SEACOR - PACKAGE LEAFLET - LEAFLETS

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Seacor - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Undesirable Effects Shelf Life and Storage

Active ingredients: Omega 3 (Ethyl esters of polyunsaturated fatty acids)

SEACOR® 500 mg soft capsules
SEACOR® 1000 mg soft capsules

Why is Seacor used? What is it for?

PHARMACOTHERAPEUTIC CATEGORY

Lipid-lowering substances - Hypocholesterolemic and hypotiglyceride-lowering substances - Omega-3-triglycerides

THERAPEUTIC INDICATIONS

Hypertriglyceridemia

Reduction of elevated triglyceride levels when the response to diets and other non-pharmacological measures alone has proved insufficient (treatment should always be combined with an adequate diet)

Secondary prevention in the patient with a previous myocardial infarction

In patients with previous myocardial infarction, in combination with other therapeutic measures when appropriate, it is indicated to reduce the risk of mortality.

Contraindications When Seacor should not be used

Hypersensitivity to the active substance or to any of the excipients.

Generally contraindicated in pregnancy and lactation (see Special Warnings).

Precautions for use What you need to know before taking Seacor

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.

Interactions Which drugs or foods can change the effect of Seacor

Concomitant use of the drug with anticoagulants may result in a modest increase in bleeding time.

Warnings It is important to know that:

The safety of use in pregnancy and lactation has not been established.

Dose, Method and Time of Administration How to use Seacor: Posology

Hypertriglyceridemia:

1 capsule of 1000 mg 1-3 times a day s.p.m.

500 mg capsules can be used for dose adjustment and maintenance therapy.

Secondary prevention in the patient with a previous myocardial infarction:

1 capsule of 1000 mg per day.

Side Effects What are the side effects of Seacor

Mild and transient manifestations of nausea and diarrhea have been observed.

The patient is invited to report any undesirable effect not described in the package leaflet to his doctor or pharmacist.

Expiry and Retention

Check the expiration date indicated on the package.

The expiry date refers to the product in intact packaging, correctly stored.

Warning: do not use the medicine after this date.

Keep this medicine out of the reach of children.

COMPOSITION

Each capsule contains:

Active principle:

CAPSULES OF 500 mg

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

CAPSULES OF 1000 mg

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

Excipients:

D, Lα-tocopherol, gelatin succinate, glycerol, sodium ethyl p-oxybenzoate, sodium propyl p-oxybenzoate.

PHARMACEUTICAL FORM AND CONTENT

Box of 30 soft capsules of 500 mg

Box of 20 soft capsules of 1000 mg

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.

Further information on Seacor is available in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OFTEXT 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXTEMPORARY PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

SEACOR 500 mg Soft capsules

SEACOR 1000 mg Soft capsules

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains:

CAPSULES OF 500 mg

Active principle:

Ethyl esters of polyunsaturated fatty acids 500 mg

with a content of EPA and DHA not lower

at 85% and in a ratio of 0.9 - 1.5 to each other

CAPSULES OF 1000 mg

Active principle:

Ethyl esters of polyunsaturated fatty acids 1000 mg

with a content of EPA and DHA not lower

at 85% and in a ratio of 0.9 - 1.5 to each other

03.0 PHARMACEUTICAL FORM

Soft capsules.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Hypertriglyceridemia

Reduction of elevated triglyceride levels when the response to diets and other non-pharmacological measures alone has proved insufficient (treatment should always be associated with an adequate dietary regimen).

Secondary prevention in the patient with a previous myocardial infarction

In patients with previous myocardial infarction, in combination with other therapeutic measures when appropriate, it is indicated to reduce the risk of mortality.

04.2 Posology and method of administration

Hypertriglyceridemia:

1 capsule of 1000 mg 1-3 times a day s.p.m.

500 mg capsules can be used for dose adjustment and maintenance therapy.

Secondary prevention in the patient with a previous myocardial infarction:

1 capsule of 1000 mg per day.

04.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Generally contraindicated during pregnancy and lactation (see p. 4.6).

04.4 Special warnings and appropriate precautions for use

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 anticoagulants 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

Seacor does not affect the ability to drive or use machines.

04.8 Undesirable effects

Mild and transient manifestations of nausea and diarrhea have been observed.

04.9 Overdose

No cases of overdose have been reported.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: Lipid-lowering substances - Hypocholesterolemics and hypotiglyceridemics - Omega-3-triglycerides; ATC code: C10AX06.

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 aggregability and a reduced chemotactic and proinflammatory 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 in 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

Toxicological studies conducted on the product with acute and chronic treatments have excluded toxic phenomena, even after administration of high doses.

No teratogenic and general effects on reproductive function were observed during reproduction studies. Studies conducted in rats for 24 months did not reveal the presence of a carcinogenic potential.