Famenita

PROGESTERONE EFFIK, 100 mg, Soft Capsules

PROGESTERONE EFFIK, 200 mg, Soft Capsules

Read the leaflet carefully before taking the medicine, as it contains important information for you.

Important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist. This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Progesterone Effik 100 mg and 200 mg and what is it used for
• 2. Important information before taking Progesterone Effik 100 mg and 200 mg
• 3. How to take Progesterone Effik 100 mg and 200 mg
• 4. Possible side effects
• 5. How to store Progesterone Effik 100 mg and 200 mg
• 6. Contents of the pack and other information

1. What is Progesterone Effik 100 mg and 200 mg and what is it used for

This medicine is used for hormone replacement therapy with progesterone.
It is indicated in disorders related to progesterone deficiency:

• irregular cycles resulting from ovulation disorders,
• premenstrual pain and disorders,
• bleeding (bleeding caused by fibroids,...)
• in the treatment of menopause (in combination with estrogen therapy).

2. Important information before taking Progesterone Effik 100 mg and 200 mg

When not to take Progesterone Effik 100 mg and 200 mg:

• if you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver disease;
• if you have vaginal bleeding of unknown origin;
• if you have active breast cancer or genital cancer or if there is a suspicion of such cancer;
• if you have currently or in the past had blood clots in the veins (thrombosis), for example in the legs (deep vein thrombosis) or lungs (pulmonary embolism);
• if you have currently had a disease caused by blood clots in the arteries, for example heart attack, stroke or angina;
• if you have had bleeding in the brain;
• if you have a rare, inherited blood disorder called porphyria.

Warnings and precautions

Before starting to take Progesterone Effik 100 mg and 200 mg, you should discuss it with your doctor.
Warnings
If you have had any of the following conditions: heart attack, cerebrovascular disorders, sudden, severe headaches, vision disorders, and if you have had blood clots in the veins or arteries, you should stop taking the medicine and contact your doctor.
Progesterone Effik capsules may be prescribed in combination with estrogens as hormone replacement therapy. The use of hormone replacement therapy is associated with an increased risk of deep vein thrombosis or pulmonary embolism.
Available data indicate a slight increase in the risk of breast cancer during estrogen replacement therapy. It is not known whether the simultaneous use of progesterone affects the risk of breast cancer in postmenopausal women taking hormone replacement therapy.
This medicine does not treat all causes of spontaneous early abortion. It does not work in cases resulting from genetic abnormalities (i.e. in more than half of abortions).
This medicine is not a contraceptive.
Precautions
You should take this product outside of meals, preferably in the evening, when going to bed.

• -Before starting hormone replacement therapy (and then at regular intervals), each patient should consult a doctor. During the visit, a clinical breast examination and gynecological examination can be performed;
• Progesterone Effik capsules should not be taken with food, they should be taken when going to bed.
• You should be cautious when taking Progesterone Effik capsules if:
• you have conditions that may exacerbate fluid retention (e.g. hypertension, heart disease, kidney disease, epilepsy, migraine, asthma);
• you have had depression, diabetes, mild to moderate liver function disorders, migraine, hypersensitivity to light, or if you are breastfeeding.

Progesterone Effik 100 mg and 200 mg and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may affect the action of Progesterone Effik 100 mg and 200 mg. These include:

• medicines used to treat epilepsy (such as phenobarbital, phenytoin, and carbamazepine);
• medicines used to treat tuberculosis (such as rifampicin, rifabutin);
• herbal medicines containing St. John's Wort (Hypericum perforatum);
• bromocriptine;
• cyclosporine;
• ketokonazole. Smoking and drinking alcohol may also affect Progesterone Effik 100 mg and 200 mg.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Data from a large number of uses of the product during pregnancy indicate that progesterone does not cause developmental abnormalities and does not harm the fetus or newborn. Before taking any medicine, you should consult your doctor or pharmacist.
Breastfeeding
Measurable amounts of progesterone pass into breast milk. There are no indications for prescribing progesterone during breastfeeding. However, it seems that taking progesterone during breastfeeding does not have a harmful effect on the development of the child.
Fertility
The product does not have a harmful effect on fertility.

Driving and using machines

People driving vehicles or operating machines should be aware that taking this medicine is associated with a risk of drowsiness (or) dizziness.

Progesterone Effik 100 mg and 200 mg contains soy lecithin

If you are allergic to peanuts or soy, you should not use this medicinal product.

3. How to take Progesterone Effik 100 mg and 200 mg

Method of administration

This product is intended for oral use only. Progesterone Effik 100 mg and 200 mg should be taken outside of meals, preferably in the evening, when going to bed.
This medicine should always be taken according to the doctor's instructions. If you have any doubts, you should consult your doctor or pharmacist.

Dose

On average, in cases of progesterone deficiency, the recommended dose is 200 to 300 mg per day, in one or two portions: 100 mg in the morning and 100 or 200 mg in the evening, when going to bed.
In no case can a single dose be greater than 200 mg. If you feel that the dose of Progesterone Effik 100 mg or 200 mg is too strong or too weak, you should consult your doctor or pharmacist.

Frequency of administration

Depending on the case, continuous or cyclic treatment for several days a month may be prescribed, which may be associated with estrogen therapy.
Swallow the capsule with a glass of water, outside of meals, in one or two portions, depending on the treatment schedule prescribed by your doctor.

Duration of treatment

The duration of treatment is given by the doctor depending on the case.
Depending on the nature of the indications and the effectiveness of the treatment, the doctor may consider it necessary to change the duration of the treatment.

Taking a higher dose of Progesterone Effik 100 mg or 200 mg than recommended

Contact your doctor or pharmacist immediately.
Symptoms of overdose may include drowsiness, dizziness, euphoria, or painful menstruation.

Missing a dose of Progesterone Effik 100 mg or 200 mg

You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed :

• Common side effects(may affect up to 1 in 10 people): changes in menstruation, amenorrhea, intermenstrual bleeding; headache.
• Uncommon side effects(may affect up to 1 in 100 people): breast tenderness; risk of drowsiness or transient dizziness, occurring 1 to 3 hours after taking the product; gastrointestinal disorders; rash, acne; fluid retention.
• Rare side effects(may affect up to 1 in 1,000 people): nausea; jaundice; weight change.
• Very rare side effects(may affect up to 1 in 10,000 people): changes in libido; depression; urticaria; hirsutism; fever; hair loss; excessive hair growth.

These side effects are usually related to overdose.
In such a case, your doctor may recommend:

• reducing the amount of medicine taken in a single dose
• or changing the rhythm of taking doses

In no case can a single dose be greater than the maximum dose of 200 mg.
If you experience symptoms of overdose, you should consult your doctor, who will adjust the treatment.
If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301; Fax: +48 22 49 21 309; e-mail: adr@urpl.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Progesterone Effik 100 mg and 200 mg

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Do not store above 30°C. Store in the original package to protect from light.
Do not use this medicine if you notice signs of deterioration. Return the medicine to your pharmacist.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Progesterone Effik 100 mg and 200 mg contains

The active substance of the medicine is progesterone. Each capsule contains 100 mg and 200 mg of progesterone.
The other ingredient is purified peanut oil (type II).
The ingredients of the capsule itself are gelatin, glycerol, and titanium dioxide (E 171).
Intermediate products used in the manufacturing process: medium-chain triglycerides and soy lecithin (see section 2 "Progesterone Effik 100 mg and 200 mg contains soy lecithin").

What Progesterone Effik 100 mg and 200 mg looks like and contents of the pack

Each blister pack contains 15 capsules.
Progesterone Effik 100 mg: Each pack contains 30 or 90 soft capsules
Progesterone Effik 200 mg: Each pack contains 15 or 45 soft capsules

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratoire EFFIK

Bâtiment le Newton
9/11 rue Jeanne Braconnier
92366 Meudon la Foret
France

Manufacturer

EFFIK

Bâtiment le Newton
9/11 rue Jeanne Braconnier
92366 Meudon la Foret
France
or

Laboratorios Leon Farma SA

C/ La Vallina s/n
Polígono Industrial Navatejera
Villaquilambre
24008 LEÓN
Spain

Date of last revision of the leaflet: