Prospect: information for the user

Ceziboe 0.25 mg injectable solution in preloaded syringe

cetrorelix (as acetate)

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Ceziboe and how it is used

2. What you need to know before starting to use Ceziboe

3. How to use Ceziboe

4. Possible adverse effects

5. Storage of Ceziboe

6. Contents of the package and additional information

What is Ceziboe

Ceziboe contains a substance called “cetrorelix acetate”.This substance prevents your body from releasing an egg from the ovary (ovulation) during your menstrual cycle.Ceziboe belongs to a group of medications known as “gonadotropin-releasing hormone antagonists”.

What is Ceziboe used for

Ceziboe is one of the medications used during “assisted reproductive techniques” to help you get pregnant.It acts by immediately stopping the release of eggs. This is because if the eggs are released too early (premature ovulation), it may be possible that your doctor will not be able to collect them.

How Ceziboe works

Ceziboe blocks a natural hormone in your body, called LHRH (“luteinizing hormone-releasing hormone”).

• LHRH controls another hormone, called LH (“luteinizing hormone”).
• LH stimulates ovulation during the menstrual cycle.

This means that Ceziboe stops the chain of events that leads to the release of an egg from the ovary.When your eggs are ready for collection, you will be given another medication that will release them (ovulation induction).

DO NOT use Ceziboe

• If you are allergic to cetrorelix (as acetate) or to any of the other components of this medication (listed in section 6).
• If you are allergic to similar medications to Ceziboe (any other peptide hormone).
• If you are pregnant or breastfeeding.
• If you have severe kidney disease.

Do not use Ceziboe if any of the above conditions apply to you.In case of doubt, consult your doctor before starting to use this medication.

Warnings and precautions

Allergies

Consult your doctor before starting to use Ceziboe if you have an active allergy or have had allergies in the past.

Ovarian Hyperstimulation Syndrome (OHSS)

Ceziboe is used together with other medications that stimulate your ovaries to develop more eggs ready to be released.During or after receiving these medications, you may experience OHSS. This situation occurs when your follicles develop too much and become large cysts.

To know the possible signs to be aware of and what to do if they occur, see section 4 “Possible side effects”.

Use of Ceziboe for more than one cycle

The experience of using Ceziboe for more than one cycle is limited. Your doctor will carefully evaluate the benefits and risks for you if you need to use Ceziboe for more than one cycle.

Liver disease

Inform your doctor before starting to use Ceziboe if you have any liver disease. Ceziboe has not been studied in patients with liver disease.

Kidney disease

Inform your doctor before starting to use Ceziboe if you have any kidney disease. Ceziboe has not been studied in patients with kidney disease.

Children and adolescents

Ceziboe is not indicated for use in children and adolescents.

Other medications and Ceziboe

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

Pregnancy and breastfeeding

Do not use Ceziboe if you are pregnant, think you may be pregnant, or are breastfeeding.

Driving and operating machines

Ceziboe is not expected to affect your ability to drive and operate machines.

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

Use of this medication

This medication is exclusively intended to be injected just below the skin of your abdomen (subcutaneous route).To reduce skin irritation, select a different part of your abdomen each day.

• Your doctor must supervise the first injection. Your doctor or nurse will teach you how to prepare and inject the medication.
• You can administer the following injections yourself, provided your doctor has informed you of the symptoms that may indicate an allergy and of the possible severe or potentially life-threatening consequences that require immediate treatment (see section 4 “Possible side effects”).
• Read and carefully follow the instructions gathered at the end of this leaflet, titled “How to inject Ceziboe”.
• You will begin using another medication on day 1 of your treatment cycle.Then, you will begin using Ceziboe a few days later.(See the next section “How much to use”).

How much to use

Inject the contents of a syringe (0.25 mg of Ceziboe) once a day.It is best to use the medication at the same time each day, leaving 24 hours between each dose.

You can choose to administer the injection either in the morningorat night.

• If you administer the injection in the morning: Start your injections on the fifth or sixth day of the treatment cycle. Depending on your ovarian response, your doctor may decide to start treatment on a different day. Your doctor will indicate the exact date and time. You will continue using this medication until the morning when your eggs are collected, including that morning (ovulation induction).

OR

• If you administer the injection at night: Start your injections on the fifth day of the treatment cycle. Depending on your ovarian response, your doctor may decide to start treatment on a different day. Your doctor will indicate the exact date and time. You will continue using this medication until the night before egg collection, including that night (ovulation induction).

If you use more Ceziboe than you should

No adverse effects are expected if you accidentally inject more medication than you should.The effect of the medication will be more prolonged. In general, no specific measures are necessary.

In case of overdose or accidental ingestion, contact your doctor or call the Toxicological Information Service phone number, 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Ceziboe

• If you forget a dose, inject it as soon as you remember and consult your doctor.
• Do not inject a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Allergic Reactions

• Redness and warmth of the skin, itching (often in the groin or armpits), red, swollen, and itchy areas (urticaria), runny nose, rapid or irregular heartbeat, swelling of the tongue and throat, sneezing, high-pitched sounds during breathing (sibilance), severe difficulty breathing or dizziness. You may be experiencing a possible severe, potentially life-threatening allergic reaction to the medication. This is rare (may affect up to 1 in 100 women).

If you observe any of the previously described adverse effects, discontinue use of Ceziboe and consult your doctor immediately.

Ovarian Hyperstimulation Syndrome (OHSS)

It may occur due to other medications you are using to stimulate your ovaries.

• Lower abdominal pain, along with nausea or vomiting, may be symptoms of OHSS. This may indicate that your ovaries have overreacted to treatment and large ovarian cysts have developed.This effect is frequent (may affect up to 1 in 10 women).
• OHSS can become severe, presenting enlarged ovaries, decreased urine production, weight gain, difficulty breathing, or fluid accumulation in the stomach or chest. This effect is rare (may affect up to 1 in 100 women).

If you observe any of the previously described adverse effects, consult your doctor immediately.

Other Adverse Effects

Frequent (may affect up to 1 in 10 women):

• Mild and short-lasting skin reactions at the injection site, such as redness, itching, or swelling, may occur.

Rare (may affect up to 1 in 100 women):

• Nausea.
• Headache.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on 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 syringe after CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C).

The unopened product can be stored in the original packaging at room temperature (not above 25°C) for a maximum of three months.

Do not use this medication if you observe that the solution in the syringe is not transparent and colorless or contains particles.

Medicines should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Ceziboe

• The active principle is cetrorelix (as acetate). Each pre-filled syringe (1 ml) contains 0.25 mg of cetrorelix (in the form of acetate).
• The other components are mannitol (E421), l-sodium lactate and water for injection.

Appearance of the product and contents of the pack

Ceziboe is a transparent, colourless solution in a type I glass syringe (1 ml), fixed to a 27G 12 mm needle, sealed with a bromobutyl elastomeric stopper.The pre-filled syringe has a white plunger and an automatic safety system.

It is presented in a pack of 1 pre-filled syringe and in multiple packs that include 7 carton boxes, each containing a pre-filled syringe.

For each syringe, the pack also contains:

• a pre-filled syringe with a safety device containing the solution
• a swab soaked in alcohol for cleaning.

Only some pack sizes may be marketed.

Marketing authorisation holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Responsible for manufacturing

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

S.C. Terapia S.A.

124 Fabricii Street

400632, Cluj-Napoca

Cluj County

Romania

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Sun Pharma Laboratorios, S.L

Rambla de Catalunya, 53-55

08007- Barcelona

Spain

Phone: +34 93 342 78 90

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

BelgiumCeziboe

Czech RepublicCeziboe

GermanyCeziboe

GreeceCeziboe

FranceCeziboe

HungaryCeziboe

IrelandCeziboe

ItalyCeziboe

NetherlandsCeziboe

SpainCeziboe

United KingdomCeziboe

Last update of the summary of product characteristics: November 2020

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices:http://www.aemps.gob.es

HOW TO INJECT CEZIBOE

The different parts of the Ceziboe pre-filled syringe are

1.Needle cap

2.Plunger

3.Thumb grip for finger support

4.Safety Protector

Pre-filled syringe before use:

Pre-filled syringe after use:

This section explains how to inject your medicine.

• Before starting to use this medicine, read these instructions carefully.
• This medicine is for you only; do not let anyone else use it.
• Use each needle and syringe only once.

Before starting

1. This medicine must be at room temperature before injection. Remove it from the refrigerator about 30 minutes before use.

1. Wash your hands.

It is important that your hands and the objects you use are as clean as possible.

3.Place everything you need on a clean surface:

Preparing the injection site and injecting the medicine

1. Clean the injection site
   • Sit or lie down in a comfortable position. Choose an injection site on your abdomen. The best place is around your navel (Figure A).

To reduce skin irritation, choose a different part of your abdomen each day. Clean the injection site with a swab soaked in alcohol

Figure AFigure B

1. Pinch the cleaned skin gently to form a fold. Hold the fold between your thumb and index finger of one hand throughout the injection (Figure C).

Figure C

1. Hold the syringe with one hand, as if it were a pencil.

Pinch the skin around the injection site gently and hold it firmly with the other hand.

Push the needle slowly all the way into your skin at an angle of about 45 to 90 degrees, then release your skin.

Figure D

1. Pull the plunger of the syringe slowly. If blood appears, continue as indicated in step 5. If no blood appears, push the plungerslowlyto inject the medicine. Inject all the medicine contained in the syringe by pressinggentlythe plunger until it reaches the end (Figure E).Warning: Do not press firmly, as this will activate the safety protector of the needle, see step 6.

When the syringe is empty, remove the needle slowly with the same angle, keeping your finger on the plunger. Use your swab soaked in alcohol to apply gentle pressure where you have just injected.

Figure E

5. If blood appears:

Withdraw the needle slowly with the same angle. Use the swab soaked in alcohol to apply gentle pressure to the skin puncture site. Empty the medicine into a sink and continue as indicated in step 6 below. Wash your hands and start again with a new pre-filled syringe (Figure F).

Figure F

6. Orient the needle away from you and others, and activate the safety protector by pressing the plunger firmly. The protective cover will automatically cover the needle and you will hear an audible "click" to confirm the activation of the safety protector. (Figure G).

Figure G

Follow the instructions given by your nurse or doctor on how to dispose of used needles and syringes. There may be national laws on the correct way to dispose of used needles, syringes and disposal containers.

NOTE: