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.
Prometrium 400mg soft vaginal capsules
⚠ 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 name of your medicine is Prometrium 400mg soft vaginal capsules (called Prometrium in this package leaflet). Prometrium contains a hormone called progesterone. What Prometrium is used for Prometrium can be used to help pregnancy. To help pregnancy Prometrium can be used to help women reduce the risk of miscarriage in women with bleeding in the current pregnancy and a history of recurrent miscarriages.
2.
What you need to know before you take it
e Prometrium
Do not use Prometrium •
if you are allergic (hypersensitive) to soya or peanuts
•
if you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6)
•
if you have liver problems
•
if you have yellowing of the skin or eyes (jaundice)
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if you have undiagnosed vaginal bleeding 1_0
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if you have breast cancer or cancer of the genitals
•
if you have or have had blood clots in a vein (thrombosis), which can sometimes be painful (thrombophlebitis), for example in the leg (deep vein thrombosis) or the lungs (pulmonary embolism)
•
if you have had a cerebral haemorrhage or stroke
•
if you have a rare blood disease called porphyria, which is passed down in families (inherited).
Warnings and precautions Prometrium should only be used during the first 3 months of pregnancy. Talk to your doctor or pharmacist or nurse or mid-wife before using Prometrium. Prometrium is not a contraceptive. If you believe that you have had a miscarriage, you must speak with your doctor, because you must stop using Prometrium . You must contact your doctor if you: • •
experience any vaginal bleeding feel unwell within a few days of taking the medicine.
Children and adolescents Prometrium is not for use in children. Other medicines and Prometrium Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Prometrium can affect the way some other medicines work. Also some other medicines can affect the way Prometrium works. In particular tell your doctor or pharmacist if you are taking any of the following medicines: –
ciclosporin (used to reduce the immune response).
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bromocriptine, which is used in the treatment of pituitary gland-related problems or Parkinson's disease.
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Rifamycin medicines such as rifampicin (used to treat infections).
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Ketoconazole (used for fungal infections).
If you have recently been tested for liver or hormone problems. Prometrium with food and drink Prometrium should be inserted into the vagina. Food and drinks do not affect the treatment. Pregnancy and breast-feeding Do not use Prometrium if you are breast-feeding. Driving and using machines If this medicine makes you feel drowsy then do not drive or use machinery. Prometrium contains soybean lecithin 1_0
If you are allergic to peanut or soya, do not use this medicinal product. 3.
How to take it
Prometrium
Always use this medicine exactly as instructed by your doctor. If you have adverse reactions, check with your doctor, pharmacist or nurse or mid-wife. For treatment to reduce the risk of miscarriage in women with bleeding in the current pregnancy Prometrium should be initiated at the first sign of vaginal bleeding during the first trimester and should continue at least until the 16th week of pregnancy. Using this medicine to reduce the risk of threatened or recurrent miscarriage •
Insert this medicine deep into the vagina.
•
Do not swallow.
How much Prometrium to use •
Take one Prometrium capsule twice daily, one in the morning and one at bedtime, or as instructed by your doctor.
•
Continue with the same dose regimen until your doctor tells you to stop.
If you use more Prometrium than you should If you have used too much Prometrium, you should talk to your doctor or got to a hospital. Take the medicine pack with you. The following effects may happen: feeling dizzy or feeling tired. If you forget to use Prometrium •
If you forget to insert a dose, insert it as soon as you remember. However, if it is nearly time for your next dose, you can skip the missed dose.
•
Do not take a double dose to compensate for a forgotten dose.
If you stop using Prometrium Talk to your doctor, pharmacist or nurse or mid-wife before stopping this medicine. If you have questions regarding the use of this medicine, talk to your doctor or pharmacist or nurse or midwife. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: Frequency not known (frequency cannot be estimated from the available data): –
Itching or burning sensation Oily discharge from the vagina.
You may experience short-term tiredness or dizziness within 1 – 3 hours of using the medicine. If you notice side effects other than those mentioned above, tell your doctor or pharmacist, nurse or mid-wife.
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Reporting of side effects If you get any side effects, talk to your doctor or pharmacist or nurse or mid-wife. This includes any
Possible side effects
not listed in this leaflet. You can also report side effects via the website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Prometrium • • • • •
6.
Keep this medicine out of the sight and reach of children. Do not use this product after the expiry date which is stated in the carton after EXP. The expiry date refers to the last day of that month. Store in the original packaging 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 to protect the environment. Do not use this medicine if you notice any changes in the appearance of the capsules
Contents of the pack and other information
What Prometrium contains •
Active substance is progesterone. One capsule contains 400mg of progesterone.
•
The other ingredients in the capsule are sunflower oil, soyabean lecithin, gelatine, glycerol (E422), titanium dioxide (E171) and purified water.
What Prometrium looks like and package sizes The capsules are yellowish, soft gelatin capsules, that contain a whitish oily suspension. The dimensions of the 400mg capsule are approximately 2.5 cm x 0.9 cm. Pack size: • •
15 capsules per bottle (HDPE). The bottle is supplied in a cardboard carton. PVC/Aluminium blisters of 15, 30 or 45 capsules in a cardboard carton.
Not all pack sizes maybe marketed. Marketing Authorisation Holder Besins Healthcare SA Rue Washington 80 1050 Ixelles Belgium Manufacturer Cyndea Pharma S.L. Poligono Industrial Emiliano Revilla Sanz Avenida de Agreda, 31 Olvega 42110 (Soria) Spain Or BESINS MANUFACTURING ESPAÑA S.L. Polígono Industrial El Pitarco, Parcela 4 Muel, 50450 Zaragoza, Spain
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This leaflet was last revised in December 2025.
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Frequently asked questions about Prometrium 400mg soft vaginal capsules
How do I take Prometrium 400mg soft vaginal capsules?
Prometrium 400mg soft vaginal capsules comes as capsule containing 400mg. 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 Prometrium 400mg soft vaginal capsules?
The active substance in Prometrium 400mg soft vaginal capsules is progesterone.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Prometrium 400mg soft vaginal capsules, 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 Prometrium 400mg soft vaginal capsules 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
Prometrium 400mg soft vaginal Capsules is indicated for the prevention of miscarriage in women presenting with bleeding in the first trimester of pregnancy and have a history of recurrent miscarriages (see sections 4.2 and 5.1).
4.2. Posology and method of administration
Treatment should always be individualised to the patient. The decision to treat women who have experienced recurrent miscarriages should follow further investigation and is at the discretion of the clinician.
Posology
Vaginal use only.
The recommended dose is 400 mg twice a day (morning and night). Treatment should be initiated during the first trimester of pregnancy, at first sign of vaginal bleeding (see Section 4.4 Special Warnings and Precautions for Use) and should continue to the 16th week of gestation.
Paediatric population
There is no relevant use of Prometrium 400mg soft vaginal capsules in the paediatric population.
Elderly patients
There is no relevant use of Prometrium 400mg soft vaginal capsules in the elderly.
Method of administration
Vaginal
Each Prometrium 400mg soft vaginal capsule must be inserted deep into the vagina.
4.3. Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1
• Jaundice
• Severe hepatic dysfunction
• Undiagnosed vaginal bleeding
• Mammary or genital tract carcinoma
• Thrombophlebitis
• Thromboembolic disorders
• Cerebral haemorrhage
• Porphyria
• Allergy to nuts or soya (see Section 4.4)
4.4. Special warnings and precautions for use
Warnings:
A complete medical examination must be performed before starting the treatment and regularly during the treatment.
Prometrium 400mg soft vaginal capsules should only be used for threatened miscarriage during the first trimester; up to the 16th week of pregnancy and must only be administered by the vaginal route.
Prometrium 400mg soft vaginal capsules is not suitable as a contraceptive.
Treatment should be discontinued upon diagnosis of a missed abortion.
Precautions:
Any vaginal bleeding should always be investigated.
Prometrium 400mg soft vaginal capsules contains soybean lecithin and may cause hypersensitivity reactions (urticarial and anaphylactic shock in hypersensitive patients). As there is a possible relationship between allergy to soya and allergy to peanut, patients with peanut allergy should avoid using Prometrium 400mg soft vaginal capsules (see Section 4.3).
4.5. Interaction with other medicinal products and other forms of interaction
Prometrium 400mg soft vaginal capsules may interfere with the effects of bromocriptine and may raise the plasma concentration of ciclosporin. Prometrium 400mg soft vaginal capsules may affect the results of laboratory tests of hepatic and/or endocrine functions.
Metabolism of Prometrium 400mg soft vaginal capsules is accelerated by rifamycin medicines (such as rifampicin) and antibacterial agents.
The metabolism of progesterone by human liver microsomes was inhibited by ketoconazole (IC50 <0.1 μM). Ketoconazole is a known inhibitor of cytochrome P450 3A4. These data therefore suggest that ketoconazole may increase the bioavailability of progesterone. The clinical relevance of the in vitro findings is unknown.
4.6. Fertility, pregnancy and lactation
Pregnancy
No association has been found between the maternal use of natural progesterone in early pregnancy and foetal malformation.
Breast-feeding
Prometrium 400mg soft vaginal capsules is not indicated during breast-feeding. Detectable amounts of progesterone enter the breast milk.
Fertility
As this medicinal product is indicated to prevent miscarriage in women, there is no known deleterious effect on fertility.
4.7. Effects on ability to drive and use machines
Prometrium 400mg soft vaginal capsules can have a moderate influence on the ability to drive and use machines.
4.8. Undesirable effects
Local intolerance (burning, itching or oily discharge) has been observed, but the incidence is extremely rare.
When used as recommended, transient fatigue or dizziness may occur within 1 – 3 hours of taking the medicine.
The following frequency conventions are used in the rating of undesirable effects: Very common (≥1/10); Common (≥1/100 to < 1/10); Uncommon (≥1/1000 to < 1/100); Rare (≥1/10000 to < 1/1000); Very rare (< 1/10000); Not known (cannot be estimated from the available data).
System Organ Class (SOC)
Frequency Not known
(Cannot be estimated from the available data)
Skin and subcutaneous tissue disorders
Pruritus
Reproductive system and breast disorders
Vaginal discharge
Vaginal haemorrhage
General disorders and administrative site conditions
Burning sensation
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 the website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms of overdosage may include somnolence, dizziness, euphoria or dysmenorrhoea. Treatment is observation and, if necessary, symptomatic and supportive measures should be provided.
🇷🇴 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 Prometrium 400mg soft vaginal capsules. 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
- Crinone 8% Progesterone Vaginal Gel
- 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
- Utrogestan 100mg Capsules
- Utrogestan Vaginal 200mg Capsules
- Utrogestan Vaginal 300mg Capsules