Bocouture

Package Leaflet: Information for the Patient

BOCOUTURE, 50 units, powder for solution for injection

BOCOUTURE, 100 units, powder for solution for injection

Botulinum toxin type A (150 kD), free from complexing proteins

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult your doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents:

• 1. What is BOCOUTURE and what is it used for
• 2. Important information before using BOCOUTURE
• 3. How to use BOCOUTURE
• 4. Possible side effects
• 5. How to store BOCOUTURE
• 6. Contents of the pack and other information

1. What is BOCOUTURE and what is it used for

BOCOUTURE is a medicine that contains botulinum toxin type A as the active substance, which relaxes the muscles it is injected into.
BOCOUTURE is used to temporarily improve the appearance of wrinkles in the upper part of the face in adults under 65 years of age, when the depth of the wrinkles has significant psychological impact on the patient:

• from moderate to severe vertical wrinkles between the eyebrows, visible at maximum frowning (frown lines), and (or)
• from moderate to severe lateral canthal wrinkles, visible at full smile (crow's feet), and (or)
• from moderate to severe horizontal wrinkles on the forehead, visible at maximum frowning.

2. Important information before using BOCOUTURE

When not to use BOCOUTURE

• if the patient is allergic to botulinum toxin type A or any of the other ingredients of this medicine (listed in section 6)
• if the patient has muscle disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome)
• if the patient has an infection or inflammation at the planned injection site

Warnings and precautions

Side effects may be the result of injecting botulinum toxin type A into the wrong place, resulting in temporary paralysis of nearby muscle groups. Very rarely, side effects have been reported that are related to the spread of the toxin to distant sites from the injection site, causing symptoms consistent with the effect of botulinum toxin type A (e.g., excessive muscle weakness, weakness, swallowing disorders, or accidental choking on food or drinks). Patients receiving recommended doses may experience excessive muscle weakness.
Patients should contact their doctor or seek medical attention if they observe the following symptoms:

• difficulty breathing, swallowing, or speaking,
• hives, swelling, including swelling of the face or throat, wheezing, feeling of weakness, and shortness of breath (possible severe allergic reaction symptoms) (see section 4).

If the dose is too high or the medicine is administered too frequently, the risk of antibody formation may increase. Antibody formation may result in failure of therapy with botulinum toxin type A, regardless of the reason for administration.
Before starting treatment with BOCOUTURE, the patient should discuss the following with their doctor:

• if the patient has any bleeding disorders,
• if the patient is taking blood-thinning medications (e.g., coumarin derivatives, heparin, acetylsalicylic acid, clopidogrel),
• if the patient has significant weakness or muscle mass loss in the muscle to be injected,
• if the patient has a disease called amyotrophic lateral sclerosis, which can lead to generalized muscle atrophy,
• if the patient has any disease that disrupts the interaction between nerves and skeletal muscles (peripheral nervous system disorder),
• if the patient has had difficulty swallowing,
• if the patient has had problems with previous botulinum toxin type A injections,
• if the patient is scheduled to have surgery.

Subsequent injections of BOCOUTURE
In cases of repeated injections of BOCOUTURE, the therapeutic effect of the medicine may change. Possible reasons for its increase or decrease include:

• different techniques for preparing the solution for injection by the doctor,
• different duration of treatment breaks,
• injections into a different muscle,
• lack of response/failure of therapy during the treatment process.

Elderly patients

Information on the treatment of patients over 65 years of age is limited. Therefore, BOCOUTURE should not be used in patients over 65 years of age.

Children and adolescents

BOCOUTURE should not be used in children and adolescents under 18 years of age, as the use of BOCOUTURE in children and adolescents is not recommended.

BOCOUTURE and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The effect of BOCOUTURE may be increased by:

• medicines used to treat certain infectious diseases (spectinomycin or aminoglycoside antibiotics [e.g., neomycin, kanamycin, tobramycin]),
• other muscle relaxants (e.g., muscle relaxants from the tubocurarine group). Such medicines are used, for example, during general anesthesia. Before surgery, the anesthesiologist should be informed about the use of BOCOUTURE.

In such cases, caution should be exercised when using BOCOUTURE.
Certain antimalarial/anti-rheumatic medicines (from the aminoquinoline group) may weaken the effect of BOCOUTURE.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
BOCOUTURE should not be used during pregnancy, unless the doctor decides that it is absolutely necessary and that the expected benefit of its use outweighs the potential risk to the fetus.
BOCOUTURE is not recommended for use in breastfeeding women.

Driving and using machines

The patient should not drive or perform other potentially hazardous activities if they experience drooping eyelids, weakness, muscle weakness, dizziness, or vision disturbances. In case of doubts, the patient should consult their doctor.

3. How to use BOCOUTURE

BOCOUTURE can only be administered by doctors with specialized knowledge in the treatment with botulinum toxin type A.
Vertical wrinkles between the eyebrows visible at maximum frowning (frown lines)
(forehead lines)
During the treatment of vertical wrinkles between the eyebrows visible at maximum frowning (forehead lines), the usual total dose is 20 units. The doctor injects 4 units into each of the 5 injection sites. If necessary, the total dose may be increased by the doctor to 30 units, with a minimum of 3 months between treatment cycles.
Reduction of vertical wrinkles between the eyebrows visible at maximum frowning (forehead lines) is usually observed within 2 to 3 days after injection, and the maximum effect occurs after 30 days. The effect of the medicine lasts for up to 4 months after administration.
Lateral canthal wrinkles visible at full smile (crow's feet)
During the treatment of lateral canthal wrinkles visible at full smile (crow's feet), the doctor injects a standard dose of 24 units (12 units per eye). 4 units are injected into each of the 3 injection sites.
Reduction of lateral canthal wrinkles visible at full smile is usually observed within 6 days after injection, and the maximum effect occurs after 30 days. The effect of the medicine lasts for up to 4 months after administration.
Horizontal wrinkles on the forehead visible at maximum frowning
During the treatment of horizontal wrinkles on the forehead visible at maximum frowning, the doctor may use doses ranging from 10 to 20 units, depending on the individual needs of the patient. The recommended dose of 10 to 20 units will be injected into five horizontally arranged injection sites (2 units, 3 units, or 4 units per injection site).
Improvement of horizontal wrinkles on the forehead visible at maximum frowning occurs within 7 days, and the maximum effect is observed after 30 days. The effect lasts for up to 4 months after administration.
Method of administration
Reconstituted BOCOUTURE is intended for intramuscular injection (see information for healthcare professionals at the end of this package leaflet).
The interval between two treatments should not be less than 3 months.

Use of higher than recommended dose of BOCOUTURE

Overdose symptoms:
Overdose symptoms do not occur immediately after injection and may include general weakness, drooping eyelids, double vision, breathing difficulties, speech disorders, and respiratory muscle paralysis or swallowing difficulties, which can lead to pneumonia.
Procedure in case of overdose:
In case of overdose symptoms, the patient should immediately call the emergency services (or ask someone else to do so) or go to the hospital. Several days of medical care and respiratory support may be necessary in this situation.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, BOCOUTURE can cause side effects, although not everybody gets them.
BOCOUTURE may cause an allergic reaction. Rarely, severe and/or sudden allergic reactions (anaphylactic shock) or allergic reactions to the serum contained in the product (serum sickness) have been reported, causing, for example, breathing difficulties (dyspnea), hives (urticaria), or soft tissue swelling (edema). Some of these reactions have been observed after the use of conventional botulinum toxin type A complex. They occurred when the toxin was administered independently or in combination with other medicines that cause similar reactions. Such reactions cannot be completely ruled out in the case of BOCOUTURE.
An allergic reaction may cause any of the following symptoms:

• breathing, swallowing, or speech difficulties due to swelling of the face, lips, mouth, or throat,
• swelling of the hands, feet, or ankles.

In case of any of the above symptoms, the patient should immediately inform their doctor or ask someone else to do so and go to the emergency department of the nearest hospital.

Usually, side effects occur within the first week after injection and are temporary.
Side effects may be related to the medicine itself, the injection technique, or both. At the injection site, botulinum toxin causes local muscle weakness. Drooping eyelids may be caused by the injection technique and the effect of the medicine.
The following reactions may occur at the injection site:

• local pain
• inflammation
• tingling or prickling sensation
• numbness
• tenderness
• itching
• swelling (generalized)
• soft tissue swelling (edema)
• redness of the skin (erythema)
• local infection
• hematoma
• bleeding
• bruising

In patients who are afraid of injections or pain during needle puncture, transient generalized reactions may occur, such as:

• fainting
• circulatory problems
• nausea
• ringing in the ears

Other possible side effects

After using BOCOUTURE, the following side effects have been reported:
Vertical wrinkles between the eyebrows visible at maximum frowning (frown lines)
(forehead lines)
Frequently (may occur in up to 1 in 10 people)

• headache
• Mephisto effect (raising the lateral parts of the eyebrows)

Uncommonly (may occur in up to 1 in 100 people):

• nasopharyngitis
• bronchitis
• flu-like illness
• drooping eyebrows
• drooping eyelids
• swelling of the eyelids (periorbital edema)
• feeling of discomfort (feeling of heaviness of the eyelids/eyebrows)
• blurred vision
• muscle twitching (muscle spasms)
• asymmetry of the eyebrows
• feeling of tension at the injection site
• fatigue
• pain or bruising at the injection site
• itching
• bruises
• skin nodules
• insomnia

Lateral canthal wrinkles visible at full smile (crow's feet)
Frequently (may occur in up to 1 in 10 people):

• swelling of the eyelids
• dry eyes
• bruising at the injection site

Wrinkles of the upper face
Frequently (may occur in up to 1 in 10 people):

• headache
• bruising at the injection site

Uncommonly (may occur in up to 1 in 100 people):

• numbness
• feeling of discomfort (feeling of heaviness of the forehead)
• swelling of the eyelids
• drooping eyelids (ptosis)
• dry eye syndrome
• drooping eyebrows
• asymmetry of the face
• Mephisto effect (raising the lateral parts of the eyebrows)
• nausea

Post-marketing experience

After BOCOUTURE was placed on the market, the following side effects have been observed during its use, regardless of the treated area:
flu-like illness, muscle atrophy after injection, and hypersensitivity reactions, such as swelling, soft tissue swelling (edema), also in areas distant from the injection site, redness, itching, rash (local and generalized), and shortness of breath.
During the treatment of other conditions with botulinum toxin type A, very rarely the following side effects have been observed (see section 2):

• excessive muscle weakness
• swallowing difficulties
• swallowing difficulties leading to choking on foreign bodies, causing pneumonia, and in some cases, patient death

Such side effects are caused by muscle relaxation in areas distant from the injection site.

Reporting side effects

If side effects occur, including any not listed in this package leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store BOCOUTURE

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label of the vial after the words "Expiry date:". The expiry date refers to the last day of the month.
Unopened vial: Do not store above 25°C.
Reconstituted solution: Chemical and physical stability has been demonstrated for 24 hours at a temperature of 2°C to 8°C.
From a microbiological point of view, the medicine should be used immediately. If not used immediately, the user is responsible for the storage conditions and the storage time before reuse, which should not exceed 24 hours at 2°C to 8°C, unless reconstitution was performed under controlled aseptic conditions.
The doctor should not use BOCOUTURE if the reconstituted solution is cloudy or contains particles or sediment.
Medicines should not be disposed of via wastewater or household waste.

6. Contents of the pack and other information

What BOCOUTURE contains

• The active substance of BOCOUTURE is botulinum toxin type A (150 kD), free from complexing proteins. BOCOUTURE, 50 unitsOne vial contains 50 units of botulinum toxin type A (150 kD), free from complexing proteins. BOCOUTURE, 100 unitsOne vial contains 100 units of botulinum toxin type A (150 kD), free from complexing proteins.
• Other ingredients of the medicine are: human albumin, sucrose

What BOCOUTURE looks like and contents of the pack

BOCOUTURE is a powder for solution for injection (powder for injection).
The powder is white.
After reconstitution, the powder forms a clear and colorless solution.
Packaging: 1, 2, 3, or 6 vials.
Not all pack sizes may be marketed.

Marketing authorization holder

Merz Pharmaceuticals GmbH
Eckenheimer Landstrasse 100
60318 Frankfurt Main
Germany
Phone: +49-69/15 03-1
Fax: +49-69/15 03-200

Manufacturer

Merz Pharma GmbH & Co. KGaA
Eckenheimer Landstrasse 100
60318 Frankfurt/Main
Germany

Date of last revision of the package leaflet: 06.2025

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The following information is intended for healthcare professionals only:
Instructions for preparing the solution for injection:
Before administration, BOCOUTURE is reconstituted with sodium chloride 0.9% (9 mg/ml) solution for injection.
BOCOUTURE should only be used for the treatment of one patient during one treatment session.
Good practice is to prepare the solution and prepare the syringe over a paper towel covered with foil in case of spillage of the medicine. The syringe should be filled with the appropriate amount of sodium chloride. To prepare the solution, it is recommended to use a short-cut 20-27 G needle. The needle should puncture the rubber stopper at a right angle, and then the solvent should be slowly injected into the vial so as not to create foam. The vial should be discarded if the solvent is not drawn into the vial under vacuum. The syringe should be removed from the vial and BOCOUTURE mixed with the solvent by gently swirling the vial and rotating it/tapping it - without making sudden movements. If necessary, the needle used to prepare the solution should remain in the vial, and the appropriate amount of solution should be drawn up using a new, sterile syringe, suitable for injecting the medicine.

Reconstituted BOCOUTURE is a clear and colorless solution.
BOCOUTURE should not be used if the reconstituted solution (prepared as above) has a cloudy appearance or contains particles or sediment.
Possible dilutions for BOCOUTURE 50 and 100 units are shown in the following table:

Instructions for disposal of the medicine
Solutions for injection stored for more than 24 hours and unused solutions for injection should be discarded.
Procedures for safe disposal of vials, syringes, and used materials
Unused vials or remaining solution and/or syringes should be sterilized in an autoclave.
Alternatively, any remaining BOCOUTURE can be inactivated by adding one of the following solutions: 70% ethanol, 50% isopropanol, 0.1% SDS (anionic detergent), diluted sodium hydroxide (at least 0.1 N NaOH), or diluted sodium hypochlorite solution (at least 0.1% NaOCl).
After inactivation, the used vials, syringes, and materials should not be emptied but should be placed in appropriate containers and disposed of in accordance with local regulations.
Recommendations for procedures in case of unforeseen incidents during administration of botulinum toxin type A

• Any spillage of the medicine should be immediately removed: in the case of powder using an absorbent material soaked in one of the above solutions, or in the case of the medicine after reconstitution using a dry absorbent material.
• The contaminated surface should be wiped with an absorbent material soaked in one of the above solutions and then dried.
• If the vial is broken, the above instructions should be followed. The fragments of the broken glass should be carefully collected, and the remains of the medicine should be wiped away, avoiding cuts.
• If the medicine comes into contact with the skin, the area of contact should be rinsed with a large amount of water.
• In case of eye contact, the eyes should be thoroughly rinsed with a large amount of water or eye wash solution.
• If the medicine gets into a wound, cut, or scratch on the skin, the area should be thoroughly rinsed with a large amount of water, and then appropriate medical measures should be taken, depending on the injected dose.

Instructions for preparation and disposal of the medicine should be strictly followed.