Package Insert: Information for the User

Letybo 50Units of Powder for Injectable Solution

Botulinum Toxin Type A

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Conserve this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Letybo and how is it used

2. What you need to know before starting to use Letybo

3. How to use Letybo

4. Possible adverse effects

5. Storage of Letybo

6. Contents of the package and additional information

Letybo contains the active ingredient botulinum toxin typeA. It works by blocking nerve impulses that go to the muscles into which it is injected. In this way, it prevents the muscles from contracting, causing temporary paralysis.

Letybo is used in adults under 75years to temporarily improvevertical lines between the eyebrowsof moderate to severe degree, when their presence has a significant psychological impact on these individuals.

Do not use Letybo:

• if you are allergic to botulinum toxin type A or any of the other components of this medication (listed in section 6)
• if you have a muscle disorder, such as myasthenia gravis, Lambert-Eaton syndrome, or amyotrophic lateral sclerosis
• if you have an acute infection or inflammation in the proposed injection areas

Warnings and precautions

Consult your doctor before starting to use Letybo if you have:

• any condition that affects muscles and/or direct control by the nervous system
• difficulty swallowing or breathing, or if you have had it before
• a bleeding disorder

If you have a history of these problems, it is not recommended that you use Letybo.

Pain related to needles or fear of injections may cause a sensation of loss of consciousness due to a sudden drop in blood pressure.

Rarely reported adverse effects caused by the diffusion of botulinum toxin away from the injection site, such as excessive muscle weakness. Difficulty breathing and swallowing are serious and can cause death.

If you have trouble swallowing, speaking, or breathing, seek immediate medical help.

Children and adolescents

Letybo is not recommended for children and adolescents under 18 years old.

Other medications and Letybo

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The following medications may affect or be affected by Letybo:

• medications that affect nerve impulse transmission to muscles
• some medications used to treat bacterial infections, such as spectinomycin or aminoglycoside antibiotics
• other medications containing botulinum toxin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Letybo is not recommended during pregnancy or breastfeeding, or in women of childbearing age who are not using contraception.

Driving and operating machines

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

Letybo contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

This unit of botulinum toxin is specific to Letybo. This means that it is different from other units of botulinum toxin and cannot be exchanged with those used in other botulinum toxin preparations.

Letybo has been prescribed exclusively for you by a competent doctor who has the necessary equipment for this treatment. The detailed description of the preparation of the solution and the usage instructions are described in the section “This information is intended solely for healthcare professionals” at the end of the prospectus.

The recommended dose is

20units divided into five injections of 0.1ml (4units). Each injection is administered in the muscles located above or between the eyebrows.

Letybo is administered via intramuscular (IM) route.

Once the solution has been reconstituted, the vial should only be used in one session per patient. Any unused solution should be discarded, as explained after section6 of the information for healthcare professionals.

It is recommended to leave a minimum of 3months between two treatments with Letybo.

If you have been administered more Letybo than you should have

Overdoses may cause paralysis of the muscles and/or nerves. It is possible that the signs of overdose may not appear immediately after the injection.

In case of overdose, the doctor will keep you under observation for any symptoms, such as general weakness or muscle paralysis. You will be admitted to the hospital if you present symptoms of botulinum toxin type A poisoning, such as:

• generalized weakness
• drooping eyelid or double vision
• speech or swallowing disorders
• partial paralysis of the muscles that control breathing.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The majority of side effects are of mild to moderate intensity, occur in the first days after injection, and are transient.

Some side effects may be very serious. If you experience any of the following side effects, inform your doctor immediately or ask your family members to inform your doctor and go to the nearest emergency service:

Rare, may affect 1 in 100people

• drooping eyelid, eyelid spasm

Uncommon, may affect 1 in 1000people

• troubled sensation of the eyelid, drooping eyelid
• bleeding in the conjunctiva
• eye pain, dry eye, visual field defect, blurred vision
• reduced sensitivity in the throat
• constipation
• joint disorder

Very rare, may affect 1 in 10000people

• muscle weakness
• difficulty swallowing
• infection of the respiratory or pulmonary tract caused by aspiration of food or liquid
• difficulty breathing

In addition to these possible side effects, a severe allergic reaction could cause the following symptoms:

• difficulty swallowing, breathing, or speaking due to swelling in the face, lips, mouth, or throat; in addition to these symptoms, hives may occur (see section 2)

Other known side effects may occur with the following frequencies. Inform your doctor or pharmacist if they are severe:

Common, may affect 1in 10people

• headache
• reactions at the injection site

Uncommon, may affect 1in 100people

• headaches
• local swelling, for example on the eyelid, face, or around the eyes
• pain, redness, swelling, itching, increased volume, or pressure at the injection site
• redness, for example around the eyes
• infection, such as an upper respiratory tract viral infection, e.g. cold
• Mefisto effect (lateral elevation of the eyebrows)

Rare, may affect 1in 1000people

• migraine
• inflammation of the hair follicles
• dizziness
• abnormal sensations, such as prickling, tingling, and itching
• nausea
• dry skin, rash, itching
• facial pain
• fever
• oral herpes
• high potassium in the blood
• pseudogripal syndrome

Reporting of side effects

If you experience side effects, consult your doctor or pharmacist,even if they are possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use, https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and the box after “CAD” or “EXP”. The expiration date is the last day of the month indicated.

Store and transport refrigerated (2°C–8°C).

Reconstituted solution

Chemical and physical stability has been demonstrated in use for 24hours at 2°C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times during use and the conditions prior to use are the responsibility of the user and normally will not exceed 24hours at a temperature of between 2and 8°C, unless reconstitution/dilution (etc.) has been performed in controlled and validated aseptic conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Letybo

• The active principle is botulinum toxin typeA.
• A vial contains 50units of botulinum toxin typeA produced byClostridium botulinum.
• After reconstitution, the solution contains 4units per 0.1ml.
• The other excipients are human albumin, sodium chloride.

Appearance of the product and contents of the packaging

Letybo is a white powder for injectable solution supplied in a transparent glass vial with a rubber stopper and an aluminum safety seal.

The individual packaging contains 1 or 2 vials.

The multiple packaging contains 2boxes, each containing avial.

The multiple packaging contains 6boxes, each containing avial.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

CROMA‑PHARMA GmbH

Industriezeile6

2100Leobendorf

Austria

Responsible for manufacturing

Croma-Pharma GmbH

Cromazeile 2

2100 Leobendorf

Austria

Last review date of this leaflet:July 2023

‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑