VAZKEPA SOFT CAPSULES 998MG [SIN17418P]
Active ingredients: VAZKEPA SOFT CAPSULES 998MG
Last updated 24 April 2026
Product Info
VAZKEPA SOFT CAPSULES 998MG
[SIN17418P]
Product information
Active Ingredient and Strength | ICOSAPENT ETHYL - 998 MG |
Dosage Form | CAPSULE, LIQUID FILLED |
Manufacturer and Country | PATHEON SOFTGELS B.V. - NETHERLANDS |
Registration Number | SIN17418P |
Licence Holder | LOTUS INTERNATIONAL PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | C10AX06 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1 THERAPEUTIC INDICATIONS
VAZKEPA is indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥ 1.7 mmol/L) and
established cardiovascular disease, or
diabetes, and 2 or more additional risk factors for cardiovascular disease.
For study details including cardiovascular risk factors and results with respect to effects on cardiovascular events, see section 5.1 Pharmacodynamic properties: Clinical Trials – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information
Dosing
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended daily oral dose is 4 capsules taken as two 998 mg capsules twice daily.
If a dose is missed, patients should take it as soon as they remember. However, if one daily dose is missed, the next dose should not be doubled.
Method of administration
Oral use.
VAZKEPA should be taken with or following a meal.
To ensure the full intended dose is received, patients should be advised to swallow the capsules whole and not to break, crush, dissolve, or chew them.
Dosage adjustment in:
Renal impairment
No dose reduction is recommended (see section 5.2 Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Hepatic impairment
No dose reduction is recommended (see sections 4.4 Special warnings and precautions for use and 5.2 Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Elderly
No dose adjustment is necessary based on age (see section 5.2 Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Contraindications
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance, soya or to any of the excipients listed in section 6.1 List of excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.