Package leaflet: Information for the user

Cyclogest, 400 mg, globules
Progesteronum
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, ask 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 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 progesterone during assisted reproductive techniques (ART).
Progesterone acts on the endometrium 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) that 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 there have been in the past thrombosis 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 the 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 or 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 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 taken recently. This is particularly important for the following medicines: carbamazepine (used e.g. for treating epileptic seizures, certain types of pain, and mood disorders), rifampicin (used to treat infections), and phenytoin (used for treating epilepsy and certain types of pain), which may reduce the effectiveness of progesterone.
Concurrent use of other vaginal medications 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 technology treatment.
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 individuals driving vehicles or operating machinery.

3. How to use Cyclogest

This medicine should always be used exactly as directed by your doctor. If you have any doubts,
contact your doctor.
The recommended dose is 400 mg twice daily administered vaginally. Treatment with Cyclogest
should be started 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
Always wash your hands before and after use.
To insert the globule into the vagina, place it between the labia and push it upwards deeply.
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 taking too many globules, seek immediate medical
attention at the nearest hospital or contact your doctor for advice.
Missed dose of Cyclogest
If a dose is missed, take it as soon as possible, unless it is almost time for the next dose. Never use a
double dose. Remember to take the following 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 a higher risk of seizures.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse effects in women undergoing assisted reproductive technologies are listed below:
Common adverse effects (may occur in up to 1 in 10 women):

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

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

headache, dizziness, mood changes
taste disturbances, vomiting, flatulence, diarrhoea, bloating (gastrointestinal 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.

After administration of Cyclogest, discharge may be observed following dissolution of the granule.
This is nothing to worry about – it is a normal occurrence with vaginal or rectal medicines.
Reporting of suspected adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, please inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

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 blister and carton. The expiry date (EXP) 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. These measures 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
White to off-white torpedo-shaped globules, approximately 10 mm x 30 mm in size,
packed in soft blisters made of PVC/PE foil and placed in a cardboard box.
Pack sizes: 15, 30 or 45 globules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary
FULTON MEDICINALI S.P.A
Via Marconi, 28/9 – 20044
Arese (MI)
Italy
For further information about this medicinal product and its names in other European Economic Area (EEA) countries, please contact
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22) 755 96 48
[email protected]