Darstin 10 mg/g gel leaflet – Spain

How to use Darstin 10 mg/g gel

Introduction

Label: information for the user

Darstin 10 mg/g gel

Progesterone

Read the entire label carefully before starting to use this medication, as it contains important information for you.

Keep this label, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medication has been prescribed for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Label contents

What Darstin is and for what it is used
What you need to know before starting to use Darstin
How to use Darstin
Possible adverse effects
Storage of Darstin
Contents of the package and additional information

1. What is Darstin and what is it used for

This medication 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 diseases.

2. What you need to know before starting to use Darstin

Do not use Darstin

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use 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 medications and Darstin

Inform your doctor or pharmacist if you are using or have used recently or may have to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The use of this medication has no influence during pregnancy, nor during breastfeeding.

Driving and operating machines

Your use does not affect your ability to drive vehicles and operate machinery.

3. How to use Darstin

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

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

To measure a daily dose of 5 g:

Twist the applicator onto the tube opening.
Press 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 procedure for the other breast.
After each application, separate the plunger from the cannula and wash them.

Allow to dry before dressing.

Darstin does not have a scent 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 Toxicological Information Service, phone (91) 562 04 20, indicating the medication and the amount ingested.

If you forget to use Darstin

Do not use a double dose to compensate for the missed doses.

4. Possible Adverse Effects

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

Dermatological and subcutaneous tissue disorders

Unknown frequency (cannot be estimated from available data): skin irritation and dryness.

Reporting 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 prospectus.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

5. Darstin Storage

Store below 25°C and keep the container perfectly closed after each application.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of Darstin

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

Appearance of Darstin and contents of the packaging

Transparent gel in an aluminum tube with a dosing applicator.

Tube with 80 g of gel.

Holder of the marketing authorization and responsible for manufacturing

SEID, S.A.

Carretera de Sabadell a Granollers, Km. 15

08185 - Lliçà de Vall (Barcelona)

Date of the last review of this leaflet: November 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.