Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Crinone 8% Progesterone Vaginal Gel
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Progesterone may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for The full name of your medicine is Crinone 8% w/w vaginal gel. In this leaflet the shorter name Crinone is used. Crinone contains a hormone called progesterone. When the gel is inserted into your vagina, the progesterone is slowly released into your bloodstream throughout the day. Crinone is used to give you extra progesterone in the treatment of infertility due to incorrect levels of progesterone during the menstrual cycle or when you are having an assisted fertility procedure. This is to help you get pregnant. You may also be asked to continue using Crinone to support your new pregnancy.
What you need to know before you take it
e Crinone Do not use Crinone • • • • • •
if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6). if you have unexplained vaginal bleeding if you have porphyria (an inability to break down certain substances (porphyrins) in your blood that is passed down in families) if you have or think you might have cancer in your breasts or genital organs if you have ever had a blood clot due to swollen veins (thrombophlebitis), a blocked blood vessel (thromboembolic disorder) or a stroke if you are pregnant but your baby has died inside of you (missed abortion).
Do not use Crinone if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using this medicine. Warnings and precautions Talk to your doctor or pharmacist before using Crinone if any of the following apply to you. They may want to monitor you more closely during treatment: • • •
if you have liver or kidney problems if you have heart problems or diabetes if you have asthma
• •
if you have epilepsy or often get migraines if you have ever had depression.
Tell your doctor if you get any unexpected bleeding so that they can investigate the cause of this. Children and adolescents Crinone is not for use in children or adolescents. Tests and check ups Check ups are required before you use this medicine and every so often when you are using it. In particular:
- Before using this medicine, your doctor will need to do a smear test and check your breasts and pelvic area.
- During your treatment, your doctor will check for any problems with your womb such as the lining getting thicker (endometrial hyperplasia). They will also check for any signs of blood clots in your blood vessels. Other medicines and Crinone Do not use Crinone at the same time as any other medicines that are inserted into your vagina. Tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding
- Crinone is not normally used during pregnancy. However, if you used Crinone to help you get pregnant, you may be asked to continue using it to support your new pregnancy.
- The use of Crinone during breast-feeding is not recommended. Driving and using machines Crinone has no influence on the ability to drive and use machines. Crinone contains sorbic acid Crinone contains sorbic acid. This may cause local skin reactions such as contact dermatitis. These skin reactions might also occur on your partner's penis if you have sex while using Crinone. This may be prevented by using condoms. 3. How to use Crinone Always use Crinone exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Recommended dose Insert the contents of one applicator of Crinone into your vagina each 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, from the day of the embryo transfer, insert the contents of one applicator of Crinone into your vagina each day, preferably in the morning. Once tests confirm that you are pregnant, you may be asked to keep using Crinone to support your new pregnancy – for a total of 30 days. The applicator is designed in such a way that an exact amount of gel (1.125 g, containing 90 mg progesterone) is delivered. It is expected that a small amount of gel will be left in the applicator. This can be thrown away as you will have received all of the medicine that you need.
How to take it
This medicine is only for use in your vagina using the pre-filled applicator supplied in the pack.
Before using the applicator, please read all of the instructions below. What your applicator looks like 1. air tank 2. flat part of the thick end 3. thick end 4. thin end 5. cap
Getting your applicator ready Grip the applicator by the thick end between your thumb and index finger. Face the thin end of the applicator down to the ground and shake the applicator down to move all the gel inside to the thin end. Opening your applicator
Grip the applicator by the flat part of the thick end. Twist off and remove the cap from the opposite thin end. To stop the gel from flowing out before use, do not press the air tank at the thick end at this stage. Inserting your applicator
Lean back or lie down with your knees bent and spread apart. Carefully insert the applicator well into your vagina, until your hand touches your body. Press the air tank at the thick end of the applicator firmly to deliver the gel from the applicator into your vagina. After using your applicator Throw away the applicator, including the small amount of gel that is left inside. Use each applicator only once. Crinone gel can stay in your vagina for several days. You may get a beige to brownish clumpy or cloudy white discharge during this time. This is nothing to worry about. If you use more Crinone than you should You are unlikely to use too much of this medicine as each applicator contains the right amount.
If you forget to use Crinone Do not use a double dose to make up for a forgotten dose. If you forget to use Crinone on one day, please continue as usual with a single dose on the following day. If you have any further questions on the use of this medicine ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions If you get an allergic reaction stop taking Crinone and see a doctor straight away. You may get for example an itchy skin rash. It is not known how likely this side effect is. Other side effects Common (may affect up to 1 in 10 people): •
breast tenderness.
Frequency not known (cannot be estimated from the available data): •
bleeding between periods (spotting)
•
irritation or other mild reactions in or around your vagina.
Please note Crinone gel can stay in your vagina for several days. You may get a beige to brownish clumpy or cloudy white discharge during this time. This discharge can cause irritation, pain or swelling of the vagina but this is nothing to worry about. Reporting side effects If you get any side effects, talk to your doctor or 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.
How to store it
Crinone • • • • •
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the cartons and the wrapper after 'EXP'. The expiry date refers to the last day of that month. Do not store above 25°C. Use each applicator only once. Any gel left in the applicator must be thrown away. 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 further in formation What Crinone contains
- The active substance is progesterone. From each applicator 1.125 g vaginal gel, containing 90 mg progesterone, is delivered into the vagina.
- The other ingredients are sorbic acid, glycerine, light liquid paraffin, hydrogenated palm oil glycerides, carbomer 974P, polycarbophil, sodium hydroxide and purified water.
What Crinone looks like and contents of the pack Crinone is a smooth white to off-white gel. It is filled in single-use, one-piece, white polyethylene vaginal applicators with twist-off caps, each sealed in a paper /aluminium / ionomer resin foil wrapper. Crinone is supplied in packs of 6 or 15 single-use applicators. Not all pack sizes may be marketed. Marketing Authorisation Holder Merck Serono Ltd 5 New Square Bedfont Lakes Business Park Feltham Middlesex TW14 8HA UK Manufacturer Central Pharma (Contract Packaging) Ltd Caxton Road Bedford, MK41 OXZ United Kingdom or Millmount Healthcare Limited Block-7, City North Business Campus Stamullen, Co. Meath, K32 YD60 Ireland This leaflet was last revised in 12/2020
5
Frequently asked questions about Crinone 8% Progesterone Vaginal Gel
How do I take Crinone 8% Progesterone Vaginal Gel?
Crinone 8% Progesterone Vaginal Gel comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Crinone 8% Progesterone Vaginal Gel?
The active substance in Crinone 8% Progesterone Vaginal Gel is progesterone.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Crinone 8% Progesterone Vaginal Gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Crinone 8% Progesterone Vaginal Gel without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: progesterone
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment of infertility due to inadequate luteal phase.
For use during in-vitro fertilisation, where infertility is mainly due to tubal, idiopathic or endometriosis linked sterility associated with normal ovulatory cycles.
4.2. Posology and method of administration
Posology
Intravaginal application
Treatment of infertility due to inadequate luteal phase
One application (1.125g 8% gel) every day, starting after documented ovulation or arbitrarily on the 18th – 21st day of the cycle.
Use during in-vitro fertilisation
Daily application of Crinone 8% gel should be continued for 30 days if there is laboratory evidence of pregnancy.
Paediatric population
Not applicable
Older people
Not applicable
Method of Administration
Crinone is applied directly from the specially designed sealed applicator into the vagina. The applicator should be removed from the sealed wrapper. The twist-off cap should not be removed at this time.
1. The applicator should be gripped firmly by the thick end. It should be shaken down like a thermometer to ensure that the contents are at the thin end.
2. The tab should be twisted off and discarded.
3. The applicator may be inserted while patient is in a sitting position or when lying on her back with the knees bent. The thin end of applicator should be gently inserted well into the vagina.
4. The thick end of the applicator should be pressed firmly to deposit gel. The applicator should be removed and discarded in a waste container.
4.3. Contraindications
1. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
2. Undiagnosed vaginal bleeding
3. Known or suspected progesterone-sensitive malignant tumours
4. Porphyria
5. Thrombophlebitis, thromboembolic disorder, cerebral apoplexy, or patients with an history of these conditions
6. Missed abortion
4.4. Special warnings and precautions for use
The pre-treatment physical examination should include special reference to breast and pelvic organs, as well as Papanicolaou smear.
Cautious use in severe hepatic insufficiency.
In cases of breakthrough bleeding, as in all cases of irregular vaginal bleeding, non-functional causes should be considered. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures should be undertaken.
Crinone is not indicated in threatened abortion. Treatment should be discontinued in the event of a missed abortion.
The physician should be alert to the early manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorder, pulmonary embolism and retinal thrombosis). Should any of these symptoms occur or be suspected, the drug should be discontinued immediately. Patients who have risk factors for thrombotic disorders should be kept under careful observation.
Although risk of thromboembolism has been associated with estrogens, a link with progestins remains questionable. Therefore, in women with generally recognised risk factors for thrombo-embolic events, such as personal or family history, treatment with Crinone may further increase the risk. In these women, the benefits of Crinone administration need to be weighed against the risks. It should be noted however, that pregnancy itself carries an increased risk of thrombo-embolic events.
Because progestogens may cause some degree of fluid retention, conditions that might be influenced by this factor (e.g, epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation.
Patients who have a history of depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.
A decrease in glucose tolerance has been observed in a small number of patients on oestrogen- progestin combination drugs. The mechanism of this decrease is not known. For this reason, diabetic patients should be carefully observed while receiving progestin therapy.
The excipient sorbic acid may cause local skin reactions (e.g. contact dermatitis) or vaginal irritation.
4.5. Interaction with other medicinal products and other forms of interaction
Crinone is not recommended for use concurrently with other vaginal preparations.
Although there is evidence of interaction between oral progestogens and CYP3A4 inducers, resulting in a decrease of serum progestogen levels, no significant consequences on progesterone levels is expected from concurrent administration of CRINONE® vaginal gel with CYP3A inducers.
4.6. Fertility, pregnancy and lactation
Pregnancy
In case of corpus luteum deficiency, Crinone can be used during the first month of pregnancy.
Breast-feeding
Do not use during lactation.
4.7. Effects on ability to drive and use machines
Crinone has no influence on the ability to drive and use machines.
4.8. Undesirable effects
The adverse reactions reported below are classified according to frequency of occurrence as follows:
Very common
(≥ 1/10)
Common
(≥ 1/100 to < 1/10)
Uncommon
(≥ 1/1,000 to < 1/100)
Rare
(≥ 1/10,000 to < 1/1,000)
Very rare
(< 1/10,000)
Crinone is generally well-tolerated. In clinical studies, the following adverse events have been reported during Crinone therapy. Most adverse events observed in clinical studies cannot be distinguished from the symptoms common in early pregnancy.
Common
Breast tenderness, itching or burning.
Post Marketing Reports
For adverse reactions identified during post-marketing surveillance, the frequency is not known (cannot be estimated from the available data).
In addition, intermenstrual bleeding (spotting), vaginal irritation, hypersensitivity reactions usually manifesting as skin rash, and other mild application site reactions have been reported post-marketing.
Rare events of urticaria and pruritis were noted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
4.9. Overdose
Not applicable
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- CYCLOVITA 400 mg prescriptionPROGESTERONUM · rectal / vaginal
- CRINONE 80 mg/g prescriptionPROGESTERONUM · rectal / vaginal
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- LuteinaProgesteronum · rectal / vaginal
- CIDR 1,38 g wkłady dopochwowe dla bydłaProgesteronum · rectal / vaginal
- LutinusProgesteronum · rectal / vaginal
- Prid deltaProgesteronum · rectal / vaginal
- CrinoneProgesteronum · rectal / vaginal
- LustorkProgesteronum · rectal / vaginal
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Crinone 8% Progesterone Vaginal Gel. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
Medicines containing Progesterone
- Cyclogest 200mg pessaries
- Cyclogest 400mg pessaries
- Gepretix 100mg soft capsules
- Gepretix 200 mg soft capsules
- Lutigest 100 mg vaginal tablets
- Progesterone 100 mg Capsule
- Progesterone 100 mg Capsules, soft
- Progesterone 100 mg Soft Capsules
- Progesterone 200 mg capsules
- Progesterone Besins 100mg Soft Capsules
- Prometrium 400mg soft vaginal capsules
- Utrogestan 100mg Capsules
- Utrogestan Vaginal 200mg Capsules
- Utrogestan Vaginal 300mg Capsules