DARSTIN 10 mg/g GEL

Introduction

Package Leaflet: Information for the User

darstin 10 mg/g gel

progesterone

Contents of the Package Leaflet

1. What is Darstin and what is it used for
2. What you need to know before you start using Darstin
3. How to use Darstin
4. Possible side effects
5. Storage of Darstin
6. Contents of the pack and further information

1. What is Darstin and what is it 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), treating breast pain and other benign breast diseases locally.

2. What you need to know before you start using Darstin

Do not use Darstin

If you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before you start using Darstin.

As it is a hydroalcoholic solution, it should not be applied directly to mucous membranes. Frequent applications may cause skin irritation and dryness.

Other medicines and Darstin

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant or plan 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

Its use does not affect the ability to drive vehicles or operate machinery.

3. How to use Darstin

Follow exactly the administration instructions of this medicine as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Apply 5 g of gel to the breast skin, every day in the morning or evening, even during menstruation. Your doctor will indicate the duration of your treatment with Darstin. Do not stop treatment before the indicated time.

To measure a daily dose of 5 g:

• Screw the applicator onto the tube.
• Squeeze the tube to fill the applicator with the gel, until the plunger stops at the 2.5 g mark.
• Separate the applicator from the tube and apply the gel to the skin of one breast.
• Repeat the operation for the other breast.
• After each application, separate the plunger from the nozzle and wash them.

Let it dry before dressing.

Darstin is odorless and does not stain.

If you use more Darstin than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Darstin

Do not use a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Although they are generally not produced, the following side effects may occur according to their frequency of presentation:

Disorders of the skin and subcutaneous tissue

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet.

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Darstin

Keep below 25°C and keep the container tightly closed after each application.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after CAD. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Dispose of the container and any unused medicine in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the container and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Darstin

• The active ingredient is progesterone. Each gram of gel contains 10 mg of progesterone.
• The other ingredients (excipients) are: carbomers, tromethamine, ethanol 96%, and purified water.

Appearance of Darstin and contents of the pack

Translucent gel in an aluminum tube with a dosing applicator.

Tube with 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 last revision of this leaflet: November 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.