Progeffik 100 mg soft capsules
Spain
Table of Contents
- Patient Information Leaflet
- Introduction
- **Progesterone**
- 1. What Progeffik 100 is and what it is used for
- 2. What you need to know before starting to take/use Progeffik 100
- 3. How to take/use Progeffik 100
- 4. Possible adverse effects
- 5. Storage of Progeffik 100
- 6. Contents of the pack and other information
Patient Information Leaflet
Introduction
Package leaflet: Information for the user
PROGEFFIK 100 mg soft capsules
Progesterone
Read the entire 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.
Leaflet contents
- What Progeffik 100 is and what it is used for
- What you need to know before taking/using Progeffik 100
- How to take/use Progeffik 100
- Possible adverse effects
- Storage of Progeffik 100
- Package contents and additional information
1. What Progeffik 100 is and what it is used for
Progeffik 100 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 to prevent certain types of premature birth and miscarriage.
2. What you need to know before starting to take/use Progeffik 100
Do not take/use Progeffik 100
- If you are allergic (hypersensitive) to the active substance or to any of the other components of Progeffik 100 listed in section 6.
- This medicine contains peanut oil. It must not be used if you are allergic to peanuts or soybeans.
- 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 100.
If drowsiness occurs, it is recommended to take the capsules preferably at night before going to bed.
The treatment, depending on dosage and conditions of use, has no contraceptive effect.
Use of Progeffik 100 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 multiple medicines simultaneously may increase or reduce their effects.
Taking Progeffik 100 with food and drinks
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 one day to the next.
Pregnancy and breast-feeding
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; therefore, its administration during pregnancy does not cause adverse effects.
- Breast-feeding
Progesterone is excreted in breast milk; therefore, its administration is not recommended during breastfeeding.
Driving and using machines
Since drowsiness and/or dizziness have been reported 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 100
Follow exactly the instructions for administering 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 100; do not stop treatment before completing it.
The dosage varies depending on the indication; follow your doctor's instructions carefully.
The usual dose is:
Oral use: On average, the dosage is 200 to 300 mg of progesterone (2 to 3 capsules) per day.
Vaginal use: Dosages may range from 100 to 600 mg/day (1 to 6 capsules) depending on the indication.
If you take/use more Progeffik 100 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 100
Take it as soon as possible and then continue with your regular dosing schedule.
Do not take a double dose to make up for forgotten doses.
If you stop treatment with Progeffik 100
If you have any further questions about the use of this product, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Progeffik 100 may cause adverse effects, although not everyone will experience 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 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 100
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 containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Progeffik 100
The active substance is micronized progesterone, 100 mg per soft gelatin capsule.
The other components are:
Contents: Peanut oil and soybean lecithin.
Shell: Gelatin, glycerol, titanium dioxide.
Appearance of the medicine and contents of the pack
Progeffik 100 consists of soft gelatin capsules 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 most recent revision of this leaflet: May 2019.
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.