RELFYDESS 100 Units/mL Injectable Solution

2. What you need to know before you use Relfydess

Do not useRelfydess:

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

Warnings and precautions

Consult your doctor before starting treatment with Relfydess:

• if you have any disorder that affects your nervous system
• if you feel weak, lack strength and energy
• if you have difficulty breathing
• if you have difficulty swallowing food or often have problems with food or drink entering your airways, causing choking or coughing
• if you have previously experienced side effects with other botulinum toxin injections and/or have not experienced significant improvement after the last treatment
• if you have any inflammation at the proposed injection site
• if you have eye problems, including dry eye and drooping eyelids
• if the muscles to be injected are weak or show signs of atrophy
• if you have any coagulation disorder, meaning you may bleed more than normal, or are taking anticoagulant medications

This information will help your doctor make a decision about the risks and benefits of your treatment.

Special precautions

Very rarely, botulinum toxin can cause side effects far from the injection site (e.g., difficulty swallowing, coughing, and choking, difficulty speaking or breathing). These symptoms have been observed from hours to weeks after injection.

Seek medical attention immediately if you experience difficulty swallowing, speaking, or breathing.

The use of Relfydess may cause dry eyes. If you experience symptoms of dry eyes (such as eye irritation, sensitivity to light, or visual changes), consult your doctor.

Repeated treatments with botulinum toxin may result in muscle atrophy due to temporary paralysis of the treated muscles.

When botulinum toxin has been used at too frequent intervals or with excessive doses, it can lead to the formation of antibodies. The formation of neutralizing antibodies can reduce the effectiveness of treatment.

Children and adolescents

Relfydess is not recommended for use in persons under 18 years of age.

Other medicines and Relfydess

Tell your doctor if you are taking, have recently taken, or might take any other medicines. In particular, tell your doctor about the following medicines, as they may increase the effect of Relfydess:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Relfydess should not be used during pregnancy, or in women of childbearing potential who are not using contraceptive methods or are breastfeeding.

Driving and using machines

You may experience blurred vision or temporary muscle weakness after treatment with Relfydess. If this happens, do not drive or use machines.

Relfydess contains potassium, sodium, and polysorbate

This medicine contains potassium, less than 1 mmol of potassium (39 mg) per vial of 150 units; this is essentially "potassium-free".

This medicine contains less than 1 mmol of sodium (23 mg) per vial of 150 units; this is essentially "sodium-free".

This medicine contains 1.6 mg of polysorbate 80 per vial of 150 units, which is equivalent to 1.1 mg/mL. Polysorbates can cause allergic reactions. Tell your doctor if you have any allergies.

3. How to use Relfydess

Relfydess should only be administered by doctors with the appropriate qualification and experience in this treatment and who have the appropriate equipment. Your doctor will inject Relfydess into the muscles intended for treatment.

The units of Relfydess are specific and are not interchangeable with other botulinum toxin preparations.

The recommended dose of Relfydess is:

• For vertical lines between the eyebrows: 50 units (0.5 mL). You will be injected with 10 units (0.1 mL) at each of the 5 injection points located on the forehead above your nose and eyebrows.
• For lateral canthal lines around the eyes:60 units (0.6 mL). You will be injected with 10 units (0.1 mL) at each of the 6 injection points. These 6 injection points include 3 injection points on each side of the face, in the crow's feet area.
• For combined treatment: the same doses are recommended, i.e., 50 units for the treatment of glabellar lines and 60 units for the treatment of lateral canthal lines, for a total of 110 units (1.1 mL).

The effect of the treatment usually occurs within a few days after injection and can last 6 months. The interval between Relfydess treatments will be decided by your doctor. The interval between two treatments should not be less than 3 months.

If you use more Relfydess than you should

Since the treatment is administered by a doctor with the appropriate qualification and experience, it is unlikely that you will be given too much medicine. However, if you receive more Relfydess than necessary, other muscles different from those treated may begin to weaken. Excessive doses can cause difficulty swallowing, speaking, and breathing problems. This may not happen immediately. If these symptoms appear, inform your doctor as soon as possible.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Normally, side effects occur within the first month after injection, are transient, and are mild to moderate.

Seek urgent medical attention if:

• You experience difficulty breathing, swallowing, or speaking
• You have inflammation, including inflammation of the face or throat, hives, wheezing, feeling faint, or shortness of breath. You may be experiencing an allergic reaction to Relfydess.

Tell your doctor if you experience 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, heat
• Headache
• Drooping eyelid

Uncommon (may affect up to 1 in 100 people)

• Muscle weakness
• Muscle spasms
• Eyebrow drooping
• Allergic reaction, such as asthma or generalized hives
• Local allergic reaction, such as hives
• Blurred vision
• Dry eyes
• Eyestrain
• Eyelid swelling

Reporting of side effects:

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Relfydess

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

Do not use this medicine after the expiry date which is stated on the label. The expiry date is the last day of the month stated.

Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the vials in the outer packaging to protect them from light.

Unopened vials can be stored at 25°C and protected from light. Relfydess (unopened vial) has demonstrated stability for up to 24 hours at room temperature.

6. Contents of the pack and other information

Composition of Relfydess

• 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 excipients 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).

Appearance and pack size

Relfydess is a clear, colorless to pale yellow solution for injection.

It comes in a single pack of 1 or 10 glass vials containing 1.5 mL of solution for injection.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Ipsen Pharma

70 rue Balard

75015 Paris

France

Manufacturer:

Q-Med AB

Seminariegatan 21

752 28 Uppsala

Sweden

You can request more information about this medicine from the local representative of the Marketing Authorization Holder:

Local representative:

Laboratorios Galderma SA

Serrano Galvache, 56.

28033 Madrid - Spain

Tel: 902 02 75 95

Date of last revision of this leaflet:July 2024

Other sources of information

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

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This information is intended only for healthcare professionals:

Dosage and administration:

Relfydess should only be administered by doctors with the appropriate qualification and experience in this treatment and who have the appropriate equipment, in accordance with national legislation and guidelines.

The units of Relfydess are specific and are not interchangeable with other botulinum toxin preparations.

Relfydess is prepared for use with a concentration of 10 units per 0.1 mL and does not require reconstitution.

Each vial is intended for a single patient in a single treatment session. Any residual product should be discarded.

Table 1:Relfydess dosing instructions

The dosing and treatment interval depend on the individual response of each patient, but should not exceed the maximum allowed doses or the minimum interval of 12 weeks.

The name and batch number of the product administered should be clearly recorded to ensure the traceability of biological medicines.

Special precautions for disposal and other handling

Instructions for use, handling, and disposal should be strictly followed.

RECOMMENDATIONS FOR THE DISPOSAL OF CONTAMINATED MATERIALS

Immediatelyafter treatment and before disposal, any remaining Relfydess (in the vial or syringe) should be inactivated with a diluted solution of sodium hypochlorite (0.1% NaClO) or sodium hydroxide solution (1% NaOH). Used vials, syringes, and materials should not be emptied and should be disposed of in accordance with local requirements.

RECOMMENDATIONS IN CASE OF ACCIDENT DURING HANDLING OF BOTULINUM TOXIN

• Any spilled Relfydess should be cleaned up with a dry absorbent cloth. This 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 solution and then dried.
• If a vial is broken, proceed as indicated above, carefully collecting the glass fragments and cleaning the product, avoiding cuts with the broken glass.
• If the product comes into contact with the skin, wash the affected area with water and soap.
• If the product comes into contact with the eyes, rinse carefully with plenty of water or an eye cleaning solution.
• If the product comes into contact with a wound, cut, or broken skin, rinse carefully with plenty of water and seek medical attention.

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