Composition: Each film-coated tablet contains: active ingredients: bempedoic acid 180 mg and ezetimibe 10 mg. Excipients: microcrystalline cellulose (102), lactose monohydrate (fine), crospovidone (type B), hydroxypropyl cellulose (HPC-L), povidone (K30), sodium lauryl sulphate, colloidal silicon dioxide (200), magnesium stearate, Opadry II 85G54240 Pink, purified water.
Form: Film-coated tablets.
Indications: Bemzet, a combination of bempedoic acid and ezetimibe, is indicated as an adjunct to diet, alone or with other LDL-cholesterol lowering treatments, to reduce LDL-C in adults with primary hyperlipidaemia, including heterozygous familial hypercholesterolaemia. Bempedoic acid in Bemzet is indicated 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 established cardiovascular disease (CVD), or are at high risk of a cardiovascular event without established CVD.
Contraindications: Hypersensitivity to the active ingredient or any excipient.
Dosage: The recommended Bemzet dose is one tablet orally once daily. One tablet contains bempedoic acid 180 mg and ezetimibe 10 mg. Swallow whole, with or without food. If a dose is missed, take it as soon as possible. Do not double the next dose. Check lipid levels within 8–12 weeks after starting Bemzet.
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 and ezetimibe with simvastatin at doses greater than 20 mg. Pravastatin: avoid concomitant use of bempedoic acid and ezetimibe with pravastatin at doses greater than 40 mg.
Warnings: Increased serum uric acid levels have been reported. Check uric acid periodically as clinically indicated. Monitor for signs and symptoms of hyperuricaemia and start urate-lowering treatment if necessary. Stop bempedoic acid and ezetimibe 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 and ezetimibe 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 and ezetimibe 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.