Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Cyclogest (Amelgen)
400 mg, globules
Progesteronum
Cyclogest and Amelgen are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

What Cyclogest is and what it is used for
Important information before taking Cyclogest
How to take Cyclogest
Possible side effects
How to store Cyclogest
Contents of the pack and other information

1. What Cyclogest is and what it is used for

Cyclogest contains progesterone, which is a natural female sex hormone produced by the body.
Cyclogest is intended for women who require additional doses of progesterone during assisted reproductive technology (ART) treatments.
Progesterone acts on the endometrium (lining of the uterus) and helps achieve 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 non-menstrual origin) which has not been investigated by a doctor
if there is a tumour or suspected hormone-dependent tumour
if there is porphyria (hereditary or acquired disorders of certain enzymes)
if there have been or currently exist thrombosis in the legs, lungs, eyes, or other parts of the body
if there have been or currently exist severe liver diseases
if miscarriage has occurred and there is suspicion that dead tissue remains in the uterus.

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

calf pain or chest pain, sudden shortness of breath, or coughing up blood-stained discharge, which may indicate thrombosis in the legs, heart, or lungs
sudden severe headache or vomiting, dizziness, fainting, or disturbances in vision or speech, weakness, or numbness in the arm or leg, which may indicate thrombosis in the brain or eye
worsening of depression.

Before using Cyclogest, inform your doctor or pharmacist if you have previously had or currently have any of the following conditions:

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
Inform your doctor or pharmacist about all medicines currently taken or recently taken. This is particularly important for the following medicines: carbamazepine (used, for example, in the treatment of epileptic seizures, certain types of pain, and mood disorders), rifampicin (used to treat infections), and phenytoin (used in the treatment of epilepsy and certain types of pain), which may reduce the effectiveness of progesterone.
The simultaneous use of other vaginal medicines with 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 requiring additional progesterone treatment as part of assisted reproductive techniques.
The risk of congenital malformations, including sex organ disorders in male or female infants, following intrauterine exposure to exogenous progesterone during pregnancy has not been definitively established.
This medicine should not be used during breastfeeding.
Driving and operating machinery
Cyclogest has a minor or moderate effect on the ability to drive and operate machinery. It may cause dizziness; therefore, caution is advised for individuals driving vehicles or operating machinery.

3. How to use Cyclogest

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor.

The recommended dose of Cyclogest is 400 mg twice daily administered vaginally. Treatment with Cyclogest should begin on the day of ovulation. If pregnancy is confirmed, treatment with Cyclogest should be continued for 38 days from the start of therapy.

How to use Cyclogest globules
Page 2 of 4

Always wash your hands before and after using a globule.

To insert the globule into the vagina, place it between the labia and push it upwards deeply into the vagina. Insertion may be easier while lying down or with knees bent.

Use of a higher than recommended dose of Cyclogest

In case of accidental ingestion of the globules or administration of an excessive amount, seek immediate medical advice by going to the nearest hospital or contacting your doctor.

Missed dose of Cyclogest

If a dose of the globule has been missed, take it as soon as possible, unless it is almost time for the next dose. Never use a double dose of the medicine. Remember to take the following doses at the correct time.

Stopping Cyclogest treatment

Do not stop using Cyclogest without consulting your doctor or pharmacist. Abrupt discontinuation of the medicine may cause increased anxiety, mood swings, and a higher risk of epileptic seizures.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The adverse reactions in women undergoing assisted reproductive technologies are listed below:

Common adverse reactions (may occur in up to 1 in 10 women):

abdominal bloating, abdominal pain, constipation
drowsiness
fatigue
hot flushes
breast pain.

Uncommon adverse reactions (may occur in up to 1 in 100 women):

headache, dizziness, mood changes
taste disturbances, vomiting, flatulence, diarrhoea, bloating (stomach distension)
night sweats, skin rash or itching
joint pain
pelvic pain, ovarian enlargement, vaginal bleeding
frequent urination, urinary incontinence
weight gain
bleeding
itching at the site of administration, sensation of cold or temperature change, general discomfort.

Following administration of Cyclogest, a discharge may be observed after the suppository dissolves.
This is not a cause for concern – it is a normal occurrence with vaginal or rectal medications.

Reporting of suspected adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Page 3 of 4

5. How to store Cyclogest

Keep the medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Cyclogest contains

The active substance is progesterone. Each globule contains 400 mg of progesterone.
The other ingredient is hard fat.

What Cyclogest looks like and contents of the pack
Whiteish globules, approximately 10 mm x 30 mm in size, torpedo-shaped,
packed in soft PVC/PE blisters within a cardboard box.
Pack sizes: 15, 30 or 45 globules.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Italy, 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Italian marketing authorisation number, country of export: 044825026
Parallel import authorisation number: 272/24
Page 4 of 4