Relfydess 100 units/ml solution for injection

Patient Information Leaflet

Introduction

Patient Information Leaflet

Relfydess 100 units/mL injectable solution

Botulinum toxin type A

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. 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 a substance, botulinum toxin A, which causes muscles to relax. This medicine works by inhibiting nerve impulses to the muscles into which it is injected, thereby preventing muscle contraction.

Relfydess is indicated for the temporary improvement in 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 used in adults under 65 years of age when these facial lines have a significant impact on the patient's well-being.

2. What you need to know 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 you have an infection at the proposed injection site
• if you have myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis (chronic diseases affecting muscles)

Warnings and precautions

Talk to your doctor before starting to use Relfydess:

• if you have any disorder affecting your nervous system
• if you feel weak, lacking strength and energy
• if you have difficulty breathing
• if you have difficulty swallowing food, or frequently have problems with food or drink going into your airways, causing choking or coughing
• if you 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(s)
• if you have eye problems, including dry eye or drooping eyelids
• if the muscles to be injected are weak or show signs of atrophy
• if you have a bleeding disorder, meaning you may bleed more than normal, or if you are taking anticoagulant medications

This information will help your doctor assess the risks and benefits of your treatment.

Special precautions

Very rarely, botulinum toxin may produce adverse effects away from the injection site and cause botulism (e.g., double vision, blurred vision and/or drooping eyelids, excessive muscle weakness, difficulty swallowing, coughing, choking, difficulty speaking or breathing). These symptoms have been observed 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 experience symptoms of dry eye (such as eye irritation, light sensitivity, 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 at excessive doses, it may lead to antibody formation. The development of neutralizing antibodies may reduce the effectiveness of treatment.

Children and adolescents

The use of Relfydess is not recommended in individuals under 18 years of age.

Other medicines and Relfydess

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor about 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 or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

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

Driving and use of machines

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 medicine contains potassium, less than 1 mmol of potassium (39 mg) per 150-unit vial; hence, essentially “potassium-free”.

This medicine contains less than 1 mmol of sodium (23 mg) per 150-unit vial; hence, 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 any allergies.

3. How to use Relfydess

Relfydess should only be administered by physicians with appropriate qualifications and experience in this treatment and who have access to suitable equipment. Your doctor will inject Relfydess into the muscles targeted for treatment.

The units of Relfydess 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 receive 10 units (0.1 mL) injected at each of 5 injection sites located in the forehead area above the nose and eyebrows.
• For lateral lines at the corners of the eyes: 60 units (0.6 mL). You will receive 10 units (0.1 mL) injected at each of 6 injection sites. These 6 injection sites include 3 sites 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 eye lines, for a total of 110 units (1.1 mL).

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

If you are given more Relfydess than you should

Since the treatment is administered by a qualified and experienced physician, it is unlikely that you will receive too much medication. However, if you receive more Relfydess than required, other muscles not targeted by the treatment may begin to weaken. Excessive doses may cause difficulty in swallowing, speaking, or breathing. These effects may not occur immediately. If you experience any of these symptoms, inform your doctor as soon as possible.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Usually, side effects occur during the first month after injection, are transient, and range from mild to moderate.

Seek urgent medical attention if you:

• Experience difficulty breathing, swallowing, or speaking
• Develop swelling, including swelling of the face or throat, hives, wheezing, dizziness, or shortness of breath. You may be having an allergic reaction to Relfydess.

Tell 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 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 eyebrow
• Allergic reaction, such as asthma or generalized hives
• Local allergic reaction, such as hives
• Blurred vision
• Dry eyes
• Eye fatigue
• Swelling of the eyelid

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse 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 stated on the label. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (2 °C – 8 °C). Do not freeze. Keep 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 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 injectable solution.
• 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 of the product and contents of the pack

Relfydess is a clear, colourless to pale yellow injectable solution.

It is available in individual packs of 1 or 10 glass vials containing 1.5 mL of injectable solution.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Ipsen Pharma
70 rue Balard
75015 Paris
France

Manufacturer:

Q-Med AB
Seminariegatan 21
752 28 Uppsala
Sweden

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Local representative:

Laboratorios Galderma SA
Serrano Galvache, 56
28033 Madrid - Spain
Tel: 902 02 75 95

Date of the most recent review of this leaflet: March 2026

Other sources of information

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

This information is intended for healthcare professionals only:

Posology and method of administration:

Relfydess must only be administered by physicians with appropriate qualifications and experience in this treatment, and who have access to 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 supplied ready for use at a concentration of 10 units per 0.1 mL and does not require reconstitution.

Each vial is intended for use in a single patient during one treatment session only. Any residual product must be discarded.

Table 1: Instructions for Relfydess dosing

The dosage and treatment interval depend on the individual response of each patient, but must not exceed the maximum permitted doses or the minimum interval of 12 weeks.

The name and batch number of the administered product must be clearly recorded to ensure traceability of biological medicinal products.

Special precautions for disposal and other handling

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

RECOMMENDATIONS FOR DISPOSAL OF CONTAMINATED MATERIALS

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

RECOMMENDATIONS IN CASE OF ACCIDENT DURING HANDLING OF BOTULINUM TOXIN

• Any spilled amount of Relfydess should be cleaned up using a dry absorbent cloth. This material must be disposed of in accordance with local requirements.
• Contaminated surfaces should be cleaned with a diluted sodium hypochlorite solution or a sodium hydroxide solution, then dried.
• If a vial breaks, proceed as indicated above, carefully collecting glass fragments and cleaning up the product, taking care to avoid cuts from broken glass.
• 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, carefully rinse with abundant water or an ophthalmic cleaning solution.
• If the product comes into contact with a wound, cut, or abraded skin, carefully clean with abundant water and seek medical attention.

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