Active ingredients: Omega 3 (Ethyl esters of polyunsaturated fatty acids)
ESAPENT 1000 mg Soft capsules
ESAPENT 500 mg Soft capsules
Indications Why is Esapent used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Hypotiglyceride-lowering - Cardiovascular
THERAPEUTIC INDICATIONS
Hypertriglyceridemia
Esapent is indicated for the reduction of elevated triglyceride levels when the response to diets and other non-pharmacological measures alone has proved inadequate.
Treatment must always be associated with an adequate dietary regimen.
Secondary prevention in the patient with a previous myocardial infarction.
In patients with a history of myocardial infarction, in combination with other therapeutic measures when appropriate, ESAPENT is indicated to reduce the risk of mortality.
Contraindications When Esapent should not be used
Hypersensitivity to the active substance or to any of the excipients.
Precautions for use What you need to know before taking Esapent
Particular surveillance is recommended for subjects with bleeding diathesis and treatment with anticoagulants, in whom a moderate increase in bleeding time may occur.
Interactions Which drugs or foods can change the effect of Esapent
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
See precautions for use.
Warnings It is important to know that:
The possible presence of red-brown capsules is due to oxidation phenomena of the fish oil. If this phenomenon occurs, it is recommended not to take the medicine and return the package to the pharmacist.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. The safety of use in pregnancy and lactation has not been established.
Effects on ability to drive and use machines
Esapent has no adverse effects on the ability to drive and use machines.
Important information about some of the ingredients
Esapent contains sodium ethyl p-oxybenzoate, sodium propyl p-oxybenzoate. It can cause allergic reactions (even delayed) and, exceptionally, bronchospasm
Dose, Method and Time of Administration How to use Esapent: Posology
Hypertriglyceridemia
The recommended dosage schedule provides for the use of 1000 mg soft capsules at a dosage of 1 capsule 1-3 times a day s.p.m
For dose adjustment and maintenance therapy, 500 mg soft capsules at a dosage of 1 capsule 2-3 times a day s.p.m. can be used.
Secondary prevention in the patient with a previous myocardial infarction:
1 capsule of 1g per day.
Overdose What to do if you have taken too much Esapent
In case of accidental ingestion / intake of an excessive dose of Esapent, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of Esapent, ask your doctor or pharmacist.
There are no known toxic manifestations of overdose.
Side Effects What are the side effects of Esapent
Like all medicines, Esapent can cause side effects, although not everybody gets them.
Mild and transient manifestations of nausea and diarrhea have been observed.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep this medicine out of the reach and sight of children.
COMPOSITION
ESAPENT 1000 mg Soft capsules
Each capsule contains: Ethyl esters of polyunsaturated fatty acids with an EPA and DHA content of not less than 85% and in a ratio of 0.9 - 1.5 1000 mg. Excipients: D, L α-tocopherol. "shell: succinate gelatin, glycerol, sodium ethyl p-oxybenzoate, sodium propyl p-oxybenzoate.
ESAPENT 500 mg Soft capsules
Each capsule contains: Ethyl esters of polyunsaturated fatty acids with an EPA and DHA content of not less than 85% and in a ratio of 0.9 - 1.5 500 mg. Excipients: D, L α-tocopherol. "shell: succinate gelatin, glycerol, sodium ethyl p-oxybenzoate, propyl sodium possibenzoate.
PHARMACEUTICAL FORM AND CONTENT
ESAPENT 1000 mg soft capsules - 20 soft capsules
ESAPENT 500 mg soft capsules - 30 soft capsules
ORAL USE
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ESAPENT
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
ESAPENT 1000 mg soft capsules
Each soft capsule contains:
Active ingredient: ethyl esters of polyunsaturated fatty acids 1000 mg
with a content of EPA and DHA not less than 85%
and in a ratio of 0.9 - 1.5 to each other.
ESAPENT 500 mg Soft capsules
Each soft capsule contains:
Active ingredient: ethyl esters of polyunsaturated fatty acids 500 mg
with a content of EPA and DHA not less than 85%
and in a ratio of 0.9 - 1.5 to each other.
03.0 PHARMACEUTICAL FORM
Soft gelatin capsules.
ORAL USE.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Hypertriglyceridemia
ESAPENT is indicated for the reduction of elevated triglyceride levels when the response to diets and other non-pharmacological measures alone has proved inadequate. Treatment must always be associated with an adequate dietary regimen.
Secondary prevention in the patient with a previous myocardial infarction
In patients with a history of myocardial infarction, in combination with other therapeutic measures when appropriate, ESAPENT is indicated to reduce the risk of mortality.
04.2 Posology and method of administration
Hypertriglyceridemia
The recommended dosage schedule provides for the use of 1000 mg soft capsules (ESAPENT) at a dosage of 1 capsule 1-3 times a day s.p.m.
For dose adjustment and maintenance therapy, 500 mg soft capsules at a dosage of 1 capsule 2-3 times a day s.p.m. can be used.
Secondary prevention in the patient with a previous myocardial infarction:
1 capsule of 1 g per day.
04.3 Contraindications
Hypersensitivity to the product or to one of the components has been ascertained.
04.4 Special warnings and appropriate precautions for use
Keep out of reach of children.
As a precaution, special surveillance is recommended for subjects with haemorrhagic diathesis and treatment with anticoagulants, in which an altered increase in bleeding time may occur.
04.5 Interactions with other medicinal products and other forms of interaction
Concomitant use of the drug with anticoagulant may result in a modest increase in bleeding time.
04.6 Pregnancy and lactation
The safety of use in pregnancy and lactation has not been established.
04.7 Effects on ability to drive and use machines
ESAPENT has no negative effect on the ability to drive and use machines.
04.8 Undesirable effects
Mild and transient manifestations of nausea and diarrhea have been observed.
04.9 Overdose
There are no known toxic manifestations of overdose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Once incorporated into membrane phospholipids, EPA supplied directly with the drug or formed from DHA competes with arachidonic acid as a substrate for various enzymatic processes in platelets, endothelium and leukocytes, resulting in greater endothelial relaxation , a reduced platelet aggregation and a reduced chemotactic and pre-inflammatory potential, thus showing an antiatherosclerotic and antithrombotic effect.
EPA and DHA, like other polyunsaturated n-3 acids, show, even at low doses, an antiarrhythmic action, probably through a direct stabilizing effect on cardiomyocytes. The significant reduction in total and cardiovascular mortality, in particular sudden deaths, observed in a large prospective trial of secondary prevention in patients with previous myocardial infarction, is linked to their antiarrhythmic action. .
The favorable cardiovascular effects of EPA and DHA also include the reduction of plasma levels of triglycerides, VLDL and fibrinogen and the increase in erythrocyte deformability with consequent reduction in blood viscosity.
05.2 Pharmacokinetic properties
Absorption, excretion, tissue and plasma protein distribution were studied using the labeled product in rats and dogs.
More than 95% of the radioactivity is absorbed through the alimentary canal and a modest amount, as water-soluble material, is excreted in the urine. After 24 hours from administration, about 35% of the radioactivity is found in the tissues and in particular in the tissues involved in lipid metabolism.
The plasma peak time was 3.40 and 6.75 hours in rats and dogs, respectively.
The plasma fractions with the highest levels of radioactivity were found to be VLDL and chylomicrons.
Clinical pharmacokinetic studies have confirmed that EPA and DHA ethyl esters are hydrolyzed and incorporated into the various lipid fractions providing, after repeated administration, concentrations of EPA and DHA of the same order as those obtainable by administering natural triglycerides.
05.3 Preclinical safety data
The toxicological studies conducted on the product excluded toxic phenomena both for short and long periods of treatment at high doses.
No teratogenic effects or effects on animal fertility were observed during reproduction studies.
Carcinogenicity studies in rats also showed that oral treatment for 24 months did not cause toxic and histopathological damage.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Esapent 1000 mg Soft capsules : D L & lapha; -tocopherol; Constituents of the shell: gelatin succinate, glycerol, sodium p-oxybenzoate of ethyl, sodium p-oxybenzoate of propyl.
Esapent 500 mg Soft capsules: D L & lapha; -tocopherol; Constituents of the shell: gelatin succinate, glycerol, sodium p-oxybenzoate of ethyl, sodium p-oxybenzoate of propyl.
06.2 Incompatibility
There are no known incompatibilities of the product with other drugs.
06.3 Period of validity
36 months in intact packaging.
06.4 Special precautions for storage
Not provided.
06.5 Nature of the immediate packaging and contents of the package
Esapent 1000 mg Soft capsules - Aluminum blister and PVC / PVDC coupled
20 soft capsules 1000 mg.
Esapent 500 mg Soft capsules - Aluminum blister and PVC / PVDC coupled
30 soft capsules 500 mg.
06.6 Instructions for use and handling
Not relevant.
07.0 MARKETING AUTHORIZATION HOLDER
Pfizer Italia S.r.l., via Isonzo, 71 - 04100 Latina
08.0 MARKETING AUTHORIZATION NUMBER
- 20 soft capsules 1000 mg 027617024
- 30 soft capsules 500 mg 027617012
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
May 31, 2005
10.0 DATE OF REVISION OF THE TEXT
January 2009
