Bocouture 100 units powder for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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 all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not one of the side effects listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What BOCOUTURE is and what it is used for

BOCOUTURE is a medicine that contains the active substance botulinum toxin type A, which relaxes the injected muscles.

BOCOUTURE is indicated for the temporary improvement of upper facial lines in adults under 65 years of age when the severity of these lines has a significant psychological impact on the patient:

• moderate to severe vertical glabellar lines, produced at maximum frown, and/or
• moderate to severe lateral orbital lines, produced at maximum smile, and/or
• moderate to severe horizontal forehead lines, produced at maximum contraction

2. What you need to know before BOCOUTURE is used

Do not use BOCOUTURE

• if you are allergic to botulinum toxin type A or to any of the other ingredients of this medicine (listed in section 6)
• if you have a generalized disorder of muscle activity (e.g., myasthenia gravis, Lambert-Eaton syndrome)
• if you have an infection or inflammation at the proposed injection site

Warnings and precautions

Adverse effects may occur due to incorrect placement of botulinum toxin type A injections, resulting in temporary paralysis of nearby muscle groups. Very rare cases of side effects related to toxin spread to distant sites from the injection point and botulism have been reported, causing symptoms consistent with the effects of botulinum toxin type A (e.g.: double vision, blurred vision and/or drooping eyelids, difficulty speaking or breathing, excessive muscle weakness, difficulty swallowing, or accidental aspiration of food or drink into the airways). Patients receiving recommended doses may experience excessive muscle weakness.

Contact your doctor and seek immediate medical attention if you experience any of the following:

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

If the dose is too high or injections are too frequent, the risk of antibody formation may increase. The formation of antibodies may lead to treatment failure with botulinum toxin type A, regardless of the condition being treated.

Inform your doctor before using BOCOUTURE:

• if you have any bleeding disorder of any kind
• if you are taking medications that prevent blood clotting (e.g.: coumarin, heparin, acetylsalicylic acid, clopidogrel)
• if you have marked weakness or reduced muscle volume in the muscle where the injection will be administered
• if you have amyotrophic lateral sclerosis (ALS), which may lead to generalized muscle weakness
• if you have any disorder affecting the interaction between nerves and skeletal muscles (peripheral neuromuscular disorder)
• if you have or have had swallowing difficulties
• if you have previously experienced problems with botulinum toxin type A injections
• if you are scheduled to undergo any type of surgery

Repeated injections with BOCOUTURE

If you have received repeated injections with BOCOUTURE, the effect may increase or decrease. Possible reasons for this include:

• your doctor may use a different procedure when preparing the injection solution
• different treatment intervals
• injections into a different muscle
• lack of response or treatment failure during the treatment session

Elderly patients

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

Children and adolescents

Do not administer this medicine to children or adolescents under 18 years of age, as the use of BOCOUTURE is not recommended in children or adolescents.

Other medicines and BOCOUTURE

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

The effect of BOCOUTURE may be enhanced by:

• medicines used to treat certain infectious diseases (spectinomycin or aminoglycoside antibiotics [e.g., neomycin, kanamycin, tobramycin])
• other medicines that relax muscles (e.g., muscle relaxants of the tubocurarine type). These medicines are used, for example, during general anesthesia. Before undergoing surgery, tell your anesthetist if you have received BOCOUTURE.

In these cases, BOCOUTURE should be used with caution.

The effect of BOCOUTURE may be reduced by certain medicines used for malaria and rheumatism (known as aminoquinolines).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before this medicine is administered.

BOCOUTURE must not be used during pregnancy unless clearly necessary and the potential benefit of treatment outweighs the possible risk to the fetus. BOCOUTURE is not recommended during breastfeeding.

Driving and use of machines

Do not drive or perform other potentially hazardous activities if you experience weakness (asthenia), muscle weakness, dizziness, or visual disturbances.

If in doubt, consult your doctor.

3. How to use BOCOUTURE

BOCOUTURE can only be administered by healthcare professionals experienced in the use of botulinum toxin type A.

Glabellar Lines (frown lines) induced by maximum frowning

The usual total dose for treatment of glabellar lines induced by maximum frowning is 20 units. Your doctor will inject 4 units at each of 5 injection sites. The total dose may be increased up to 30 units if required by individual patient needs, with at least 3 months between treatments.

Improvement in glabellar lines induced by maximum frowning is generally observed within 2 to 3 days, with maximum effect seen by day 30. The effect lasts up to 4 months after injection.

Lateral Orbital Lines (crow's feet) induced by maximum smile

For the treatment of lateral orbital lines (crow's feet), your doctor will inject a standard dose of 24 units (12 units per eye). Four units will be administered bilaterally at each of the 3 injection sites.

Improvement in lateral orbital lines induced by maximum smile generally occurs within 6 days, with maximum effect observed by day 30. The effect lasts up to 4 months after injection.

Horizontal Forehead Lines induced by maximum contraction

When treating horizontal forehead lines induced by maximum contraction, your doctor will use a dose within the range of 10 to 20 units, according to individual patient needs. The recommended total dose of 10 to 20 units will be injected at five injection sites aligned horizontally (2 units, 3 units, or 4 units per injection site, respectively).

Reduction in horizontal forehead lines induced by maximum contraction usually occurs within 7 days, with maximum effect observed around day 30. The effect lasts up to 4 months after injection.

Method of administration

Reconstituted BOCOUTURE is injected intramuscularly (intramuscular use, see information for healthcare professionals at the end of this leaflet).

The interval between two treatments should not be less than 3 months.

If you are given more BOCOUTURE than you should

Symptoms of overdose:

Overdose symptoms are not immediately apparent after injection and may include generalised weakness, eyelid ptosis, double vision, difficulty breathing, speech difficulties, respiratory muscle paralysis, or swallowing difficulties which may lead to pneumonia.

Measures to take in case of overdose:

In case of overdose, contact emergency medical services immediately or ask your family to do so and take you to the hospital. Medical supervision for several days and assisted ventilation may be required.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

An allergic reaction may occur with BOCOUTURE. Immediate and/or severe allergic reactions (anaphylaxis) or serum-related allergic reactions (serum sickness) have been reported rarely and may cause, for example, difficulty breathing (dyspnea), hives (urticaria), or swelling of soft tissue (edema). Some of these reactions have been observed following the use of conventional botulinum toxin type A complex. These occurred when the toxin was administered alone or in combination with other products known to cause similar reactions. These effects cannot be completely ruled out when using BOCOUTURE.

An allergic reaction may cause one or more of the following symptoms:

• Difficulty breathing, swallowing, or speaking due to swelling of the face, lips, mouth, or throat
• Swelling of hands, feet, or ankles

If you notice any of these side effects, please inform your doctor immediately or ask your family to do so, and go to the nearest hospital's emergency medical services.

Usually, side effects occur during the first week after injection and are transient in nature. Adverse effects may be related to the medicine, the injection technique, or both. At the injection site, the action of botulinum toxin type A causes localized muscle weakness. Drooping of the eyelid may occur due to the injection technique and the effect of the medicine.

The following reactions may occur around the injection site:

• Localized pain
• Swelling
• Tingling
• Numbness
• Sensitivity
• Itching
• General swelling
• Swelling of soft tissue (edema)
• Redness of the skin (erythema)
• Localized infection
• Bruising
• Bleeding
• Bruise marks

Patients who are afraid of injections or needle-related pain may experience transient generalized reactions, such as:

• Fainting
• Circulatory problems
• Nausea
• Ringing in the ears

Other possible adverse effects

The following adverse effects have been observed with BOCOUTURE:

Glare lines (vertical frown lines) produced at maximum frowning

Frequent (may affect up to 1 in 10 people):

• Headache
• Mephisto effect (lateral elevation of the eyebrows)

Uncommon (may affect up to 1 in 100 people):

• Nasopharyngitis
• Bronchitis
• Influenza-like symptoms
• Drooping of the eyebrow (eyebrow ptosis)
• Drooping of the eyelid (palpebral ptosis)
• Fluid accumulation in the eyelids (eyelid edema)
• Discomfort (feeling of heaviness in the eyelid/eyebrow)
• Blurred vision
• Muscle spasms
• Eyebrow asymmetry
• Sensation of pressure at the injection site
• Fatigue
• Pain or bruising at the injection site
• Itching
• Bruising
• Skin nodules
• Insomnia

Lateral periorbital lines produced at maximum smile (Crow's feet)

Frequent (may affect up to 1 in 10 people):

• Eyelid swelling
• Dry eye
• Bruising at the injection site

Upper facial lines

Frequent (may affect up to 1 in 10 people):

• Headaches
• Bruising at the injection site

Uncommon (may affect up to 1 in 100 people):

• Numbness
• Discomfort (feeling of heaviness in the forehead area)
• Eyelid edema
• Drooping of the eyelid (eyelid ptosis)
• Dry eye
• Drooping of the eyebrow (eyebrow ptosis)
• Facial asymmetry
• Mephisto effect (lateral elevation of the eyebrows)
• Nausea

Post-marketing experience

The following adverse reactions have been reported since the launch of BOCOUTURE, regardless of treatment area, with unknown frequency:

Influenza-like syndrome, contraction of the injected muscle, and hypersensitivity reactions such as swelling and inflammation of soft tissue (edema), also occurring distant from the injection site, erythema, pruritus, rash (localized and generalized), and difficulty breathing.

The following adverse effects have been observed very rarely during treatment with botulinum toxin type A for conditions other than upper facial lines (see section 2):

• Excessive muscle weakness
• Difficulty swallowing
• Difficulty swallowing leading to aspiration of foreign material, which may result in lung inflammation and, in some cases, death

These adverse effects are caused by relaxation of muscles distant from the injection site.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of BOCOUTURE

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

Do not use this medicine after the expiry date stated on the carton and on the label of the vial after "EXP". The expiry date refers to the last day of the month indicated.

Unopened vial: Do not store above 25°C.

Reconstituted solution: Chemical and physical stability has been demonstrated for 24 hours at 2°C to 8°C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the in-use storage duration and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2°C to 8°C, unless reconstitution has been carried out under controlled and validated aseptic conditions.

Your doctor should not use BOCOUTURE if the solution appears cloudy or contains visible particles.

Do not dispose of any medicine via wastewater.

For instructions on disposal, see information for patients and healthcare professionals at the end of this leaflet.

6. Contents of the container and other information

Composition of BOCOUTURE

• The active substance is botulinum toxin type A (150 kD), free from complexing proteins.

BOCOUTURE 50 units

One vial contains 50 units of botulinum toxin type A (150 kD), free from complexing proteins.

BOCOUTURE 100 units

One vial contains 100 units of botulinum toxin type A (150 kD), free from complexing proteins.

• The other components are: Human albumin, sucrose.

Presentation of the product and contents of the container

BOCOUTURE is presented as a powder for solution for injection (powder for injection). The powder is white.

When dissolved, BOCOUTURE is a clear, colourless solution.

Pack sizes of 1, 2, 3 or 6 vials.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Merz Pharmaceuticals GmbH
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Germany

Manufacturer

Merz Pharma GmbH & Co. KgaA
Legal address:
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Germany
Manufacturing address:
Ludwigstraße 22
64354 Reinheim
Germany

Local Representative

Merz Aesthetics Iberia, S.L.U.
Calle de Anabel Segura 14, Planta 2 Núcleo 1
28108 Alcobendas
Madrid
Spain

Date of the most recent revision of this package leaflet: December 2025

This information is intended for healthcare professionals only:

Instructions for reconstitution of the solution for injection:

BOCOUTURE must be reconstituted before use with sodium chloride 9 mg/ml (0.9%) solution for injection.

BOCOUTURE may only be used for its intended purpose, for treating a single patient and during a single session.

It is recommended that reconstitution of the vial and syringe preparation be performed over plastic-backed paper towels to collect any spilled material. Using a syringe, draw up an appropriate amount of sodium chloride solution. A short-bevel needle of gauge 20–27 G is recommended for reconstitution. After vertically inserting the needle through the rubber stopper, carefully inject the solvent into the vial to avoid foaming. The vial should be discarded if the vacuum does not draw the solvent into the vial. Remove the syringe from the vial and mix BOCOUTURE with the solvent by gently swirling or inverting/rotating the vial; do not shake vigorously. If necessary, the needle used for reconstitution may remain in the vial, and the required amount of solution should be withdrawn using a new, sterile needle appropriate for injection.

Reconstituted BOCOUTURE is a clear, colourless solution.

BOCOUTURE must not be used if the reconstituted solution (prepared according to the instructions above) appears cloudy or contains flocculated material or particles.

The possible dilutions for BOCOUTURE 50 and 100 units are shown in the following table:

Disposal Instructions

Any injectable solution that has been stored for more than 24 hours and any unused injectable solution must be discarded.

Procedure for the safe disposal of vials, syringes, and used materials

Any unused vial or residual solution in the vial and/or syringes must be autoclaved. Alternatively, the remaining BOCOUTURE may be inactivated by adding one of the following solutions: 70% ethanol, 50% isopropanol, 0.1% SDS (anionic detergent), diluted sodium hydroxide solution (0.1 N NaOH), or diluted sodium hypochlorite solution (at least 0.1% NaOCl).

After inactivation, vials, syringes, and used materials must not be emptied, but must be disposed of in appropriate containers and eliminated in accordance with local procedures.

Recommendations in the event of any incident occurring during handling of botulinum toxin type A

• Any residue of the product must be cleaned up, using absorbent material soaked with one of the above-mentioned solutions in the case of powder, or dry absorbent material if it is reconstituted product.
• Contaminated surfaces must be cleaned with absorbent material soaked in one of the above-mentioned solutions and then dried.
• If a vial breaks, proceed as described above, carefully collecting the broken glass fragments and cleaning up the spilled product, taking care to avoid skin cuts.
• If the product comes into contact with the skin, rinse the affected area thoroughly with abundant water.
• If the product comes into contact with the eyes, rinse with abundant water or an ophthalmic irrigation solution.
• If the product comes into contact with a wound, cut, or non-intact skin, rinse thoroughly with abundant water and take appropriate medical measures according to the injected dose.

These instructions for use, handling, and disposal must be strictly followed.