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RELFYDESS 100 Units/mL Injectable Solution

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About the medicine

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

  1. What is Relfydess and what is it used for
  2. What you need to know before you use Relfydess
  3. How to use Relfydess
  4. Possible side effects
  5. Storage of Relfydess
  6. 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.

Doctor consultation

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Discuss your symptoms and treatment with a doctor online.

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.

Medicine questions

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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.

Online doctors for RELFYDESS 100 Units/mL Injectable Solution

Discuss questions about RELFYDESS 100 Units/mL Injectable Solution, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Chikeluo Okeke

General medicine 4 years exp.

Dr Chikeluo Okeke is an internal medicine doctor with extensive international clinical experience. Originally from Nigeria, he has worked across multiple European healthcare systems and currently practises in Sweden. This professional path has given him a strong understanding of different medical approaches and the ability to work effectively with patients from diverse cultural and linguistic backgrounds.

Dr Okeke focuses on general internal medicine and adult primary care, combining clinical accuracy with careful attention to lifestyle, personal context, and everyday health concerns. His consultations are particularly well suited for people who seek medical advice online, live abroad, or need clear guidance without unnecessary complexity.

He provides online consultations covering symptom assessment, prevention, and long-term management of chronic conditions, helping patients understand what is happening and decide on appropriate next steps.

Common reasons for consultation:

  • General internal medicine concerns and initial health assessment.
  • Acute symptoms such as fever, cough, infections, pain, or weakness.
  • Chronic conditions and treatment adjustment.
  • Blood pressure issues, fatigue, metabolic concerns.
  • Preventive consultations and routine check-ups.
  • Interpretation of laboratory results and medical reports.
  • Medical advice for patients receiving care online.

Dr Okeke is known for his clear communication, calm approach, and cultural awareness. He listens carefully, explains medical decisions in a structured way, and supports patients in making informed choices about their health.

Online consultations with Dr Chikeluo Okeke offer reliable internal medicine care without geographic limitations, focused on medical relevance, clarity, and patient comfort.

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Andrei Popov

General medicine 7 years exp.

Dr. Andrei Popov is a family physician with specialized training in the management of chronic pain. He provides video consultations for adults in Spain and across Europe: whether you have been living with pain for months that no one has been able to properly explain, or you need to resolve a health issue without waiting weeks for an appointment.

His approach is clear: to listen, organize your case, and provide you with a practical roadmap based on evidence-based medicine and adapted to your medical history and personal needs.

Pain: how he can help

  • Chronic pain (more than 3 months
  • Migraine and recurrent or high-intensity headaches
  •  Neck, lower back, back and joint pain
  •  Post-traumatic pain after injuries or surgeries
  •  Pain of neurological origin: neuralgia, neuropathic pain, fibromyalgia

General medicine

  • Frequent respiratory infections (cold, flu, persistent cough)
  • Hypertension, diabetes and metabolic disorders
  • Review of laboratory tests and MRI/CT reports (explained in clear language)
  • Preventive medicine and health monitoring
  • Second opinions and treatment adjustments (when clinically appropriate)

What the consultation is like
 Each session lasts up to 30 minutes. We review symptoms, medical history, medications and any tests you provide, and you finish the consultation with a clear treatment plan, defined next steps, and criteria to understand when follow-up may be needed. If warning signs are detected, he will clearly advise whether you need in-person care or urgent medical attention.

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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Doctor

Joao Silva

General medicine 6 years exp.

Dr. João Silva is a physician with training and experience in the field of General and Family Medicine, dedicated to providing healthcare focused on the well-being and quality of life of his patients. Throughout his professional career, he has developed broad clinical competencies, striving to maintain a medical practice based on scientific evidence and continuous knowledge updates.

Between 2013 and 2019, he completed the Integrated Master's Degree in Medicine at the Abel Salazar Institute of Biomedical Sciences in Porto, where he acquired a solid academic and clinical education.

Subsequently, between January 2021 and December 2021, he completed the General Internship at the Entre Douro e Vouga Hospital Center in Santa Maria da Feira, where he had the opportunity to work in different hospital settings and deepen his competencies in several areas of medicine.

From January 2022 until March 2026, he works as a Resident Physician in General and Family Medicine at USF Salvador Machado in Oliveira de Azeméis, developing clinical activities in primary healthcare, follow-up of chronic patients, and health promotion in the community.

Complementing his medical training, Dr. João Silva also completed a Postgraduate Degree in Continuing and Palliative Care at CESPU, strengthening his preparation in the comprehensive approach to patient care, especially in situations requiring prolonged care and multidisciplinary support.

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Doctor

Bulat Garipov

General medicine 15 years exp.

Dr. Bulat Garipov is a radiologist with more than 15 years of experience, specializing in magnetic resonance imaging (MRI). Throughout his professional career, he has worked in leading diagnostic imaging centers, both in on-site practice and teleradiology, which has allowed him to develop a broad and versatile approach to radiology.

Over the years, he has gained solid experience in interpreting MRI studies in various areas, including:

  •  Neuroimaging
  •  Musculoskeletal system (MSK)
  •  Angiography
  •  Abdomen and pelvis
  •  Soft tissues

Additionally, Dr. Garipov is open to new collaboration opportunities in radiology and teleradiology projects. He offers his expertise in MRI, providing both first and second readings of studies, as well as advanced image interpretation, ensuring accurate and high-quality diagnostics.

You could consult Dr. Bulat Garipov in cases where accurate interpretation of MRI studies or a second expert opinion is required. His expertise is especially valuable in cases of suspected neurological conditions, back and joint pain, vascular disorders, as well as in the diagnosis of abdominal and pelvic diseases. The doctor also provides support in complex or unclear clinical situations, including the review of previously performed studies, which helps improve diagnostic accuracy and determine the optimal treatment strategy. A teleradiology format is available, allowing you to receive a professional opinion remotely.

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Frequently Asked Questions

Is a prescription required for RELFYDESS 100 Units/mL Injectable Solution?
RELFYDESS 100 Units/mL Injectable Solution requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in RELFYDESS 100 Units/mL Injectable Solution?
The active ingredient in RELFYDESS 100 Units/mL Injectable Solution is botulinum toxin. This information helps identify medicines with the same composition but different brand names.
Who manufactures RELFYDESS 100 Units/mL Injectable Solution?
RELFYDESS 100 Units/mL Injectable Solution is manufactured by Ipsen Pharma. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of RELFYDESS 100 Units/mL Injectable Solution online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether RELFYDESS 100 Units/mL Injectable Solution is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to RELFYDESS 100 Units/mL Injectable Solution?
Other medicines with the same active substance (botulinum toxin) include ALLUZIENCE 200 Units/mL Injectable Solution, AZZALURE 125 units SPEYWOOD powder for injectable solution, BOCOUTURE 100 units powder for injectable solution. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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