Leaflet:information for the user

Cyclogest 400 mg pessaries

progesterone

Read this leaflet carefully before you start using this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.

-This medicine has been prescribedonlyfor you, and you must not give it to others even iftheyhavethe same symptomsas you,as it may harm them.

• If you experience any side effects,consult your doctor, pharmacist or nurse,eveniftheyare not listed in this leaflet. See section 4.

1.What Cyclogest is and what it is used for

2.What you need to knowbeforestarting touse Cyclogest

3.How to use Cyclogest

4.Possible side effects

5Storage of Cyclogest

6.Contents of the pack and additional information

Cyclogest contains progesterone, which is a natural female sex hormone produced in the body.

Cyclogest is for women who need extra progesterone while undergoing treatment as part of an Assisted Reproductive Techniques (ART) procedure.

Progesterone acts on the inner lining of the uterus and helps to stay and remain pregnant when undergoing fertility treatment.

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 current 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 especially careful and consult your doctor directly if you experience any of these symptoms during treatment or even some days after the last administration:

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

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

• liver problems
• epilepsy
• migraine
• asthma
• cardiac or renal disease
• diabetes

Children and adolescents

There is no specific use for Cyclogest in children.

Use of Cyclogest with other medications

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

This is especially important if you are taking carbamazepine (for example, to prevent seizures, to treat certain types of pain or mood disorders), rifampicin (to treat infections), or phenytoin (for example, to prevent 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 used vaginally is not recommended as it is not known if it affects the treatment.

Pregnancy and lactation

Cyclogest may be used during the first trimester of pregnancy for women who need extra progesterone while undergoing treatment as part of an Assisted Reproductive Techniques (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 lactation.

Driving and operating machinery

Cyclogest has a low to moderate effect on the ability to drive or operate machinery. It may cause dizziness; therefore, caution is recommended for drivers and users of machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor.This medicationindicated by your doctor.Consult your doctor again if you are unsure.

The recommended doseis400 mg twice a day by vaginal insertion. Start using Cyclogest on the day of oocyte recovery. If pregnancy is confirmed, Cyclogest administration should continue until 38 days of treatment have been completed since the start of treatment.

How to insert Cyclogest

Always wash your hands before and after inserting the ovule.

To insert it into the vagina, place the ovule between the labia of the vagina and push the ovule upwards and backwards. It may be easier if you are lying down or squatting.

If you use more Cyclogest than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological 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 an ovule, do it as soon as you remember, unless it is close to the time of your next administration.

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

If you interrupt the treatment with Cyclogest

Consult your doctor or pharmacist if you intend to interrupt or have interrupted the use of Cyclogest. Sudden discontinuation of progesterone administration may cause anxiety, irritability, and increased sensitivity to seizures.

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse reactions in patients undergoing TRA treatment are listed below:

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

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

The following infrequent adverse effects(may affect up to 1 in 100 people):

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

You may notice some leakage after the tablet has dissolved. Do not worry, this is quite normal when using medications inserted into the vagina or rectum.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Human Use Medications: https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above 30º C.

Do not usethis medicationafter the expiration date that appears onthe labeland on the packagingafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need.This will help protect the environment.

Composition of Cyclogest

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

Appearance of the product and contents of the pack

White, torpedo-shaped capsules, approximately 10 mm x 30 mm, packaged in PVC/PE strip packs.

Pack size: 12, 15, 30, 45 capsules.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest,

Hungary

Manufacturer responsible

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 medicinal product is authorized in the Member States of the European Economic Area with 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

Last review date of thisleaflet:September 2021

Other sources of information

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)} (http://www.aemps.gob.es/)