Specific treatment of benign breast conditions. Mastodynia. Painful breast tension, alone or associated to: Contraceptive treatments. Premenstrual syndromes. Onset of pregnancy. Benign breast conditions.
Active ingredient: Progesterone
SUMMARY OF PRODUCT CHARACTERISTICS
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
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Specific treatment of benign breast disease.
Painful breast pressure, either isolated or associated with:
– Contraceptive treatment
– Premenstrual syndromes
– Onset of pregnancy
· Benign mastopathy
4.2 Posology and method of administration
Apply 5 g of gel onto the breast skin (one spatula measure on each breast) every day, including during menstruation.
The duration of treatment depends on the indication and is established by the physician on
an individual basis.
Method of administration
Hold the end of the spatula with one hand, the tube with the other and spread the gel along the length of the spatula. This amount is the correct dose for one breast (2.5 g).
Repeat this procedure for the other breast.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
As it is a water/alcohol solution it must not be applied directly onto mucosa.
Frequent application may cause skin irritation and dryness.
4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant interactions have been observed in the studies performed.
4.6 Fertility, pregnancy and lactation
The data available indicate that Darstin has no effect on pregnancy.
As Darstin lacks systemic effects, it may 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 events. However, those listed below may occur:
Skin and subcutaneous tissue disorders
Frequency not known (cannot be estimated from the available data): skin irritation and dryness.
Due to the special pharmacokinetics of this product, there is no risk of overdose.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties:
Pharmacotherapeutic group: progestogen derivatives of 4-pregnene.
ATC code: G03DA04.
Mechanism of action
Darstin is a pure progesterone dispersed in an appropriate excipient for percutaneous administration. Its antioestrogenic action corrects local imbalances between oestrogens and progesterone.
It acts directly on the mammary gland, where the hormone is concentrated. As Darstin does not generally cause adverse events, it is well tolerated.
Darstin prevents the vascular and cellular effects of local progesterone deficiency in the
mammary glands. At this level, progesterone:
– Prevents the capillary permeability increase caused by oestrogens.
– Acts against the growth and differentiation of galactophores and acini.
– Blocks the epithelial mitosis cycle provoked by oestrogens.
5.2 Pharmacokinetic properties
The absorption coefficient is around 10% of the dose administered.
Approximately 80% of the drug absorbed is metabolised in the mammary gland, whereas only 20% reaches systemic circulation.
Peak metabolite clearance occurs after 48 hours.
5.3 Preclinical safety data
Local safety and tolerance tests:
In the tests performed, the skin area onto which the product was applied was inspected periodically and at the end of treatment. The skin area treated remained intact after the end of treatment.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.3 Shelf Life
6.4 Special precautions for storage
Store below 25 ºC and close the container tightly after each application.
6.5 Nature and contents of container
Aluminium tube lacquered internally with gold-type varnish and sealed at one end, 80 g, with dosing spatula.
6.6. Special precautions for disposal and other handling
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Carretera de Sabadell a Granollers, Km. 15
08185 – Lliçà de Vall (Barcelona)
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE
14 April 1983
10. DATE OF REVISION OF THE TEXT