Famenita

PROGESTERONE EFFIK, 100 mg, soft capsules
PROGESTERONE EFFIK, 200 mg, soft capsules
Please read the package leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist. This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any possible adverse reactions not listed in this leaflet, inform 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 progesterone hormone therapy.
It is indicated in disorders associated with progesterone deficiency:

• irregular cycles due to ovulation disorders,
• pain and disturbances preceding menstruation,
• bleeding (bleeding caused by fibroids, ...),
• in the treatment of menopause (in combination with estrogen therapy).

2. Information before taking Progesterone Effik 100 mg and 200 mg

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

• if the patient is allergic to progesterone or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe liver disease;
• if the patient has vaginal bleeding of unknown cause;
• if the patient has an active breast or genital cancer, or if such cancer is suspected;
• if the patient currently has or has had venous thrombosis (blood clots), for example in the veins of the legs (deep vein thrombosis) or in the lungs (pulmonary embolism);
• if the patient has an active or ongoing arterial disease caused by blood clots, such as myocardial infarction, stroke, or angina;
• if the patient has bleeding within the brain;
• if the patient has a rare, inherited blood disorder called porphyria.

Warnings and precautions
Before starting Progesterone Effik 100 mg and 200 mg, discuss this with your doctor.
Warnings
If the patient has ever experienced any of the following conditions: myocardial infarction, cerebrovascular disorders, sudden severe headaches, visual disturbances, or has had venous or arterial thrombosis, treatment with this medicine should be discontinued and the patient should contact her doctor immediately.
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-only hormone replacement therapy. It is not known whether the addition of progesterone affects the risk of breast cancer in postmenopausal women receiving hormone replacement therapy.
This medicine does not treat all causes of spontaneous early miscarriage. It is not effective in cases due to genetic abnormalities (i.e., in more than half of miscarriages).
This medicine, when used under recommended conditions, is not a contraceptive.

Precautions
This product should be taken without food, preferably in the evening before going to sleep.

• Before starting hormone replacement therapy (and subsequently at regular intervals), each patient should consult her doctor. A clinical breast examination and gynecological examination may be performed during the visit.
• Progesterone Effik, capsules should not be taken with food; it should be taken at bedtime.
• Exercise caution when using Progesterone Effik, capsules if:
• the patient has conditions that may worsen fluid retention (e.g., hypertension, heart disease, kidney disease, epilepsy, migraine, asthma);
• the patient has a history of depression, diabetes, mild to moderate liver dysfunction, migraine, photosensitivity, or is breastfeeding.

Progesterone Effik 100 mg and 200 mg and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or 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 products containing St. John's wort (Hypericum perforatum);
• bromocriptine;
• cyclosporine;
• ketoconazole.
  Smoking and alcohol consumption may also affect Progesterone Effik 100 mg and 200 mg.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Data from widespread use of the product during pregnancy indicate that progesterone does not cause developmental abnormalities and is not harmful to the fetus or newborn. Before taking any medicine, consult your doctor or pharmacist.

Breastfeeding
Detectable amounts of progesterone pass into breast milk. There are no specific indications for prescribing progesterone during breastfeeding. However, it appears that taking progesterone during breastfeeding does not have a harmful effect on child development.

Fertility
The product has no harmful effect on fertility.

Driving and operating machinery
Patients who drive vehicles or operate machinery should be aware that use of this medicine may be associated with drowsiness and/or dizziness.

Progesterone Effik 100 mg and 200 mg contains soya lecithin
If the patient is allergic to peanuts or soya, this medicinal product should not be used.

3. How to take the medicine 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 at bedtime.
This medicine should always be taken as directed by the physician. If in doubt, consult a doctor or pharmacist.
Dosage
In typical cases of progesterone deficiency, the recommended dose is 200 to 300 mg daily, in one or two divided doses: 100 mg in the morning and 100 or 200 mg in the evening at bedtime.
Under no circumstances should a single dose exceed 200 mg. If you feel that the dose of Progesterone Effik 100 mg or 200 mg is too strong or too weak, consult your doctor or pharmacist.
Frequency of administration
Depending on the case, treatment may be prescribed continuously or in cycles of several days per month, and may be combined with estrogen therapy.
Swallow the capsule with a glass of water, outside of meals, in one or two doses, according to the treatment regimen prescribed by the doctor.
Duration of treatment
The duration of treatment will be determined by the physician depending on the individual case.
Depending on the nature of the indication and the effectiveness of treatment, the physician may decide that a change in the duration of treatment is necessary.
Taking more than the recommended dose of Progesterone Effik 100 mg or 200 mg
Contact your doctor or pharmacist immediately.
Symptoms of overdose may include drowsiness, dizziness, euphoria, or painful menstruation.
Missed dose of Progesterone Effik 100 mg or 200 mg
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been observed:

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

These reactions are usually associated with overdose.
In such a case, the physician may recommend:

• reducing the amount of medicine taken per single dose,
• or changing the dosing schedule.

Under no circumstances should a single dose exceed the maximum dose of 200 mg.
If symptoms of overdose occur, medical advice should be sought; the physician will adjust the treatment accordingly.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions of 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: [email protected]. By reporting adverse reactions, additional information on the safety of the medicine's use can be collected.

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

Keep this medicine 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 stated month.
Do not store above 30°C. Store in the original packaging to protect from light.
Do not use this medicine if you notice any signs of deterioration. Return the medicine to the pharmacist.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Progesterone Effik 100 mg and 200 mg contains
The active substance is progesterone. Each capsule contains 100 mg or 200 mg of progesterone.
The other ingredient is purified crocus oil (type II).
Ingredients of the capsule shell are gelatin, glycerol and titanium dioxide (E 171).
Excipients used during manufacturing: 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 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 Authorisation Holder and Manufacturer
Marketing Authorisation 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