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PROGESTERONE 400 MG PESSARIES

Active substance(s): PROGESTERONE / PROGESTERONE

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Package leaflet: Information for the user
Progesterone 400 mg pessaries
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 further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

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

1.

What Progesterone is and what it is used for

Progesterone contains progesterone which is a natural, female sex hormone, produced in the body.
Progesterone is for women who need extra progesterone while undergoing treatment in an Assisted
Reproductive Technology (ART) programme.
Progesterone acts on the lining of the womb and it helps you to become and to stay pregnant when
you are treated for infertility.
2.

What you need to know before you use Progesterone

Do not use Progesterone:

if you are allergic to progesterone or any of the other ingredients of this medicine (listed in
section 6),

have unusual vaginal bleeding that has not been evaluated by the doctor,

have known or suspected tumour that is hormone sensitive,

have porphyria disorders (a group of inherited or acquired disorders of certain enzymes),

have or have had blood clots in the legs, lungs, eyes or elsewhere in the body,

currently have or have had severe liver problems.

have a miscarriage and your physician suspects some tissue is still in the uterus or pregnancy
outside of the womb.
Warnings and precautions
Take special care and tell your doctor straight away if you experience any of these symptoms during
treatment or even few days after the last dosage:

pains in the calves or chest, a sudden shortness of breath or coughing blood indicating possible
clots in the legs, heart, or lungs

severe headache or vomiting, dizziness, faintness, or changes in vision or speech, weakness or
numbness of an arm or leg indicating possible clots in the brain or eye

worsening of depression

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Check with your doctor or pharmacist before using Progesterone if you have or ever have had:

liver problems

epilepsy

migraine

asthma

cardiac or renal dysfunction

diabetes
Children and adolescents
There is no relevant use of Progesterone in children.
Other medicines and Progesterone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
This is especially important in case you are taking carbamazepine (e.g. to prevent fits, treat certain
type of pain or mood disorders), rifampicin (to treat infections) or phenytoin (e.g. to prevent fits or
treat certain type of pain) as they may decrease the effectiveness of progesterone.
Using other vaginal products at the same time as Progesterone is used vaginally is not recommended
as it is not known if it affects the treatment.
Pregnancy and breast-feeding
Progesterone can be used during the first trimester of pregnancy for women who need extra
progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) programme.
The risks of congenital (conditions present at birth) anomalies, including genital abnormalities in male
or female infants, from exposure to exogenous progesterone during pregnancy have not been fully
established.
This medicine should not be used during breast feeding.
Driving and using machines
Progesterone has minor or moderate influence on the ability to drive and use machines. It may cause
dizziness; therefore caution is advised in drivers and users of machines.

3.

How to use Progesterone

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not
sure.
The recommended dose is 400 mg twice a day by vaginal insertion. Start using Progesterone on the
day of egg retrieval. The administration of Progesterone should be continued for 38 days if pregnancy
has been confirmed.
How to insert Progesterone
Always wash your hands before and after inserting the pessary.
To insert into thev vagina, place the pessary between the lips of the vagina and push the pessary
upwards and backwards. You may find it easier to do this if you are lying down or squatting.
If you use more Progesterone than you should
If you (or someone else) has accidentally swallowed any of the pessaries or you use too many, contact
your nearest hospital casualty department or your doctor immediately for advice.

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If you forget to use Progesterone
If you forget to insert a pessary, do so as soon as you remember, unless it is nearly time for the next
dose. Never use two doses together. Remember to use the remaining doses at the correct time.
If you stop using Progesterone
Please consult your doctor or pharmacist for advice if you intend to stop or have stopped using
Progesterone. Abrupt discontinuation of progesterone dosing may cause increased anxiety,
moodiness, and increased sensibility to seizures.
If you have any further questions on the use of this medicine, ask 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 ART treatment is presented below:
The following common side effects (may affect up to 1 in 10 people):

Abdominal distension (swelling in the abdomen), abdominal pain, constipation

Sleepiness

Tiredness

Hot flush

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

Headache, dizziness, mood changes

Change in taste, vomiting, flatulence (wind), diarrhoea, bloat (gastric dilatation), rectal tumour

Night sweats, skin rash or itching

Joint pain

Pelvic pain, ovarian enlargement, vaginal bleeding

Frequent urination, involuntary excretion of urine

Weight increase

Bleeding

Itching at the application site, feeling cold or body temperature change or general discomfort
After using Progesterone you may notice some leakage after the pessary has dissolved. Do not worry,
this is quite normal when using medicines that are inserted into the vagina or rectum.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Progesterone

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 strip and carton after EXP. The
expiry date refers to the last day of that month.

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Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Progesterone contains



The active substance is progesterone. Each pessary contains 400 mg progesterone
The other ingredient is hard fat

What Progesterone looks like and contents of the pack
Off-white, approximately 10mm x 30mm, torpedo shaped pessary packed in PVC/PE strip packs
Pack size: 12, 15 pessaries
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Actavis Group PTC ehf, Reykjavíkurvegi 76-78, Hafnarfjördur 220, Iceland
Manufacturer:
Actavis UK Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS

This leaflet was last revised in 01/2017
PL 30306-0693

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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