Patient leaflet - Gestone 50 mg/ml solution for injection
1. What Gestone is and what it is used for
Gestone 50 mg/ml Solution for
Injection contains the active substance
progesterone, a hormone which acts
on the lining of the uterus and is
produced naturally by the body.
It may be prescribed in women for the
following conditions:-
To help early pregnancy to continue
in cases where the body is not
producing enough progesterone and
where there have been 3 or more
unexplained miscarriages
In selected cases, to assist infertility
treatment techniques such as in-vitro
fertilisation (IVF) or gamete intra-
fallopian transfer (GIFT)
- Bleeding disorders of the uterus.
2. What you need to know before you use Gestone
Do not use Gestone 50 mg/ml
Solution for Injection if:
If you are allergic (hypersensitive) to
progesterone or any of the other
ingredients of Gestone
If you are suffering from vaginal
bleeding (other than normal periods)
that has not been evaluated by your doctor
- If you have ever had a missed or incomplete abortion
- If you have had a miscarriage and your doctor suspects some tissue is still in the womb
- If you currently have a pregnancy outside of the womb (ectopic pregnancy)
- If you currently have or have had severe liver problems
- If you have known or suspected breast cancer or cancer of the reproductive tract
- 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)
- If during pregnancy you have suffered from jaundice (yellowing of eyes and skin due to liver problems) severe itching and/or blisters on the skin
- If you are under 18 years of age
Talk to your doctor, pharmacist or nurse if any of the above conditions apply to you, before you use Gestone 50 mg/ml Solution for Injection.
Warnings and precautions
Take special care with Gestone
If you experience any of the following during treatment tell your doctor immediately as your treatment may need to be stopped. Also tell your doctor immediately if you experience these a few days after the last dosage:
- Heart attack (pains in the chest, or back pain and/or deep aching and throbbing in one or both arms, a sudden shortness of breath, sweating, dizziness, lightheadedness, nausea, palpitations)
- Stroke (severe headache or vomiting, dizziness, faintness, or changes in vision or speech, weakness or numbness of an arm or leg)
- Blood clots in the eyes or anywhere in the body (pain in your eyes or pain and swelling in your ankles, feet and hands)
- Worsening of depression
- Severe headaches, changes in vision
- Sensitivity to light
Before treatment with Gestone
Tell your doctor if you have had or have any of the following before using Gestone:
- Liver problems (mild or moderate)
- Epilepsy
- Migraine
- Asthma
- High blood pressure, Heart or kidney problems
- Diabetes
- Depression
If any of the above applies to you, your doctor will monitor you carefully during treatment.
Tell your doctor if you are having regular blood tests to check your liver or hormones (Gestone 50 mg/ml Solution for Injection may interfere with these tests).
Children and adolescents
Gestone 50 mg/ml Solution for Injection should not be used in children and adolescents.
Other medicines and Gestone 50 mg/ml Solution for Injection
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Some medicines may interact with Gestone. For example:
- Carbamazepine (used to treat seizures/ fits)
- Rifampicin (an antibiotic)
- Griseofulvin (an antifungal medicine)
- Phenytoin and Phenobarbital (used to treat epilepsy)
- St. John’s Wort-containing herbal products
- Ciclosporin (a medicine for some types of inflammation and after organ transplants)
- Diabetic medicines
- Ketoconazole (an antifungal medicine)
- Bromocriptine (a medicine used to regulate prolactin and dopamine levels in treating diseases linked to substances) Do not administer Gestone at the same time as any other injectable medicine
Pregnancy, breast-feeding and fertility
Gestone 50 mg/ml Solution for Injection will support pregnancy if you are having fertility treatment. See Section 3 on how to use Gestone 50 mg/ml Solution for Injection.
Use of Gestone 50 mg/ml Solution for Injection is not recommended if you are breast-feeding.
Driving and using machines
Do not drive or use any tools or machines if you feel drowsy and/or dizzy whilst using Gestone 50 mg/ml Solution for Injection.
Gestone 50 mg/ml Solution for Injection contains benzyl alcohol.
This medicine contains 100 mg/ml benzyl alcohol which may cause allergic reactions.
Ask your doctor or pharmacist for advice before you use Gestone 50 mg/ml Solution for Injection if you are breast-feeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol can build up in your body and may cause side effects (called metabolic acidosis).
3. How to use Gestone
Your doctor, pharmacist or nurse will advise you on how Gestone 50 mg/ml Solution for Injection should be given at home. Gestone 50 mg/ml solution for injection is given by intramuscular injection. It should be injected deep into the buttock, rather than the thigh or deltoid, using a 1.5 inch (3.8cm) needle. This site has ample fat cells where a depot of progesterone can be formed for slow release.
The number of injections given to you per day or per week is called the ‘dose’. Depending on which condition you are being treated for, the appropriate dose is given by injection into a muscle (this should be deep into the buttock rather than the thigh) using a 1.5 inch (3.8 cm) needle. The site of injection has ample fat cells where a depot of progesterone can be formed for slow release.
The dose varies depending on the reason you are prescribed progesterone. Suggested doses and durations of doses are detailed below, but these may vary in your particular case according to advice from your specialised prescriber. If you are not sure ask your prescriber.
Adults
The use of Gestone 50 mg/ml Solution for Injection is only for women of childbearing age.
The most common dose for bleeding of the uterus is 5-10 mg daily for 5-10 days until 2 days before the anticipated start of a menstrual period.
The most common dose for maintaining pregnancy is twice weekly (or more frequent) injections of 25-100 mg starting from about day 15, or day of transfer of embryo or gametes, usually until 8-16 weeks of pregnancy when secretion of progesterone from the placenta should be established. The maximum frequency of injections should be once a day.
Daily dosage can be increased to 200 mg at the discretion of your doctor.
If you use more Gestone than you should
Tell your doctor, pharmacist or nurse. The symptoms of an overdose include drowsiness.
If you forget to use Gestone
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. Tell your doctor, pharmacist or nurse what you have done.
If you stop using Gestone
Do not stop using Gestone without speaking to your doctor or pharmacist first. Abrupt discontinuation of Gestone may cause increased anxiety, moodiness, and increase your risk of having seizures (fits).
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, Gestone 50 mg/ml Solution for Injection can cause side effects, although not everybody gets them.
Stop taking this medicine and seek immediate medical help if you have any of the following symptoms:
- Overstimulation of the ovaries (symptoms include lower stomach pain, feeling thirsty and sick, and sometimes being sick, passing reduced quantities of concentrated urine and weight gain)
- Depression
- Yellowing of your skin and the whites of your eyes (jaundice), fever
- Severe allergic reaction which may cause difficulty breathing, swelling of the face and throat or a severe rash (anaphylactoid reactions)
Very common: may affect more than 1 in 10 people
- Pain, redness, itching, irritation or swelling at the injection site
- Uterine spasm
- Vaginal bleeding
Common: may affect up to 1 in 10 people
- Headache
- Bloated stomach GesSFI-PIL-UK-3a
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Nordic Pharma Ltd., Gestone 50mg/ml - Ampoule Internal
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07.09.26
- Stomach pain
- Constipation
- Being sick and feeling sick
- Breast tenderness and/or pain
- Vaginal discharge
- A tingling or uneasy irritation or itching of the skin of the vagina and the surrounding area
- Hardening of area around injection site
- Bruising around injection site
Fatigue (excessive tiredness,
exhaustion, lethargy)
Uncommon: may affect up to 1 in 100 people
- Changes in mood
- Dizziness
- Insomnia
- Stomach and intestinal disturbance (including stomach discomfort and/or tenderness, wind, painful spasms and retching)
- Skin rashes (including red, warm skin, or raised, itchy bumps or wheals or dry, cracked or blistered or swollen skin)
- Breast swelling and/or enlargement
- Feeling hot
- General feeling of discomfort or “feeling out of sorts”
- Pain
Not known (cannot be estimated from the available data):
- Inability to sleep (insomnia),
- Premenstrual like syndrome and menstrual disturbances, unexpected light bleeding or spotting between your regular periods, periods stopping or not happening at all
- Hives, allergic reaction, acne, excessive hair growth, facial hyperpigmentation, hair loss (alopecia), weight gain or weight loss, oedema.
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 UK 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. How to store Gestone
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 label and carton after EXP. The expiry date refers to the last date of that month.
Store below 25°C. Store in the original package in order to protect from light. During storage, solid matter may form in the ampoule. This should be re-dissolved by warming the ampoule before use.
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 protect the environment.
6. Contents of the pack and other information
What Gestone 50 mg/ml Solution for Injection ampoules contain
The active substance is progesterone. Each 2 ml ampoule of Gestone 50 mg/ml Solution for Injection contains 100 mg of progesterone in 2 ml of liquid.
Each 2 ml ampoule also contains benzyl alcohol (100 mg/ml) and ethyl oleate.
What Gestone 50 mg/ml Solution for Injection ampoules look like and contents of the pack
Gestone 50 mg/ml Solution for Injection is a sterile, clear, colourless to slightly yellow oily solution. It is supplied in a clear glass ampoule containing 2 ml of solution. Each pack contains 10 ampoules.
Marketing Authorisation Holder
Nordic Pharma Ltd, Building 1410, Arlington Business Park, Theale, Reading, RG7 4SA, United Kingdom
Manufacturer
Qmed Pharmaceuticals Ltd, Unit 4, Thornham Grove, London, E15 1DN, United Kingdom
This leaflet was prepared in August 2026.