What it is and what it is used for

for

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Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate and occur within the first few days following injection and are temporary. Some side effects could be very serious. If you experience any of the following side effects, tell your doctor immediately or ask your relatives to tell your doctor and go to the nearest emergency room:

Uncommon, may affect up to

Letybo® contains the active substance 1 in 100 people botulinum toxin type A. It works by blocking • drooping of the upper eyelid, eyelid spasm nerve impulses to the muscles in which it Rare, may affect up to 1 in 1000 people has been injected. It prevents muscles from contracting, leading to a temporary paralysis. • eyelid sensory disorder, drooping of the brow Letybo® is used in adults less than 75 years

• bleeding in the conjunctiva of age to temporarily improve moderate to severe vertical lines between the eyebrows, • eye pain, dry eye, visual field defect, blurred vision when their presence has a significant • reduced sensation in the throat psychological impact on them.
• constipation 2. What you need to know before • speech sound disorder

you use Letybo®

Do not use Letybo®:

Very rare, may affect up to 1 in 10 000 people

• muscle weakness
• difficulty in swallowing
• infection caused by breathing in food or liquid into airways or lung
• difficulty in breathing Beside these possible side effects a severe allergic reaction could cause the following symptoms: Warnings and precautions
• difficulty swallowing, breathing or speaking Talk to your doctor before using Letybo® if due to swelling of the face, lips, mouth or you have: throat beside these symptoms hives could occur (see section 2.)
• any disorder affecting muscles and/or their direct nervous system control Other known side effects can occur with
• difficulties swallowing or breathing, or have the following frequencies. Please tell your had these in the past doctor or pharmacist if they get serious:
• a bleeding disorder
• if you are allergic to botulinum toxin type A or any of the other ingredients of this medicine (listed in section 6)
• if you have muscle activity disorders, such as myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis
• if you have acute infection or inflammation at the proposed injection sites

If you have a history of these problems, Letybo® is not recommended for you. Needle-related pain and/or fear of injections can lead to feeling faint due to a sudden drop in blood pressure. Side effects due to botulinum toxin's spread away from the injection site and botulism have been reported very rarely with botulinum toxin (e.g. double vision, blurred vision and/or drooping eyelids, trouble breathing or speaking, excessive muscle weakness, difficulty swallowing, or unwanted food or liquid in the airways). Swallowing and breathing difficulties are serious and can result in death. If you have problems with your swallowing, speech or breathing, seek medical help immediately.

Children and adolescents

Common, may affect up to 1 in 10 people

• headache
• injection site reactions

Uncommon, may affect up to 1 in 100 people

• head discomfort
• local swelling, such as of the eyelid, face, around the eyes
• injection site: pain, bruising, swelling, itching, mass, pressure
• bruising, such as around the eyes
• infection, such as viral infection of the upper airways, e.g. common cold
• Mephisto sign (raising of the outer eyebrows)

Rare, may affect up to 1 in 1000 people

• migraine
• inflammation of hair follicle
• dizziness Other medicines and Letybo®
• abnormal sensation such as prickling, tingling and itchiness Tell your doctor or pharmacist if you are using, have recently used or might use any
• nausea other medicines.
• dry skin, nettle-rash, itching The following medicines could affect or • face pain be affected by Letybo®:
• fever
• medicines affecting the transfer of nerve
• oral herpes impulses to muscles
• increased blood potassium
• certain medicines used to treat bacterial infections, such as spectinomycin or those • influenza like illness called aminoglycoside antibiotics Reporting of side effects
• other medicines containing a botulinum If you get any side effects, talk to your doctor, toxin. pharmacist or nurse. This includes any

What you need to know before you take it

e Letybo® 3. How to use Letybo® 4. Possible side effects 5. How to store Letybo®

How to take it

Letybo® The botulinum toxin unit is specific to Letybo®. This means that it is different to other botulinum toxin units and is not interchangeable with those used for other preparations of botulinum toxin. Letybo® is only given to you by an appropriately qualified doctor who has the correct equipment for this treatment. The detailed description of the preparation of the solution and the instructions for use are described in the section "The following information is intended for healthcare professionals only" at the end of this leaflet.

The recommended dose is 20 units divided into five injections of 0.1 mL (4 units). Each injection is given into the muscles above or between the eyebrows. Letybo® is for intramuscular use (IM use). After the solution is reconstituted, the vial must be used only for one session per patient. Any unused solution must be

Possible side effects

not listed in this leaflet. Pregnancy and breast-feeding You can also report side effects directly via If you are pregnant or breast-feeding, think you may be pregnant or are planning to have the Yellow Card Scheme Website: a baby ask your doctor for advice before you www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or receive this medicine. Apple App Store. By reporting side effects, Letybo® is not recommended if you are you can help provide more information on pregnant or breast-feeding, or if you the safety of this medicine. are of childbearing age and not using contraception. Children and adolescents under 18 years are not recommended to have Letybo®.

Driving and using machines Botulinum toxin type A can cause weakness, dizziness and visual disturbances. Do not drive or operate machines if your ability to react is reduced.

Letybo® contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially 'sodium-free'.

How to store it

Letybo®

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 carton after EXP. The expiry date refers to the last day of that month. Store and transport refrigerated (2 °C – 8 °C).

Reconstituted solution Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8 °C. From a microbiological point of view, unless the method of opening/reconstitution/ dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

135 x 556 mm

Process Black

PMS 326C

6. Contents of the pack and other Instructions for use information Intramuscular injections should be

performed using a sterile insulin or tuberculin-type syringe of 1 mL value with 0.01 mL graduation and a needle with a

• The active substance is botulinum toxin type A. gauge range of 30 to 31 G.
• One vial contains 50 units botulinum toxin A volume of 0.5 mL of the properly type A produced by Clostridium botulinum. reconstituted Letybo® solution should be
• After reconstitution each 0.1 mL of the drawn into the sterile syringe and any air solution contains 4 units. bubbles in the syringe barrel expelled. The
• The other excipients are human albumin needle used to reconstitute the medicinal and sodium chloride. product should be removed and replaced for What Letybo® looks like and contents administration. of the pack Care should be taken to ensure that Letybo® is not injected into a blood vessel. Letybo® is a white powder for solution for injection provided in a clear glass vial with a In order to reduce the complication of rubber stopper and aluminium tamper-proof blepharoptosis, injections near the levator seal. palpebrae superioris must be avoided, particularly in patients with large brow Single pack contains one vial or two vials. depressor complexes. When injecting into Multipack contains 2 cartons, each carton two sites of each corrugator supercilii muscle, contains one vial. the first injection should be made right Multipack contains 6 cartons, each carton above the medial margin of eyebrows. The contains one vial. second injection will be made approximately Not all pack sizes may be marketed. 1 cm above the supraorbital ridge (rigid Marketing Authorisation Holder and bony boundaries palpable above the upper Manufacturer part of the upper eyelid) where midlines of CROMA-PHARMA GmbH the eyebrows meet. The injection site of the Industriezeile 6 procerus muscle is just above the midline of 2100 Leobendorf the nasal bridge where horizontal wrinkles Austria are made between the medial ends of eyebrows. When injecting into the medial This leaflet was last revised in ends of corrugator supercilii muscles and on December 2025. the midlines of the eyebrows, the injection sites should be at least 1 cm away from the The following information supraorbital ridge (rigid bony boundaries is intended for healthcare palpable above the upper part of the upper professionals only: eyelid).

What Letybo® contains

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Botulinum toxin units are not interchangeable from one product to another. Doses recommended in units are different from other botulinum toxin preparations. The instructions for use, handling and disposal should be strictly followed.

Preparation of the solution

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procerus muscle corrugator supercilii muscle

Reconstitution should be performed in accordance with good practice rules, particularly in the respect of asepsis. Injections need to be made with caution Sodium chloride 9 mg/mL (0.9 %) solution to avoid intravascular injection. Before for injection must be used as the diluent for reconstitution of Letybo® and must be added injecting, a thumb or an index finger can be placed firmly below the orbital rim to at a volume of 1.25 mL. prevent effusion of the medicinal product to It is good practice to reconstitute the vial content and prepare the syringe over plastic- this area. The needle needs to be oriented superiorly and medially. lined paper towels to catch any spillage. In case of treatment failure one month Sodium chloride 9 mg/mL (0.9 %) solution after the first treatment session, i.e. in the for injection is drawn up into a syringe and must be injected gently into the vial, to avoid absence of significant improvement from foam/bubble formation or vigorous agitation baseline, the following approaches may be which may cause denaturation. The vial must considered: be discarded if the vacuum does not pull the • Analysis of the causes of failure, e.g. solvent into the vial. Reconstituted Letybo® incorrect muscles injected, injection technique, formation of toxin neutralising is a clear, colourless solution practically antibodies, insufficient dose free of particulate matter. Prior to use, the vial should be visually inspected to ensure

• Re-evaluation of the relevance of treatment with botulinum toxin type A the product is free from foreign particulate matter. In the absence of any undesirable effects Letybo® must not be used if the reconstituted secondary to a treatment session, initiation solution has a cloudy appearance or contains of another treatment session with at least a particulate matter. three-month interval between the treatment sessions is possible.

Reconstituted solution

Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8 °C. From a microbiological point of view, unless the method of opening/reconstitution/ dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. Any solution for injection that has been stored for more than 24 hours must be discarded. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Procedure to follow for a safe disposal of vials, syringes and materials used

For safe disposal, un-reconstituted Letybo® should be reconstituted in the vial with a small amount of water and then autoclaved. Any empty vials, vials containing residual solution, syringes or spillage should be autoclaved. Alternatively, the remaining Letybo® can be inactivated with diluted sodium hydroxide solution (0.1 N NaOH) or with diluted sodium hypochlorite solution (0.5 % or 1 % NaOCl). After inactivation used vials, syringes and materials should not be emptied and must be discarded into appropriate containers and disposed of in accordance with local requirements.

Recommendations should any incident occur during the handling of botulinum toxin

• Any spills of the product must be wiped up: either using absorbent material impregnated with a solution of sodium hypochlorite in case of the powder, or with dry, absorbent material in case of reconstituted product.
• The contaminated surfaces should be cleaned using absorbent material impregnated with a solution of sodium hypochlorite, then dried.
• If a vial is broken, proceed as mentioned above by carefully collecting the pieces of broken glass and wiping up the product, avoiding any cuts to the skin.
• If the medicinal product has had contact with the skin, wash the affected area with a solution of sodium hypochlorite then rinse abundantly with water.
• If the medicinal product has had contact with the eyes, rinse thoroughly with plenty of water or with an ophthalmic eyewash solution.
• If the medicinal product has had contact with a wound, cut or broken skin, rinse thoroughly with plenty of water and take the appropriate medical steps according to the dose exposed to.