Relfydess

Package leaflet: Information for the user

Relfydess 100 units/ml, solution for injection
Botulinum toxin type A
This medicinal product is subject to additional monitoring. This will allow rapid identification of
new safety information. You can also help by reporting any side effects you experience after using
this medicine. For information on how to report side effects – see section 4.
Please read this leaflet carefully before using this medicine, as it contains important information
for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• If you experience any adverse effects after using this medicine, including any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Relfydess is and what it is used for
2. Important information 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 type A, which causes muscle relaxation.
It works by blocking nerve signals to the muscles into which it has been injected, thereby preventing
muscle contraction.
Relfydess is used to temporarily improve the appearance of moderate to severe vertical frown lines
between the eyebrows (glabellar lines) and moderate to severe crow’s feet lines (lateral orbital lines,
also known as crow’s feet). It is used in adults under 65 years of age in whom these dynamic facial
lines significantly affect their well-being.

2. Important information before using Relfydess

Do not use Relfydess:

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

Warnings and precautions
Before starting treatment with Relfydess, discuss with your doctor if you:

• have any neurological disorder,
• are weakened due to lack of strength and energy,
• have breathing difficulties,
• have difficulty swallowing food or frequently experience food or drink entering the airways, causing coughing or choking,
• experienced side effects after previous botulinum toxin injections and/or did not achieve significant improvement in the appearance of wrinkles after the last treatment,
• have inflammation at the proposed injection sites,
• have eye problems, including drooping eyelids and dry eyes,
• have weak muscles or signs of muscle atrophy at the proposed injection site,
• have bleeding disorders, meaning prolonged bleeding, or are taking blood-thinning medications (anticoagulants).

This information will help healthcare professionals make an informed decision regarding the risks and benefits of treatment.
Special warnings
Very rarely, adverse events related to the spread of botulinum toxin beyond the injection site have been reported (e.g., difficulty swallowing, coughing or choking while swallowing, difficulty speaking or breathing). These symptoms have been reported from several hours to several weeks after injection.
If you experience difficulty swallowing, speaking, or breathing, contact your doctor immediately.
Treatment with Relfydess may cause dry eyes. If you experience symptoms of dry eyes (e.g., eye irritation, light sensitivity, or changes in vision), contact your doctor.
Repeated treatment with botulinum toxin may lead to muscle atrophy due to temporary paralysis of treated muscles.
Excessive or too frequent use of botulinum toxin or administration of higher doses may lead to the formation of antibodies. The development of neutralizing antibodies may reduce treatment effectiveness.
Children and adolescents
Relfydess is not recommended for use in children and adolescents under 18 years of age.
Relfydess and other medicines
Inform your doctor about all medicines you are currently using, have recently used, or plan to use.
In particular, inform your doctor if you are taking the following medicines, as they may enhance the effect of Relfydess:

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

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor before using this medicine.
Relfydess must not be used during pregnancy, in reproductive age without using contraception, or during breastfeeding.
Driving and operating machinery
After using Relfydess, temporary visual disturbances or muscle weakness may occur. In such cases, 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, meaning the medicine is considered “potassium-free”.
This medicine contains sodium, less than 1 mmol (23 mg) per 150-unit vial, meaning the medicine is considered “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 of any known allergies.

3. How to use Relfydess

Relfydess must be administered only by a qualified healthcare professional with appropriate training and experience in this treatment, and who has access to the necessary equipment. Relfydess is administered by intramuscular injection at selected sites.

Units of Relfydess are not interchangeable with units used for other botulinum toxin products.

The recommended dosage of Relfydess is:

• For glabellar lines (vertical frown lines between the eyebrows): 50 units (0.5 ml), injected as 10 units (0.1 ml) into each of 5 injection sites in the forehead area above the nose and eyebrows.
• For lateral canthal lines (crow's feet wrinkles): 60 units (0.6 ml), injected as 10 units (0.1 ml) into each of 6 injection sites. The 6 injection sites consist of 3 injections on the right and 3 on the left crow’s feet areas.
• 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 noticeable within a few days after injection and may last up to 6 months. The interval between subsequent treatments with Relfydess is determined by the physician. Treatment should not be performed more frequently than every 3 months.

Accidental overdose of Relfydess
Since this medicine will be administered by a qualified healthcare professional, it is unlikely that the patient will receive an excessive dose. However, if a patient receives more Relfydess than recommended, muscles other than those intended for injection may become weakened. Higher doses may cause difficulty swallowing and speaking, as well as breathing problems. These effects may not occur immediately. If this happens, seek medical help immediately.

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

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Most adverse reactions are mild or moderate and occur within the first month after injection and are temporary.
Seek urgent medical attention if any of the following symptoms occur,
which have been reported very rarely:

• Difficulty breathing, swallowing, or speaking,
• Swelling, including swelling of the face or throat, hives, wheezing, feeling faint or short of breath. These may indicate an allergic reaction to Relfydess.

Inform your doctor if any of the following adverse reactions occur:
Common (occurring in up to 1 in 10 people)

• Reactions at the injection site such as bruising, pain, itching, redness, swelling, discomfort, tenderness, sensation of warmth
• Headache
• Drooping of the upper eyelid

Uncommon (occurring in more than 1 in 100 people)

• Muscle weakness
• Muscle twitching
• Drooping brow
• Allergic reaction such as asthma or widespread urticaria
• Local allergic reaction, e.g., urticaria
• Blurred vision
• Dry eyes
• Eye fatigue
• Eyelid swelling

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-02-222 Warsaw,
Tel.: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder or its representative.
Reporting adverse reactions helps 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 and carton after {EXP}. The expiry date refers to the last day of the stated month.
Store the medicine in a refrigerator, at a temperature of (2°C – 8°C). Do not freeze. Keep the vial in the outer packaging to protect it from light.
An unopened vial may be kept at room temperature (up to 25°C) and protected from light. Relfydess medicine (unopened vial) has been shown to be stable for up to 24 hours at room temperature.

6. Contents of the pack 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 for injection.
• The other ingredients are: disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, potassium chloride, sodium chloride, polysorbate 80, L-tryptophan and water for injections (see section 2: Relfydess contains potassium, sodium and polysorbate).

What Relfydess looks like and contents of the pack
Relfydess is a clear, colourless to pale yellow solution for injection.
It is available in packs containing 1 or 10 glass vials, each containing 1.5 ml of solution for injection.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ipsen Pharma
65 Quai Georges Gorse
F-92100 Boulogne-Billancourt
France
Manufacturer
Q-Med AB
Seminariegatan 21
752 28 Uppsala
Sweden

Information intended exclusively for medical professionals:

Dosage and administration
Relfydess should be administered only by healthcare professionals with appropriate qualifications and experience in this type of treatment, and who have access to the required equipment, in accordance with national guidelines and regulations.
The dosage units of Relfydess are not interchangeable with dosage units used for other botulinum toxin products.
Relfydess is ready for use at a concentration of 10 units per 0.1 ml and does not require reconstitution.
Each vial should be used for only one patient during a single treatment session. Any remaining product after the procedure must be discarded.
Table 1: Dosing instructions for Relfydess

Dosage and treatment intervals depend on the individual assessment of the patient's response, but must not exceed the maximum recommended doses or the minimum interval of 12 weeks.

To improve traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

Special precautions for disposal and handling

Strictly follow instructions for use, handling, and disposal.

RECOMMENDATIONS FOR DISPOSAL OF CONTAMINATED MATERIAL

Immediately after use and prior to disposal, any unused Relfydess product (which may be in a vial or syringe) should be inactivated with a diluted sodium hypochlorite solution (0.1% NaOCl) or a sodium hydroxide solution (1% NaOH). Used vials, syringes, and materials must not be emptied and should be discarded into appropriate containers and disposed of in accordance with local requirements.

RECOMMENDATIONS IN CASE OF ANY INCIDENT DURING ADMINISTRATION OF BOTULINUM TOXIN

• Any product leaks should be wiped with a dry, absorbent material. The material should be disposed of in accordance with local requirements.
• Contaminated surfaces should be cleaned with a diluted solution of sodium hypochlorite or sodium hydroxide, then dried.
• In case of broken vial, follow the procedure described above, carefully collecting the broken glass pieces and wiping up the product, avoiding skin cuts.
• If the product comes into contact with the skin, wash the affected area thoroughly with soap and water.
• If the product gets into the eyes, rinse them thoroughly with large amounts of water or ophthalmic irrigation solution.
• If the product contacts a wound, cut, or damaged skin, rinse thoroughly with large amounts of water and contact a physician.

Strictly follow instructions for use, handling, and disposal.