• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Fyremadel is and what it is used for
2. What you need to know before you use Fyremadel
3. How to use Fyremadel
4. Possible side effects
5. How to store Fyremadel
6. Contents of the pack and other information

• if you are allergic to ganirelix or any of the other ingredients of this medicine (listed in section 6)
• if you are hypersensitive to gonadotrophin releasing hormone (GnRH) or a GnRH analogue
• if you have a moderate or severe kidney or liver disease
• if you are pregnant or breast-feeding.

Talk to your doctor, pharmacist or nurse before using Fyremadel

• if you have an active allergic condition, please tell your doctor. Your doctor will decide, depending on the severity, if additional monitoring is required during treatment. Cases of allergic reactions have been reported, as early as with the first dose.
• allergic reactions, both generalised and local, including hives (urticaria), swelling of the face, lips, tongue and/or throat that may cause difficulty in breathing and/or swallowing (angioedema and/or anaphylaxis) have been reported (see also section 4.) If you have an allergic reaction, stop taking Fyremadel and seek immediate medical assistance.
• latex allergy, the needle cover contains dry natural rubber/latex which comes into contact with the needle and may cause allergic reactions.
• during or following hormonal stimulation of the ovaries, ovarian hyperstimulation syndrome may develop. This syndrome is related to the stimulation procedure with gonadotrophins. Please refer to the Package Leaflet of the gonadotrophin-containing medicine prescribed for you.
• the incidence of congenital malformations after assisted reproduction techniques may be slightly higher than after spontaneous conceptions. This slightly higher incidence is thought to be related to characteristics of the patients undergoing fertility treatment (e.g. age of the woman, sperm characteristics) and to the higher incidence of multiple gestations after assisted reproduction techniques. The incidence of congenital malformations after assisted reproduction techniques using Fyremadel is not different from that after using other GnRH analogues in the course of assisted reproduction techniques.
• there is a slightly increased risk of pregnancy outside of the uterus (an ectopic pregnancy) in women with damaged fallopian tubes.
• the efficacy and safety of Fyremadel has not been established in women weighing less than 50 kg or more than 90 kg. Ask your doctor for further information.

There is no relevant use of Fyremadel in children or adolescents.

Tell your doctor or pharmacist if you are taking, have recently taken or might take, any other medicines.

Fyremadel should be used during controlled ovarian stimulation for assisted reproduction techniques (ART). Do not use Fyremadel during pregnancy and breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The effects of Fyremadel on ability to drive and use machines have not been studied.

This medicine contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially “sodium-free”.

Injection site

Fyremadel is supplied in pre-filled syringes which contain one dose. The contents should be injected slowly, just under the skin, preferably in the upper leg. Inspect the solution before use. Do not use if the solution contains particles or is not clear. If you administer the injections yourself or have it done by your partner, follow the instructions below carefully. Do not mix Fyremadel with any other medicines.

Preparing the injection site

Wash your hands thoroughly with soap and water. Swab the injection site with a disinfectant (for example alcohol) to remove any surface bacteria. Clean about 5 cm (two inches) around the point where the needle will go in and let the disinfectant dry for at least one minute before proceeding.

Inserting the needle

Remove the needle cover. Pinch up a large area of skin between finger and thumb. Insert the needle at the base of the pinched-up skin at an angle of 45° to the skin surface. Use a different place for each injection.

Checking the correct needle position

Gently draw back the plunger of the syringe to check if the needle is positioned correctly. If any blood is drawn into the syringe it means the needle tip has penetrated a blood vessel. If this happens, do not continue with the injection of Fyremadel. Remove the syringe, cover the injection site with a swab containing disinfectant and apply pressure; bleeding should stop in a minute or two. Do not use this syringe and dispose of it properly. Start again with a new syringe.

Injecting the solution

Once the needle has been correctly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin tissues are not damaged.

Removing the syringe

Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant.

Use the pre-filled syringe only once.

Contact your doctor.

If you realise that you forgot a dose, administer it as soon as possible.

Do not inject a double dose to make up for a forgotten dose.

If you are more than 6 hours late (so the time between two injections is longer than 30 hours) administer the dose as soon as possible and contact your doctor for further advice.

Do not stop using Fyremadel unless advised to by your doctor, as this may affect the outcome of your treatment.

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 Yellow Card Scheme at: 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.

• The active substance is ganirelix. Each pre-filled syringe contains 0.25 mg ganirelix (as acetate) in 0.5 ml aqueous solution.
• The other ingredients are acetic acid, glacial (E260), mannitol (E421) and water for injection. The pH (a measurement of the acidity) may have been adjusted with sodium hydroxide and acetic acid, glacial.

Fyremadel is a clear and colourless aqueous solution for injection. The solution is ready for use and intended for subcutaneous administration. The needle cover contains dry natural rubber/latex which comes into contact with the needle.

Fyremadel is available in packs of 1 or 5 pre-filled syringes with injection needles (27 G).

Not all pack sizes may be marketed.

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