400 mg vagitorium 
progesterone

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Cyclogest is and what it is used for 
2. What you need to know before taking Cyclogest 
3. How to take Cyclogest 
4. Possible side effects 
5. How to store Cyclogest 6. Contents of the pack 
and other ingredients information

1. What Cyclogest is and what it is used for

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

Cyclogest is for women who need extra progesterone while undergoing treatment in an assisted reproduction program (ART).

Progesterone acts on the uterine lining and helps you get pregnant and maintain your pregnancy when you are being treated for infertility (involuntary infertility.

Progesterone contained in Cyclogest may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before taking Cyclogest

Do not take Cyclogest:

  • if you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6),
  • if you have abnormal vaginal bleeding, which has not been assessed by a doctor
  • if you have a known or suspected tumor that is hormone-sensitive
  • if you have porphyria (a group of congenital or acquired disorders of certain enzymes )
  • if you have or have had blood clots in your legs, lungs, eyes, or anywhere else in your body
  • if you have or have had severe liver problems
  • if you have a miscarriage and your doctor suspects that some tissue is still in the uterus or suspects ectopic pregnancy (ectopic pregnancy)

Warnings and cautions

Take special care and tell your doctor immediately if you experience any of these symptoms during treatment or a few days after the last dose:

  • pain in the calves or chest, sudden shortness of breath, or coughing up of blood, which may indicate clots in the legs, heart, or lungs
  • severe headache or vomiting, dizziness, lethargy or changes in vision or speech, weakness or numbness in an arm or leg, which may indicate clots in the brain or eyes
  • aggravated depressive symptoms

Talk to your doctor or pharmacist before taking Cyclogest if you have or have ever had

  • liver problem
  • epilepsy
  • migraine
  • asthma
  • impaired cardiac or renal function
  • diabetes.

Children and young people

There is no relevant use of Cyclogest in children.

Other medicines and Cyclogest

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is especially important if you are taking carbamazepine (eg to prevent cramps, treat certain types of pain or emotional disturbances, rifampicin (against infections ), or phenytoin (eg to prevent cramps or to treat certain types of pain) because they can lower the effect of progesterone.

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

Pregnancy and breastfeeding

Cyclogest can be used during the first trimester of pregnancy in women who need extra progesterone while undergoing treatment in an assisted reproduction program (ART).

The risk of congenital abnormalities, including genital malformations in infants (boys or girls) due to exposure to externally administered progesterone during pregnancy, has not been fully established.

This medicine should not be used during breast-feeding.

Driving and using machines

Cyclogest has a minor or moderate effect on the ability to drive and use machines. It can cause dizziness. Therefore, vehicle drivers and users of machines should be careful.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to take Cyclogest

Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

The recommended dose is 400 mg, which is placed directly in the vagina twice a day, starting on the day the eggs are taken. If pregnancy has been confirmed, Cyclogest treatment should be continued for 38 days from the start of treatment.

How to enter Cyclogest

Always wash your hands before and after entering the auditorium.

To insert the vagitorium into the vagina, hold the auditorium between the labia and insert the vagitorium upwards and backward. It may be easier to do this if you are lying or squatting.

If you take more Loglogest than you should

If you or someone else happens to swallow the medicine, if you have ingested too much medicine, or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Cyclogest

If you forget to take a vomitorium, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose instead. Never take two doses at the same time. Remember to take the remaining doses at the correct time.

If you stop taking Cyclogest

Ask your doctor or pharmacist if you are planning to stop taking Cyclogest. Suddenly discontinued progesterone treatment may cause increased anxiety, mood swings, and increased susceptibility to 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 undergoing treatment in an assisted reproduction program (ART) are presented below:

Common (may affect more than 1 user in 10):

  • Stretched abdomen (swollen abdomen), abdominal pain, constipation
  • somnolence
  • fatigue
  • hemorrhage
  • chest pain.

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

  • Headache, dizziness, mood swings
  • taste changes, vomiting, gas, diarrhea, bloating/swelling (gastric dilatation), a tumor of the rectum
  • night sweats, rash, or itching
  • joint pain
  • vaginal bleeding, pelvic pain, enlargement of the ovaries, non-menstrual bleeding from the uterus
  • frequent urination, involuntary urine leakage
  • weight gain
  • bleeding
  • itching in the abdomen, feeling cold (freezing), changed body temperature, or general discomfort.

When you use Cyclogest, you may notice some leakage after the vagitorium has dissolved. This is nothing to worry about but is completely normal when using drugs that are inserted into the vagina or rectum.

5. How to store Cyclogest

Keep this medicine 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 strips and carton after EXP. The expiration date is the last day of the specified month.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is progesterone.
  • The other ingredient is hard fat.

What the medicine looks like and the contents of the pack

Off-white torpedo-shaped victorias, size about 10×30 mm, packed in PVC / PE strip packaging.

Pack sizes: 12, 15, 30 or 45 vagitorias.

Not all packaging may be marketed.

Marketing Authorisation Holder

Gedeon Richter Plc.

Gyömrői out 19-21.

1103 Budapest

Hungary

Manufacturer

ACCORD-UK Limited

Whiddon Valley, Barnstaple, North Devon, EX32 NS, UK

Gedeon Richter Plc.

Gyömrői out 19-21.

1103 Budapest

Hungary

Muhammad Nadeem

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