What it is and what it is used for

for BOCOUTURE is a medicine that contains the active substance Botulinum toxin type A which relaxes the injected muscles. BOCOUTURE is used for temporary improvement of upper facial lines in adults under 65 years of age when the severity of these lines has an important psychological impact for the patient: •

 moderate to severe vertical lines between the eyebrows seen at maximum frown and/or

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moderate to severe lateral periorbital lines seen at maximum smile and/or

•

 moderate to severe horizontal forehead lines seen at maximum contraction

Elderly

Other medicines and BOCOUTURE Tell your doctor, pharmacist or healthcare professional if you are taking, have recently taken or might take any other medicines. 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  medicines that relax the muscles (e.g. muscle relaxants of the tubocurarine type). Such medicines are used, for example, in general anaesthesia. Before you have surgery, tell your anaesthetist if you have received BOCOUTURE.

In these cases, BOCOUTURE must be used carefully.

2. What  you need to know before BOCOUTURE is used Do not use BOCOUTURE • • •

if you are allergic to Botulinum neurotoxin type A or any of the other ingredients of this medicine (listed in section 6) if you suffer from a generalised 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 Side effects may occur from misplaced injections of Botulinum neurotoxin type A temporarily paralysing nearby muscle groups. There have been very rare reports of side effects that may be related to the spread of toxin distant from the injection site and botulism to produce symptoms consistent to Botulinum toxin type A effects (e.g. double vision, blurred vision and/or drooping eyelids, trouble speaking or breathing, excessive muscle weakness, swallowing difficulties or accidental swallowing of food or drink into the airways). Patients who receive the recommended doses may experience excessive muscle weakness. Contact your doctor or healthcare professional and seek medical attention immediately if you experience any of the following: •

difficulty in breathing, swallowing or speaking

•

hives,  swelling including swelling of the face or throat, wheezing, feeling faint and shortness of breath (possible symptoms of severe allergic reactions) (see section 4).

If the dose is too high or the injections too frequent, the risk of antibody formation may increase. Antibody formation can cause treatment with Botulinum toxin type A to fail, whatever the reason for its use.

MN 170003746 MC 520, UK

The effect of BOCOUTURE may be reduced by certain medicines for malaria and rheumatism (known as aminoquinolines). Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or healthcare professional for advice before this medicine is administered. BOCOUTURE should not be used during pregnancy unless your doctor decides that the necessity and potential benefit of the treatment justifies the possible risk on the foetus. BOCOUTURE is not recommended if you are breast-feeding. Driving and using machines You should not drive or engage in other potentially hazardous activities if drooping eyelids, weakness (asthenia), muscle weakness, dizziness or vision disorders occur. If in doubt, ask your doctor or healthcare professional for advice.

How to take it

BOCOUTURE BOCOUTURE may only be administered by doctors or healthcare professionals with appropriate specialist knowledge of treatment with Botulinum neurotoxin type A. Vertical Lines between the Eyebrows seen at maximum frown (Glabellar Frown Lines) When treating your vertical lines between the eyebrows seen at maximum frown (glabellar frown lines) the usual total dose is 20 units. Your doctor or healthcare professional will inject 4 units into each of the 5 injection sites. The total dose may be increased by the physician to up to 30 units if required by the individual needs of the patient, with at least '3-months' interval between treatments.

A reduction in the vertical lines between the eyebrows seen at maximum frown generally occurs within 2 to 3 days with the maximum effect observed on day 30. The effect lasts for up to 4 months after the injection. Lateral Periorbital Lines seen at maximum smile (Crow's feet lines) For the treatment of lateral periorbital lines seen at maximum smile (crow's feet lines) your doctor or healthcare professional will inject a standard dose of 24 units (12 units per eye). 4 units will be applied bilaterally into each of the 3 injection sites. A reduction in lateral periorbital lines seen at maximum smile mostly occurs within 6 days with the maximum effect observed on day 30. The effect lasts for up to 4 months after the injection. Horizontal Forehead Lines seen at maximum contraction When treating horizontal forehead lines seen at maximum contraction your doctor will use a dose within a range of 10 to 20 units according to the individual needs of the patient. The recommended dose of totally 10 to 20 units will be injected into the five h orizontally a ligned i njection s ites ( 2 u nits, 3 u nits, o r 4 units, per injection point respectively). A reduction in the horizontal forehead lines seen at maximum contraction usually occurs within 7 days with the maximum effect observed on day 30. The effect lasts up to 4 months after the injection. Method of administration Dissolved BOCOUTURE is intended for injections into the muscle (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 require Symptoms of overdose Symptoms of overdose are not apparent immediately after the injection and may include general weakness, drooping eyelid, double vision, breathing difficulties, speech difficulties, and paralysis of the respiratory muscles or swallowing difficulties which may result in pneumonia. Measures in cases of overdose In case you feel symptoms of overdose please seek medical emergency services immediately or ask your relatives to do so, and have yourself admitted to hospital. Medical supervision for up to several days and assisted ventilation may be necessary. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or healthcare professional. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. An allergic reaction may occur with BOCOUTURE. Serious and/or immediate allergic reactions (anaphylaxis) or allergic reactions to the serum in the product (serum sickness), causing for example difficulty in breathing (dyspnoea), hives (urticaria) or swelling of the soft tissue (oedema), have been rarely reported. Some of these reactions have been observed following the use of conventional Botulinum toxin type A complex. They occurred when the toxin was given alone or in combination with other products known to cause similar reactions. These effects cannot be ruled out completely when using BOCOUTURE. An allergic reaction can cause any of the following symptoms: •

difficulty with breathing, swallowing or speaking due to the swelling of the face, lips, mouth or throat

•

swelling of the hands, feet or ankles.

If you notice any of these side effects, please inform your doctor immediately or ask your relatives to do so and go to the accident and emergency department of your nearest hospital. Usually, side effects occur in the first week after the injection and are temporary in nature. Side effects may be related to the medicine, injection technique or both. At the injection sites, the action of Botulinum toxin type A causes localised muscle weakness. Drooping eyelids can be caused by the injection technique and the effect of the medicine. The following reactions may occur around the injection site: •

Localised pain

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Inflammation

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Pins and needles

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Numbness

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Tenderness

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Itching

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Swelling (general)

Job No.:

me4022622

Created at: 07.11.2025

Operator: lw

Size:

300 x 390 mm (w x h)

1. AC:

5. AC:

MN:

170003746

MC:

2. AC:

6. AC:

LX:

20415

MZ / AZ: 928

3. AC:

7. AC:

4. AC:

8. AC:

520

Type size: 9 pt

Typestyle: Helvetica Neue LT Std

Bocouture, 50+100 units, PL, UK

PANTONE 3005 C

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Swelling of the soft tissue (oedema)

facial lines (see section 2):

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Skin redness (erythema)

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Excessive muscle weakness

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Localised infection

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Swallowing difficulties

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Haematoma

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Bleeding

Swallowing difficulties causing inhalation of foreign bodies resulting in lung inflammation and, in some cases, death

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Bruising

Such side effects are caused by the relaxation of muscles far from the injection site.

Patients with a fear of injections or needle related pain may experience temporary generalised reactions, e.g. •

Fainting

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Circulatory problems

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Nausea

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Noises in the ears

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or healthcare professional. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/ yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

Other possible side effects The following BOCOUTURE:

How to store it

BOCOUTURE

with

Vertical Lines between the Eyebrows seen at maximum frown (Glabellar Frown Lines) Common (may affect up to 1 in 10 people):

• Headache •

Mephisto sign (raising of the outer eyebrows)

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

• Nasopharyngitis

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

Reconstituted BOCOUTURE is a clear, colourless solution.

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

BOCOUTURE must not be used if the reconstituted solution (prepared as above) has a cloudy appearance or contains floccular or particulate matter.

Unopened vial: Do not store above 25 °C. Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C to 8 °C.

Possible dilutions for BOCOUTURE 50 and 100 units are indicated in the following table:

Bronchitis

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Influenza like illness

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Drooping eyebrow (brow ptosis)

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Drooping eyelids (eyelid ptosis)

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Accumulation of fluid in the eyelids (eyelid oedema)

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Discomfort (heavy feeling of eyelid/eyebrow)

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Blurred vision

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Muscle twitching (muscle spasm)

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Asymmetry of eyebrows

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Feeling of tightness at the injection site

Contents of the pack and other information

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Tiredness

What BOCOUTURE contains

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Pain or bruising at the injection site

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Itching

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Bruise

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Skin nodule

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Insomnia

Your doctor or healthcare professional should not use BOCOUTURE if the solution has a cloudy appearance or contains visible particles. Do not throw away any medicines via wastewater. For instructions on disposal, please see information for healthcare professionals at the end of this leaflet.

The active substance is: Botulinum toxin type A (150 kD), free from complexing proteins. BOCOUTURE 50 units  One vial contains 50 units Botulinum toxin type A (150 kD), free from complexing proteins. BOCOUTURE 100 units  One vial contains 100 units Botulinum toxin type A (150 kD), free from complexing proteins. The other ingredients are: human albumin, sucrose.

Lateral Periorbital Lines seen at maximum smile (Crow's feet lines)

•

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

• Eyelid swelling

What BOCOUTURE looks like and contents of the pack BOCOUTURE is presented as a powder for solution for injection (powder for injection). The powder is white.

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Dry eye

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Bruising at the injection site

Upper Facial Lines Common (may affect up to 1 in 10 people):

• Headache Injection site hematoma

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

• Numbness •

Discomfort (heavy feeling of frontal area)

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Eyelid swelling

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Drooping eyelids (eyelid ptosis)

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Dry eye

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Drooping eyebrow (brow ptosis)

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Facial asymmetry

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Mephisto sign (raising of the outer eyebrows)

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Nausea

Manufacturer Merz Pharma GmbH & Co. KGaA Eckenheimer Landstraße 100 60318 Frankfurt am Main Germany This leaflet was last revised in 01/2026. The following information is intended for healthcare professionals only: Instructions for reconstitution of the solution for injection BOCOUTURE is reconstituted prior to use with sodium chloride 9 mg/ml (0.9 %) solution for injection.

The following side effects were reported with unknown frequency for the use of BOCOUTURE since market launch independent from treatment area:

BOCOUTURE may only be applied for its intended use to treat one patient for one session.

The following very rare side effects have been observed during Botulinum toxin type A treatment of conditions other than upper

MN 170003746 MC 520, UK

It is good practice to reconstitute the vial contents and prepare the syringe over plastic-lined paper towels to catch any spillage. An appropriate amount of sodium chloride solution is drawn up into a syringe. A 20-27 gauge needle is recommended for reconstitution. After vertical insertion of the needle through the rubber stopper, the solvent is injected gently into the vial in order to avoid foam formation. The vial must be discarded if

Vial with 100 units

5 units

1 ml

2 ml

4 units

1.25 ml

2.5 ml

Procedure to follow for a safe disposal of vials, syringes and materials used Any unused vials or remaining solution in the vial and/or syringes should be autoclaved. Alternatively, the remaining BOCOUTURE can 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 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 type A •

Any spills of the product must be wiped up: either using absorbent material impregnated with any of the above solutions 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 any of the above solutions, 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.

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 If the product comes into contact with skin, rinse the affected area abundantly with water.

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If product gets into the eyes, rinse thoroughly with plenty of water or with an ophthalmic eyewash solution.

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If product comes into contact with a wound, cut or broken skin, rinse thoroughly with plenty of water and take the appropriate medical steps according to the dose injected.

Marketing Authorisation Holder Merz Pharmaceuticals GmbH 60048 Frankfurt am Main Germany

Vial with 50 units

Any solution for injection that has been stored for more than 24 hours as well as any unused solution for injection should be discarded.

Pack sizes of 1, 2, 3 or 6 vials. Not all pack sizes may be marketed.

Solvent added (sodium chloride 9 mg/ml (0.9 %) solution for injection)

Instructions for disposal

Dissolving the powder produces a clear, colourless solution.

Post-marketing experience

Influenza like illness, shrinkage of injected muscle, and hypersensitivity reactions, such as swelling and swelling of the soft tissue (oedema), also distant from injection site, redness, itching, rash (local and generalised) and breathlessness.

Resulting dose (in units per 0.1 ml)

From a microbiological point of view, 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 and would normally not be longer than 24 hours at 2 °C to 8 °C, unless reconstitution has taken place in controlled and validated aseptic conditions.

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•

the vacuum does not pull the solvent into the vial. Remove the syringe from the vial and mix BOCOUTURE with the solvent by carefully swirling and inverting/flipping the vial – do not shake vigorously. If needed, the needle used for reconstitution should remain in the vial and the required amount of solution should be drawn up with a new sterile syringe suitable for injection.

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