Package Leaflet: Information for the User

Orgalutran 0.25mg/0.5ml Injectable Solution

ganirelix

Read this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet.See section 4.

1.What Orgalutran is and what it is used for

2.What you need to know before using Orgalutran

3.How to use Orgalutran

4.Possible side effects

5.Storage of Orgalutran

6.Contents of the pack and additional information

Orgalutrancontains the active ingredientganirelix andbelongs to a group of medicines called “antagonists of the gonadotropin-releasing hormone” that acts against the action of the endogenous gonadotropin-releasing hormone (GnRH).The GnRHregulates the release of gonadotropins (luteinizing hormone (LH) and follicle-stimulating hormone (FSH)). Gonadotropins play an important role in human fertility and reproduction.The FSHis necessary in women for the growth and development of follicles in the ovaries. Follicles are small rounded vesicles that contain the oocytes.The LHis necessary for the mature oocytes to be released from the follicles of the ovaries (i.e., ovulation). Orgalutran inhibits the action ofthe GnRH, which causes the suppression of the release especially ofthe LH.

What Orgalutran is used for

In women undergoing assisted reproduction techniques, such as in vitro fertilization (IVF) and other methods, premature ovulation may occasionally occur, which causes a significant reduction in the probability of becoming pregnant. Orgalutran is used to prevent the premature release of LH, which may cause premature ovulation.

In clinical studies, Orgalutran was used with recombinant follicle-stimulating hormone (FSH) or withcorifolitropin alfa,a prolonged-acting follicular stimulant.

Do not use Orgalutran

• if you are allergic to ganirelix or any of the other components of this medication (listed in section6);
• if you are hypersensitive to the hormone-releasing hormone (GnRH) or its analogs;
• if you have a moderate or severe kidney or liver disease;
• if you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Orgalutran

Allergic reactions

If you have an active allergy, inform your doctor. Your doctor will decide, depending on the severity, if additional controls are needed during treatment. Cases of allergic reactions, even after the first dose, have been observed.

Allergic reactions, both general and local, have been reported, including hives (urticaria),swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing and/or swallowing (angioedema and/oranaphylaxis) (See also section4). If you have an allergic reaction, stop using Orgalutran and seek medical assistance immediately.

Ovarian Hyperstimulation Syndrome (OHSS)

During or after ovarian stimulation, the ovarian hyperstimulation syndrome may develop. This syndrome is related to the gonadotropin stimulation procedure. We recommend that you read the prospectus of the gonadotropin medication that you have been prescribed.

Multiple births or birth defects

The incidence of congenital malformations after the use of assisted reproduction techniques may be slightly higher than after spontaneous conceptions. This slightly higher incidence is considered to be related to the characteristics of patients undergoing fertility treatments (e.g., age of the woman, semen characteristics) and the higher incidence of multiple pregnancies registered after the use of assisted reproduction techniques with Orgalutran. The incidence of congenital malformations after the use of Orgalutran in assisted reproduction techniques is not different from the incidence with the use of other GnRH analogs in assisted reproduction techniques.

Pregnancy complications

There is a slight increase in the risk of anectopic pregnancyin women with damaged fallopian tubes.

Women weighing less than 50kg or more than 90kg

The efficacy and safety of Orgalutran have not been established in women weighing less than 50kg or more than 90kg. Consult your doctor for more information.

Children and adolescents

The use of Orgalutran is not appropriate in children or adolescents.

Use of Orgalutran with other medications

Inform your doctor or pharmacist if you are using, have used recently, ormayhave to use any other medication.

Pregnancy, breastfeeding, and fertility

Orgalutran should be used during controlled ovarian stimulation for assisted reproduction techniques (ART). Do not use Orgalutran during pregnancy and breastfeeding.

Consult your doctor or pharmacist before using this medication.

Driving and operating machinery

The effects on the ability to drive and operate machinery have not been studied.

Orgalutran contains sodium

This medicationcontains less than 23mg of sodium (1mmol) per injection; this is, essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Orgalutran is used as part of the treatment in assisted reproduction techniques (ART), including in vitro fertilization (IVF).

Ovarian stimulation with follicle-stimulating hormone (FSH) or with corifolitropin may start on the second or third day of your menstruation. Orgalutran (0.25 mg) must be injected once a day just under the skin, starting on the fifth or sixth day of stimulation. According to your ovarian response, your doctor may decide to start on another day.

Orgalutran and FSH preparations should not be mixed, even though they should be administered approximately at the same time, injected in different locations.

Daily treatment with Orgalutran should continue until there are sufficient follicles of adequate size. The final maturation of the oocytes in the follicles may be induced by administering human chorionic gonadotropin (hCG). The time elapsed between two injections of Orgalutran and between the last injection of Orgalutran and the hCG injection should not exceed 30 hours, otherwise, premature ovulation (i.e., release of the oocytes) may occur. Therefore, if the Orgalutran injection is in the morning, Orgalutran treatment should be maintained throughout the gonadotropin treatment period, including the day when ovulation is induced.If the Orgalutran injection is in the afternoon, the last Orgalutran injection should be administered the evening before the day when ovulation is induced.

Instructions for use

Injection site

Orgalutran is presented in pre-filled syringes and should be injected slowly just under the skin, preferably in the thigh. Check the solution before use. Do not use the solution if it contains particles or is not transparent. You may notice air bubbles in the pre-filled syringe. This is expected and does not need to be removed. If you administer the injections yourself or your partner, follow the instructions below carefully. Do not mix Orgalutran with other medications.

Preparation of the injection site

Wash your hands thoroughly with water and soap. The injection site should be cleaned with a disinfectant (e.g., alcohol) to eliminate bacteria from the surface. Clean a 5 cm area around the point where you will be pinched and let the disinfectant dry for at least one minute before injecting.

Insertion of the needle

Remove the needle protector. Pinch a large area of skin between your index and middle fingers. Insert the needle into the base of the area where you have pinched the skin at an angle of 45° with respect to the skin surface. The injection site should be varied for each injection.

Verification of the correct needle position

Withdraw the plunger gently to check if the needle is in the correct position. If blood enters the syringe, it means that the needle tip has penetrated a blood vessel. If this occurs, do not inject Orgalutran, but rather remove the syringe, cover the injection site with a disinfectant pad, and press; it should stop bleeding within one or two minutes. Do not use this syringe and dispose of it properly. Start again with a new syringe.

Injection of the solution

Once the needle is correctly positioned, press the plunger slowly and constantly to inject the solution correctly and avoid damaging the skin tissues.

Removal of the syringe

Withdraw the syringe quickly and press the injection site with a disinfectant pad.

Use the pre-filled syringe only once.

If you use more Orgalutran than you should

Consult your doctor.

If you forget to use Orgalutran

If you realize you have forgotten to inject a dose, administer it as soon as possible.

Do not administer a double dose to compensate for the missed doses.

If you delay more than 6 hours (thus prolonging the interval between two injections by more than 30 hours), administer the dose as soon as possible and consult your doctor for advice.

If you interrupt the treatment with Orgalutran

Do not stop using Orgalutran unless your doctor advises you to, as this may affect the outcome of your treatment.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications,this medicationcanproduceadverse effects,although not all people will experience them.

The possibility of experiencing an adverse effect is classified into the following categories:

Very Common: can affect more than 1 in 10 women

• Local skin reactions at the injection site (mainly redness, with or without swelling). The local reaction usually disappears within 4hours after administration.

Uncommon: can affect up to 1 in 100 women

• Headache
• Nausea
• Discomfort

Very Rare: can affect up to 1 in 10,000 women

• Severe allergic reactions have been observed, even after the first dose.

• Rash
• Facial swelling
• Difficulty breathing (dyspnea)
• Swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing and/or swallowing (angioedema and/or anaphylaxis)
• Hives (urticaria)

• After the first dose of Orgalutran, worsening of an existing eczema has been reported in a patient.

Additionally, adverse effects related to controlled ovarian hyperstimulation treatment (such as abdominal pain, ovarian hyperstimulation syndrome (OHSS), ectopic pregnancy(when the embryo develops outside the uterus)and miscarriage (see the prospectus of the FSH medication you are using)).

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is apossibleadverse effect not listed in this prospectus.You can also report them directlythrough thenational notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after ‘CAD’. The expiration date is the last day of the month indicated.

Do not freeze.

Store in the original packaging, to protect it from light.

Inspect the syringe before use. The syringe should only be used if the solution is transparent and particle-free and the container is not damaged.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Orgalutran

- The active principle is ganirelix (0.25 mg in 0.5 ml of solution).

- The other components are acetic acid, mannitol, water for injectable preparations. The pH (acidity measurement) may have been adjusted with sodium hydroxide and acetic acid.

Aspect of the product and contents of the package

Orgalutran is a transparent and colorless injectable aqueous solution. The solution is ready to use, administered subcutaneously.

Orgalutran is presented in 1 or 5 preloaded syringes.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing and responsible for manufacturing

Holder of the marketing authorization

N.V. Organon

Kloosterstraat 6

5349 AB Oss

Netherlands

Responsible for manufacturing

N.V. Organon,

Kloosterstraat 6,

Postbus 20,

5340 BH Oss,

Netherlands.

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last date of revision of this leaflet: {mes AAAA}

The detailed information about this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.