NUCLEO CMP FORTE Injectable

Introduction

Package Leaflet: Information for the Patient

Nucala 40mginjectable solution in pre-filled syringe

mepolizumab

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

• 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 the child in your care, and you should not give it to others, even if their symptoms are the same, as it may harm them.
• If the child experiences side effects, consult a doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Nucala is and what it is used for
2. What you need to know before you use Nucala
3. How to use Nucala
4. Possible side effects
5. Storage of Nucala
6. Contents of the pack and further information
7. Step-by-step instructions for use

1. What Nucala is and what it is used for

Nucala contains the active substance mepolizumab,a monoclonal antibody, a type of protein designed to recognize a specific target substance in the body. It is used to treat severe asthmain adults, adolescents, and children from 6 years of age.

Some people with severe asthma have too many eosinophils(a type of white blood cell) in their blood and lungs. This condition is called eosinophilic asthma– the type of asthma that Nucala can treat.

If the child is already using medicines such as high-dose inhalers, but their asthma is not well-controlled by these medicines, Nucala may reduce the number of asthma attacks. If the child is taking medicines called oral corticosteroids, Nucala may also help reduce the daily dose they need to control their asthma.

Mepolizumab, the active substance of Nucala, blocks a protein called interleukin-5. By blocking the action of this protein, it limits the production of eosinophils by the bone marrow and decreases the number of eosinophils in the blood and lungs.

2. What you need to know before you use Nucala

Do not use Nucala:

• if the child in your care is allergicto mepolizumab or any of the other ingredients of this medicine (listed in section 6).

• Consult your doctorif you think this applies to the child.

Warnings and precautions

Consult your doctor before starting treatment with Nucala.

Asthma worsening

Some people may experience side effects related to asthma, or their asthma may worsen during treatment with Nucala.

• Consult your doctor or nurseif the child's asthma remains uncontrolled or worsens after starting treatment with Nucala.

Allergic reactions and injection site reactions

Medicines of this type (monoclonal antibodies) can cause severe allergic reactions when injected into the body (see section 4, “Possible side effects”).

If the child has ever had a similar reaction to any injection or medicine:

• Consult your doctorbefore administering Nucala.

Parasitic infections

Nucala may weaken the child's resistance to parasitic infections. If they already have a parasitic infection, it should be treated before starting treatment with Nucala. If they live in an area where these infections are common or if they are traveling to such an area:

• Consult your doctorif you think any of these circumstances apply to the child.

Children and adolescents

This medicine is not intended for use in children under 6 years of age.

Other medicines and Nucala

Tell your doctorif the child is taking, has recently taken, or might take any other medicines.

Other asthma medicines

• Once you have started treatment with Nucala, do not suddenly stop givingthe child the medicines they were taking to prevent their asthma. These medicines (especially those called oral corticosteroids) should be stopped gradually, under the direct supervision of their doctor and depending on their response to Nucala.

Pregnancy and breastfeeding

Patients who are pregnant, think they may be pregnant, or plan to become pregnant should consult their doctorbefore using this medicine.

It is not known whether the components of Nucala can pass into breast milk. Patients who are breastfeeding should consult their doctorbefore using Nucala.

Driving and using machines

It is unlikely that the possible side effects of Nucala will affect the child's ability to drive or use machines.

Nucala contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 40 mg; i.e., it is essentially “sodium-free”.

3. How to use Nucala

Nucala is given by injection just under the skin (subcutaneous injection).

Your doctor or nurse will decide if you can inject Nucala to the child in your care. If they consider it appropriate, you will receive training to use Nucala correctly.

The recommended dosefor children from 6 to 11 years is 40 mg. It will be given as 1 injection every 4 weeks.

On the other side of the leaflet, you can find the Instructions for use of the pre-filled syringe.

If you use more Nucala than you should

Consult your doctorif you think too much Nucala has been administered.

If you miss a dose of Nucala

You should inject the next dose of Nucala as soon as you remember. If you do not realize you have missed a dose until it is time for the next dose, just inject the next dose as planned. If you are not sure what to do, ask your doctor, pharmacist, or nurse.

If you stop treatment with Nucala

Do not stop giving Nucala injections unless your doctor tells you to. Stopping or interrupting treatment with Nucala may cause the child's asthma symptoms and attacks to return.

If the child's asthma symptoms worsen while they are receiving Nucala injections:

• Tell your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects caused by Nucala are generally mild to moderate, although they can occasionally be severe.

Allergic reactions

Some people may have allergic reactions or reactions of an allergic type. These reactions can be common (may affect up to 1 in 10 people). They usually occur within minutes to hours after the injection, but sometimes the symptoms may start even several days later.

The symptoms may include:

• chest tightness, cough, difficulty breathing
• fainting, dizziness, feeling dizzy (due to a drop in blood pressure)
• swelling of the eyelids, face, lips, tongue, or mouth.
• hives
• rash

• If you think the child is having an allergic reaction, seek medical attention immediately.

If the child has ever had a similar reaction to any injection or medicine:

• Consult your doctorbefore administering Nucala to the child.

Other side effects include:

Very common:may affect more than 1 in 10 people

• headache

Common:may affect up to 1 in 10 people

• chest infection, whose symptoms may include cough and fever (high temperature)
• urinary tract infection (blood in the urine, painful and frequent urination, fever, pain in the lower back)
• upper abdominal pain (stomach pain or discomfort in the upper abdomen)
• fever (high temperature)
• eczema (red itchy patches on the skin)
• injection site reactions (pain, redness, swelling, itching, and burning at the injection site)
• back pain
• arthralgia (joint pain)
• pharyngitis (sore throat)
• nasal congestion (stuffy nose)

Uncommon:may affect up to 1 in 100 people

• herpes zoster (shingles)

Rare:may affect up to 1 in 1,000 people

• severe allergic reactions (anaphylaxis)

• If the child has any of these symptoms, consult a doctor or nurse immediately.

Reporting of side effects

If you experience any side effects, consult a doctor or nurse, even if they are side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nucala

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 label or carton after EXP. The expiry date is the last day of the month shown.

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

Do not freeze.

Keep the pre-filled syringe in the original packaging to protect it from light.

The Nucala pre-filled syringe can be removed from the refrigerator and stored in the outer packaging without opening for up to 7 days at room temperature (below 30°C) and protected from light. Discard if left out of the refrigerator for more than 7 days.

6. Container Contents and Additional Information

Nucala Composition

The active ingredient is mepolizumab.

Each 0.4 ml of the pre-filled syringe contains 40 mg of mepolizumab.

The other components are: sucrose, disodium phosphate heptahydrate, citric acid monohydrate, polysorbate 80, disodium edetate, water for injectable preparations.

Product Appearance and Container Contents

Nucala is presented in a single-use pre-filled syringe as 0.4 ml of a clear to opalescent, colorless to pale brown-yellow solution.

Nucala is available in a pack containing 1 pre-filled syringe, or in a multipack containing 3 x 1 pre-filled syringes.

Marketing Authorization Holder

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

Manufacturer

GlaxoSmithKline Manufacturing S.P.A

Strada Provinciale Asolana, No 90

43056 San Polo di Torrile, Parma

Italy

You can request more information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu

1. Step-by-Step Instructions for Using Nucala 40 mg Pre-filled Syringe

Administration once every 4 weeks.

Follow these instructions on how to use the pre-filled syringe. Failure to follow these instructions may affect the proper functioning of the pre-filled syringe. You should also receive training on how to use the pre-filled syringe. Nucala pre-filled syringe is for subcutaneous use only.

• Keep refrigerated before use.
• Do not freeze.
• Keep the pre-filled syringe in the original packaging to protect it from light.
• Keep out of sight and reach of children.
• If necessary, the pre-filled syringe can be kept at room temperature, below 30 °C, for no more than 7 days, if kept in the original packaging. Carefully discard the syringe if it is left out of the refrigerator for more than 7 days.
• Store below 30 °C.

The pre-filled syringe should be used only once and then discarded.

• Do notshare your pre-filled syringe with another person.
• Do notshake the syringe.
• Do notuse the syringe if it falls on a hard surface.
• Do notuse the syringe if it appears to be damaged.
• Do notremove the needle cap until just before injection.