Patient Information Leaflet: Information for the User

AMELGEN 400 mg vaginal suppositories

Progesterone
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What AMELGEN is and what it is used for
What you need to know before using AMELGEN
How to use AMELGEN
Possible side effects
How to store AMELGEN
Contents of the pack and other information

1. What AMELGEN is and what it is used for

AMELGEN contains progesterone, a female sex hormone naturally produced by the body.
AMELGEN is used in women who require progesterone supplementation as part of an assisted reproductive technology (ART) treatment program.
Progesterone acts on the lining of the uterus, helping the establishment and maintenance of pregnancy in women undergoing infertility treatment.

2. What you should know before using AMELGEN

Do not use AMELGEN:

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

Warnings and precautions
Pay particular attention and inform your doctor immediately if, during treatment or a few days after the last dose, any of the following symptoms occur:

pain in the calves or chest, sudden shortness of breath, or coughing up blood; these symptoms may indicate blood clots in the legs, heart, or lungs

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severe headache or vomiting, dizziness, feeling faint, changes in vision or speech, weakness or numbness in one arm or leg; these symptoms may indicate blood clots in the brain or in an eye
worsening of depression.

Before using AMELGEN, check with your doctor or pharmacist if you have or have had:

liver problems
epilepsy
migraine
asthma
heart or kidney dysfunction
diabetes.

Children and adolescents
There is no specific indication for the use of AMELGEN in children.
Other medicines and AMELGEN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important if you are taking carbamazepine (e.g. to prevent epileptic seizures, treat certain types of pain or mood disorders), rifampicin (for the treatment of infections), or phenytoin (e.g. to prevent epileptic seizures or to treat certain types of pain), as these may reduce the effectiveness of progesterone.
The use of other vaginal products at the same time as AMELGEN is not recommended, as it is unknown whether they may affect the treatment.
Pregnancy and breastfeeding
AMELGEN may be used during the first trimester of pregnancy in women who require progesterone supplementation as part of an assisted reproductive technology (ART) treatment programme.
The risks of congenital anomalies (present at birth), including genital abnormalities in male or female newborns, due to exposure to exogenous progesterone during pregnancy have not been fully established.
This medicine must not be used during breastfeeding.
Driving and using machines
AMELGEN has mild to moderate effects on the ability to drive and use machines. It may cause dizziness; therefore, caution is advised for individuals who drive or operate machinery.

3. How to use AMELGEN

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
The recommended dose is 400 mg twice daily via vaginal administration. Begin using AMELGEN on the day of oocyte retrieval. If pregnancy is confirmed, treatment with AMELGEN must continue for 38 days from the start of therapy.

How to administer AMELGEN
Always wash your hands before and after inserting the suppository.
To insert the suppository into the vagina, place it between the labia minora and then push it upward and backward.
It may help to perform this while lying on your back or in a squatting position.
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If you use more AMELGEN than you should
If you (or another person) accidentally swallow one of the suppositories or use too many, contact immediately the nearest hospital emergency department or your doctor for advice.

If you forget to use AMELGEN
If you forget to use a suppository, use it as soon as you remember, unless it is almost time for your next dose. Never use a double dose. Remember to take the remaining doses at the correct times.

If you stop using AMELGEN
If you intend to stop or have stopped using AMELGEN, consult your doctor or pharmacist.
Sudden discontinuation of progesterone administration may lead to increased anxiety, mood swings, and increased susceptibility to epileptic seizures.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Adverse reactions in patients undergoing treatment with PMA are listed below:
Common side effects (may affect up to 1 in 10 people):

Abdominal distension (bloating), abdominal pain, constipation.
Drowsiness.
Fatigue.
Hot flushes.
Breast pain.

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

Headache, dizziness, mood changes.
Taste disturbances, vomiting, flatulence, diarrhoea, bloating (gastric dilation).
Night sweats, skin rash or itching.
Joint pain.
Pelvic pain, ovarian enlargement, vaginal bleeding.
Frequent urination, involuntary loss of urine.
Weight gain.
Bleeding.
Itching at application site, sensation of cold or change in body temperature, or general discomfort.

After using AMELGEN, you may notice some discharge following the dissolution of the suppository.
Do not be concerned: this is a normal effect when using medicines applied in the vagina or rectum.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
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5. How to store AMELGEN

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 stated on the strip and on the carton after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What AMELGEN contains

The active substance is progesterone. Each ovule contains 400 mg of progesterone.
The other components are solid semisynthetic glycerides.

Description of the appearance of AMELGEN and contents of the pack
Whitish ovule, approximately 10 mm x 30 mm, torpedo-shaped, in PVC/PE strips.
Pack sizes: 12, 15 vaginal ovules.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Gedeon Richter Plc.
Gyömrői ut 19-21
1103 Budapest
Hungary

Manufacturer:
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary
FULTON MEDICINALI S.P.A
Via Marconi, 28/9 – 20044
Arese (MI)
Italy
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