Relfidess

Package Leaflet: Information for the User

Relfydess 100 units/ml, solution for injection

Botulinum toxin type A
This medicinal product is subject to additional monitoring. This will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. To find out more, see section 4.

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• 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 Relfydess is and what it is used for
• 2. Important information 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 the active substance botulinum toxin type A, which causes muscle relaxation. It works by blocking the nerve signals to the muscles into which it is injected, to prevent muscle contraction.
Relfydess is used to temporarily improve the appearance of moderate to severe vertical frown lines between the eyebrows (glabellar lines) and moderate to severe lateral canthal lines (crow’s feet lines) in adults under 65 years of age, where these facial lines have an important psychological impact.

2. Important information before using Relfydess

When not to use Relfydess:

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

Warnings and precautions

Before starting treatment with Relfydess, you should discuss with your doctor if you:

• have any neurological disease,
• are weakened due to lack of strength and energy,
• have difficulty breathing,
• have difficulty swallowing food or frequently have problems with food or liquids entering the airways, causing coughing or choking,
• have experienced side effects after previous botulinum toxin injections and/or did not experience significant improvement in the appearance of wrinkles after the last treatment,
• have inflammation at the proposed injection site,
• have eye problems, including drooping eyelids and dry eyes,
• have weak or atrophied muscles at the proposed injection site,
• have bleeding disorders, which means that bleeding lasts longer than usual, or are taking blood-thinning medicines (anticoagulants).

This information will help healthcare professionals make an informed decision about the risks and benefits of treatment.

Special warnings

With botulinum toxin, very rare side effects have been reported that may be related to the spread of the toxin from the injection site (e.g., difficulty swallowing, coughing, and choking while swallowing, difficulty speaking or breathing). These symptoms have been reported from a few hours to several weeks after injection.
If you experience difficulty swallowing, speaking, or breathing, you should contact your doctor immediately.
Relfydess may cause dry eyes. If you experience symptoms of dry eyes (e.g., eye irritation, sensitivity to light, or changes in vision), you should contact your doctor.
Repeated treatment with botulinum toxin may lead to muscle atrophy due to temporary paralysis of the treated muscles.
Too frequent or excessive use of botulinum toxin may lead to the formation of antibodies. The development of neutralizing antibodies may reduce the effectiveness of treatment.

Children and adolescents

Relfydess is not recommended for use in children and adolescents under 18 years of age.

Relfydess and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
In particular, tell your doctor if you are taking any of the following medicines, as they may enhance the effect of Relfydess:

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Relfydess should not be used during pregnancy, in women of childbearing potential not using contraception, or during breastfeeding.

Driving and using machines

After using Relfydess, you may experience temporary vision disturbances or muscle weakness. In this case, you should not drive or operate machinery.

Relfydess contains potassium, sodium, and polysorbate

This medicine contains potassium, less than 1 mmol (39 mg) per 150-unit vial, i.e., the medicine is considered "potassium-free".
This medicine contains sodium, less than 1 mmol (23 mg) per 150-unit vial, i.e., the medicine is considered "sodium-free".
This medicine contains 1.6 mg of polysorbate 80 per 150-unit vial, which corresponds to 1.1 mg/ml.
Polysorbates may cause allergic reactions. You should inform your doctor about any known allergies.

3. How to use Relfydess

Relfydess should only be administered by a healthcare professional with the appropriate qualifications and experience in the use of this treatment and with the required equipment. Relfydess is administered by injection into the muscle at the selected site.
The units of Relfydess are not interchangeable with units of other botulinum toxin preparations.
The recommended dose of Relfydess is:

• For vertical frown lines between the eyebrows: 50 units (0.5 ml), injected as 10 units (0.1 ml) at each of 5 injection sites on the forehead in the area above the nose and eyebrows.
• For lateral canthal lines: 60 units (0.6 ml), injected as 10 units (0.1 ml) at each of 6 injection sites. The 6 injection sites include 3 injections on each side in the orbicularis oculi muscle.
• For combined treatment: the same doses are recommended, i.e., 50 units for glabellar lines and 60 units for lateral canthal lines, with a total dose of 110 units (1.1 ml).

The effect of the treatment should be noticeable within a few days after injection and may last for 6 months. The intervals between repeated treatments with Relfydess should be determined by the doctor. Treatment should not be performed more frequently than every 3 months.

Overdose of Relfydess

Since this medicine will be administered to you by a healthcare professional with the appropriate qualifications and experience, it is unlikely that you will receive too much of this medicine. However, if you receive more Relfydess than you should, muscles other than those into which the medicine was injected may be weakened. Administration of higher doses may cause difficulty swallowing and speaking, as well as breathing problems. This may not occur immediately. If this happens, you should seek medical attention immediately.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Relfydess can cause side effects, although not everybody gets them.
Most side effects are mild or moderate and occur within the first month after injection and are temporary.

You should seek medical attention immediately if you experience any of the following symptoms, which have been reported very rarely:

• difficulty breathing, swallowing, or speaking,
• swelling, including swelling of the face or throat, hives, wheezing, feeling of fainting or shortness of breath. This may indicate an allergic reaction to Relfydess.

You should inform 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, sensitivity, or warmth
• headache
• drooping eyelid.

Uncommon (may affect up to 1 in 100 people)

• muscle weakness
• muscle twitching
• drooping eyebrow
• allergic reaction, such as asthma or widespread hives
• local allergic reaction, such as hives
• blurred vision
• dry eyes
• eye fatigue
• swelling of the eyelids

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Side effects can be reported to the national agency responsible for the authorization of medicinal products or to the manufacturer.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 and carton after {EXP}. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light.
The unopened vial can be stored at room temperature (up to 25°C) and protected from light. The stability of Relfydess (unopened vial) has been demonstrated for 24 hours at room temperature.

6. Contents of the pack and other information

What Relfydess contains

• The active substance is botulinum toxin type A, 100 units/ml. One vial contains 150 units in 1.5 ml solution.
• The other excipients are disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, potassium chloride, sodium chloride, polysorbate 80, L-tryptophan, and water for injection (see section 2 Relfydess contains potassium, sodium, and polysorbate).

What Relfydess looks like and contents of the pack

Relfydess is a clear, colorless to pale yellow solution for injection.
It is available in packs containing 1 or 10 glass vials containing 1.5 ml solution for injection.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Ipsen Pharma
65 Quai Georges Gorse
F-92100 Boulogne-Billancourt
France

Manufacturer

Q-Med AB
Seminariegatan 21
752 28 Uppsala
Sweden

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:

Dosage and administration

Relfydess should only be administered by healthcare professionals with the appropriate qualifications and experience in the use of this treatment and with the required equipment, in accordance with national guidelines and regulations.
The units of Relfydess are not interchangeable with units of other botulinum toxin preparations.
Relfydess is ready to use at a concentration of 10 units per 0.1 ml and does not require reconstitution.
Each vial should only be used for one patient during one treatment session. Any remaining product after the procedure should be discarded.

Table 1: Relfydess dosing instructions

Dosing and intervals between treatments depend on the individual patient response, but should not exceed the maximum recommended doses and minimum interval of 12 weeks.
In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

Special precautions for disposal and other handling

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

RECOMMENDATIONS FOR THE DISPOSAL OF CONTAMINATED MATERIALS

Immediately after use and before disposal, any unused Relfydess product (which may be in the vial or syringe) should be inactivated with a diluted solution of sodium hypochlorite (0.1% NaOCl) or sodium hydroxide (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 ANY INCIDENT DURING ADMINISTRATION OF BOTULINUM TOXIN

• Any spills of the product should be wiped up with a dry, absorbent material. The 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 and then dried.
• In case of a broken vial, you should proceed as described above, carefully collecting the broken glass and wiping up the product, avoiding skin cuts.
• If the product comes into contact with the skin, the affected area should be washed with soap and water.
• If the product gets into the eyes, they should be rinsed thoroughly with plenty of water or an ophthalmic irrigation solution.
• If the product comes into contact with a wound, cut, or damaged skin, it should be rinsed thoroughly with plenty of water and medical attention should be sought.

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