Progeffik 200 mg soft capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

PROGEFFIK 200 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 leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Package leaflet contents

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 adverse effects
5. Storage of Progeffik 200
6. Contents of the pack and other information

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

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

This medicine is used for disorders associated with progesterone deficiency, also in hormone replacement therapy for menopause, to address certain fertility problems, and for the prevention of certain types of preterm birth and miscarriage.

2. What you need to know before starting to take/use Progeffik 200

Do not take/use Progeffik 200

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

Warnings and precautions

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

If drowsiness occurs, it is recommended to take the capsules preferably at night before going to bed.

The treatment, according to dosage and conditions of use, has no contraceptive effect.

Use of Progeffik 200 with other medicines

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

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

Taking Progeffik 200 with food and drink

Taking the medicine with meals increases its absorption; therefore, it is advisable to always follow the same administration schedule in relation to meals (for example: every day at bedtime after dinner), avoiding variations from day to day.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

• Pregnancy

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

• Breast-feeding

Progesterone is excreted in breast milk; therefore, its administration during breast-feeding is not recommended.

Driving and using machines

Since drowsiness and/or dizziness have been reported in association with oral use of progesterone, situations requiring special alertness, such as driving vehicles or operating machinery, should be avoided.

3. How to take/use Progeffik 200

Follow exactly the administration instructions for this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

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

The dosage varies depending on the indication; always follow your doctor's instructions carefully.

The usual dosage is:

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

Vaginal route: Doses may 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 then continue with your regular dosing schedule.

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

If you stop treatment with Progeffik 200

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

4. Possible adverse effects

Like all medicines, Progeffik 200 can cause adverse effects, although not everybody gets them.

The possible adverse reactions are as follows:

Oral route:

Somnolence and/or transient sensations of dizziness occurring 1 to 3 hours after taking the product.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Progeffik 200

Keep this medicine out of sight and reach of children.

Store in the original packaging.

Do not use this medicine after the expiry date stated on the packaging 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 unused medicines and their containers at the SIGRE point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Progeffik 200

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

The other components are:

Contents: Peanut oil and soybean lecithin.

Capsule shell: Gelatin, glycerol, titanium dioxide.

Appearance of the product and pack contents

Progeffik 200 consists of 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 most recent review of this leaflet: May 2019.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.