PROGEFFIK 100 mg Soft Capsules

Зміст інструкції

1. Progeffik 100 mg soft capsules for oral and vaginal use, 200 mg soft capsules for oral and vaginal use
   1. What Progeffik is and what it is used for
   2. What you need to know before taking Progeffik
   3. How to take Progeffik
   4. Possible side effects
   5. How to store Progeffik
   6. Contents of the pack and other information

Progeffik 100 mg soft capsules for oral and vaginal use, 200 mg soft capsules for oral and vaginal use

progesterone

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Progeffik is and what it is used for
• 2. What you need to know before you take Progeffik
• 3. How to take Progeffik
• 4. Possible side effects
• 5. How to store Progeffik
• 6. Contents of the pack and other information

1. What Progeffik is and what it is used for

Progeffik belongs to the pharmaceutical category of sex hormones and modulators of the genital system (progestogens).

Oral use
Progeffik is used for disorders due to progestin deficiency, in particular:

• premenstrual syndrome (the symptoms preceding menstruation);
• alterations of the menstrual cycle due to alterations of ovulation or anovulation (menstrual cycle in which the release of an oocyte from the ovary is missing);
• benign mastopathies (breast nodules);
• premenopause (the period preceding the definitive cessation of the menstrual cycle);
• hormone replacement therapy for menopause (in association with estrogen therapy).

Vaginal use(represents an alternative to oral use)
Progeffik is used as:

• supplement in the luteal phase (the last phase of the menstrual cycle, after ovulation) during spontaneous or induced cycles, in case of subfertility (reproductive capacity lower than normal) or primary (the inability to conceive) or secondary (the inability to conceive again after carrying a pregnancy to term), due in particular to primary ovarian insufficiency (the ovaries are unable to respond to normal stimulation) or secondary (the ovaries are normal but are not stimulated enough) with alterations of ovulation;
• supplement in the luteal phase during in-vitro fertilization cycles or other assisted reproductive techniques, limited to women who have undergone oophorectomy (surgical removal of the ovary);
• in case of threatened abortion or in the prevention of recurrent abortions due to luteal insufficiency (inadequate production of progesterone by the ovary in the second phase of the menstrual cycle), up to the 12th week of amenorrhea (absence of menstruation);
• prevention of preterm delivery in singleton pregnancies with shortened cervix (≤15 mm) clinically silent, detected by ultrasound examination performed in the second trimester of pregnancy. In all other indications of progesterone, vaginal use represents an alternative to oral use in case of: side effects due to progesterone (drowsiness after oral administration);

contraindications to oral use in case of hepatopathies (liver diseases).

2. What you need to know before taking Progeffik

Do not take Progeffik

• if you are allergic to progesterone, to substances closely related from a chemical point of view or to any of the other components of this medicine (listed in paragraph 6), if you are allergic to peanuts or soy;
• if you suffer from severe liver failure (reduced liver function);
• if you have vaginal bleeding of an uncertain nature;
• in case of incomplete or threatened miscarriage;
• if you suffer or have suffered in the past from thromboembolism (blockage of blood vessels caused by the formation of blood clots);
• if you have or suspect you have breast or genital cancer;
• if you suffer from thrombophlebitis (inflammation of superficial veins);
• if you have cerebral hemorrhage (rupture of a blood vessel in the brain area).

Warnings and precautions
Consult your doctor or pharmacist before taking this medicine.

Treatment, at the recommended doses, is not a contraceptive.
Undergo a thorough general and gynecological examination (pelvic and breast exam), including a Pap-
test, before starting treatment.
Since some progestins can cause a certain degree of fluid retention, your doctor will need to carefully monitor
your condition to closely observe conditions that could be
influenced by this factor:

• if you suffer from epilepsy (a disease that causes seizures);
• if you suffer from migraine (unilateral headache);
• if you suffer from asthma;
• if you suffer or have suffered in the past from heart failure (the inability of the heart to pump the adequate amount of blood needed by the body);
• if you suffer or have suffered in the past from kidney failure (reduced kidney function).

In particular, talk to your doctor if:

• you have vaginal bleeding, as in cases of metrorrhagia (bleeding from the uterus, outside of menstrual periods) of an uncertain nature, your doctor will first identify the causes;
• you have a history of mental depression; in this case your doctor will need to carefully monitor your condition;
• you suffer from diabetes mellitus, as progestins can cause or worsen fluid retention (water) and reduce glucose tolerance. If you are going to undergo a histological examination (analysis of tissue taken with a biopsy), inform your doctor that you are being treated with Progeffik.

In case of association of Progeffik with estrogens, in the context of hormone replacement therapy (HRT),
be careful if during treatment you notice the appearance of symptoms of partial or total loss of
vision or double vision; interrupt treatment at the first symptoms of thrombotic (blood clot) disorders
affecting the peripheral, cerebral or pulmonary vessels.
Your doctor will prescribe Progeffik only if you suffer from luteal insufficiency, as this medicine
does not represent a treatment for all cases of early miscarriage. The only effect of
administering progesterone in cases of miscarriages due to genetic conditions would be
to delay the evacuation of a non-viable egg or the interruption of a pregnancy that could not
be carried to term.

Specifically regarding use in menopausal disorders in association with hormone replacement therapy (HRT)
In the context of treatment of menopausal symptoms, start hormone replacement therapy (HRT)
only for symptoms that compromise your quality of life. In any case, it is advisable to have
at least an annual thorough assessment of the risks and benefits of treatment, continuing the
HRT only as long as the benefit obtained is greater than the risk.
Before starting or resuming HRT, the doctor will ask you about your personal and family medical history
(anamnesis) and will subject you to a thorough general and gynecological examination (including
pelvic and breast exam), based on the anamnesis, contraindications and warnings for
use.
During treatment with HRT, the doctor will subject you to periodic checks, the nature and frequency of which
will be adapted according to individual clinical needs, for an accurate assessment of the risks and benefits in relation to the continuation of therapy. Undergo the examinations in accordance with
currently used screening programs, including mammography, and report any
changes to your doctor.
You will be subjected to close monitoring if you have a family history of tumors or if you suffer or have suffered from:

• recurrent cholestasis (blockage of bile excretion) or persistent itching during pregnancy;
• liver dysfunction (liver) alterations;
• renal or heart failure;
• breast lumps of undetermined nature;
• an ear disease that manifests with deafness (otosclerosis);
• diabetes mellitus;
• multiple sclerosis;
• autoimmune disease (systemic lupus erythematosus).

Use of Progeffik in menopause in association with hormone replacement therapy (HRT)
Taking hormone replacement therapy (HRT) increases the probability that you will be diagnosed with breast cancer from slight to moderate if you are postmenopausal.
The risk of breast cancer may in fact increase with the duration of treatment. This risk appears
to return to the initial value after five years from the suspension of HRT. In women between the ages of
fifty and seventy, who do not use HRT, breast cancer is diagnosed in about 45
subjects per 1000, with an increase related to age. In women who use HRT, for at least five
years, the number of cases of breast cancer diagnosis increases between 2 and 12 subjects per 1000, depending on
the age at which the patient starts treatment and its duration.
Your doctor will discuss with you the increased probability of breast cancer diagnosis, evaluating it in
relation to the benefits of HRT.

Use of Progeffik in the prevention of preterm labor
There is no long-term safety data following the use of Progeffik in the prevention of
preterm labor, especially regarding the effects on children (at birth and during
childhood) born to mothers exposed to Progeffik (see paragraph 3).

Other medicines and Progeffik
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicine, including those available without a prescription.
Progesterone can cause amenorrhea (absence or cessation of menstruation) and galactorrhea
(secretion of breast milk outside of the breastfeeding period), interfering with the action of

bromocriptine(a substance used to correct hormonal imbalances). Do not take the two medicines in the
same time frame.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Progeffik can be used during pregnancy, preferably vaginally, and under medical supervision.
Administration of micronized progesterone during the second and third trimester of pregnancy may
cause cholestatic jaundice (yellowish discoloration of the skin, whites of the eyes and mucous membranes caused
by blockage of bile excretion) or hepatocellular (liver cell) diseases.

Breastfeeding
Do not take Progeffik during breastfeeding as progesterone is excreted in breast milk.

Driving and operating machinery
Be careful when driving vehicles and operating machinery, as this medicine can cause
drowsiness and dizziness.

Progeffik contains peanut oil and soy lecithin
Do not take this medicine if you are allergic to peanuts or soy.

3. How to take Progeffik

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Strictly respect the recommended doses.
The dose should not exceed 200 mg per each administration, regardless of the indication and
route of administration (oral or vaginal).

Oral use
In progestin deficiencies, the average daily dose is 200 mg -300 mg of micronized progesterone
divided into two administrations.
Take the medicine away from meals.

In luteal deficiencies(premenstrual syndrome, benign mastopathies, alterations of the cycle,
perimenopause), the average daily dose is 200 mg-300 mg of progesterone:

• or 200 mg in a single administration in the evening before bedtime (1 capsule of 200 mg or 2 of 100 mg)
• or 300 mg in two administrations: 1 capsule of 100 mg + 1 capsule of 200 mg (or 2 of 100 mg) for a therapeutic cycle of 10 days, usually from the 17th to the 26th day inclusive of the cycle.

In hormone replacement therapy in menopause, estrogen-only therapy is not recommended
(risk of endometrial hyperplasia [thickening of the uterine lining]). Progesterone should be
administered at a dose of 200 mg per day:

• or in two administrations of 100 mg each
• or in a single administration of 200 mg in the evening before bedtime (1 capsule of 200 mg or 2 of 100 mg) for 12 - 14 days per month, or during the last two weeks of each therapeutic cycle. Hormone replacement therapy should be interrupted for about a week during which you may experience vaginal bleeding. For these indications, if you suffer from liver diseases (hepatic disorders) and side effects due to progesterone (drowsiness after oral administration), vaginal use should be used as an alternative to oral use at the same doses.

Vaginal use
Insert each capsule deeply into the vagina.

Supplement in the luteal phase during spontaneous or induced cycles,in case of subfertility or primary or secondary sterility, particularly in case of alteration of ovulation: the recommended daily
dose is 200 mg (in two administrations of 100 mg each), or 300 mg in two
administrations: 1 capsule of 100 mg + 1 capsule of 200 mg (or 2 of 100 mg), starting from the 17th day
of the cycle for 10 consecutive days. Resume treatment as soon as possible in case of amenorrhea and
confirmed pregnancy, until the 12th week of pregnancy.

Threat of spontaneous abortion or prevention of recurrent abortions due to luteal insufficiency: the
recommended daily dose is 200 mg (in two administrations of 100 mg each), or 400 mg
(in two administrations of 200 mg each: 1 capsule of 200 mg or 2 of 100 mg) until the 12th week
of pregnancy.

Prevention of preterm delivery in singleton pregnancies with shortened cervix (≤15 mm)
clinically silent, detected by ultrasound examination performed in the second trimester of
pregnancy:the recommended daily dose is 200 mg (two 100 mg capsules or one 200 mg capsule) until the 34th week of pregnancy.
Long-term safety data are not available, especially in children (both at
birth and during childhood) born to mothers exposed to Progeffik (see paragraph 2)
If you take more Progeffik than you should
If you accidentally ingest/take an excessive dose of Progeffik, immediately inform your doctor
or go to the nearest hospital.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following lists the side effects that have been associated with the use of Progeffik:

Classification by systemsSide effects

and organs
Nervous system Drowsiness and dizziness*, headache**.
Skin and subcutaneous tissue
disorders
Skin reactions (urticaria, skin rash with or without itching)**,
appearance of yellow-brown spots on the face during pregnancy (chloasma**).
Reproductive system and breast
disorders
Reduction of the menstrual cycle or metrorrhagia***,
intermenstrual bleeding**,
changes in menstrual flow**,
amenorrhea**,
alteration of cervical mucus **,
breast pain**.
Psychiatric disorders Depression**, insomnia **, nervousness**.
Metabolism and nutrition
disorders
Weight change (increase or decrease) **.
Hepatobiliary disorders yellowish discoloration of the skin, whites of the eyes and mucous membranes
caused by blockage of bile excretion (cholestatic jaundice**).
(*) Drowsiness and dizziness may occur occasionally up to three hours after oral administration of Progeffik. In this case the dose should be reduced or readjusted, for example, with a daily dose of 200 mg in a single dose away from meals (1 capsule of 200 mg or 2 of 100
mg), before bedtime for 12-14 days each cycle). Vaginal administration can also be used.
(***) In case of reduction of the menstrual cycle or metrorrhagia, it is advisable to postpone the treatment for a few days (for example, start the treatment on the 19th day of the cycle instead of the 17th day).
(**) All other side effects have been reported following the administration of progestogens in
general.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system, http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Progeffik

Keep this medicine out of sight and reach of children.
Store at a temperature below 30°C
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The expiry date refers to the product in intact packaging, correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Progeffik contains
Soft capsule 100 mg:

• The active ingredient is micronized progesterone. Each capsule contains 100 mg micronized progesterone.
• The other ingredients are: peanut oil, soybean lecithin (E322).
• The capsule components are: gelatin, glycerol, titanium dioxide (E171).

Soft capsule 200 mg:

• The active ingredient is micronized progesterone. Each capsule contains 200 mg micronized progesterone.
• The other ingredients are: peanut oil, soybean lecithin (E322).
• The capsule components are: gelatin, glycerol, titanium dioxide (E171).

Description of the appearance of Progeffik and contents
Soft capsules for oral or vaginal use.
Progeffik 100 mg: pack of 30 capsules.
Progeffik 200 mg: pack of 15 capsules.

Marketing Authorisation Holder
EFFIK ITALIA SpA
Via Lincoln 7/A
20092 Cinisello Balsamo (MI)

Manufacturer
Laboratoires EFFIK
Parc Tertiaire de Meudon, Immeuble Le Newton, 9/11 rue Jeanne Braconnier,
F-92 366 MEUDON LA FORET CEDEX, France
Leon Farma
C/ La Vallina, s/n, Poligono Industrial Navatejera, 24008 Villaquilambre – Leon – Spain