AMELGEN 400 mg Pessary

Зміст інструкції

1. AMELGEN 400 mg vaginal suppositories
   1. What is AMELGEN and what is it used for
   2. What you need to know before using AMELGEN
   3. How to use AMELGEN
   4. Possible side effects
   5. How to store AMELGEN
   6. Contents of the pack and other information

AMELGEN 400 mg vaginal suppositories

Progesterone

Read this leaflet carefully before you start to use this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What AMELGEN is and what it is used for
• 2. What you need to know before you use AMELGEN
• 3. How to use AMELGEN
• 4. Possible side effects
• 5. How to store AMELGEN
• 6. Contents of the pack and other information

1. What is AMELGEN and what is it used for

AMELGEN contains progesterone, a female sex hormone naturally produced by the body.
AMELGEN is used in women who need progesterone supplementation as part of an
assisted reproductive technology (ART) treatment program.
Progesterone acts on the uterine lining, promoting the initiation and continuation of pregnancy in
cases where you are undergoing fertility treatment.

2. What you need to 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 a doctor,
• if you have or suspect you have a hormone-sensitive tumor,
• if you suffer from porphyria (a group of inherited or acquired diseases affecting certain enzymes),
• if you have or have had blood clots in the legs, lungs, eyes, or other parts of the body,
• if you have or have had serious liver problems,
• if you have had a miscarriage and your doctor suspects that tissue is still present in the uterus, or if you have an ectopic pregnancy.

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

• pain in the calves or chest, sudden shortness of breath or coughing up blood; these symptoms may indicate the presence of 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 of an arm or leg; these symptoms may indicate the presence of 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 adolescentsThere is no indication for specific use of AMELGEN in children.

Other medicines and AMELGEN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
This is particularly important if you are taking carbamazepine (e.g. to prevent seizures, treat certain types of pain or mood disorders), rifampicin (for the treatment of infections)
or phenytoin (e.g. to prevent seizures or to treat certain types of pain) as they may reduce
the effectiveness of progesterone.
The use of other vaginal products at the same time as AMELGEN is not recommended, as it is not known whether it has
effects on treatment.

Pregnancy and breastfeeding
AMELGEN can be used during the first trimester of pregnancy in women who need
progesterone supplementation as part of an assisted reproductive technology (ART) treatment program.
The risks of birth defects (present at birth), including genital abnormalities in male or
female newborns, due to exposure to exogenous progesterone during pregnancy have not been fully
defined.
This medicine should not be used during breastfeeding.

Driving and using machines
AMELGEN has mild or moderate effects on the ability to drive and operate machines. It may cause
dizziness; therefore, caution is advised in subjects driving vehicles and operating machinery.

3. How to use AMELGEN

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor.
The recommended dose is 400 mg twice a day by intravaginal application. Start using
AMELGEN on the day of oocyte retrieval. In case of pregnancy confirmation, the administration of
AMELGEN must continue for 38 days starting from the beginning of therapy.

How to apply AMELGEN
Always wash your hands before and after applying the vaginal suppository.
To insert the suppository into the vagina, position it between the labia minora, then push it upwards and backwards.
It may help to perform this operation by lying down or squatting.
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If you use more AMELGEN than you should
In the event that you (or another person) accidentally ingest one of the suppositories or use too many,
immediately contact the emergency room of the nearest hospital or your doctor for advice.

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

If you stop using AMELGEN
If you intend to stop or have stopped using AMELGEN, ask your doctor or pharmacist for advice.
Sudden discontinuation of progesterone administration can cause increased anxiety, mood swings and increased susceptibility to seizures.
If you have any doubts 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 everybody gets 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 (abdominal 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 alteration, vomiting, flatulence, diarrhoea, bloating (gastric dilatation).
• Night sweats, 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 coldness or change in body temperature or general discomfort.

After use of AMELGEN some leakage may be noticed subsequently to the dissolution of the ovule.
Do not worry: this is a normal effect with the use of medicines that are applied in the vagina or in the
rectum.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through 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 at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the blister and on the box after Expiry. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What AMELGEN contains

• The active ingredient is progesterone. Each suppository contains 400 mg of progesterone
• The other ingredients are solid semi-synthetic glycerides.

Description of the appearance of AMELGEN and contents of the pack
Whitish-colored suppository, approximately 10 mm x 30 mm, torpedo-shaped in PVC/PE strips
Pack sizes: 12, 15 vaginal suppositories
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Gedeon Richter Plc.
Gyomroi ut 19-21
1103 Budapest
Hungary

Manufacturer:
ACCORD-UK Limited
Whiddon Valley, Barnstaple, North Devon
EX32 8NS
United Kingdom
Gedeon Richter Plc.
Gyömrői út 19-21.
1103, Budapest
Hungary
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