Ciclogest

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Cyclogest (Amelgen)

400 mg, pessaries

Progesteronum
Cyclogest and Amelgen are different trade names for the same medicine.

It is necessary to carefully read the contents of the leaflet before using the medicine because it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Cyclogest and what is it used for
• 2. Important information before using Cyclogest
• 3. How to use Cyclogest
• 4. Possible side effects
• 5. How to store Cyclogest
• 6. Contents of the packaging and other information

1. What is Cyclogest and what is it used for

Cyclogest contains progesterone, which is a natural female sex hormone produced by the body.
Cyclogest is intended for women who need additional doses of progesterone during treatment with assisted reproductive technology (ART).
Progesterone acts on the uterine lining and helps to become pregnant and maintain pregnancy during infertility treatment.

2. Important information before using Cyclogest

When not to use Cyclogest:

• if the patient is allergic to progesterone or any of the other ingredients of this medicine (listed in section 6)
• if there is vaginal bleeding (of unknown origin, other than menstrual bleeding) that has not been investigated by a doctor
• if there is a tumor or suspected hormone-dependent tumor
• if there is porphyria (inherited or acquired disorders of certain enzymes)
• if there are or have been blood clots in the legs, lungs, eyes, or other parts of the body
• if there are or have been severe liver diseases
• if there has been a miscarriage and there is a suspicion that dead tissue has remained in the uterus.

Warnings and precautions

Page 1 4
If any of the following symptoms occur during treatment or within a few days of taking the last dose, caution should be exercised and the doctor should be informed immediately:

• pain in the calves or chest pain, sudden shortness of breath, or coughing up blood, which may indicate blood clots in the legs, heart, or lungs
• sudden severe headache or vomiting, dizziness, fainting, or vision and speech disorders, weakness, or numbness of the arm or leg, which may indicate blood clots in the brain or eye
• worsening of depression.

Before using Cyclogest, the doctor or pharmacist should be informed if the following conditions have occurred or are currently present:

• liver disease
• epilepsy
• migraine
• asthma
• heart or kidney disease
• diabetes.

Children and adolescents

Cyclogest is not indicated for use in children.

Cyclogest and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken or taken recently. This is especially important for the use of the following medicines: carbamazepine (used, for example, in the treatment of epileptic seizures, certain types of pain, and mood disorders), rifampicin (used in the treatment of infections), and phenytoin (used in the treatment of epilepsy and certain types of pain), which may reduce the effectiveness of progesterone.
Using other vaginal medicines at the same time as Cyclogest is not recommended, as their effect on Cyclogest is unknown.

Pregnancy and breastfeeding

Cyclogest may be used during the first trimester of pregnancy in women who require additional progesterone as part of assisted reproductive technology treatment.
The risk of congenital defects, including sexual disorders in male or female infants, after intrauterine exposure to exogenous progesterone during pregnancy has not been clearly established.
This medicine should not be used during breastfeeding.

Driving and using machines

Cyclogest has a minor or moderate effect on the ability to drive and use machines. It may cause dizziness, so caution is recommended for people driving vehicles or operating machines.

3. How to use Cyclogest

This medicine should always be used according to the doctor's recommendations. In case of doubts, the doctor should be consulted.
The recommended dose of the medicine is 400 mg twice a day vaginally. Taking Cyclogest should be started from the day of egg release from the ovaries. If pregnancy is confirmed, the use of Cyclogest should be continued for 38 days from the start of therapy.

How to use Cyclogest pessaries

Page 2 4
Hands should always be washed before and after using the pessary.
To insert the pessary into the vagina, it should be placed between the parted labia and pushed deep upwards. Insertion of the pessary may be easier in a lying position or with bent legs.

Using a higher dose of Cyclogest than recommended

In case of accidental swallowing of pessaries or taking too many pessaries, the nearest hospital should be visited or the doctor should be consulted for advice.

Missing a dose of Cyclogest

In case of missing a pessary, the missed dose should be taken as soon as possible, unless the time for the next dose is approaching. A double dose of the medicine should never be taken. Subsequent doses should be taken at the right time.

Stopping the use of Cyclogest

The use of Cyclogest should not be stopped without consulting a doctor or pharmacist. Sudden withdrawal of the medicine may cause increased anxiety, mood swings, and increased susceptibility to epileptic seizures.
In case of any further doubts about the use of the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Cyclogest can cause side effects, although not everybody gets them.
Side effects in patients treated with assisted reproductive technology are presented below:
Common side effects(may occur in up to 1 in 10 patients):

• bloating, abdominal pain, constipation
• drowsiness
• fatigue
• hot flashes
• breast pain.

Uncommon side effects(may occur in up to 1 in 100 patients):

• headache, dizziness, mood changes
• taste disorders, vomiting, gas, diarrhea, bloating (stomach expansion)
• night sweats, rash, or skin itching
• joint pain
• pelvic pain, ovarian enlargement, vaginal bleeding
• urinary frequency, uncontrolled urination
• weight gain
• bleeding
• itching at the site of administration, feeling of cold or temperature changes, general discomfort.

After using Cyclogest, discharge may be observed after the pessary has dissolved. This should not be a cause for concern – it is a normal symptom when using vaginal or rectal medicines.

Reporting suspected side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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, website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Cyclogest

Store out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Cyclogest contains

• The active substance is progesterone. Each pessary contains 400 mg of progesterone.
• The other ingredient is solid fat.

What Cyclogest looks like and what the pack contains

Pessaries are white, approximately 10 mm x 30 mm in size, and torpedo-shaped, packaged in soft PVC/PE blisters in a cardboard box.
Pack sizes: 15, 30, or 45 pessaries.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Italy, the country of export:

Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary

Manufacturer:

Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
Fulton Medicinali S.p.A., Via Marconi, 28/9 – 20044, Arese (MI), Italy

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Italy, the country of export: 044825026

Parallel import authorization number: 272/24

Date of leaflet approval: 04.07.2024

[Information about the trademark]
Page 4 4