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.
Utrogestan Vaginal 200mg 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 Utrogestan Vaginal 200mg Capsules (called Utrogestan Vaginal in this leaflet). Utrogestan Vaginal contains a hormone called progesterone. What Utrogestan Vaginal is used for To support pregnancy during fertility treatment Utrogestan Vaginal is for women who need extra progesterone to support pregnancy while undergoing treatment in an Assisted Reproductive Technology (ART) programme. To prevent premature birth in women with a singleton pregnancy Utrogestan Vaginal is for women who have previously had a premature baby and/or who may have a problem with part of their womb, known as a short cervix.
What you need to know before you take it
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 mammary or genital tract carcinoma 4_0
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If you have thrombophlebitis If you have or have had blood clots in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism) If you have had a cerebral haemorrhage or stroke If you have a rare blood problem called "porphyria" which is passed down in families (inherited) If you are pregnant but your baby has died inside of you (missed abortion) If your "waters break".
Do not use Utrogestan Vaginal if any of the following applies to you. If you are not sure, talk to your doctor or pharmacist before using Utrogestan Vaginal. Warning and precautions Utrogestan Vaginal is not a contraceptive. If you think you may have miscarried, you should speak tor your doctor as you must to stop using Utrogestan Vaginal. If you have unexpected vaginal bleeding speak to your doctor. If you are taking this medicine as part of fertility treatment Utrogestan Vaginal should only be used during the first 3 months of pregnancy. If you are taking this medicine to prevent preterm birth in women with a singleton pregnancy
Your doctor should discuss the risks and benefits of the options available to you. You and your doctor should make a shared decision on which treatment is most suitable. If you are at risk of having your baby prematurely, you may be given Utrogestan Vaginal from around week 20 to week 34 of your pregnancy. If your waters break while you are taking the medicine, you must see your doctor as soon as possible. If this happens there may be an immediate risk to you and your baby. In rare cases, use during the second and third trimester of pregnancy may lead to the development of liver problems. Contact your doctor if you experience itching which may be a sign of liver problems. Children Utrogestan vaginal is not for use in children. Tests and Check-ups Your doctor will perform a complete medical examination before starting the treatment and regularly during the treatment. 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:
- Bromocriptine used for problems with the pituitary gland or Parkinson's Disease.
- Ciclosporin (used to suppress the immune system). 4_0
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Rifamycin medicines such as rifampicin (used to treat infections). Ketoconazole (used for fungal infections).
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 help support pregnancy if you are having fertility treatment or if your doctor has told you that you are at risk of having your baby prematurely. 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 negligible effects on driving or using machinery. Utrogestan Vaginal contains soybean lecithin If you are allergic to peanut or soya, do not use this medicinal product.
How to take it
Utrogestan vaginal
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. • •
Use this medicine by inserting it deep into the vagina. 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 For support during in vitro fertilization (IVF) cycles:
- The treatment is started no later than the third day after egg retrieval.
- Every day, use 600 mg of Utrogestan Vaginalas instructed by the doctor. Insert one capsule deep into the vagina in the morning, at midday and at bedtime.
- If laboratory tests confirm that you are pregnant, continue with the same dose until at least the 7th week of pregnancy but no longer than the 12th week of pregnancy, according to your doctor's instructions. For prevention of premature birth in certain women: •
Every day, insert one capsule (200mg) of Utrogestan Vaginal deep into the vagina, in the evening at bedtime. This medicine may be given from around week 20 to week 34 of pregnancy.
If you use more Utrogestan Vaginal than you should If you use to much Utrogestan Vaginal, 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 the next dose, skip the missed dose.
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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. 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 side effects may happen with this medicine: Frequency not known (frequency cannot be estimated from the available data):
- itching
- oily discharge from the vagina
- vaginal haemorrhage
- burning sensation Short-term tiredness or dizziness may be experienced within 1 – 3 hours after taking the medicine. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible
Possible side effects
not listed in this leaflet. You can also report side effects directly 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.
How to store it
Utrogestan Vaginal • •
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. 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. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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Contents of the pack and other information
What Utrogestan Vaginal contains • •
The active substance is progesterone. Each capsule contains 200mg progesterone. The other ingredients are sunflower oil and soybean lecithin. The other 4_0
ingredients in the capsule shell are gelatin, glycerol, titanium dioxide (E171) and water, purified. What Utrogestan Vaginal looks like and contents of the pack
- Utrogestan Vaginal 200mg Capsules are oval and slightly yellow soft capsules, containing whitish oily suspension.
- They are supplied in cartons containing PVC/Aluminium blisters of 15, 21, 45 or 90 capsules Marketing Authorisation Holder and Manufacturer The Marketing Authorisation for Utrogestan Vaginal is held by Besins Healthcare, Rue Washington 80 1050 Ixelles Belgium Utrogestan Vaginal is manufactured by: Cyndea Pharma, S.L. Poligono Industrial Emiliano Revilla Sanz, Avenida de Agreda, 31, Ólvega 42110 (Soria), Spain. Or BESINS MANUFACTURING ESPAÑA Polígono Industrial El Pitarco, parcela nr. 4 50450 Muel (Zaragoza) Spain This medicine is distributed in the UK by: Besins Healthcare (UK) Ltd, Lion Court, 25 Procter Street London, Holborn, United Kingdom Tel: +44(0)203862 0920 This medicinal product is authorised in the Member States of the EEA under the following names: Bulgaria: Utrogestan 200mg vaginal capsules, soft Croatia: Utrogestan 200 mg meke kapsule za rodnicu. Czech Republic: Progesteron Besins 200 mg měkké tobolky Denmark: Progestan
Estonia: Utrogestan 200 mg vaginaalpehmekapslid Hungary: Utrogestan 200 mg lágy hüvelykapszula
Iceland: Progestan 200 mg Mjúkt skeiðarhylki Ireland: Utrogestan Vaginal 200mg Vaginal Capsules, soft Italy: Utrogestan Vaginale 200 mg Capsula molle
Latvia: Progesterone Besins 200 mg vaginālās mīkstās kapsulas Lithuania: Progesterone Besins 200 mg makšties minkštosios kapsulės Malta: Utrogestan Vaginal 200 mg Capsules, soft
Netherlands: Utrogestan 200 mg, zachte capsules voor vaginaal gebruik Norway: Utrogestan 200 mg vaginalkapsler, myke 4_0
Poland: Utrogestan 200 mg, kapsułki dopochwowe, miękkie Portugal: Utrogestan Vaginal 200 mg Cápsula mole
Slovakia: Utrogestan 200 mg mäkké vaginálne kapsuly Slovenia: Utrogestan 200 mg mehke vaginalne kapsule Spain: Utrogestan Vaginal 200 mg Cápsula blanda
Sweden: Utrogestan 200 mg mjuk Vaginalkapsel United Kingdom: Utrogestan Vaginal 200mg Capsules This leaflet was last revised in March 2024 For information in large print, tape, CD or Braille, telephone +44(0)203862 0920.
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Frequently asked questions about Utrogestan Vaginal 200mg Capsules
How do I take Utrogestan Vaginal 200mg Capsules?
Utrogestan Vaginal 200mg Capsules comes as capsule containing 200mg. 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 Utrogestan Vaginal 200mg Capsules?
The active substance in Utrogestan Vaginal 200mg Capsules is progesterone.
Are there equivalent medicines to Utrogestan Vaginal 200mg Capsules?
Medicines with the same active substance, strength and form include: Gepretix 200 mg soft capsules, Progesterone 200 mg capsules. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Utrogestan Vaginal 200mg 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 Utrogestan Vaginal 200mg 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
Utrogestan Vaginal 200 mg Capsules is indicated in women for
- Supplementation of the luteal phase during Assisted Reproductive Technology (ART) cycles.
- Prevention of preterm birth in women with a singleton pregnancy who have a short cervix (mid-trimester sonographic cervix ≤25 mm) and/or a history of spontaneous preterm birth (see Section 4.4).
4.2. Posology and method of administration
Posology
For supplementation of the luteal phase during Assisted Reproductive Technology cycles - the recommended dose is 600 mg/day, given in three divided doses, one in the morning, one at midday and the third at bedtime. The treatment is started not later than the third day after oocyte retrieval. If pregnancy has been confirmed, continue treatment until at least the 7th week of pregnancy but no longer than the 12th week..
For prevention of preterm birth in women with a singleton pregnancy who have a short cervix and/or a history of spontaneous preterm birth, the recommended dosage is 200 mg per day in the evening at bedtime from around week 20 to week 34 of pregnancy.
For information on shared decision making, see Section 4.4.
Paediatric population
There is no relevant use of Utrogestan Vaginal 200 mg Capsules in the paediatric population.
Elderly patients
There is no relevant use of Utrogestan Vaginal 200 mg Capsules in the elderly.
Method of Administration:
Vaginal
Each capsule of Utrogestan Vaginal 200mg 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 (see Section 4.4),
• Mammary or genital tract carcinoma,
• Thrombophlebitis,
• Thromboembolic disorders,
• Cerebral haemorrhage,
• Porphyria.
• Missed abortion
• Premature rupture of membranes (PPROM) (see Section 4.4.),
• Allergy to peanuts 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.
• Utrogestan Vaginal 200mg Capsules is not suitable as a contraceptive.
• In rare cases, 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.
• Treatment should be discontinued upon diagnosis of a missed abortion.
Precautions:
• Any vaginal bleeding should always be investigated.
Warning specific for supplementation of the luteal phase during Assisted Reproductive Technology cycles:
• Utrogestan Vaginal 200mg Capsules should only be used during the first three months of pregnancy and must only be administrated by vaginal route.
Precautions specific for prevention of preterm birth in women with a singleton pregnancy who have a short cervix and/or a history of spontaneous preterm birth:
Before treatment is initiated:
• The risks and benefits of the options available, should be discussed with the patient. The physician and patient should make a shared decision on which treatment is most suitable (see section 5.1).
• Premature rupture of membranes (PPROM) should be excluded (see section 4.3). Should rupture of membranes occur during treatment, further treatment with Utrogestan Vaginal 200mg Capsules should be discontinued.
Utrogestan Vaginal 200 mg Capsules contains soya 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 200mg Capsules.
4.5. Interaction with other medicinal products and other forms of interaction
Utrogestan Vaginal 200mg Capsules may interfere with the effects of bromocriptine and may raise the plasma concentration of ciclosporin. Utrogestan Vaginal 200mg Capsules may affect the results of laboratory tests of hepatic and/or endocrine functions.
Metabolism of Utrogestan Vaginal 200mg 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
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. Natural progesterone may also be given vaginally for prevention of preterm birth, from the 20th week of pregnancy to the 34th week of pregnancy.
Pregnancy
No association has been found between the maternal use of natural progesterone in early pregnancy and foetal malformations.
Breastfeeding
Utrogestan Vaginal 200 mg Capsules 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.
4.7. Effects on ability to drive and use machines
Utrogestan Vaginal Capsules has negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
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 authorisationThe information given below is based on extensive post marketing experience from vaginal administration of progesterone.
Adverse effects have been ranked under headings of frequency using the following convention: 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); frequency 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 haemorrhage
Vaginal discharge
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.
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.
💬 Ask about this leaflet
Ask anything about Utrogestan Vaginal 200mg 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
- Prometrium 400mg soft vaginal capsules
- Utrogestan 100mg Capsules
- Utrogestan Vaginal 300mg Capsules