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Assessed against UK PIL granted January 2011

By Aneela Mahmood at 10:23 am, Dec 22, 2011

Crinone 8% Vaginal Gel
Patient Information Leaflet
Please read this leaflet carefully before you start to use your medication. It contains a summary of the
information available on your medication. If after reading this you have any questions ask your doctor or
The name of your medication is Crinone 8% Vaginal Gel. Its active ingredient is progesterone.
Each application of the gel contains a 90 mg dose of progesterone. The gel also contains the following
inactive ingredients: glycerin, light liquid paraffin, hydrogenated palm oil glycerides, carbomer 974P, sorbic
acid, polycarbophil, sodium hydroxide and purified water.
Crinone 8% Vaginal Gel is available in packs containing 15 applicators.
Your medication, containing progesterone, belongs to a group of medicines called female hormones.
PL 10383/1936

Crinone 8% Vaginal Gel


This product is manufactured by Baxter Oncology GmbH, Frankfurt, Germany and is procured from within
the EU and repackaged by the Product Licence holder who is Primecrown Ltd, 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Crinone 8% Vaginal Gel is for the treatment of infertility due to incorrect levels of the female hormone
progesterone during the menstrual cycle. It is also used during in-vitro fertilisation when infertility, in women
who have normal ovulatory menstrual cycles, may be due to problems with the fallopian tubes or the womb.
Sometimes there may be no apparent cause for the infertility.
Please read the following questions. If your answer to any of them is YES, then tell your doctor or pharmacist
before starting treatment:
 Are you allergic to any of the ingredients listed above?
 Do you have any unusual or heavy vaginal bleeding of unknown cause?
 Are you breast feeding?
 Do you suffer from the hereditary metabolic disease porphyria?
 Are you using any other vaginal preparations?
 Have, or suspect you have, a tumour of the breast or genitals
The excipient sorbic acid has the potential to irritate the skin and cause inflammation (i.e. dermatitis)
Take special care with your medicine:
 Talk to your doctor or pharmacist if you have severe liver disease.
 You have a personal or family history of blood clots
 There have been occasional reports of drowsiness associated with the use of this product. Therefore
TAKE CARE if you intend to drive or operate machinery.
 If in doubt, consult your doctor or pharmacist before using this product.
 Stop treatment in case of miscarriage.
One application every day, starting after your doctor tells you that you have ovulated, or on the 18th-21st day
of your menstrual cycle. (The first day of your menstrual cycle is the day your period starts.) When used
during in-vitro fertilisation, daily application of your medicine should be continued for 30 days if there is
laboratory evidence of pregnancy.
The gel is to be applied directly from the specially designed sealed applicator into the vagina. Remove the
applicator from the sealed wrapper. DO NOT remove the twist-off cap at this time.

1. Grip the applicator by the thick end. Shake down like a
thermometer to ensure that the contents are at the thin end.

2. Twist off the tab and discard.

3. The applicator may be inserted into the vagina
while you are in a sitting position or when lying on your
back with the knees bent.
Gently insert the thin end of the applicator well
into the vagina.

4. Press the thick end of the applicator firmly to deposit gel.
Remove the applicator and discard into a waste container.

5. Your medication coats the vaginal mucosa to
provide long- lasting release of progesterone.

If you forget to use your medication on a normal dosage day, don’t worry. Just use it the following day and
then continue as before.
There have been occasional reports of drowsiness occurring during Crinone 8% Vaginal Gel treatment.
If you are affected in this way do not drive or operate machinery. There have also been reports of headache,
breast tenderness, vaginal irritation, burning, slight bleeding or ‘’spotting’’. There have also been rare reports
of itching and hypersensitivity reactions which can cause a skin rash.
If you experience these effects and they become troublesome, or you experience different side-effects,
please consult your doctor or pharmacist.

 Do not use after the expiry date printed on the carton label or applicator label.
 Do not store above 25°C. Do not freeze.
 If the medicine become discoloured or show signs of any deterioration, you should seek the advice of
your pharmacist.
 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.

Leaflet date: 15.12.11

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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.