Read all of this leaflet carefully before you start using this medicine.
- Save this information, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
This leaflet contains information about:
1. What Crinone vaginal gel is and what it is used for
2. Before you use Crinone vaginal gel
3. How to use Crinone vaginal gel
4. Possible side effects
5. How to store Crinone vaginal gel
6. Other information
1. WHAT CRINONE VAGINAL GEL IS AND WHAT IT IS USED FOR
Crinone vaginal gel belongs to the drug group female sex hormone. Crinone vaginal gel is used as an adjunct to other treatments for infertility.
Progesterone contained in Crinone may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. BEFORE YOU USE CRINONE VAGINAL GEL
Do not use Crinone vaginal gel
- if you are allergic (hypersensitive) to progesterone or any of the other ingredients of Crinone vaginal gel
- in case of bleeding from the abdomen whose cause has not been investigated
- in acute porphyria (hereditary metabolic disorder)
- if you have breast or genital cancer
- if you have or have had a blood clot disease e.g. stroke
Take special care with Crinone vaginal gel
- if you have irregular bleeding from the abdomen
- if you have impaired liver function
Use of other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. You should not use Crinone vaginal gel with other medicines that are administered in the vagina.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Crinone vaginal gel can be used during the first trimester (first 3 months) of pregnancy.
Crinone vaginal gel should not be used if you are breast-feeding.
Driving and using machines
During treatment with Crinone vaginal gel, in some patients, the ability to react may be reduced. Fatigue can occur and caution should therefore be exercised when sharper attention is required, for example when driving a car and during precision work.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.
Important information about some of the ingredients of Crinone vaginal gel
The preservative sorbic acid can cause local skin reactions (eg contact dermatitis).
3. HOW TO USE CRINONE VAGINAL GEL
Always use Crinone vaginal gel exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Instructions for use
Crinone vaginal gel is applied to the vagina directly from the specially designed closed applicator. Remove the applicator from the cover. NOTE: Do not remove the swivel closure yet.
If you use more Crinone vaginal gel than you should
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 use Crinone vaginal gel
If you forget to take Crinone vaginal gel one day, take this dose the next day and then continue as your doctor advised. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Crinone vaginal gel can cause side effects, although not everybody gets them.
Common adverse s (occurring in more than 1 in 100): fatigue, headache, vaginal discharge, and breast tenderness.
Uncommon (affects less than 1 user in 100): Bleeding disorders in the form of spotting (small bleeding) irritation at the application site and hypersensitivity reactionare usually in the form of skin rash.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CRINONE VAGINALGEL
Keep out of sight and reach of children.
Do not store above 25 ° C.
Do not use this medicine after the expiry date which is stated on the carton after EXP. dat. The expiration date is the last day of the specified month.
The medicine 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. FURTHER INFORMATION
- The active substance is progesterone . Each dose of vaginal gel contains 90 mg of progesterone .
- The other ingredients are glycerol , easy-flowing paraffin, hydrogenated palm oil glycerides, carbomer, polycarbophil, sorbic acid ( preservative ), sodium hydroxide, purified water
What the medicine looks like and the contents of the pack
A disposable white polyethylene applicator with a closure that can be turned off. Each applicator contains 1.45 g of gel and dispenses 1.125 g of gel . Each applicator is packaged and wrapped in a paper / aluminum / polyethylene foil.
Applicator being packaged in an outer carton box and contains:
6 or 15 applicator s of Crinone 8% vaginal gel .
Marketing Authorisation Holder
169 03 Solna
Tel: 08–562 445 00
Central Pharma (Contract Packing) Ltd.
Bedford MK41 0XZ
Millmount Healthcare Limited
Block-7, City North Business Campus
Stamullen, Co. Meath, K32 YD60