What it is and what it is used for

for MENOPUR is provided as a powder which must be mixed with liquid (solvent) before it is used. It is given as an injection under the skin or in the muscle. The active ingredient in MENOPUR is highly purified and is known as menotrophin. Menotrophin is extracted from the urine of postmenopausal women and contains three hormones: follicle stimulating hormone (FSH), human chorionic gonadotrophin (hCG) and luteinising hormone (LH). hCG, extracted from the urine of pregnant women may be added to contribute to the total LH bioactivity. FSH, hCG and LH are natural hormones produced in women. They help the reproductive organs to work normally. In women, MENOPUR is used to treat infertility in the following two situations:

• To promote the release of eggs from the ovaries (ovulation) in women who are not ovulating including with polycystic ovarian disease and who have not responded to treatment with another medicine called clomiphene citrate.
• To help multiple follicles and therefore eggs to develop in women having in vitro fertilisation (IVF) treatment or other types of 'assisted conception'. The eggs are then harvested and fertilised outside the body. In men, MENOPUR is used to treat infertility in the following situation:
• Low sperm count (oligospermia).

What you need to know before you take it

e MENOPUR Before starting treatment with MENOPUR, you and your partner should be evaluated by a doctor for the causes of your fertility problems. In particular you should be checked for the following conditions so that any other appropriate treatment can be given:

• Underactive thyroid or adrenal glands
• High levels of a hormone called prolactin (hyperprolactinemia)
• Tumours of the pituitary gland (a gland located on the base of the brain which produces certain hormones, including growth hormones)
• Tumours of the hypothalamus (an area located under the part of the brain called the thalamus, which controls the conditions within your body including body temperature and blood pressure) If you know you have any of the conditions listed above, please tell your doctor before starting treatment with MENOPUR. Do not use MENOPUR if:
• You are allergic (hypersensitive) to menotrophin or any of the other ingredients of MENOPUR (listed in Section 6).
• You have a tumour in your pituitary gland
• You have a tumour in the hypothalamus Also, if you are a woman do not use MENOPUR if:
• You have tumours of the womb (uterus), ovaries or breasts.
• You have sacs of fluid known as cysts on your ovaries (ovarian cysts) or enlarged ovaries that are not due to polycystic ovarian disease (a condition that prevents eggs from being released from the ovaries).
• You have bleeding from your vagina for an unknown reason.
• You are having an early (premature) menopause.
• You have certain physical problems in your reproductive organs (womb, fallopian tubes, ovaries or cervix).
• Your womb has been removed (hysterectomy).
• You have fibroid tumours (tumours in your womb that are not cancer).
• You are pregnant or breast-feeding. Also, if you are a man do not use MENOPUR if:
• You have cancer of your testicles.
• You have prostate cancer. Do not use Menopur if any of the above applies to you. If you are not sure, talk to your doctor, nurse or pharmacist before you start using MENOPUR. Warnings and precautions Talk to your doctor or nurse if:
• You get pain or swelling in the stomach
• You get nausea or vomiting
• You get diarrhea
• You gain weight
• You have difficulty in breathing
• You get decreased urination (produce less urine) Tell your doctor straight away, even if the symptoms develop some days after the last injection has been given. These can be signs of high levels of activity in the ovaries which might become severe. If these symptoms become severe, the infertility treatment should be stopped and you should receive treatment in hospital. Keeping to your recommended dose and careful monitoring of your treatment will reduce your chances of getting these symptoms. If you stop using MENOPUR you might still experience these symptoms. Please contact your doctor immediately if any of these symptoms occur. While you are being treated with this medicine, your doctor will normally arrange for you to have ultrasound scans and sometimes blood tests to monitor your response to treatment. Being treated with hormones like MENOPUR can increase the risk of:
• Ectopic pregnancy (pregnancy outside of the womb) if you have a history of fallopian tube disease.
• Miscarriage
• Multiple pregnancy (twins, triplets, etc)
• Congenital malformations (physical defects present in baby at birth).

Children There is no relevent use of MENOPUR in children. Other medicines and MENOPUR Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Clomiphene citrate is another medicine used in the treatment of infertility. If MENOPUR is used at the same time as clomiphene citrate the effect on the ovaries may be increased. Pregnancy and breast-feeding MENOPUR should not be used during pregnancy or breast-feeding. Driving and using machines MENOPUR is unlikely to affect your ability to drive and use machines. Important information about some of the ingredients of MENOPUR MENOPUR contains less than 1 mmol sodium (23 mg) per dose, so it is essentially 'sodium-free'. MENOPUR also contains lactose (which is a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before using this medicine.

How to take it

Menopur Always use Menopur exactly as your doctor or nurse has told you. You should check with your doctor, nurse or pharmacist if you are not sure. Using Menopur

• You will have Menopur as an injection into a muscle or under the skin.
• You will either be given Menopur by a doctor or nurse or you will be taught how to give it to yourself.
• Menopur comes as a dry powder in small bottles (vials).
• Once the dry powder has been mixed with the salt solution (solvent) it should be used straight away. The dose and length of your treatment
• The dose, and how long your treatment lasts, depends on why you are using Menopur and how well it works.
• Your doctor or nurse will monitor how you respond to your treatment.
• This will help them to work out what dose you need and how long you need to use Menopur for. In women: i. Women who are not ovulating (not producing eggs): Treatment should start within the first 7 days of the menstrual cycle (day 1 is the first day of your period). Treatment should be given every day for at least 7 days. The starting dose is normally 75-150 IU daily but this may be adjusted depending on your response (up to a maximum of 225 IU). A particular dose should be given for at least 7 days before the dose is changed by your doctor. It is recommended that the dose should be increased by 37.5 IU per adjustment (and not more than 75 IU). The cycle of treatment should be abandoned if there is no response after 3 weeks. When a good response is obtained a single injection of another hormone called human chorionic gonadotrophin (hCG), at a dose of 5,000 to 10,000 IU, should be given 1 day following the last MENOPUR injection. It is recommended to have sexual intercourse on the day of the hCG injection and the day after. Alternatively, artificial insemination (injection of sperm directly into the womb) may be performed. Your doctor will closely monitor your progress for at least 2 weeks after you have received the hCG injection. Your doctor will monitor the effect of MENOPUR treatment. If an excessive response occurs, your doctor may decide to stop treatment with MENOPUR and not give you the hCG injection. In this case, you will be instructed to use a barrier method of contraception (e.g. condom) or not have sexual intercourse until your next period has started. For the following cycle your doctor will give you a lower dose of MENOPUR than before. ii. Women in assisted reproductive technology programs: If you are also receiving treatment with a GnRH agonist (a medicine which helps a hormone called Gonadotropin Releasing Hormone (GnRH) to work), MENOPUR should be started approximately 2 weeks after the start of the GnRH agonist therapy. If you are also receiving treatment with a GnRH antagonist, MENOPUR treatment should be started on day 2 or 3 of the menstrual cycle (day 1 is the first day of your period). MENOPUR should be given every day for at least 5 days. The initial dose of MENOPUR is normally 150-225 IU. This dose may be increased according to your response to the treatment up to a maximum of 450 IU per day. The dose should not be increased by more than 150 IU per adjustment. Normally treatment should not continue for more than 20 days. If enough egg sacs are present, you will be given a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of up to 10,000 IU to induce ovulation (release of an egg). Your doctor will closely monitor your progress for at least 2 weeks after you have received the hCG injection. Your doctor will monitor the effect of MENOPUR treatment. If an excessive response occurs, your doctor may decide to stop treatment with MENOPUR and not give you the hCG injection. In this case, you will be instructed to use a barrier method of contraception (e.g. condom) or not have sexual intercourse until your next period has started. For the following cycle your doctor will give you a lower dose of MENOPUR than before. In men: For low sperm count:
• The usual dose is 75 or 150 IU two or three times a week.
• Treatment is normally continued for at least 3 or 4 months. "INSTRUCTIONS FOR USE" If your doctor has asked you to inject MENOPUR yourself, you should follow the instructions provided below. The first injection of MENOPUR should be given under the supervision of a doctor or nurse. DISSOLVING MENOPUR: MENOPUR is provided as a powder and must be dissolved before it is injected. The liquid (solvent) which you should use to dissolve MENOPUR is provided with the powder. MENOPUR should only be dissolved immediately before use. Please note: 1 drop of solvent can dissolve the powder immediately, leading to the impression that no powder was present in the vial. Check the vial for powder before mixing the solvent. What to do:

Some women who have been given infertility treatment with multiple medicines have developed tumours in the ovaries and other reproductive organs. It is not yet known if treatment with hormones like MENOPUR causes these problems.

Blood clot formation inside the blood vessels (veins or arteries) are more likely to occur in women who are pregnant. Infertility treatment can increase the chances of this happening, especially if you are overweight or known with blood clotting disease (thrombophilia) or if you or someone in your family (blood relative) has had blood clots. Tell your doctor if you think this applies to you.

1.  Firmly attach a long, thick needle (drawing up/ reconstitution needle) to the syringe. 2. Break the liquid (solvent) ampoule with the dot pointing towards yourself. 3. Insert the needle in the liquid ampoule. XXXXXXXXXX

• Nausea
• Pelvic pain
• Overstimulation of the ovaries resulting into high levels of activity (OHSS)
• Pain or inflammation at the injection site (redness, bruising, swelling and/or itching)

4. Draw up all the liquid from the ampoule into the syringe. 5. Insert the needle through the rubber stopper of the powder vial and slowly inject all of the liquid. Aim at the side of the vial to avoid creating bubbles. 6. The powder should quickly dissolve (within 2 min) to form a clear solution.

7. To help the powder dissolve, swirl the solution Do not shake as this will cause air bubbles to form. If the solution is not clear or if it contains particles, it SHOULD NOT be used.

8. Draw up the solution back into the syringe. If you have been prescribed more than one vial of MENOPUR powder per injection, you can draw up the solution (the first MENOPUR dilution) back into the syringe and inject it into a second vial of powder. You can do this with up to three vials of powder in total – but only do as your doctor has told you. INJECTING MENOPUR:

9. Once you have your prescribed dose drawn up into the syringe, change the needle to a short, thin needle (the injection needle). 10. Turn the syringe with the needle upwards and flick it gently so if any air bubbles, they are collected at the tip. Depress the plunger carefully until the first drop of fluid comes out. 11 Your doctor or nurse will tell you where to inject yourself (e.g. front of the thigh, stomach (abdomen), etc) 12 Disinfect the injection site.

13 To inject, pinch the skin to produce a fold, and insert the needle in one swift motion at 90 degrees to the body. Press down on the plunger to inject the solution, and then remove the needle. 14 After removing the syringe, apply pressure to the injection site to stop any bleeding. Gently massaging the injection site will help to disperse the solution under the skin. 15 Do no put used items into normal domestic waster; these should be disposed of appropriately If you use more Menopur than you should If you think you have used too much Menopur, tell your doctor, nurse or pharmacist. If you forget to use Menopur , Do not take a double dose to make up for a forgotten dose. Please tell your doctor, nurse or pharmacist. 4. Possible side effects Like all medicines, Menopur can cause side effects, although not everybody gets them. Side effects that can happen in women: If you notice any of the following signs, tell your doctor immediately. It may mean that your ovaries have been stimulated too much Ovarian Hyperstimulation Syndrome (OHSS), especially in women with polycystic ovaries and you may need urgent medical treatment. Symptoms include:

• Nausea (feeling sick)
• Vomiting (being sick)
• Diarrhoea.
• Weight gain.
• Pain or swelling of the stomach In cases of severe OHSS:
• Fluid build-up in the stomach, pelvis and/or chest
• Difficulty in breathing.
• Decreased urination (producing less urine when you go to the toilet or going to the toilet less often.
• Formation of blood clots in blood vessels (thromboembolism)
• Twisting of ovaries (ovarian torsion) If you notice any of the above signs, tell your doctor immediately.

Possible side effects

that can happen in both women and men: STOP USING Menopur if you experience allergic (hypersensitivity) reactions including; itching, skin rashes, swelling of the face, lips or throat, difficulty in breathing. If you experience any of these rare side effects, you should contact your doctor or go to the nearest hospital immediately. Common (may affect up to 1 in 10 people):

• Pain or swelling of the stomach
• Headache.

Uncommon (may affect up to 1 in 100 people):

• Vomiting
• Discomfort in the stomach
• Diarrhoea
• Fatigue
• Dizziness
• Sacs of fluid within ovaries (ovarian cysts)
• Breast complaints (include breast pain, breast tenderness, breast discomfort, nipple pain and breast swelling)
• Hot flush Rare (may affect up to 1 in 1,000 people)
• Acne
• Rash Unknown (the frequency of these reported side effects is not known)
• Eyesight disturbances
• Allergic reactions
• Pain in muscle and joint (e.g. back pain, neck pain and pain in arms and legs)
• Twisting of ovary (ovarian torsion) as a complication of OHSS
• Itching
• Hives Reporting of side effects If you get any side effects, talk to your doctor 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, website: https://yellowcard.mhra.gov.uk/. By reporting side effects, you can help provide more information on the safety of this medicine.

How to store it

Menopur

• Keep out of the sight and reach of children.
• Do not use Menopur after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
• For immediate and single use following reconstitution.
• Do not store above 25°C. Do not freeze.
• Store in the original package in order to Protect from light.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Content of the pack and other information What MENOPUR contains
• MENOPUR is a sterile freeze dried powder for injection. The active substance is Highly Purified Menotrophin (human menopausal gonadotrophin, hMG) corresponding to 75 IU follicle stimulating hormone (FSH) bioactivity and 75 IU luteinising hormone bioactivity (LH).
• The other ingredients for powder are Lactose monohydrate, Polysorbate 20, Sodium hydroxide and Hydrochloric acid.
• The solvent (Sodium Chloride Solution for Injections 0.9% w/v) contains Sodium chloride, diluted Hydrochloric acid, Sodium hydroxide and Water for injection. What MENOPUR looks like and contents of the pack MENOPUR is a powder and solvent for solution for injection. Supplied in cartons of 1, 5 and 10 clear glass vials which contain a white to off-white lyophilised powder. The carton also contains an equal number of clear glass ampoules containing a colourless solvent (Sodium Chloride Solution for Injection 0.9%w/v). The solvent is used to dissolve the powder before it is injected. Not all pack sizes may be marketed Marketing Authorisation Holder: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, (UK). Manufacturer: Ferring GmbH Wittland 11, D-24109 Kiel, Germany This leaflet was last revised in June 2026 Menopur, Ferring and the Ferring Pharmaceuticals logo are trademarks of Ferring

Date: 04 Jun 2026 Title

PIL MENOPUR powd and solv for sol for inj vial 10x 75IU GB

Perigord No 941563 Proof No 03

F-MS N°/ Version 3019/00

Barcode No N/A Approving Country GB Dimensions 210 x 550 mm

Colours P Pro Black, P Pro Blue, P 249.