Omlyclo contains the active substance omalizumab. Omalizumab is a man-made protein, similar to natural proteins produced by the body. It belongs to a class of medicines called monoclonal antibodies.

Omlyclo is used to treat:
- allergic bronchial asthma
- chronic rhinosinusitis (inflammation of the nose and sinuses) with nasal polyposis
- chronic spontaneous urticaria (CSU)

Allergic asthma:
This medicine is used to prevent asthma from getting worse by controlling the symptoms of severe allergic asthma in adults, adolescents and children (aged 6 years and over) who are already receiving medicines to treat asthma, but whose asthma symptoms are not well controlled by medicines such as high-dose inhaled corticosteroids and
inhaled beta agonists.

Chronic rhinosinusitis with nasal polyposis:
This medicine is used to treat chronic rhinosinusitis with nasal polyps in adults (aged 18 years and over) who are already taking intranasal corticosteroids (corticosteroid nasal sprays) but whose symptoms are not well controlled with these medicines. Nasal polyps are small growths on the lining of the nose. Omlyclo helps to
reducing the size of polyps and relieving symptoms, including nasal congestion, loss of smell, mucus in the back of the throat, and nasal discharge.

Chronic spontaneous urticaria (CSU):
This medicine is used to treat chronic spontaneous urticaria in adults and adolescents (12 years of age and older) who are already taking antihistamines but whose associated symptoms are not well controlled with these medicines.
Omlyclo works by blocking a substance called immunoglobulin E (IgE), which is produced by the body. IgE contributes to a type of inflammation that plays a key role in the development of allergic asthma, chronic rhinosinusitis with nasal polyposis, and CUS.

Do not use Omlyclo:
- if you are allergic to omalizumab or any of the other ingredients of this medicine.

Before using Omlyclo, consult your doctor.

Pregnancy and breastfeeding:
If you are pregnant, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine. Your doctor will discuss with you the potential benefits and risks of using this medicine during pregnancy.

If you become pregnant while taking Omlyclo, tell your doctor immediately.

Omlyclo may pass into breast milk. If you are breast-feeding or planning to breast-feed, ask your doctor for advice before taking this medicine.

Driving and using machines:
Omlyclo is unlikely to affect your ability to drive or use machines. Omlyclo contains polysorbate

Each pre-filled syringe of Omlyclo 150 mg contains 0.40 mg of polysorbate 20, and each pre-filled syringe of Omlyco 300 mg contains 0.80 mg of polysorbate 20, which is equivalent to 0.40 mg/ml.
Polysorbates may cause allergic reactions. Ask your doctor if you or your child have any known allergies.

Always use this medicine exactly as your doctor has told you. Talk to your doctor or pharmacist if you are not sure.

How to use Omlyclo:
Omlyclo is used as an injection under the skin (known as a subcutaneous injection).

Omlyclo injection
- You and your doctor will decide whether you should inject Omlyclo yourself. The first 3 doses are always given by or under the supervision of a healthcare professional (see section 2).
- It is important that you are properly trained on how to inject the medicine before giving yourself the injection.
- A caregiver (for example, a parent) can give you the Omlyclo injection after being properly trained.
For detailed instructions on how to inject Omlyclo, see “Instructions for use of Omlyclo pre-filled syringe” at the end of this leaflet.

Training to recognize serious adverse reactions:
It is also important not to inject Omlyclo yourself before being instructed by your doctor or nurse about:
- how to recognize the first signs and symptoms of serious allergic reactions.
- what to do if such symptoms occur.

For more information about the early signs and symptoms of serious allergic reactions, see section.

How much to use:
Allergic asthma and chronic rhinosinusitis with nasal polyposis
Your doctor will decide how much Omlyclo you need and how often you will need it. This depends on your body weight and the results of a blood test carried out before starting treatment to determine the amount of IgE in your blood.

You will need 1-4 injections at a time. You will need to give the injections either every two weeks or every four weeks.

Continue taking your current asthma and/or nasal polyposis medication while taking Omlyclo. Do not stop taking any asthma and/or nasal polyposis medications without talking to your doctor.

You may not notice an immediate improvement after starting treatment with Omlyclo. In patients with nasal polyposis, effects were seen 4 weeks after starting treatment. In patients with asthma, it usually takes 12 to 16 weeks to achieve the maximum effect.

Chronic spontaneous urticaria (CSU):
You will need two 150 mg injections at the same time or one 300 mg injection every four weeks.

Continue taking your current medication for your UTI while taking Omlyclo. Do not stop taking any medication without first talking to your doctor.

Use in children and adolescents:
Allergic asthma
Omlyclo can be used in children and adolescents aged 6 years and over who are already taking asthma medicines but whose asthma symptoms are not well controlled by medicines such as high-dose steroid inhalers and beta-agonist inhalers. Your doctor will decide how much Omlyclo your child needs and how often it should be given. This will depend on your child's weight and the results of blood tests carried out before starting treatment to determine the amount of IgE in your child's blood.

Children (aged 6 to 11 years) should not self-administer Omlyclo. However, if their doctor considers it appropriate, a caregiver may administer the Omlyclo injection to them after being properly trained.
Omlyclo 300 mg pre-filled syringe is not intended for use in children under 12 years of age.
Omlyclo 75 mg pre-filled syringe and Omlyclo 150 mg pre-filled syringe can be used in children aged 6 to 11 years who suffer from allergic asthma.

Chronic rhinosinusitis with nasal polyposis:
Omlyclo should not be administered to children and adolescents under 18 years of age.

Chronic spontaneous urticaria (CSU):
Omlyclo can be used in adolescents aged 12 years and over who are already taking antihistamines but whose symptoms associated with USC are not well controlled by these medicines. The dose for adolescents aged 12 years and over is the same as for adults.

- The active substance is omalizumab. One syringe with 0.5 ml solution contains 75 mg of omalizumab.
- The other ingredients are L-arginine hydrochloride, L-histidine hydrochloride monohydrate, L-histidine, polysorbate 20 (E 432) and water for injections.

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

1 pre-filled syringe