Mirtilene

Package Leaflet

MIRTILENE

Soft Capsules
Composition
One capsule contains:
Active substances: Black bilberry hydroalcoholic dry extract, standardized to 25% anthocyanidins mg 70 - d,l-alpha-Tocopheryl acetate mg 40 - Beta-carotene mg 10.
Excipients: Soybean vegetable oil - Gelatin - Glycerol - Red iron oxide - Black iron oxide - Sodium ethyl paraben - Sodium propyl paraben.
Pharmaceutical form and content
20 soft capsules in blister pack
Pharmacotherapeutic category
Mirtilene is a pharmaceutical combination containing anthocyanosides extracted from bilberry and vitamins.
Anthocyanosides and vitamins promote the regeneration of rhodopsin, the photosensitive pigment of the retina, thereby improving retinal sensitivity to varying light intensities.
Marketing Authorization Holder
S.I.F.I. S.p.A. - Registered office: via Ercole Patti, 36 - 95020 Lavinaio - Aci S. Antonio (CT)
Manufacturer and final controller
Encapsulation:
CATALENT ITALY S.p.A. - Aprilia (LT) facility
Packaging and controls:
S.I.F.I. S.p.A. - Aci S. Antonio (CT) facility
Marketing Authorization Holder and Distributor
EYELAB S.R.L. – Via Ercole Patti, 36 - 95025 Aci S. Antonio (CT)
Therapeutic indications
Conditions of capillary fragility.
Contraindications
Hypersensitivity to any of the components of the product.
Due to its high vitamin A content, the product must not be used during pregnancy.
Precautions for use
To avoid the onset of signs and symptoms of vitamin overdose, it is recommended to adhere to the recommended doses, use the product under medical supervision, and only for the necessary duration.
Preparations containing vitamin E should be administered with caution in diabetic patients and those with cardiac insufficiency, as this vitamin may reduce the requirement for insulin and digitalis.
Interactions
Vitamin E may enhance the pharmacological action of insulin and digitalis.
The absorption and accumulation of vitamin A may be reduced by sulfate neomycin and certain drugs such as corticosteroids administered over long periods, phenobarbital, caffeine, and alcohol.
Special warnings
Very high doses of vitamin A have been shown to be teratogenic in animals and have been associated, in isolated cases, with malformations in humans. Daily intakes of vitamin A exceeding 10,000 IU should be avoided during pregnancy (especially during the first months), and medical advice should be sought regarding the total amount of vitamin A intake from all sources. Therefore, due to its high vitamin A content, this product must not be used during pregnancy.
Dosage, administration and duration of treatment
The recommended dosage regimen is 4 to 6 capsules daily, or as otherwise prescribed by a physician.
Overdose
No cases of overdose have been reported with use of the product at the recommended dosage.
Undesirable effects
The product is generally well tolerated when used at the recommended doses.
Prolonged administration of excessive doses may lead to hypervitaminosis.
Following the instructions provided in this leaflet reduces the risk of undesirable effects. It is important to inform your doctor or pharmacist if any adverse effect occurs, even if not described in this leaflet.
Expiry date and storage
Refer to the packaging for the expiry date.
Do not use the medicine after the expiry date stated on the packaging.
Store at a temperature not exceeding 25 °C.
This medicine must not be taken by patients who smoke 20 or more cigarettes per day.
KEEP THE MEDICINE OUT OF THE REACH OF CHILDREN

Package leaflet

MIRTILENE FORTE

Soft capsules
Hydroalcoholic dry extract of Blackberry (Vaccinium myrtillus) standardized to 25%
anthocyanidins

Composition
One capsule contains:
Active substance: Hydroalcoholic dry extract of Blackberry (Vaccinium myrtillus) standardized to 25%
Anthocyanidins 177 mg.
Excipients: Soybean vegetable oil - Partially hydrogenated vegetable fats -
Gelatin - Glycerol - Red iron oxide - Black iron oxide - Sodium ethyl
paraben - Sodium propyl paraben.

Pharmaceutical form and contents
20 soft capsules in blister pack.

Therapeutic category
The anthocyanosides of Blackberry (Vaccinium myrtillus) promote the regeneration of rhodopsin,
the photosensitive pigment of the retina. Therefore, they improve retinal sensitivity to varying light intensities and visual acuity under low-light conditions.

Marketing Authorization Holder
S.I.F.I. S.p.A. - Registered office: via Ercole Patti, 36 - 95020 Lavinaio - Aci S.
Antonio (CT)

Manufacturer and final controller
Encapsulation:
CATALENT ITALY S.p.A. - Aprilia (LT) facility
Packaging and controls:
S.I.F.I. S.p.A. - Aci S. Antonio (CT) facility

Marketing Authorization Holder (for sale)
EYELAB S.R.L. – Via Ercole Patti, 36 - 95025 Aci S. Antonio (CT)

Therapeutic indications
Capillary fragility states.

Contraindications
Individual hypersensitivity to any component of the product.

Precautions for use
None.

Interactions
Not known.

Special warnings
The safety of this medicinal product during pregnancy has not been established; therefore, it is advisable not to administer the product during pregnancy.

Dosage, method and duration of administration
The recommended dosage is 3 capsules daily, or as otherwise directed by a physician.

Overdose
No cases of overdose have been reported with use of the product at the recommended dosage.

Undesirable effects
The product is generally well tolerated when used at the recommended doses.
Following the instructions provided in the package leaflet reduces the risk of undesirable effects.
It is important to inform your doctor or pharmacist of any adverse reaction occurring, even if not described in the package leaflet.

Expiry date and storage
Refer to the expiry date indicated on the packaging.
Warning: do not use the medicinal product after the expiry date stated on the
packaging.
Store at a temperature not exceeding 25 °C.
KEEP THIS MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN.

2010