Ciclogest

Package Leaflet: Information for the User

Cyclogest, 400 mg, pessaries

Progesteronum

Read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What is Cyclogest and what is it used for
• 2. Before you use Cyclogest
• 3. How to use Cyclogest
• 4. Possible side effects
• 5. How to store Cyclogest
• 6. Contents of the pack 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 for women who need extra progesterone while being treated with assisted reproductive technology (ART).
Progesterone works on the lining of the womb and helps you become pregnant and maintain pregnancy during infertility treatment.

2. Before you use Cyclogest

When not to use Cyclogest:

• if you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6)
• if you have vaginal bleeding (other than menstrual bleeding) that has not been investigated by a doctor
• if you have or have had cancer or suspected cancer that is affected by hormones
• if you have porphyria (a rare inherited or acquired disorder that affects the production of heme, a vital molecule for all of the body's organs)
• if you have or have had blood clots in your legs, lungs, eyes, or other parts of your body
• if you have or have had severe liver disease
• if you have had a miscarriage and there is a suspicion that dead tissue is still in the womb.

Warnings and precautions

If you experience any of the following symptoms during treatment, or in the days after stopping treatment, be aware of the risks and tell your doctor immediately:

• pain in your calves or chest, sudden shortness of breath, or coughing up blood, which could be a sign of a blood clot in your legs, heart, or lungs
• sudden severe headache or vomiting, dizziness, fainting, or problems with your vision or speech, weakness, or numbness in your arm or leg, which could be a sign of a blood clot in your brain or eye
• worsening of depression.

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

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

Children and adolescents

Cyclogest is not intended for use in children.

Cyclogest and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have taken recently. This is especially important for the following medicines: carbamazepine (used to treat epilepsy, some types of pain, and mood disorders), rifampicin (used to treat infections), and phenytoin (used to treat epilepsy and some types of pain), as they 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 malformations, including genital abnormalities in male or female babies, following in utero exposure to exogenous progesterone during pregnancy has not been fully determined.
This medicine should not be used during breastfeeding.

Driving and using machines

Cyclogest has a minor or moderate influence on the ability to drive and use machines. It may cause dizziness, so caution is recommended when driving or operating machinery.

3. How to use Cyclogest

Always use this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
The recommended dose is 400 mg twice daily, administered vaginally. Treatment with Cyclogest should be started on the day of egg release from the ovaries. If pregnancy is confirmed, treatment with Cyclogest should be continued for 38 days from the start of treatment.

How to use Cyclogest pessaries

Wash your hands before and after using the pessary.
To insert the pessary into the vagina, place it between the folded labia and push it high up into the vagina. Insertion may be easier when lying down or with your legs bent.

What to do if you use more Cyclogest than you should

If you accidentally swallow a pessary or take too many pessaries, go to your nearest hospital or contact your doctor for advice.

What to do if you forget to use Cyclogest

If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose. Remember to take your next doses at the right time.

What to do if you stop using Cyclogest

Do not stop using Cyclogest without talking to your doctor or pharmacist. Stopping treatment suddenly may cause increased anxiety, mood changes, and increased risk of seizures.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

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

Uncommon side effects(may affect up to 1 in 100 people):

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

After using Cyclogest, you may notice a discharge as the pessary dissolves. This is a normal effect of using vaginal or rectal medicines.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system listed in the website. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cyclogest

Keep out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
The batch number is printed on the blister as "Lot".
Medicines should 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 pack 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 contents of the pack

The pessaries are white, approximately 10 mm x 30 mm in size, and torpedo-shaped, packaged in blister packs of PVC/PE in a cardboard box.
Pack sizes: 15, 30, or 45 pessaries.
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

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 medicine or its authorized names in other European Economic Area countries, contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22) 755 96 48
[email protected]
Date of last revision of the leaflet:May 2023