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.
Lutigest 100 mg vaginal tablets
⚠ 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 2. What you need to know before you use Lutigest 3. How to use Lutigest 4. Possible side effects 5. How to store Lutigest 6. Contents of the pack and other information
Lutigest is for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) programme. Progesterone acts on the lining of the womb and it helps you to become and to stay pregnant when you are treated for infertility.
What you need to know before you take it
e Lutigest Lutigest can be used only in women who are undergoing infertility treatment in an Assisted Reproductive Technology (ART) programme. The treatment is started on the day of egg retrieval. Your doctor will tell you when the treatment is started. Do not use Lutigest • if you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6). • if you have unusual vaginal bleeding that has not been evaluated by the doctor. • if you have a miscarriage and your physician suspects some tissue is still in the uterus or pregnancy outside of the womb. • if you currently have or have had severe liver problems. • if you have known or suspected breast or genital tract cancer.
if you have or have had blood clots in the legs, lungs, eyes or elsewhere in the body. if you have porphyria disorders (a group of inherited or acquired disorders of certain enzymes)
Children There is no relevant use of Lutigest in children. Other medicines and Lutigest Tell your doctor if you are using, have recently used or might use any other medicines.
Warnings and precautions
Some medicines may interact with vaginal progesterone tablets. For example, carbamazepine, rifampin as well as St. John's wort-containing herbal products may decrease the effectiveness, whereas products containing ketoconazole and vaginal antifungal creams may alter the actions of progesterone.
Take special care and tell your doctor straight away if you experience any of these symptoms during treatment or even few days after the last dosage: • pains in the calves or chest, a sudden shortness of breath or coughing blood indicating possible clots in the legs, heart, or lungs • severe headache or vomiting, dizziness, faintness, or changes in vision or speech, weakness or numbness of an arm or leg indicating possible clots in the brain or eye • worsening symptoms of depression
Pregnancy and breast-feeding Lutigest can be used during the first trimester of pregnancy for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) programme.
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How to take it
Lutigest Always use this medicine exactly as your doctor has told you. You should check with your doctor if you are not sure. The usual dose is 100 mg placed directly into your vagina three times daily starting on the day of egg retrieval. The administration of Lutigest should be continued for 30 days if pregnancy has been confirmed.
1. Remove one blister from the strip by tearing along the perforations. 2. To remove the foil seal on the back of the blister, start in the corner of the blister pack that has a printed arrow
6. Push the plunger to release the tablet. Remove the applicator and rinse it thoroughly in warm running water, wipe dry with a soft tissue and keep the applicator for subsequent use. If you use more Lutigest than you should Please consult your doctor or pharmacist if you have used more Lutigest than your doctor has told you.
This medicine should not be used during breast feeding. Driving and using machines Lutigest has minor or moderate influence on the ability to drive and use machines. It may cause drowsiness and/or dizziness; therefore caution is advised in drivers and users of machines.
5. The applicator with the tablet may be inserted into the vagina while you are standing, sitting, or when lying on your back with your knees bent. Gently insert the thin end of the applicator well into the vagina.
Instructions for use Lutigest is to be placed directly into your vagina by using the applicator provided.
The risks of congenital (conditions present at birth) anomalies, including genital abnormalities in male or female infants, from exposure to exogenous progesterone during pregnancy have not been fully established.
Before starting treatment with Lutigest tell your doctor if you have had or have any of the following health problems: • Epilepsy • Migraine • Asthma • Cardiac or renal dysfunction • Diabetes
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Vaginal tablets Progesterone
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3. Unwrap the applicator.
If you forget to use Lutigest Take the dose as soon as you remember and then carry on as before. Do not take a double dose to make up for a forgotten dose.
4. Put one tablet in the space provided at the end of the applicator. The tablet should fit securely and not fall out.
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4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common side effects are headache, vaginal disorders and uterine cramping.
The following uncommon side effects affect between 1 and 10 of every 1000 patients treated: Dizziness Insomnia Diarrhoea Constipation Urticaria (allergic rash) Rash
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Vaginal disorders (e.g. vaginal discomfort, burning sensation, discharge, dryness, and bleeding) Fungal infection in vagina Breast disorders (e.g. breast pain, breast swelling and breast tenderness) Itching in the genital area Peripheral edema (swelling due to the build up of fluid)
The following side effects have been seen after the product was marketed. Frequency is not known (cannot be estimated from the available data): Fatigue Vomiting Allergic reactions Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: 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
Lutigest
Store in the original container in order to protect from light.
What Lutigest looks like and contents of the pack This medicine is a vaginal tablet. It is a white to off-white convex and oblong tablets debossed with "FPI" on one side and "100" on the other side.
This medicinal product does not require any special temperature storage conditions.
Pack sizes: 21 or 90 vaginal tablets, supplied with one polyethylene vaginal applicator. Not all pack sizes may be marketed.
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.
Marketing Authorisation Holder PL 03194/0103 Ferring Pharmaceuticals Ltd. Drayton Hall, Church Road West Daryton UB7 7PS UK
Contents of the pack and other information
What Lutigest contains The active substance is progesterone.
Manufacturer Ferring GmbH Wittland 11, D-24109 Kiel, Germany
Each vaginal tablet contains 100 mg progesterone. The other ingredients are: • Hydrophobic colloidal silica • Lactose monohydrate • Pregelatinized maize starch • Povidone • Adipic acid • Sodium hydrogen carbonate • Sodium laurilsulfate • Magnesium stearate
This medicinal product is authorised in the Member States of the EEA under the following names: Bulgaria, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Ireland, the Netherlands, Norway, Poland, Slovak Republic, Spain and Sweden: Lutinus Portugal: Luferti Romania: Lutinus 100 mg, comprimate vaginale Slovenia: Lutinus 100 mg vaginalne tablete United Kingdom: Lutigest
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 carton. The expiry date refers to the last day of that month.
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The following common side effects affect between 1 and 10 of every 100 patients treated: Headache Abdominal distension (swelling in the abdomen) Abdominal pain Nausea Uterine cramping
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If you stop using Lutigest Please consult your doctor or pharmacist for advice if you intend to stop or have stopped using Lutigest. Abrupt discontinuation of progesterone dosing may cause increased anxiety, moodiness, and increased sensibility to seizures.
This leaflet was last revised in March 2018
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Frequently asked questions about Lutigest 100 mg vaginal tablets
How do I take Lutigest 100 mg vaginal tablets?
Lutigest 100 mg vaginal tablets comes as tablet containing 100mg. 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 Lutigest 100 mg vaginal tablets?
The active substance in Lutigest 100 mg vaginal tablets is progesterone.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Lutigest 100 mg vaginal tablets, 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 Lutigest 100 mg vaginal tablets 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
Lutigest is indicated for luteal support as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.
4.2. Posology and method of administration
Posology
Adults
The dose of Lutigest is 100 mg administered vaginally three times daily starting at oocyte retrieval. The administration of Lutigest should be continued for 30 days, if pregnancy has been confirmed.
Paediatric population
There is no relevant use of Lutigest in the paediatric population.
Elderly
No clinical data have been collected in patients over age 65.
Use in special populations
There is no experience with use of Lutigest in patients with impaired liver or renal function.
Method of Administration
Lutigest is to be placed directly into the vagina by the applicator provided.
4.3. Contraindications
Lutigest should not be used in individuals with any of the following conditions:
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Undiagnosed vaginal bleeding
• Known missed abortion or ectopic pregnancy
• Severe hepatic dysfunction or disease
• Known or suspected breast or genital tract cancer
• Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events
• Porphyria
4.4. Special warnings and precautions for use
Lutigest should be discontinued if any of the following conditions are suspected:
myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary embolism), thrombophlebitis, or retinal thrombosis.
Cautious use in patients with mild to moderate hepatic dysfunction.
Patients with a history of depression need to be closely observed. Consider discontinuation if symptoms worsen.
Because progesterone 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.
A decrease in insulin sensitivity and thereby in glucose tolerance has been observed in a small number of patients on oestrogen-progestogen combination drugs. The mechanism of this decrease is not known. For this reason, diabetic patients should be carefully observed while receiving progesterone therapy.
Sex steroid use may also increase the risk of retinal vascular lesions. To prevent these latter complications, caution is to be taken in users >35 years, in smokers, and in those with risk factors for atherosclerosis. Use should be terminated in case of transient ischemic events, appearance of sudden severe headaches, or vision impairments related to papillary edema or retinal hemorrhage.
Abrupt discontinuation of progesterone dosing may cause increased anxiety, moodiness, and increased sensibility to seizures.
Before starting treatment with Lutigest, the patient and her partner should be assessed by a doctor for causes of infertility.
4.5. Interaction with other medicinal products and other forms of interaction
Drugs known to induce the hepatic cytochrome-P450-3A4 system (e.g. rifampicin, carbamazepine or St. John's wort (Hypericum perforatum)-containing herbal products) may increase the elimination rate and thereby decrease the bioavailability of progesterone.
In contrast ketoconazole and other inhibitors of cytochrome P450-3A4 may decrease elimination rate and thereby increase the bioavailability of progesterone.
The effect of concomitant vaginal products on the exposure of progesterone from Lutigest has not been assessed. However, Lutigest is not recommended for use with other vaginal products (such as antifungal products) as this may alter progesterone release and absorption from the vaginal tablet.
4.6. Fertility, pregnancy and lactation
Pregnancy:
Lutigest vaginal tablets are only indicated during the first trimester of pregnancy for use as part of an assisted reproduction (ART) regimen.
There is limited and inconclusive data on the risk of congenital anomalies, including genital abnormalities in male or female infants, following intrauterine exposure during pregnancy.
In the pivotal trial, the rate of foetal anomalies following 10-week exposure to Lutigest 100 mg TID was 4.5% in the Lutigest TID group, a total of 7 cases of foetal anomalies (i.e. oesophageal fistula, underdeveloped right ear with hypospadias, small aorta/ valvular regurgitation/ deviated septum, hand deformity, cleft palate/cleft lip, hydrocephalus and holoprosencephaly/ proboscis/ polydactylia) were seen in 404 patients. The rate of foetal anomalies observed during the clinical trial is comparable with the event rate described in the general population, although the total exposure is too low to allow conclusions to be drawn.
During the conduct of the pivotal clinical trial, the number of spontaneous abortions and ectopic pregnancies associated with the use of Lutigest100 mg TID were 5.4% and 1%, respectively.
Breast-feeding:
Detectable amounts of progesterone have been identified in the milk of mothers. Therefore Lutigest should not be used during lactation.
4.7. Effects on ability to drive and use machines
Lutigest has minor or moderate influence on the ability to drive and use machines. Progesterone may cause drowsiness and/or dizziness; therefore caution is advised in drivers and users of machines.
4.8. Undesirable effects
The most frequently reported adverse drug reactions during treatment with Lutigest in IVF patients during clinical trials are headache, vulvovaginal disorders and uterine spasm, reported in 1.5%, 1.5% and 1.4% subjects, respectively. The table below displays the main adverse drug reactions in women treated with Lutigest in the clinical trial distributed by system organ classes (SOCs) and frequency.
System Organ Class (SOC)
Common
(> 1/100 and < 1/10)
Uncommon
(> 1/1000 and < 1/100)
Not known***
(cannot be estimated from the available data)
Nervous system disorders
Headache
Dizziness,
Insomnia
Fatigue
Gastrointestinal disorders
Abdominal distension
Abdominal pain
Nausea
Diarrhoea
Constipation
Vomiting
Skin and subcutaneous tissue disorders
Urticaria
Rash
Hypersensitivity reactions
Reproductive system and breast disorders
Uterine spasm
Vulvovaginal disorders*
Vaginal mycosis
Breast disorders**
Pruritus genital
General disorders and administration site conditions
Oedema peripheral
* Vulvovaginal disorders such as vulvovaginal discomfort, vaginal burning sensation, vaginal discharge, vulvovaginal dryness and vaginal haemorrhage, have been reported following use of Lutigest, with cumulative reporting frequency of 1.5%.
** Breast disorders, such as breast pain, breast swelling and breast tenderness have been reported in the clinical trial as single cases, with cumulative reporting frequency of 0.4%.
***Cases seen during post marketing experience.
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 Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.
4.9. Overdose
High doses of progesterone may cause drowsiness.
Treatment of overdosage consists of discontinuation of Lutigest together with institution of appropriate symptomatic and supportive care.
🇷🇴 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 Lutigest 100 mg vaginal tablets. 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
- 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