PROGEFFIK 100 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

PROGEFFIK100 mg soft capsules

Progesterone

Read the entire package leaflet carefully before starting to take the 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 100 is and what it is used for
2. What you need to know before taking/using Progeffik 100
3. How to take/use Progeffik 100
4. Possible side effects
5. Storage of Progeffik 100
6. Contents of the pack and further information

1. What Progeffik 100 is and what it is used for

Progeffik 100 belongs to the group of medicines called progestogens and contains a natural progestogen.

This medicine is used for disorders related to progesterone deficiency, also in hormone replacement therapy for menopause, to solve some fertility problems, and for the prevention of certain types of preterm labor and abortion.

2. What you need to know before taking/using Progeffik 100

Do not take/use Progeffik 100

• If you are allergic (hypersensitive) to the active substance or any of the other ingredients of Progeffik 100 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 100.

In case of drowsiness, it is recommended to take the capsules preferably at night when going to bed.

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

Using Progeffik 100 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 its effect.

Taking Progeffik 100 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 when going to bed 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 100

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 100; 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:On average, the dosage will be 200 to 300 mg of progesterone (2 to 3 capsules) per day.

Vaginal route:The doses can range from 100 to 600 mg/day (1 to 6 capsules) according to the indication.

If you take/use more Progeffik 100 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 100

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 100

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 100 can cause side effects, although not everyone will experience 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 consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of Progeffik 100

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 point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Progeffik 100

The active substance is micronized progesterone, 100 mg per soft gelatin capsule.

The other ingredients are:

Content: Peanut oil and soy lecithin.

Coating: Gelatin, glycerol, titanium dioxide.

Appearance of the Product and Contents of the Pack

Progeffik 100 is a soft gelatin capsule for oral or vaginal use. It is available in packs of 30 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/.