Gepretix

What is Gepretix?

Gepretix is a prescription-only medicine containing micronised progesterone, a natural form of the female hormone progesterone. It is available as Gepretix 100 mg and Gepretix 200 mg soft capsules and is used as part of hormone replacement therapy (HRT) in post-menopausal women who still have a womb (intact uterus).

Gepretix is taken alongside an oestrogen medicine to protect the lining of the womb from the effects of oestrogen taken alone. It is not a contraceptive and is not suitable for use during pregnancy or breastfeeding.

How Does Gepretix HRT Work?

Oestrogen is a central part of HRT and helps relieve common menopausal symptoms such as hot flushes, night sweats and vaginal dryness. However, in women who still have a womb, taking oestrogen without a progestogen causes the lining of the womb (the endometrium) to thicken excessively over time. This can increase the risk of endometrial (womb) cancer.

Gepretix works by counteracting this effect. As a natural progestogen, it acts on the endometrium, shifting it from the growing (proliferative) phase to the secretory phase and stabilising and protecting the womb lining.

As Gepretix contains micronised progesterone that is chemically identical to the progesterone your body produces naturally, many people prefer it to synthetic progestogens. It also has mild anti-oestrogenic, anti-androgenic and anti-aldosterone properties. These all contribute to its overall hormonal effects within your body.

How Long Does Gepretix Take to Work?

Gepretix begins protecting the endometrium (womb lining) from the first cycle you take it alongside an oestrogen product as part of HRT. It’s important to remember that you won’t be taking Gepretix without an oestrogen component, and the menopausal symptom relief is primarily driven by the oestrogen medication. You may notice symptom improvement within a few weeks of starting HRT, but it may take up to 3 months to see its full effects. 

How Effective is Gepretix HRT?

Various clinical studies support Gepretix's effectiveness as part of combined HRT by examining protection of the endometrium (inner lining of the womb), breast tolerability, and cardiovascular safety.

A multicentre, randomised, double-blind, placebo-controlled trial in 875 post-menopausal women over three years discovered these key findings:

• Micronised progesterone 200 mg combined with oestrogen effectively prevented oestrogen-induced thickening of the endometrium throughout the study 
• There was a more favourable effect on HDL (good) cholesterol compared to synthetic progestogens

The trial design reduced the risk of bias, increasing the reliability of findings.

Meanwhile, a French prospective study in over 80,000 women found that HRT using natural progesterone was associated with a significantly lower risk of breast cancer compared to some synthetic progestogens, with a risk profile closer to that of non-HRT users. Finally, in a third case-control study, oral micronised progesterone was associated with a lower risk of venous thromboembolism (blood clots) compared with some synthetic progestogens.

Altogether, these studies support Gepretix as a well-evidenced component of combined HRT, with a hormonal profile that may offer advantages over some synthetic alternatives in terms of tolerability and safety.

How to Take Gepretix Capsules

Take your Gepretix capsule by mouth at bedtime, as directed by your prescriber. Your prescriber will prescribe the lowest possible dose to treat your symptoms effectively for as short a time as necessary. Take it on an empty stomach, as food increases the amount of medicine your body absorbs and may intensify side effects such as drowsiness or dizziness.

Swallow the capsule whole with a glass of water. Your prescriber will advise you on when in your monthly cycle to take Gepretix, as this depends on the type of oestrogen HRT you are using. Take your oestrogen HRT at the same time as Gepretix. You should continue to take your oestrogen HRT every day, following your prescriber’s advice.

After you have completed the Gepretix-taking phase of your monthly cycle, you will usually have a few days of withdrawal bleeding. If you have a problem with this bleed, your prescriber may change the way you take Gepretix. 

Gepretix Dosage Information 

The usual dose is 200 mg taken once daily at bedtime for twelve consecutive days per cycle, typically from Day 15 to Day 26. Alternatively, your prescriber may recommend 100 mg taken daily from Day 1 to Day 25 of each cycle. This method can lead to less withdrawal bleeding. Your prescriber will determine the most appropriate dose and schedule for you.

If You Forget to Take Gepretix HRT

If you forget to take Gepretix as normal, take it as soon as you remember. If it’s nearly time for your next dose, skip the missed one and take the next at the regular time. Do not try to take a double dose to make up for a forgotten one. 

If You Take Too Many Gepretix Capsules 

If you take more Gepretix than you should, speak to a clinician or go to a hospital. Remember to take the medicine pack (containing the Patient Information Leaflet) with you to the hospital. You may experience adverse reactions such as drowsiness, sleepiness, tiredness, or dizziness. 

Gepretix Side Effects and Cautions

Before taking Gepretix, it’s important that you are aware of potential side effects and risks associated with treatment. Some risks are associated with HRT in general and are often driven by the oestrogen component. This information will cover the listed side effects of Gepretix, as well as other potential risks of HRT use. 

Side Effects of Gepretix HRT

Not everyone who takes Gepretix will experience side effects. The frequency of side effects is not reported in the patient information leaflet; however, certain effects have been noted in clinical trials and with prescribed use:

This is not an exhaustive list of potential side effects of Gepretix. More information, including a detailed breakdown of potentially serious risks of HRT use, is available in the Patient Information Leaflet that comes with the medication. If you do experience any adverse reactions to the treatment, you can also report them using the MHRA’s Yellow Card Scheme.

Possible Side Effects From HRTs

Further side effects have been reported by women who use HRT. These side effects may not occur as a direct result of Gepretix use, but you should still be aware of them before commencing HRT:

• Gallbladder disease
• Various skin disorders and rashes (chloasma, melasma, urticaria, erythema nodosum, and erythema multiforme)
• Breast pain
• Fluid retention (oedema)
• Weight changes
• Increase or decrease in sexual desire
• Depression
• Fever
• Insomnia 
• Alopecia (hair loss)
• Irregular menstruation
• Lack of menstruation

Information regarding serious risks associated with HRT is discussed in the section “Gepretix Warnings and Interactions”.

Gepretix Warnings and Interactions

Gepretix is prescribed for post-menopausal women who still have a womb and are taking oestrogen as part of HRT. It is not suitable for women who:

• Are allergic to progesterone or any other ingredient of this medicine (this includes soya bean and peanut)
• Have ever had breast cancer or if you suspect you may have it 
• Have a cancer that is sensitive to oestrogens (e.g. endometrial) or are suspected of having it 
• Have any unexplained vaginal bleeding 
• Have or have ever had a blood clot in a vein (e.g. deep vein thrombosis or pulmonary embolism)
• Have a blood clotting disorder
• Have or recently have had a disease caused by blood clots in the arteries (e.g. stroke, heart attack, or angina)
• Have or have ever had a liver disease and your liver function tests have not returned to normal 
• Have a rare blood disorder called porphyria
• Have bleeding in the brain (cerebral haemorrhage) 
• Are breastfeeding

If any of these conditions appear for the first time whilst taking Gepretix, stop taking it and contact your doctor. You should undergo regular medical checkups whilst taking HRT. 

Precautions Before Taking Gepretix

You must tell your prescriber before taking Gepretix if any of the following apply to you, as they may return or become worse during treatment with HRT:

• Abnormal tumours/growths (fibroids inside your womb)
• Growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia)
• Increased risk of developing blood clots
• Increased risk of getting an oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)
• High blood pressure
• Liver problems such as a benign tumour
• Diabetes
• Gallstones
• Migraine or severe headaches
• A disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
• Epilepsy
• Asthma
• A disease affecting the eardrum and hearing (otosclerosis)
• You have ever had depression
• Your skin is sensitive to light (photosensitivity)

Your prescriber will assess the benefits and risks of taking HRT, ensuring you are informed about your options.

When to Stop Taking Gepretix 

If you notice any of the following whilst taking Gepretix, stop taking it and seek immediate advice from your doctor:

• Any condition listed in the “DO NOT take Gepretix” section of the patient information leaflet
• Yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease
• A large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
• Migraine-like headaches which happen for the first time
• Sudden or gradual, partial or complete loss of vision
• Proptosis (forward displacement of the eye) or diplopia (double vision)
• Swelling of the optic nerve (papilloedema)
• Eye diseases (retinal vascular lesions)
• If you become pregnant
• If you notice signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, or difficulty in breathing

HRT Risk Information 

HRT can provide significant relief for those struggling with the symptoms of the menopause. However, taking HRT can increase your risk of certain serious conditions. A full breakdown of the risk information is available in the Patient Information Leaflet contained within the medicine package.

Oestrogen HRT thickens the lining of the womb and can increase your risk of endometrial cancer. Gepretix is designed to protect you from this extra risk. You will have a monthly withdrawal bleed whilst taking Gepretix. If you experience bleeding or spotting besides your monthly bleeding which carries on after 6 months of taking Gepretix, starts after 6 months of taking it, or carries on after you have stopped taking it, see your doctor as soon as possible.

Taking HRT has also been linked to an increased risk of breast cancer. You should check your breasts regularly and see your doctor if you notice any changes. Taking HRT has also been associated with a slightly increased risk of ovarian cancer. Ovarian cancer is much rarer than breast cancer.

The risk of blood clots in the veins is 1.3 to 3 times higher in women who take HRT (especially during the first year of taking it). The patient information leaflet lists risk factors and symptoms of a blood clot that you should be aware of. Women over 60 who use oestrogen-progestogen HRT are slightly more likely to develop heart disease. HRT users also have about a 1.5 times higher risk of stroke. There is evidence of a higher risk of memory loss in women who start HRT after the age of 65.

Overall, you should speak to your doctor about the benefits and risks of HRT. They will help you to assess your individual risk factors and suitability for HRT. If you notice any signs of a serious condition whilst taking HRT, you should see your doctor immediately. 

Gepretix and Other Medicines

Tell your prescriber if you are currently taking or have recently taken any other prescribed medicines, over-the-counter medications, herbal remedies, or supplements. Gepretix can affect the way some medicines work and other medicines may interfere with the effect of Gepretix:

• Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepine)
• Medicines for tuberculosis (such as rifampicin, rifabutin)
• Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir)
• Herbal remedies containing St John’s Wort 
• Bromocriptine
• Cyclosporin 
• Ketoconazole
• Spironolactone
• Antibiotics (ampicillins, tetracyclines)
• Antisteroids (medroxyprogesterone acetate, megestrol)
• Medicines to prevent blood clots (such as coumarins, phenindione)
• Diabetic medicines
• Emergency contraceptives (ulipristal acetate)
• Diazepam
• Tizanidine

Pregnancy and Breastfeeding 

Gepretix is for use by post-menopausal women only. Do not take Gepretix if you are pregnant or may become pregnant. If you do become pregnant, stop taking Gepretix and contact your doctor immediately. You must talk to your doctor before taking this medicine if you are breastfeeding. 

Frequently Asked Questions About Gepretix HRT