Relfyd Ess

Package leaflet: Information for the patient

Relfydess 100 units/mL solution for injection

botulinum toxin type A
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please 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 or pharmacist.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Relfydess is and what it is used for

Relfydess contains the active substance botulinum toxin A, which causes muscle relaxation.
It works by inhibiting nerve impulses to the muscles into which it has been injected, thereby preventing the muscles from
contracting.
Relfydess is used to temporarily improve the appearance of moderate to severe vertical lines between the eyebrows
(glabellar lines) and moderate to severe lines at the outer corners of the eyes (lateral canthal lines, also known as crow's feet). It is used in adults under 65 years of age in whom these facial lines have a significant impact on their
well-being.

2. What you should know before using Relfydess

Do not administer a Relfydess injection if:

• you are allergic to botulinum toxin or to any of the other ingredients of this medicine (listed in section 6).
• you have an infection at the proposed injection sites.
• you have myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis (chronic diseases affecting the muscles).

Warnings and precautions
Talk to your doctor before receiving a Relfydess injection if:

• you have any disease affecting the nervous system
• you are debilitated, with lack of strength and energy
• you have difficulty breathing
• you have difficulty swallowing food, or frequently experience food or drinks entering the airways, causing coughing or choking
• you have experienced side effects from previous botulinum toxin injections and/or did not achieve significant improvement in your wrinkles after the last treatment
• you have inflammation at the proposed injection site(s)
• you have eye problems, including drooping eyelids and dry eyes
• the muscles at the proposed injection site are weak or show signs of wasting
• you have a bleeding disorder, meaning you continue to bleed longer than normal, or you are taking medications to thin the blood (anticoagulants)

These details will help the healthcare provider make an informed decision about the risks and benefits of treatment.
Special warnings
Very rare cases of side effects possibly related to the spread of botulinum toxin effects beyond the injection site and cases of botulism have been reported with botulinum toxin (e.g., double vision, blurred vision and/or drooping eyelids, excessive muscle weakness, difficulty swallowing, coughing and choking during swallowing, difficulty speaking or breathing). These symptoms have been reported from hours to weeks after injection.
Seek immediate medical attention if you experience difficulty swallowing, speaking, or breathing.
Use of Relfydess may cause dry eyes. If you develop symptoms of dry eyes (e.g., eye irritation, light sensitivity, or visual disturbances), consult your doctor.
Repeated treatment with botulinum toxin may lead to muscle atrophy due to temporary paralysis of the treated muscles.
Too frequent use or higher doses of botulinum toxins may lead to antibody formation. The development of neutralizing antibodies may reduce the effectiveness of treatment.
Children and adolescents
Relfydess is not recommended for use in children and adolescents under 18 years of age.
Other medicines and Relfydess
Inform your doctor if you are using, have recently used, or might use any other medicines.
In particular, inform your doctor if you are taking the following medicines, as they may increase the effect of Relfydess:

• certain antibiotics used to treat infections (e.g., aminoglycosides)
• other muscle relaxants
• other medicines containing botulinum toxin.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Relfydess must not be used during pregnancy, if you are of childbearing potential and not using contraception, or if you are breastfeeding.
Driving and use of machines
After treatment with Relfydess, you may experience temporary visual disturbances or muscle weakness. If this occurs, do not drive or operate machinery.
Relfydess contains potassium, sodium, and polysorbate.
This medicine contains potassium: less than 1 mmol (39 mg) per 150-unit vial, i.e., essentially "potassium-free".
This medicine contains less than 1 mmol (23 mg) of sodium per 150-unit vial, i.e., essentially "sodium-free".
This medicine contains 1.6 mg of polysorbate 80 per 150-unit vial, equivalent to 1.1 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Relfydess

Relfydess must be administered exclusively by a qualified healthcare professional with appropriate training and experience in this treatment, and who has access to the necessary equipment. Relfydess will be administered as intramuscular injections at the designated sites.

The dose units of Relfydess are not interchangeable with those used for other botulinum toxin-containing products.

The recommended dose for Relfydess is:

• For glabellar lines (vertical frown lines between the eyebrows): 50 units (0.5 mL), injected as 10 units (0.1 mL) at each of 5 injection sites in the forehead, in the area above the nose and eyebrows.
• For lateral periorbital lines (crow’s feet wrinkles at the outer corners of the eyes): 60 units (0.6 mL), injected as 10 units (0.1 mL) at each of 6 injection sites. The 6 injection sites include 3 injections in each of the crow’s feet areas, on both the right and left sides.
• For combined treatment: the same doses are recommended, i.e., 50 units for glabellar lines and 60 units for lateral canthal lines, for a total dose of 110 units (1.1 mL).

The effect of treatment should become visible within a few days after injection and may last up to 6 months. The interval between Relfydess treatments will be determined by the physician. Treatment must not be performed more frequently than every 3 months.

If you receive more Relfydess than you should

Since this medicine will be administered by a qualified and experienced healthcare professional, it is unlikely that an excessive amount will be given. However, if you are administered more Relfydess than needed, muscles other than those injected may begin to weaken. Excessive doses may cause difficulty in swallowing and speaking, as well as breathing problems. These effects may not occur immediately. If such events occur, seek medical attention immediately.

If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them. Most of the side effects are mild or moderate and occur within the first month after injection; they are temporary.
Contact a doctor urgently if you experience any of the following symptoms, which have been reported very rarely:

• Difficulty breathing, swallowing, or speaking.
• Swelling, including swelling of the face or throat, hives, wheezing, feeling faint, and shortness of breath. This may mean you are having an allergic reaction to Relfydess.

Tell your doctor if you notice any of the following side effects:
Common (may affect up to 1 in 10 people)

• Injection site reactions such as bruising, pain, itching, redness, swelling, discomfort, hypersensitivity, warmth.
• Headache
• Drooping of the upper eyelid.

Uncommon (may affect up to 1 in 100 people)

• Muscle weakness
• Muscle spasm
• Drooping of the eyebrow
• Allergic reaction, such as asthma or widespread hives
• Local allergic reaction, such as hives
• Blurred vision
• Dry eyes
• Eye fatigue
• Swelling of the eyelids.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Relfydess

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vial in the outer packaging to protect it from light.
The unopened vial may be brought to room temperature (up to 25°C) and protected from light. The stability of Relfydess (unopened vial) has been demonstrated for up to 24 hours at room temperature.

6. Package contents and other information

What Relfydess contains

• The active substance is botulinum toxin type A, 100 units/mL. One vial contains 150 units in 1.5 mL of solution.
• The other excipients are: disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, potassium chloride, sodium chloride, polysorbate 80, tryptophan, and water for injections (see section 2: Relfydess contains potassium, sodium, and polysorbate).

Description of the appearance of Relfydess and contents of the pack
Relfydess is a clear, colourless to pale yellow injectable solution (injection). It is available in packs containing 1 or 10 glass vials, each containing 1.5 mL of injectable solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ipsen Pharma
70 rue Balard
75015 Paris
France
Local representative:
Galderma Italia S.p.A.
Via Manara Luciano, 15
20122 Milano
Italy

Manufacturer:
Q-Med AB
Seminariegatan 21
752 28 Uppsala
Sweden

The following information is intended exclusively for physicians or healthcare professionals:

Dosage and method of administration:
Relfydess must be administered only by healthcare professionals with appropriate qualifications and experience in treatment, and equipped with the necessary equipment, in accordance with current local guidelines and regulations.
The potency units are specific to Relfydess and are not interchangeable with those of other botulinum toxin-containing preparations.
Relfydess is ready for use at a concentration of 10 units per 0.1 mL and does not require reconstitution.
Each vial must be used for a single patient during a single treatment session. Any unused product remaining after treatment must be discarded.

Table 1: Dosing instructions for Relfydess

The dosage and treatment intervals depend on the assessment of the individual patient's response, but must not exceed the maximum permitted doses or the minimum interval of 12 weeks.
To improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product must be clearly recorded.
Special precautions for disposal and handling
Instructions for use, handling, and disposal must be strictly followed.
RECOMMENDATIONS FOR DISPOSAL OF CONTAMINATED MATERIALS
Immediately after use and prior to disposal, any unused Relfydess (which may be present in the vial or syringe) must be inactivated with a diluted solution of sodium hypochlorite (0.1% NaOCl) or sodium hydroxide solution (1% NaOH). Vials, syringes, and used materials must not be emptied and must be discarded into appropriate containers and disposed of in accordance with local regulations.
RECOMMENDATIONS IN CASE OF INCIDENTS DURING HANDLING OF BOTULINUM TOXIN

• Any product spills should be cleaned up using dry, absorbent material. The material must be disposed of in accordance with applicable local regulations.
• Contaminated surfaces must be cleaned using a diluted solution of sodium hypochlorite or sodium hydroxide and then dried.
• If a vial breaks, follow the procedure described above, carefully collecting glass fragments and drying up the product, taking care not to cause injury.
• If the product comes into contact with the skin, wash the affected area thoroughly with water and soap.
• If the product comes into contact with the eyes, rinse thoroughly with abundant water or an ophthalmic irrigation solution.
• If the product comes into contact with a wound, cut, or skin lesion, rinse thoroughly with abundant water and seek medical assistance.

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