RELFYDESS 100 Units/mL Injectable Solution
How to use RELFYDESS 100 Units/mL Injectable Solution
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Relfydess 100units/mL solution for injection
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, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack
- What is Relfydess and what is it used for
- What you need to know before you use Relfydess
- How to use Relfydess
- Possible side effects
- Storage of Relfydess
- Contents of the pack and other information
1. What is Relfydess and what is it used for
Relfydess contains a substance, botulinum toxin type A, that causes muscles to relax. This medicine works by inhibiting nerve impulses in the muscles into which it is injected, preventing muscle contraction.
Relfydess is indicated for the temporary improvement of moderate to severe vertical lines between the eyebrows (glabellar lines) and lateral periorbital lines of moderate to severe severity (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 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
Indication(s) | Recommended total dose | Dose per injection |
Glabellar lines (GL) | 50 units (0.5 mL) | 5 injections of 10 units (0.1 mL): 2 injections on each side of the corrugator muscle and 1 injection in the procerus muscle near the nasofrontal angle |
Lateral canthal lines (LCL) | 60 units (0.6 mL) | 6 injections of 10 units (0.1 mL): 3 injections on each side of the face in the orbicularis oculi muscle |
Combined treatment of glabellar lines and lateral canthal lines | 110 units (1.1 mL) | 11 total injections of 10 units (0.1 mL) for combined treatment of GL and LCL |
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.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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