemia.
Contraindications: Hypersensitivity to the active ingredient or any excipient.
Dosage: Take bempedoic acid 180 mg tablets orally once daily, with or without food. Check lipid levels within 8–12 weeks after starting Bemkor.
Side effects: • Upper respiratory tract infection. • Muscle spasms. • Hyperuricaemia. • Back pain. • Abdominal pain or discomfort. • Bronchitis. • Pain in the extremities. • Anaemia. • Elevated liver enzymes.
Interactions: Simvastatin: avoid concomitant use of bempedoic acid with simvastatin at doses greater than 20 mg. Pravastatin: avoid concomitant use of bempedoic acid with pravastatin at doses greater than 40 mg.
Warnings: Increased serum uric acid levels have been reported. Check uric acid regularly as clinically indicated. Monitor for signs and symptoms of hyperuricaemia and start urate-lowering treatment if necessary. Tendon rupture may occur. Stop bempedoic acid at the first sign of tendon rupture. Avoid use in patients with a history of tendon disorders or tendon rupture. Tendon rupture may occur more frequently in patients over 60 years of age, those taking corticosteroids or fluoroquinolones, patients with renal failure, and those with previous tendon disorders. Pregnancy and breastfeeding Pregnancy: discontinue bempedoic acid when pregnancy is confirmed, unless the benefits of treatment outweigh the potential risk to the fetus. No data are available on use in pregnant women to assess the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Breastfeeding: no information is available on the presence of bempedoic acid in human or animal milk, its effects on the breastfed infant, or its effects on milk production. Breastfeeding is not recommended during treatment. Driving and operating machinery: no cases of an effect on the ability to drive or operate machinery are known.
Age restrictions: For adult patients only.
Pregnancy: Discontinue treatment if pregnancy is confirmed unless the expected benefit outweighs the potential risk to the fetus. Breastfeeding is not recommended during therapy.
Country of origin: Bangladesh
Manufacturer: Incepta Pharmaceuticals Ltd. Head office: 40, Shahid Tajuddin Ahmed Sarani; Tejgaon I/A, Dhaka-1208; Bangladesh. Organisation receiving medicine quality complaints in the Republic of Uzbekistan: NEO-FARM LLC, 5 A Chimbay residential area, Almazar district, Tashkent 100179, Republic of Uzbekistan. Tel.: +998712292709.
Storage conditions: Store at a temperature not exceeding 30°C. Protect from light. Keep out of reach of children.
Shelf life: 2 years. Do not use after the expiry date.
Dispensing conditions: Prescription only.