PROGEFFIK 200 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

PROGEFFIK 200 mg soft capsules

Progesterone

Read the entire package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Contents of the Package Leaflet

1. What Progeffik 200 is and what it is used for
2. What you need to know before taking/using Progeffik 200
3. How to take/use Progeffik 200
4. Possible side effects
5. Storage of Progeffik 200
6. Contents of the pack and further information

1. What Progeffik 200 is and what it is used for

Progeffik 200 belongs to the group of medicines called progestogens and contains a natural progestogen.

This medicine is used for disorders related to progesterone deficiency, also for hormone replacement therapy during menopause, to resolve some fertility problems, and to prevent certain types of premature birth and abortion.

2. What you need to know before taking/using Progeffik 200

Do not take/use Progeffik 200

• If you are allergic (hypersensitive) to the active substance or any of the other components of Progeffik 200 listed in section 6.
• This medicine contains peanut oil. It should not be used in case of peanut or soy allergy.
• If you have undiagnosed vaginal bleeding.
• If you have liver disorders (only oral route).
• If you have a history of thromboembolic disorders.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Progeffik 200.

In case of drowsiness, it is recommended to take the capsules preferably at night before bedtime.

Treatment, according to the doses and conditions of use, has no contraceptive effect.

Using Progeffik 200 with other medicines

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicine, including those obtained without a prescription.

This is very important, as taking more than one medicine at the same time can enhance or weaken their effect.

Taking Progeffik 200 with food and drinks

Taking the medicine with meals increases its absorption, so it is recommended to always maintain the same administration schedule in relation to meals (e.g., every day at bedtime after dinner), avoiding variations from one day to another.

Pregnancy and breastfeeding

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

• Pregnancy

Progesterone is the hormone that increases during pregnancy, so its administration during pregnancy does not induce adverse effects.

• Breastfeeding

Progesterone is eliminated in breast milk, so its administration during breastfeeding is not recommended.

Driving and using machines

Given that there is a risk of drowsiness and/or vertigo related to the use of progesterone orally, situations that require a special state of alertness, such as driving vehicles or operating machines, should be avoided.

3. How to take/use Progeffik 200

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

Remember to take your medicine.

Your doctor will indicate the duration of treatment with Progeffik 200; do not stop treatment before completing it.

The dosage varies according to the indications; follow your doctor's instructions faithfully.

The normal dose is:

Oral route:The average dosage will be 200 to 300 mg of progesterone per day.

Vaginal route:The doses can range from 100 to 600 mg/day depending on the indication.

If you take/use more Progeffik 200 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 take/use Progeffik 200

Take it as soon as you can and resume treatment as usual.

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

If you stop treatment with Progeffik 200

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Progeffik 200 can cause side effects, although not everyone gets them.

The adverse reactions that may occur are as follows:

Oral route:

Drowsiness and/or fleeting vertigo sensations that occur 1 to 3 hours after taking the product.

Shortening of the menstrual cycle duration or intercurrent bleeding in luteal insufficiency.

If you think any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of Progeffik 200

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

Store in the original packaging.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Progeffik 200

The active substance is micronized progesterone, 200 mg per soft gelatin capsule.

The other components are:

Content: Peanut oil and soy lecithin.

Coating: Gelatin, glycerol, titanium dioxide.

Appearance of the product and contents of the pack

Progeffik 200 are soft gelatin capsules for oral or vaginal use. It is available in packs of 15 and 60 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Effik, S.A.

C/ San Rafael, 3

28108 Alcobendas (Madrid)

Spain

Manufacturer

Laboratoire Effik

Bâtiment «Le Newton»

9-11, rue Jeanne Braconnier

92366 Meudon La Forêt

France

Date of the last revision of this package leaflet: May 2019

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/.