CYCLOGEST 400 mg Vaginal Suppositories

2. What you need to know before starting to use Cyclogest

Do not use Cyclogest:

• if you are allergic to progesterone or any of the other components of this medication (listed in section 6),
• if you have unusual vaginal bleeding that has not been evaluated by your doctor,
• if you have or suspect a hormone-sensitive tumor,
• if you have porphyria (a group of inherited or acquired disorders of certain enzymes),
• if you have or have had blood clots in your legs, lungs, eyes, or any other part of your body,
• if you have or have had liver problems,
• if you have had a miscarriage and your doctor suspects that some tissue is still in the uterus or you have an ectopic pregnancy.

Warnings and precautions

Be particularly careful and consult your doctor directly if you experience any of these symptoms during treatment or even a few days after the last administration:

• pain in the calves or chest, sudden difficulty breathing or coughing up blood, which could indicate possible blood clots in the legs, heart, or lungs
• severe headache or vomiting, dizziness, feeling of fainting, or changes in vision or speech, weakness or numbness of an arm or leg, which could indicate possible blood clots in the brain or eye
• worsening of depression symptoms

Before treatment with Cyclogest, consult your doctor if you have or have had any of the following health problems:

• liver problems
• epilepsy
• migraine
• asthma
• heart or kidney disorder
• diabetes

Children and adolescents

There is no specific use for Cyclogest in children.

Using Cyclogest with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

This is especially important if you are taking carbamazepine (e.g., to prevent epileptic seizures, to treat certain types of pain or mood disorders), rifampicin (to treat infections), or phenytoin (e.g., to prevent epileptic seizures or treat certain types of pain), as they may reduce the effectiveness of progesterone.

The use of other vaginal products at the same time as Cyclogest is not recommended, as it is not known whether it affects treatment.

Pregnancy and breastfeeding

Cyclogest may be used during the first trimester of pregnancy for women who need extra progesterone while undergoing treatment as part of an Assisted Reproduction Technique (ART) procedure.

The risk of congenital anomalies (conditions present at birth), including abnormalities in the genitals of boys and girls, from exposure to exogenous progesterone during pregnancy has not been fully established.

This medication should not be used during breastfeeding.

Driving and using machines

Cyclogest has a low to moderate influence on the ability to drive or use machines. It may cause dizziness; therefore, caution is recommended for drivers and machine users.

3. How to use Cyclogest

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor again.

The recommended dose is 400 mg twice a day by vaginal insertion. Start using Cyclogest on the day of egg retrieval. If pregnancy is confirmed, Cyclogest administration should be continued until 38 days of treatment have been completed from the start.

How to insert Cyclogest

Always wash your hands before and after inserting the pessary.

To insert it into the vagina, place the pessary between the vaginal lips and push it upwards and backwards. You may find it easier if you are lying down or squatting.

If you use more Cyclogest than you should

If you (or someone else) have accidentally swallowed a pessary or used too many, contact the emergency department of your nearest hospital or consult your doctor immediately for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used or ingested.

If you forget to use Cyclogest

If you forget to insert a pessary, do so as soon as you remember, unless it is almost time for your next dose.

Never use two doses together. Remember to use the remaining doses at the correct time.

If you stop using Cyclogest

Consult your doctor or pharmacist if you intend to stop or have stopped using Cyclogest. Abruptly stopping progesterone administration may cause anxiety, irritability, and increased sensitivity to seizures.

If you have any other doubts about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Adverse reactions in patients undergoing ART treatment are presented below:

The following frequent side effects(may affect up to 1 in 10 people):

• Abdominal distension (bloating in the abdomen), abdominal pain, constipation
• Drowsiness
• Fatigue
• Hot flashes
• Breast pain

The following uncommon side effects(may affect up to 1 in 100 people):

• Headache, dizziness, mood changes
• Changes in taste, vomiting, flatulence (gas), diarrhea, bloating (gastric dilation)
• Nocturnal sweats, skin rash or itching
• Joint pain
• Pelvic pain, ovarian enlargement, vaginal bleeding
• Frequent urination, involuntary urination
• Weight gain
• Bleeding
• Itching at the application site, feeling of cold or temperature change in the body or general discomfort

After using Cyclogest, you may notice some discharge after the pessary has dissolved. Do not worry, this is quite normal when using medications that are inserted into the vagina or rectum.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Cyclogest

Keep this medication out of the sight and reach of children.

Do not store above 30°C.

Do not use this medication after the expiration date stated on the strip and on the package after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the package and additional information

Composition of Cyclogest

• The active ingredient is progesterone. Each pessary contains 400 mg of progesterone.
• The other excipient is hard fat.

Appearance of the product and package contents

Pessary of white color, approximately 10 mm x 30 mm, torpedo-shaped, packaged in PVC/PE strip packs.

Package size: 12, 15, 30, 45 pessaries.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest,

Hungary

Manufacturer

Gedeon Richter Plc.

Gyömroi út 19-21.,

Budapest, 1103

Hungary

FULTON MEDICINALI S.P.A

Via Marconi, 28/9 – 20044

Arese (MI)

Italy

Local representative:

Gedeon Richter Ibérica, S.A.

Sabino Arana nº 28, 4º 2ª

08028 Barcelona

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

United KingdomProgesterone 400mg Pessaries

AustriaCyclogest 400 mg Vaginalzäpfchen

BelgiumCyclovita

BulgariaCyclogest 400 mg pessaries

????????? 400 mg ??????

CyprusCyclogest

Czech RepublicCyclovita

GermanyCyclogest

DenmarkCyclogest

EstoniaCyclogest

GreeceCyclogest

SpainCyclogest

FinlandCyclogest

FranceCyclogest

CroatiaCyclogest 400 mg vagitoriji

HungaryCyclogest 400 mg hüvelykúp

IrelandProgesterone 400 mg

IcelandCyclogest

ItalyCyclovita

LuxembourgCyclovita

LatviaProgesterone 400 mg ovulas

MaltaCyclogest

NetherlandsCyclovita

NorwayCyclogest

PolandCyclogest

PortugalCyclogest

RomaniaCyclovita

SwedenCyclogest

SloveniaCyclovita

SlovakiaCyclovita

Date of the last revision of this leaflet:September 2021

Other sources of information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)