Darstin 10 mg/g gel
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
darstin 10 mg/g gel
progesterone
Read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
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Package leaflet
- What Darstin is and what it is used for
- What you need to know before you start using Darstin
- How to use Darstin
- Possible side effects
- How to store Darstin
- Contents of the pack and other information
1. What Darstin is and what it is used for
This medicine contains progesterone, a natural female sex hormone.
Darstin locally corrects the imbalance between estrogens and progesterone (two types of female sex hormones), locally treating breast pain and other benign breast disorders.
2. What you need to know before starting to use Darstin
Do not use Darstin
If you are allergic to progesterone or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Darstin.
As it is a hydroalcoholic solution, it must not be applied directly onto mucous membranes. Frequent applications may cause skin irritation and dryness.
Other medicines and Darstin
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
The use of this medicine has no influence during pregnancy or breastfeeding.
Driving and using machines
This medicine does not affect your ability to drive or operate machinery.
3. How to use Darstin
Follow exactly the instructions given by your doctor for using this medicine. If in doubt, consult your doctor or pharmacist again.
Apply 5 g of gel daily to the skin of the breasts, either in the morning or at night, even during menstruation. Your doctor will advise you on the duration of your treatment with Darstin. Do not stop treatment earlier than instructed.
To measure a daily dose of 5 g:
- Screw the applicator onto the mouth of the tube.
- Squeeze the tube to fill the applicator with gel, until the plunger stops at the 2.5 g mark.
- Remove the applicator from the tube and apply the gel to the skin of one breast.
- Repeat the procedure for the other breast.
- After each application, separate the plunger from the cannula and wash them.
Allow to dry before dressing.
Darstin is odourless and does not stain.
If you use more Darstin than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service on (91) 562 04 20, stating the medicine and the amount ingested.
If you forget to use Darstin
Do not use a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Although adverse effects generally do not occur, the following may appear, listed according to their frequency of occurrence:
Disorders of the skin and subcutaneous tissue
Frequency not known (cannot be estimated from available data): skin irritation and dryness.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet.
You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Darstin
Store below 25°C and keep the container tightly closed after each use.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Darstin
- The active substance is progesterone. Each gram of gel contains 10 mg of progesterone.
- The other components (excipients) are: carbomers, triethanolamine, 96% ethanol, and purified water.
Appearance of Darstin and contents of the pack
Translucent gel in an aluminum tube with a dosing applicator.
Tube containing 80 g of gel.
Marketing Authorization Holder and Manufacturer
SEID, S.A.
Carretera de Sabadell a Granollers, Km. 15
08185 - Lliçà de Vall (Barcelona)
Date of the most recent review of this leaflet: November 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.