Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
for
The name of your medicine is Utrogestan Vaginal 300 mg Capsules (called Utrogestan Vaginal in this leaflet). Utrogestan Vaginal contains a hormone called progesterone. What Utrogestan Vaginal is used for Utrogestan Vaginal can be used to support pregnancy during in vitro fertilization (IVF) cycles. To support pregnancy Utrogestan Vaginal is for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) program. 2.
e Utrogestan Vaginal
Do not use Utrogestan Vaginal •
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)
•
if you have unexplained vaginal bleeding
•
if you have breast cancer or genital tract carcinoma
•
if you have thrombophlebitis
•
if you have or have had blood clots in a vein (thrombosis), such as in the leg (deep vein thrombosis) or the lungs (pulmonary embolism)
•
if you have had a cerebral haemorrhage or stroke 1_0
•
if you have a rare blood disease called porphyria, which is passed down in families (inherited)
•
if you are pregnant but your baby has died inside of you (missed abortion).
Warnings and precautions Utrogestan Vaginal should only be used during the first 3 months of pregnancy. Talk to your doctor or pharmacist before using Utrogestan Vaginal. Utrogestan Vaginal is not a contraceptive. If you have diabetes and use insulin to control your blood sugar levels, progesterone treatment may affect your response to insulin and your antidiabetics' medication might need adjustment. If you have vaginal bleeding speak to your doctor. If you believe that you have had a miscarriage, you must speak with your doctor, because you must stop using Utrogestan Vaginal. You must contact your doctor if you feel unwell within a few days of taking the medicine. Children and adolescents Utrogestan Vaginal is not for use in children and adolescents. Other medicines and Utrogestan Vaginal 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 Utrogestan Vaginal can affect the way some other medicines work. Also some other medicines can affect the way Utrogestan Vaginal works. In particular tell your doctor or pharmacist if you are taking any of the following medicines: –
blood thinners such as coumarins or phenindione
–
ciclosporin or tacrolimus (used to reduce the immune response)
–
tizanidine (muscle relaxant)
–
bromocriptine, which is used in the treatment of pituitary gland-related problems or Parkinson's disease
–
selegiline (for treating Parkinson's disease)
–
diazepam, chlordiazepoxide, alprazolam, oxazepam or lorazepam (for treating anxiety or insomnia)
–
tuberculosis medicines (such as rifampicin and rifabutin)
–
antibiotics (for example griseofulvin, ampicillin, amoxicillin and tetracyclines), which are used to treat certain infections
–
phenytoin, phenobarbital, carbamazepine, eslicarbazepine, oxcarbazepine, primidone/rufinamide, perampanel or topiramate (used for epilepsy)
–
herbal medicine products, containing St John ́s Wort
–
darunavir, nelfinavir, fosamprenavir or lopinavir (used to treat viral infections)
–
bosentan (used to treat lung problems)
–
fluconazole, itraconazole, voriconazole (for the treatment of fungal infections)
–
ketoconazole (used to treat Cushing's syndrome – when the body produces and excess of cortisol)
–
atorvastatin or rosuvastatin (used to control cholesterol)
–
aprepitant (used to prevent nausea and vomiting).
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If you have recently been given an anaesthetic, such as bupivacaine or if you have been recently been tested for liver or hormone problems. Utrogestan Vaginal with food and drink Utrogestan Vaginal should be inserted into the vagina. Food and drink do not affect the treatment. Pregnancy, breast-feeding and fertility •
Utrogestan Vaginal will support pregnancy if you are having fertility treatment. For instructions on how to use Utrogestan Vaginal, see Section 3.
•
Do not use Utrogestan Vaginal if you are breast-feeding.
Driving and using machines Utrogestan Vaginal has no or negligible effects on driving or using machinery. Utrogestan Vaginal contains soyabean lecithin If you are allergic to peanut or soya, do not use this medicinal product. 3.
Utrogestan Vaginal
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Using this medicine to assist in getting pregnant •
Do not take it by mouth. If you accidentally take Utrogestan Vaginal by mouth, it will not harm you, but your chances of becoming pregnant will be reduced.
Recommended dose •
The treatment is started no later than the third day after egg retrieval.
•
Every day, use 600 mg of Utrogestan Vaginal as instructed by the doctor. Insert one capsule deep into the vagina in the morning and the other at bedtime.
•
If laboratory tests confirm that you are pregnant, continue with same dose until at least the 7th week of pregnancy and not later than the 12th week of pregnancy according to your doctor's instructions.
If you use more Utrogestan Vaginal than you should If you use too much Utrogestan Vaginal you should talk to your doctor or go to a hospital. Take the medicine pack with you. The following effects may happen: feeling dizzy or feeling tired. If you forget to use Utrogestan Vaginal •
If you forget a dose, insert it as soon as you remember it. However, if it is nearly time for your next dose, skip the missed dose.
•
Do not use a double dose to make up for a forgotten dose.
If you stop using Utrogestan Vaginal Talk to your doctor, pharmacist or nurse before stopping to use this medicine. If you stop using the medicine, it will not help you to get pregnant. 1_0
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following
may happen with this medicine: Very rare (may affect up to 1 in 10,000 people): –
Serious allergic reaction which causes difficulty in breathing or dizziness
Frequency not known (frequency cannot be estimated from the available data): –
Itching Vaginal bleeding Oily discharge from the vagina.
Short-term tiredness or dizziness may be experienced within 1 – 3 hours from using the medicine. If you notice side effects other than those mentioned above, tell your doctor. 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 national reporting system listed in the Yellow Card Scheme. 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.
Utrogestan Vaginal • • • • • • •
6.
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 packaging after EXP. The expiry date refers to the last day of that month. Once the bottle has been opened, use the capsules within 15 days. Store in the original packaging. Store below 30°C. Do not use this medicine if you notice visible changes in the appearance of the medicine. 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.
What Utrogestan Vaginal contains •
The active substance is progesterone. One capsule contains 300mg of progesterone.
•
The other ingredients in the capsule are refined sunflower oil, soyabean lecithin, gelatin, glycerol (E422), titanium dioxide (E171) and purified water.
What Utrogestan Vaginal looks like and contents of the pack The capsules are oblong yellowish, soft gelatin capsules, that contain a whitish oily suspension. The dimensions of the 300 mg capsule are approximately 2.5 cm x 0.8 cm. Utrogestan Vaginal are supplied in cartons containing: • •
white high density polyethylene plastic bottles with a child resistant white polypropylene screw cap and a tearable silver coloured seal. Pack size: 1 bottle containing 15 capsules. PVC/Aluminium blisters of 15, 30 or 45 capsules.
Not all pack sizes may be marketed
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Marketing Authorisation Holder The Marketing Authorisation for Utrogestan Vaginal is held by 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 Polígono Industrial El Pitarco, parcela nr. 4 50450 Muel (Zaragoza) Spain This leaflet was last revised in January 2026 <Company logo>
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Utrogestan Vaginal 300mg Capsules comes as capsule containing 300mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Utrogestan Vaginal 300mg Capsules is progesterone.
This leaflet reproduces the patient information leaflet approved for Utrogestan Vaginal 300mg Capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Utrogestan Vaginal 300 mg is indicated in adult women for supplementation of the luteal phase during Assisted Reproductive Technology (ART) cycles.
Posology
Vaginal use only.
The recommended dose is 600 mg/day, given in two divided doses, one in the morning and the other at bedtime. The treatment is started not later than the third day after oocyte retrieval day and is continued until at least the 7th week of pregnancy and not later than the 12th week of pregnancy or until menstruation begins.
Paediatric population
There is no relevant use of Utrogestan Vaginal 300 mg in the paediatric population.
Elderly patients
There is no relevant use of Utrogestan Vaginal 300 mg in the elderly.
Method of administration
Vaginal
Each Utrogestan Vaginal 300 mg capsule must be inserted deep into the vagina.
One capsule should be inserted deep into the vagina in the morning and the other at bedtime.
• 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 diseases
• Cerebral haemorrhage
• Porphyria
• Missed abortion
• Allergy to nuts or soya (see Section 4.4)
Warnings:
A complete medical examination must be performed before starting the treatment and regularly during the treatment.
Utrogestan Vaginal 300 mg should only be used during the first three months of pregnancy and must only be administered by the vaginal route.
Utrogestan Vaginal 300 mg is not suitable as a contraceptive.
Utrogestan Vaginal 300 mg is not intended to treat an imminent premature delivery.
The use of micronised progesterone during the second and third trimester of pregnancy may lead to the development of gravidic cholestasis or hepatocellular liver disease.
Glucose tolerance may be impaired during progesterone treatment, and more frequent monitoring should be performed. Progesterone has been linked to an increase in Type 2 diabetes, and adjustments in the medication of diabetes-treated patients may be required.
Treatment should be discontinued upon diagnosis of a missed abortion.
Precautions:
Any vaginal bleeding should always be investigated.
Utrogestan Vaginal 300 mg 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 Utrogestan Vaginal 300 mg (see Section 4.3).
Progestagens may affect the treatment balance of diabetes and have been linked to an increase in Type 2 diabetes. The diabetes medicine of patients being treated simultaneously with progestagens may need to be adjusted (see Section 4.4).
Effects which progesterone may have on other medicines:
Progesterone may:
• Enhance or weaken the coagulating effect of coumarins and prevent the coagulating effect of phenindione
• Prevent the metabolism of ciclosporin, which increases the concentration of ciclosporin in plasma and the risk of toxicity
• Increase the concentration of tizanidine in plasma
• Interfere with the effect of bromocriptine
• Enhance the arrhythmogenicity of bupivacaine
• Alter the results of liver and/or endocrine function tests
• Prevent the oxidation of some benzodiazepine derivatives such as diazepam, chlordiazepoxide and alprazolam and to induce glucuronidation of oxazepam and lorazepam. These synergistic effects are probably not clinically significant, because the therapeutic spectrum of benzodiazepines are wide.
Interaction of other medicines on progesterone
The following medicines may increase the metabolism of progesterone:
• Perampanel or topiramate
• Some antibiotics, such as ampicillin, amoxicillin and tetracyclines may lower the concentration of steroids in plasma, because these antibiotics can have an effect on the hydrolysis of steroid conjugates in the bowel and on the reabsorption of non-conjugated steroid, in which case the concentration of the active steroid in the bowel will be reduced.
• Rifampicin and rifabutin
• Epilepsy medicines (not valproic acid): phenytoin, phenobarbital, carbamazepine, eslicarbazepine, oxcarbazepine, and primidone/rufinamide (by inducing oxidative decomposition)
• Herbal medicinal products, which contain St John's wort
• Antiretroviral medicines (protease blockers): darunavir, nelfinavir, fosamprenavir, lopinavir
• Bosentan
• Aprepitant.
The following medicines may prevent the metabolism of progesterone, which will lead to an increase in the bioavailability of progesterone:
• Fungal medicines (fluconazole, itraconazole, ketoconazole, voriconazole)
• Immunosuppressants (tacrolimus)
• Statins (atorvastatin, rosuvastatin)
• Monoamine oxidase (MAO) inhibiters (selegiline).
Natural progesterone may be given orally, vaginally or by the intramuscular route to treat luteal phase deficiency until at least the 7th week of pregnancy and not later than the 12th week of pregnancy.
Pregnancy
No association has been found between the maternal use of natural progesterone in early pregnancy and foetal malformation.
Breast-feeding
Utrogestan Vaginal 300 mg is not indicated during breast-feeding. Detectable amounts of progesterone enter the breast milk.
Fertility
As this medicinal product is indicated to support luteal deficiency in subfertile or infertile women, there is no deleterious known effect on fertility.
Utrogestan Vaginal 300 mg has no influence on the ability to drive and use machines.
Local intolerance (burning, itching or oily discharge) has been observed in clinical studies and has been reported in publications, but the incidence is extremely rare.
When used as recommended, transient fatigue or dizziness may occur within 1 – 3 hours of taking the medicine.
Reporting of suspected adverse reactions after authorisation
The information below is based on experience gathered after the authorisation of progesterone administered into the vagina.
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 very rare
(< 1/10000)
Frequency Not known
(Cannot be estimated from the available data)
Immune system disorders
Anaphylactic reactions
Skin and subcutaneous tissue disorders
Pruritus
Reproductive system and breast disorders
Vaginal haemorrhage
Vaginal discharge
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 national reporting system listed in the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms of overdosage may include somnolence, dizziness, euphoria or dysmenorrhoea. Treatment is observation and, if necessary, symptomatic and supportive measures should be provided.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
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 →
Medicines sold in Poland with the same active substance: W Polsce znany jako
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 anything about Utrogestan Vaginal 300mg 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.
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