Prospecto: information for the user

Relfydess 100units/mL injectable solution

Botulinum toxin type A

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What Relfydess is and for what it is used

2.What you need to know before starting to use Relfydess

3.How to use Relfydess

4.Possible adverse effects

5.Storage of Relfydess

6.Contents of the package and additional information

Relfydesscontains a substance, botulinum toxin A, which causes muscles to relax.This medication acts by inhibiting nerve impulses in the muscles into which it is injected, preventing muscle contraction.

Relfydess is indicated to temporarily improve the appearance of moderate to severe vertical lines between the eyebrows (glabellar lines) and moderate to severe lateral periorbital lines (lateral canthal lines, also known as crow's feet). It is usedin adults under 65years of age, when these facial lines have a significant impact on the patient's well-being.

Do not useRelfydess:

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

Warnings and precautions

Consult your doctor before starting to use Relfydess:

• if you have any disorder that affects your nervous system
• if you feel weak, lack of strength and energy
• if you have difficulty breathing
• if you have difficulty swallowing food or, often, have problems with food or drink because it enters your respiratory tract causing choking or coughing
• if you have previously experienced adverse effects with other botulinum toxin injections and/or did not experience 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 where you are going to inject are weak or show signs of atrophy
• if you have any coagulation disorder, which means 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 adverse effects away 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 eye. If you experience symptoms of dry eye (such as eye irritation, sensitivity to light or visual changes) consult your doctor.

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

When botulinum toxin is used at too frequent intervals or with excessive doses, it may lead to the formation of antibodies.Antibody formation can reduce the effectiveness of treatment.

Children and adolescents

Relfydess is not recommended for use in people under 18 years old.

Other medications and Relfydess

Inform your doctor if you are taking, have taken recently or may need to take any other medication. In particular, inform your doctor of the following medications as they may increase the effect of Relfydess:

• certains antibiotics to treat infections (e.g.: aminoglycosides)
• other muscle relaxants
• other medications containing botulinum toxin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor before using this medication.

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

Driving and operating machinery

You may experience blurred vision or temporary muscle weakness after treatment with Relfydess. If this occurs, do not drive or operate machinery.

Relfydess contains potassium, sodium, and polysorbate

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

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

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

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

Relfydess units 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). They will inject 10 units (0.1 mL) into each of the 5 injection points located on your forehead above your nose and eyebrows.
• For lines at the lateral canthus of your eyes:60 units (0.6 mL). They will inject 10 units (0.1 mL) into each of the 6 injection points. These 6 injection points include 3 injection points on each side of the face, in the area of the crow's feet.
• For combined treatment: the same doses are recommended, that is, 50 units for the treatment of glabellar lines and 60 units for the treatment of the lateral canthus, a total of 110 units (1.1 mL).

The effect of the treatment usually occurs 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 necessary qualifications and experience, it is unlikely that you will receive too much medication. However, if you receive more Relfydess than necessary,other muscles different from those treated may begin to weaken.Excessive doses may cause difficulty swallowing, speaking, and breathing problems. This may not occur immediately. If you experience these symptoms, inform your doctor as soon as possible.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them. Normally, side effects occur in the first month after injection, are transient, and of mild to moderate severity.

Seek urgent medical assistance if:

• Experiences difficulty breathing, swallowing, or speaking
• Inflammation, including facial or throat inflammation, urticaria, wheezing, dizziness, or shortness of breath.You may be experiencing an allergic reaction toRelfydess.

Inform your doctor if you experience any of the following adverse effects:

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

• Reactions at the injection site, such as redness, pain, itching, swelling, tenderness, hypersensitivity, warmth
• Headache
• Upper eyelid drooping.

Rare (may affect up to 1 in 100 people))

• Muscle weakness
• Muscle spasm
• Upper eyelid drooping
• Allergic reaction, such as asthma or generalized urticaria
• Local allergic reaction, such as urticaria
• Blurred vision
• Dry eyes
• Ocular fatigue
• Puffiness of the eyelid.

Reporting Adverse Effects:

Ifyou experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance for Medicinal Products for Human Use:https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date shown on the label. The expiration date is the last day of the month indicated.

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

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

Composition of Relfydess

• The active principle is botulinum toxin type A, 100units/mL. A vial contains 150units in 1.5 mL of injectable solution.
• The other excipients are: dihydrogen phosphate dihydrate of sodium, dihydrogen phosphate dihydrate of sodium, potassium chloride, sodium chloride, polisorbate80, L‑tryptophan and water for injectable preparations (see section 2 Relfydess contains potassium, sodium and polisorbate).

Aspect of the product and content of the packaging

Relfydess is a transparent, colorless to pale yellow injectable solution.

It comes in an individual packaging of 1 or 10 glass vials containing 1.5 mL of injectable solution.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Ipsen Pharma

65 quai Georges Gorse

92100 Boulogne-Billancourt

France

Responsible for manufacturing:

Q-Med AB

Seminariegatan 21

752 28 Uppsala

Sweden

You can request more information about this medication by contacting the local representative of the Holder of the Marketing Authorization:

Local Representative:

Laboratorios Galderma SA

Serrano Galvache, 56.

28033 Madrid - Spain

Phone: 902 02 75 95

Last review date of this leaflet:July 2024

Other sources of information

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

------------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

Dosage and administration:

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

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

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 remaining product should be discarded.

Table 1:Dosage instructions for Relfydess

The dosage and treatment interval depend on the individual response of each patient, but should not exceed the maximum permitted 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 manipulations

Strictly follow the usage, handling and disposal instructions.

RECOMMENDATIONS FOR DISPOSAL OF CONTAMINATED MATERIALS

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

RECOMMENDATIONS IN CASE OF ACCIDENT DURING HANDLING OF BOTULINUM TOXIN

• Any amount ofRelfydessthat has been spilled must be cleaned up with a dry absorbent cloth.The material should be disposed of in accordance with local requirements.
• Contaminated surfaces should be cleanedwith diluted sodium hypochlorite solution or sodium hydroxide solution and then dried.
• If a vial is broken, proceed as indicated above, carefully collecting the broken glass fragments and cleaning the product, avoiding cutting yourself on the broken glass..
• If the product comes into contact with the skin, wash the affected area withwater and soap.
• If the product comes into contact with the eyes, clean it carefully with plenty of water or with an eye cleaning solution.

If the product comes into contact with a wound, cut or raised skin, clean it carefully with plenty of water and seek medical attention.

These usage, handling and disposal instructions should be strictly followed.