Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Cyclogest (Amelgen), 400 mg, globules
Progesteronum
Cyclogest and Amelgen are different trade names for the same medicinal product.
Please read carefully all information in this leaflet 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 further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It 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
What you need to know before using Cyclogest
How to use 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 (the 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 (inherited or acquired disorders of certain enzymes)
if there have been or there are present thromboses in the legs, lungs, eyes, or other parts of the body
if there are or have been severe liver diseases in the past
if miscarriage has occurred and there is suspicion that dead tissue remains in the uterus.

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

calf pain or chest pain, sudden shortness of breath, or coughing up blood-stained sputum, which may indicate thrombosis in the legs, heart, or lungs
sudden severe headache or vomiting, dizziness, fainting, or disturbances in vision and speech, weakness, or numbness of 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 any of the following conditions have occurred in the past or are currently present:

liver diseases
epilepsy
migraine
asthma
heart or kidney diseases
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 particularly applies to 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.
The simultaneous use of other vaginal medicines with Cyclogest is not recommended, as their effect on the action of Cyclogest is unknown.
Pregnancy and breastfeeding
Cyclogest may be used during the first trimester of pregnancy in women requiring additional progesterone as part of assisted reproductive techniques.
The risk of congenital malformations, including sexual 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 people driving vehicles or operating machinery.

3. How to use Cyclogest

This medicine should always be used exactly as your doctor has told you. If you are unsure, you should
contact your doctor.
The recommended dose of Cyclogest is 400 mg twice daily administered vaginally. Treatment with
Cyclogest should begin on the day of ovulation (release of the egg from the ovary). If pregnancy is
confirmed, treatment with Cyclogest should be continued for 38 days from the start of therapy.
How to use Cyclogest globules
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 deeply upwards. Insertion
may be easier when lying down or with knees bent.
Use of a higher than recommended dose of Cyclogest
In case of accidental swallowing of the globule or administration of an excessive dose, you should
immediately go to the nearest hospital or contact your doctor for advice.
Missed dose of Cyclogest
If you miss a dose, 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 subsequent doses at the correct time.
Stopping Cyclogest treatment
Do not stop using Cyclogest without consulting your doctor or pharmacist. Sudden discontinuation
of the medicine may increase feelings of anxiety, mood swings, and increase the risk of 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 will experience them.
The adverse reactions observed in patients undergoing assisted reproductive techniques are listed below:

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

abdominal distension, abdominal pain, constipation
drowsiness
fatigue
hot flushes
breast pain

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

headache, dizziness, mood changes
taste disturbances, vomiting, flatulence, diarrhoea, abdominal distension (gastrointestinal bloating)
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

After administration of Cyclogest, discharge may be observed following dissolution of the suppository. This is normal when using vaginal or rectal medicines and should not be a cause for concern.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also 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.

5. How to store Cyclogest

Keep this 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.
The batch number on the blister is marked with the abbreviation LOT.
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 package and other information

What Cyclogest contains

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

What Cyclogest looks like and contents of the pack
Whiteish globules, approximately 10 mm x 30 mm in size and torpedo-shaped,
packed in soft PVC/PE blisters, in a cardboard box.
Pack sizes: 15, 30 or 45 globules.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing authorization 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Italy, country of export: 044825026
Parallel import authorization number: 50/24