• 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to galcanezumab or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor, pharmacist or nurse before or during treatment with Emgality if:

• you have a serious cardiovascular disease. Emgality has not been studied in patients with serious cardiovascular diseases.

Emgality can potentially cause serious allergic reactions. Serious allergic reactions happen mainly within 1 day after having taken Emgality, but some reactions can be delayed (happen more than 1 day to 4 weeks after having taken Emgality). Some allergic reactions can be prolonged in duration. You must look out for signs of these reactions while you are using Emgality. Stop using Emgality and tell your doctor or seek medical help immediately if you notice any signs of a serious allergic reaction. Such signs are listed under “Serious side effects” in section 4.

This medicine should not be given to children and adolescents under 18 years of age because it has not been studied in this age group.

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.

If you are a woman able to have children, you are advised to avoid becoming pregnant while using Emgality.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. It is preferable to avoid the use of Emgality in pregnancy as the effects of this medicine in pregnant women are not known.

If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine. You and your doctor should decide if you should breast feed and use Emgality.

Galcanezumab could have a minor effect on your ability to drive and use machines. Some patients have had vertigo whilst using Emgality.

This medicine contains less than 1 mmol sodium (23 mg) per 120 mg dose, that is to say essentially “sodium-free”.

If you have injected more Emgality than you should, e.g. if after the first dose of 240 mg, you have injected it twice in a single month, or if anyone else has accidentally used Emgality, contact your doctor immediately.

Do not take a double dose to make up for forgotten injection

If you have forgotten to inject a dose of Emgality, inject the missed dose as soon as possible and then inject the next dose after a month from that date.

You should not stop using Emgality without speaking to your doctor first.

Allergic reactions with Emgality are usually mild to moderate (such as rash or itching). Serious allergic reactions may occur rarely (may affect up to 1 in 1 000 people) and the signs may include:

• difficulty breathing or swallowing,
• low blood pressure, which can cause dizziness or light-headedness,
• swelling of the neck, face, mouth, lips, tongue or throat which may develop rapidly,
• severe itching of the skin, with a red rash or raised bumps.

Tell your doctor or get emergency medical help straight away if you notice any of those signs.

Very common side effects (may affect more than 1 in 10 people):

• Injection site pain
• Injection site reactions (e.g. red skin, itching, bruising, swelling)

Common side effects (may affect up to 1 in 10 people):

• Vertigo (a feeling of dizziness or “spinning”)
• Constipation
• Itching
• Rash

Uncommon side effects (may affect up to 1 in 100 people):

• Hives (raised itchy areas of skin)

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is galcanezumab. Each pre-filled pen contains 120 mg of galcanezumab in 1 mL solution.

The other ingredients are: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium chloride and water for injections.

Emgality is a solution for injection in a clear glass syringe. Its colour may vary from colourless to slightly yellow.

The syringe is encased in a disposable, single-dose pen. Pack sizes of 1, 2 or 3 pre-filled pens.

Not all pack sizes may be marketed.