User Information: Package Insert

PROGEFFIK 200 mg Soft Capsules

Progesterone

Read this package insert carefully before starting to take the medication, as it contains important information for you.

- Keep this package insert, as you may need to refer to it again.

- If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed only for you and should not be given to others, 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 not listed in this package insert.

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

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

3. How to take/use Progeffik 200

4. Possible adverse effects

5. Storage of Progeffik 200

6. Contents of the package and additional information

Progeffik 200belongs 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 200

• If you are allergic (hypersensitive) to the active ingredient or to any of the other components of Progeffik 200 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 200.

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 200 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 200 with food and drinks

Taking the medication with meals increases its absorption, so it is recommended to always maintain the same administration pattern 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, or 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 pregnancy 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

Since there has been a 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 200, 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 per day.

Vaginal route:The doses can range from 100 to 600 mg/day according to 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 Toxicological Information Service, phone91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take/use Progeffik 200

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

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

If you interrupt the treatment with Progeffik 200

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

Like all medications, Progeffik 200 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 dizziness that occurs from 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. If in 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 200

The active principle is micronized progesterone, 200 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 200 are soft gelatin capsules for oral or vaginal use. It is available in packs of 15 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.

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