CEZIBOE

Package leaflet: Information for the user

Cetrorelix SUN 0.25 mg solution for injection in pre-filled syringe
cetrorelix (as acetate)
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Cetrorelix SUN is and what it is used for

What Cetrorelix SUN is
Cetrorelix SUN contains an active substance called "cetrorelix acetate". This medicine inhibits the release of an oocyte from the ovary (ovulation) during the menstrual cycle. Cetrorelix SUN belongs to a group of medicines known as "gonadotropin-releasing hormone antagonists".

What Cetrorelix SUN is used for
Cetrorelix SUN is one of the medicines used during "assisted reproductive techniques" to help achieve pregnancy. It prevents the premature release of oocytes. If oocytes are released too early (premature ovulation), the doctor cannot retrieve them.

How Cetrorelix SUN works
Cetrorelix SUN blocks a natural hormone in the body called LHRH ("luteinizing hormone-releasing hormone").

• LHRH controls another hormone called LH ("luteinizing hormone").
• LH stimulates ovulation during the menstrual cycle. Therefore, Cetrorelix SUN blocks the chain of events leading to the release of the oocyte from the ovary. When the oocytes are ready to be retrieved, you will be given another medicine to trigger their release (ovulation induction).

2. What you need to know before using Cetrorelix SUN

Do not use Cetrorelix SUN:

• if you are allergic to cetrorelix (as acetate) or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to medicines similar to Cetrorelix SUN (any other peptide hormone);
• if you are pregnant or breastfeeding;
• if you have severe kidney disease.

Do not use Cetrorelix SUN if any of the above apply to you. If you have any doubts, consult your doctor before using this medicine.
Warnings and precautions
Allergies
If you currently have an allergy or have had allergies in the past, inform your doctor before taking Cetrorelix SUN.
Ovarian Hyperstimulation Syndrome (OHSS)
Cetrorelix SUN is used together with other medicines that stimulate the ovaries to produce a greater number of oocytes ready for release. During or after taking these medicines, Ovarian Hyperstimulation Syndrome (OHSS) may occur. This happens when follicles develop excessively, becoming large cysts.
For possible side effects to monitor and what to do if they occur, see section 4 “Possible side effects”.
Use of Cetrorelix SUN for more than one cycle
Experience with the use of Cetrorelix SUN for more than one cycle is limited. If you need to use Cetrorelix SUN for more than one cycle, your doctor will carefully evaluate the benefits and risks.
Liver disease
Inform your doctor before using Cetrorelix SUN if you have liver disease. Cetrorelix SUN has not been studied in patients with liver disease.
Kidney disease
Inform your doctor before using Cetrorelix SUN if you have kidney disease. Cetrorelix SUN has not been studied in patients with kidney disease.
Children and adolescents
Cetrorelix SUN is not indicated for use in children and adolescents.
Other medicines and Cetrorelix SUN
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Do not use Cetrorelix SUN if you are pregnant, suspect you may be pregnant, or are breastfeeding.
Driving and using machines
Cetrorelix SUN is not expected to affect your ability to drive or operate machinery.
For individuals involved in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to use Cetrorelix SUN

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.

How to use this medicine
This medicine is intended only for abdominal injection just beneath the skin surface (subcutaneous). To avoid skin irritation, select a different abdominal area each day.

• The first administration must be performed under the supervision of your doctor. Your doctor or nurse will show you how to prepare and inject the medicine.
• You may carry out subsequent administrations yourself, once your doctor has informed you about symptoms indicating possible allergic reactions and other serious or life-threatening side effects requiring immediate treatment (see section 4 "Possible side effects").
• Read carefully and follow the instructions described in the section at the end of this leaflet entitled “How to inject Cetrorelix SUN”.
• Day 1 of the treatment cycle will begin with the use of another medicine. You will start using Cetrorelix SUN a few days later. (See section “How much medicine to use”.)

How much medicine to use
Inject the contents of one syringe (0.25 mg/ml of Cetrorelix SUN) once daily. It is recommended to take the medicine at the same time each day, with an interval of 24 hours between doses. You may choose to administer the injection each morning or each evening.

• If you choose morning administration: start injections on day 5 or 6 of the treatment cycle. Depending on ovarian response, your doctor may decide to start on a different day. Your doctor will inform you of the exact date and time. Continue using this medicine until the morning of oocyte retrieval (ovulation induction). OR
• If you have chosen evening administration: start injections on day 5 of the treatment cycle. Depending on ovarian response, your doctor may decide to start on a different day. Your doctor will inform you of the exact date and time. Continue using this medicine until the evening before oocyte retrieval (ovulation induction).

If you use more Cetrorelix SUN than you should
No negative effects are expected if you accidentally inject a higher dose than intended. The effect of the medicine will simply last longer. Therefore, specific corrective measures are generally not required.

If you forget to use Cetrorelix SUN

• If you forget a dose, inject it as soon as you remember and contact your doctor.
• Do not inject a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Allergic reactions

• Warmth, skin redness, itching (often in the groin or armpits), red, itchy, raised areas (urticaria), runny nose, rapid or irregular heartbeat, swelling of the tongue and throat, sneezing, wheezing or severe breathing difficulties, or dizziness. You may be experiencing a severe or life-threatening allergic reaction to this medicine. This reaction is not common (it may affect up to 1 in 100 women).

If you notice any of these side effects, stop using Cetrorelix SUN and inform your doctor immediately.

Ovarian Hyperstimulation Syndrome (OHSS)

This may occur due to other medicines you are using to stimulate the ovaries.

• Symptoms of OHSS may include lower abdominal pain with a feeling of illness (nausea) or actual illness (vomiting). This may indicate that the ovaries have over-responded to treatment and large ovarian cysts have developed. This event is common (it may affect up to 1 in 10 women).
• OHSS may become severe, with markedly enlarged ovaries, reduced urine output, weight gain, difficulty breathing, or fluid accumulation in the abdomen or chest. This event is not common (it may affect up to 1 in 100 women). If you notice any of these side effects, inform your doctor immediately.

Other side effects

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

• Mild and short-lived skin irritation at the injection site, such as redness, itching, or swelling.

Not common (may affect up to 1 in 100 women):

• Feeling unwell (nausea)
• Headache.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cetrorelix SUN

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 syringe after "Exp". The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
The unopened product may be stored in its original packaging at room temperature (not above 25°C) for up to three months.
Do not use the medicine if the solution in the syringe is not clear and colourless or if it contains particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Cetrorelix SUN contains

• The active substance is cetrorelix (as acetate). Each pre-filled syringe (1 ml) contains 0.25 mg of cetrorelix (as acetate).
• The other components are: mannitol (E421), s-lactic acid and water for injections.

Description of the appearance of Cetrorelix SUN and contents of the pack
Cetrorelix SUN is a clear, colourless solution in a 1 ml transparent type I glass cartridge,
fitted with a 27 G x ½ inch needle and closed with a bromobutyl rubber plunger stopper. The pre-filled
syringe has a white plunger and an automatic safety system.
It is available in packs of 1 or 7 pre-filled syringes.
For each syringe, the pack contains:

• one assembled pre-filled syringe with a safety device containing the solution
• one alcohol-impregnated swab for cleaning.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Local representative in Italy:
Sun Pharma Italia Srl – Viale Giulio Richard, 1 – 20143 Milano
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
S.C. Terapia S.A.
124 Fabricii Street
400632, Cluj-Napoca
Cluj County
Romania

This medicinal product is authorized in the European Economic Area countries under the
following names:
Belgium Cetrorelix SUN
Czech Republic Cetrorelix SUN
Germany Cetrorelix SUN
Greece Cetrorelix SUN
France Cétrorélix SUN
Hungary Cetrorelix SUN
Ireland Cetrorelix SUN
Italy Cetrorelix SUN
The Netherlands Cetrorelix SUN
Spain Cetrorelix SUN
United Kingdom Cetrorelix SUN

HOW TO INJECT CETRORELIX SUN
The components of the Cetrorelix SUN pre-filled syringe are:

1. Needle guard
2. Plunger
3. Finger grip
4. Safety shield

Syringe before use:

Syringe after use:

This section explains how to inject the medicine.

• Before starting to use this medicine, read these instructions completely.
• This medicine is for your use only – do not allow anyone else to use it.
• Use each needle and syringe only once.

Before you start

1. This product should be at room temperature before injection. Remove it from the refrigerator approximately 30 minutes before use.
2. Wash your hands. It is important that your hands and the items you use are as clean as possible.
3. Prepare all the items you need on a clean surface:
   • one pre-filled syringe
   • one alcohol-impregnated swab.

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. It is best around the navel (Figure A). To reduce skin irritation, select a different area of the abdomen each day. Clean the injection site with an alcohol-impregnated swab.
   • Remove the needle cap by pulling it off the syringe (Figure B). Discard the needle cap. To prevent infection, do not touch the needle or let it come into contact with any surface before injection. A small air bubble in the syringe is normal. To ensure you do not lose any medicine, do not attempt to remove air bubbles from the syringe before injecting.

Figure A Figure B

2. Gently pinch the cleaned skin to form a skin fold. Hold the skin fold between your thumb and index finger throughout the injection (Figure C).

Figure C

3. Hold the syringe in one hand, as if holding a pencil. Gently pinch the skin around the injection site and hold it firmly with the other hand. Insert the needle completely into the skin at an angle of approximately 45–90 degrees, then release the skin.

Figure D

4. Gently pull back on the syringe plunger. If blood appears, follow step 5 below. If no blood appears, slowly push the plunger to inject the medicine. Inject all the medicine by gently pressing the plunger fully down (Figure E). Caution: Do not press forcefully, as this will activate the needle safety shield – see step 6. When the syringe is empty, slowly withdraw the needle at the same angle, keeping your finger on the plunger. Use the alcohol swab to gently press on the injection site.

Figure E

5. If blood appears

Slowly withdraw the needle at the same angle. Use the alcohol swab to
gently apply pressure at the site where the skin was punctured. Empty the medicine into
a sink and proceed to step 6 below. Wash your hands and start again with a new
pre-filled syringe (Figure F).

Figure F

6. Point the needle away from yourself and others and activate the safety shield by firmly pushing the plunger. The protective sheath will automatically cover the needle and you will hear an audible "click" to confirm activation of the safety feature. (Figure G)

Figure G
Follow the instructions provided by your nurse or doctor on the proper way to dispose of used syringes and needles. There may be national regulations regarding the correct disposal of syringes, needles, and used containers.
NOTE:

• The safety mechanism can only be activated after the syringe has been emptied.
• The safety mechanism must only be activated after removing the needle from the patient's skin.
• Do not remove the needle cap after injection.
• The safety mechanism must not be sterilized.
• Activation of the safety mechanism may cause minimal fluid splashing. For optimal safety, activate the mechanism with the syringe pointed downward and away from yourself and others.