Active ingredient
- deoxycholic acid
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 41042/0055.
BELKYRA 10 mg/ml solution for injection
Package leaflet: Information for the user
BELKYRA 10 mg/ml solution for injection
deoxycholic acid
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
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
1. What BELKYRA is and what it is used for
Belkyra contains the active substance deoxycholic acid. Deoxycholic acid is produced naturally in your body to aid in the digestion of fats.
The medicine is used in adults for the treatment of submental fat (unwanted fat under the chin) when its presence has an important psychological impact for the patient.
Belkyra contains a non-human, non-animal version of deoxycholic acid which is identical to naturally-occuring deoxycholic acid. Belkyra is an injectable medicine given by your doctor or nurse.
2. What you need to know before you use BELKYRA
Do not use BELKYRA:
Warnings and precautions
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).
Belkyra should not be used if you are obese or if you are suffering from body dysmorphic disorder (distorted view of how you look).
Children and adolescents
This medicine is not indicated for use in children and adolescents.
Other medicines and BELKYRA
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
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.
Driving and using machines
Belkyra is not expected to affect your ability to drive a car or operate machinery.
BELKYRA contains sodium
This medicinal product contains 4.23 mg sodium per mL, to be taken into consideration by patients on a controlled sodium diet.
3. How to use BELKYRA
How BELKYRA is administered
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.
Dose
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 you have been administered more BELKYRA than you should
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 have any further questions on the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the above side effects, contact your doctor or nurse immediately.
Following is a list of the side effects, which have been observed according to the following frequencies:
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Side effects where the frequency is not known(frequency cannot be estimated from the available data):
Most of the side effects seen got better during the 4-week period between treatments. However, some of the injection site reactions may be present for a longer period.
Reporting of side effects
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
Ireland
Malta
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store BELKYRA
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 and the carton after “EXP”. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions. After opening, an immediate use of the solution for injection is recommended.
Do not use this medicine if you notice any visible particles.
6. Contents of the pack and other information
What BELKYRA contains
What BELKYRA looks like and contents of the pack
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.
Marketing Authorisation Holder
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Bulgaria, Estonia, Finland, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Spain, Sweden: BELKYRA
Czech Republic, Slovakia: BELKYRA 10 mg/ml
Norway: Belkyra
Slovenia: BELKYRA 10 mg/ml raztopina za injiciranje
This leaflet was last revised in February 2022
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