DARSTIN^®

Name: Darstin^®
Presentation: Gel 80 grams.
Active substance: Progesterone.

Specific treatment of benign breast conditions. Mastodynia. Breast tenderness, in isolation or associated with: Contraceptive treatment. Premenstrual syndrome. Early pregnancy. Benign mastopathies.

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1 - NAME OF THE MEDICINAL PRODUCT

Darstin^® 10 mg/g gel

2 - QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram of gel contains: 10 mg of progesterone.

For the full list of excipients, see section 6.1.

3 - PHARMACEUTICAL FORM

Translucent gel.

4 - CLINICAL PARTICULARS

4.1 Therapeutic indications

Specific treatment of benign breast conditions.

Mastodynia

Breast tenderness, in isolation or associated with:

- - - - Contraceptive treatment
      - Premenstrual syndrome
      - Early pregnancy

Benign mastopathies

4.2 Posology and method of administration

Posology

Apply 5 g of gel (one spatula measure for each breast) to the skin of the breasts every day, even during menstruation.

The duration of treatment depends on the indication and will be decided by the doctor on an individual basis.

Method of administration

Topical use

Hold the end of the spatula with one hand and the tube with the other and squeeze the gel along the length of the spatula. This quantity is the right dose for one breast (2.5 g). Repeat for the other breast.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Since it is a water-alcohol solution, it should not be applied directly to mucous membranes.

Frequent applications may cause skin irritation and dryness.

4.5 Interaction with other medicinal products and other forms of interaction

No significant clinical interaction has been observed in the studies conducted.

4.6 Fertility, pregnancy and lactation

The data obtained do not suggest that Darstin® has an influence on pregnancy.

Since Darstin® does not have any systemic effects, it can be used during breast-feeding.

4.7 Effects on ability to drive and use machines

Darstin® has no influence on the ability to drive and use machines.

4.8 Undesirable effects

Darstin® does not generally cause adverse effects. However, those described below may occur:

Skin and subcutaneous tissue disorders

Frequency not known (cannot be estimated from the available data): skin irritation and dryness.

4.9 Overdose

Due to the particular pharmacokinetics of this product, there is no risk of overdose.

5 - PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties:

Pharmacotherapeutic group: progestogens, pregnen (4) derivatives.

ATC code: G03DA04.

Mechanism of action

Darstin® is a pure progesterone dispersed in a suitable excipient for percutaneous administration. Thanks to its anti-oestrogenic action, it locally corrects the imbalance between oestrogens and progesterone.

It acts directly on the mammary gland, where the hormone is concentrated. In general, Darstin® has no adverse effects, so it is well tolerated.

Darstin® prevents the vascular and cellular effects of a local progesterone deficiency in the mammary glands. At this level, progesterone:

- - - - Prevents an increase in capillary permeability caused by oestrogens.
        
        Acts on the growth and differentiation of galactophores and acini.
        
        Blocks the cycle of epithelial mitosis caused by oestrogens.

5.2 Pharmacokinetic properties

Absorption

The absorption coefficient is about 10% of the administered dose.

Biotransformation

Eighty percent of the absorbed drug is metabolised in the mammary gland, while only 20% reaches the systemic circulation.

Elimination

The maximum elimination of the metabolites takes place after 48 hours.

5.3 Preclinical safety data

Safety and local tolerance tests:

In the studies conducted, the skin surface where the product was applied was observed regularly and also at the end of treatment. The skin surface where the product is applied remains intact after finishing treatment.

6 - PHARMACEUTICAL PARTICULARS

6.1 List of excipients