User Information: Product Information

PROGEFFIK100 mg Soft Capsules

Progesterone

Read this entire leaflet carefully before you start taking 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 should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

1. What is Progeffik 100 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 side effects

5. Storage of Progeffik 100

6. Contents of the pack and additional information

Progeffik 100belongs to a group of medications called progestogens andcontains a natural progestogen.

This medication is used for disorders related to progesterone deficiency, also in hormonal replacement therapy for menopause, to resolve some fertility problems and for the prevention of certain types of premature birth and abortion.

Do not take/use Progeffik 100

• If you are allergic (hypersensitive) to the active ingredient or to any of the other components of Progeffik 100 included in section 6.
• This medication contains peanut oil. It should not be used in case of an allergy to peanuts or soy.
• If you observe undiagnosed vaginal bleeding.
• If you have liver function abnormalities (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 before going to bed.

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

Use of Progeffik 100 with other medications

Inform your doctor or pharmacist if you are using or have used recently or may have to use any other medication, even those acquired without a prescription.

This is very important since taking more than one medication at the same time, its effect may be potentiated or weakened.

Taking Progeffik 100 with food and drinks

Taking the medication with meals increases its absorption, so it is recommended to always maintain the same administration schedule in relation to meals (for example: every day before 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

-Pregnancy

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

-Breastfeeding

Progesterone is eliminated through breast milk, therefore it is not recommended to administer it during the breastfeeding period.

Driving and operating machines

Given the risk of drowsiness and/or vertiginous sensations related to the use of progesterone by the oral route, situations requiring a special state of alertness, such as driving vehicles or operating machines, should be avoided.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate the duration of treatment with Progeffik 100, do not suspend the treatment before concluding it.

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

The normal dose is:

Oral route:On average, the dosage will be200 to300 mg of progesterone (from2 to3 capsules) per day.

Vaginal route:Doses can range from100 to600 mg/day (from1 to6 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 Toxicological Information Service, phone91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take/use Progeffik 100

Take it as soon as possible and resume treatment in the usual way.

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

If you interrupt the treatment with Progeffik 100

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

Like all medications, Progeffik 100 may produce adverse effects, although not all people will experience them.

The adverse reactions that may occur are as follows:

Oral Route:

Drowsiness and/or brief episodes of dizziness that occur 1 to 3 hours after taking the product.

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

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

Store in the original packaging.

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

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Progeffik 100

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

The other components are:

Content: Peanut oil and soy lecithin.

Covering: Gelatin, glycerol, titanium dioxide.

Appearance of the product and content of the packaging

Progeffik 100 are soft gelatin capsules for oral or vaginal use. They are available in packs of 30 and 60 capsules.

Holder of the marketing authorization and responsible manufacturer

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

Last review date of this leaflet May 2019.

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