BELKYRA 10 mg/ml solution for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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 BELKYRA is and what it is used for
2. What you need to know before you use BELKYRA
3. How to use BELKYRA
4. Possible side effects
5. How to store BELKYRA
6. Contents of the pack and other information

• if you are allergic to deoxycholic acid or any of the other ingredients of this medicine (listed in section 6).
• if you have an infection in your chin or neck area where the product will be injected.

Talk to your doctor, pharmacist or nurse before using Belkyra. Your doctor or nurse will check how well you are before each treatment. Make sure you tell your doctor or nurse about any illness you have before each treatment.

Your doctor or nurse will pay particular attention to the area around your neck because caution is necessary in the case of any diseases or previous surgery (e.g. scarring, liposuction, difficulty swallowing, enlargement of the thyroid gland or lymph glands).

• Temporary nerve injury in the jaw, leading to an uneven smile or facial muscle weakness, can occur.
• Tissue damage around the treatment area (i.e., skin erosion, ulceration, necrosis) can occur. This can result in scarring. If ulceration or necrosis occur, you should never be given treatment with Belkyra again (see section 4).
• Infection around the treatment area can occur and may require additional medical treatment. If redness or pain develops, talk to your doctor, pharmacist, or nurse.

Belkyra should not be used if you are obese or if you are suffering from body dysmorphic disorder (distorted view of how you look).

This medicine is not indicated for use in children and adolescents.

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

The effects of this medicine in pregnant and breast-feeding women are not known. As a precaution the use of Belkyra during pregnancy is not recommended.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.

Belkyra is not expected to affect your ability to drive a car or operate machinery.

This medicine contains 4.23 mg sodium (main component of cooking/table salt) in each mL. This is equivalent to 0.2% of the recommended maximum daily dietary intake of sodium for an adult.

Belkyra will be given by a doctor, (or if national guidance permits, a healthcare professional under the supervision of a doctor), directly underneath the skin (‘subcutaneous use’). Belkyra will be injected in small amounts in several locations in your treatment area, that is the fat tissue directly below the skin in the area under your chin.

Your doctor or nurse may take some measures for the relief of pain before and after the injection.

A doctor will decide how much Belkyra will be administered.

You will receive multiple injections per treatment session. The total number of injections and treatment sessions needed to achieve a satisfactory response depends upon your individual needs and will be decided by the doctor. Treatment can be repeated multiple times but should not exceed 6 treatment sessions; 2 to 4 treatment sessions are usually sufficient. The time between each treatment session should be at least 4 weeks.

If more Belkyra is given to you than recommended, this can lead to a possible increase of local side effects (see section 4). If this does happen, talk to your doctor or nurse.

Additional information regarding the use and handling by the medical or healthcare professional is given at the end of this leaflet.

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

UK

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 deoxycholic acid.
  1 ml of solution for injection (injection) contains 10 mg deoxycholic acid. 1 vial with 2 ml contains 20 mg deoxycholic acid.
• The other ingredients are water for injection, sodium chloride, sodium hydroxide (for dissolution and pH adjustment), hydrochloric acid (for pH adjustment) and disodium phosphate anhydrous.

Belkyra is a clear, colourless and sterile solution for injection.

Pack size:

One carton with 4 vials (Type I glass with a chlorobutyl rubber stopper, aluminium seal and polypropylene flip-top lid).

Each vial contains 2 ml solution for injection.