Relfydess 100 units/mL solution for injection

• 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.

1. What Relfydess is and what it is used for
2. What you need to know before you use Relfydess
3. How to use Relfydess
4. Possible side effects
5. How to store Relfydess
6. Contents of the pack and other information

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

Talk to your doctor before you have the Relfydess injection if:

• you have any disease affecting your nervous system
• you are debilitated with lack of strength and energy
• you have difficulties breathing
• you have difficulty swallowing food or often have problems with food or drink getting into your airways causing you to cough or choke
• you have had side effects from previous botulinum toxin injections and/or no significant improvement of your lines after your last treatment
• you have inflammation at the proposed injection site(s)
• you have problems with the eyes including drooping eyelids and dry eyes
• the muscles at the proposed injection site are weak or show signs of wasting
• you have a bleeding disorder which means you continue to bleed for longer than normal, or are taking blood thinning medication (anticoagulant)

This information will help your health care professional to make an informed decision about the risk and benefit of your treatment.

Special warnings

Side effects possibly related to the spread of toxin effect away from the site of injection have been reported very rarely with botulinum toxin (e.g. difficulty swallowing, coughing and choking when swallowing, difficulty speaking or breathing). These symptoms have been reported hours to weeks after the injection. Seek immediate medical attention if you experience difficulties in swallowing, speaking or breathing.

Use of Relfydess may cause dry eyes. If you experience symptoms of dry eye (e.g., eye irritation, light sensitivity or visual changes) talk to your doctor.

Repeated botulinum toxin treatment can lead to muscle wasting due to the temporary paralysis of the treated muscles.

Too frequent use of botulinum toxins or used at higher doses may lead to antibody formation. The formation of neutralising antibodies may reduce the effectiveness of treatment.

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

Tell your doctor if you are using, have recently used or might use any other medicines.

In particular, tell your doctor if you are taking the following medicines, since they may increase the effect of Relfydess:

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

If you are pregnant or breast-feeding, 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, if you are of childbearing age and not using contraception or if you are breast-feeding.

You may experience temporary visual disturbances or muscle weakness following treatment with Relfydess. If affected, do not drive or use machinery.

This medicine contains potassium, less than 1 mmol (39 mg) per 150 units vial, i.e. essentially ‘potassium-free’.

This medicine contains sodium, less than 1 mmol (23 mg) per 150 units vial, i.e. essentially ‘sodium-free’.

This medicine contains 1.6 mg of polysorbate 80 (E433) per 150 units vial which is equivalent to 1.1 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

As this medicine will be given to you by a health care professional with appropriate qualifications and expertise, it is not likely that you will be given too much of this medicine. If you however are given more Relfydess than you need, muscles other than the ones that were injected may begin to feel weak. Excessive doses may cause swallowing and speech difficulties and breathing problems. This may not happen straight away. If this happens, seek immediate medical attention.

• difficulties breathing, swallowing or speaking.
• swelling including swelling of the face or throat, hives, wheezing, feeling faint or shortness of breath. This may mean you are having an allergic reaction to Relfydess.

Common (may affect up to 1 in 10 people)

• Injection site reactions like bruising, pain, itching, redness, swelling, discomfort, hypersensitivity, warmth
• Headache
• Drooping of the upper eyelid.

Uncommon (may affect up to 1 in 100 people)

• Muscular weakness
• Muscle twitching
• Drooping of eyebrow
• Allergic reaction, like asthma or widespread nettle rash
• Local allergic reaction, like nettle rash
• Blurred vision
• Dry eyes
• Eye strain
• Swelling of eyelids.

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• 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 hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, potassium chloride, sodium chloride, polysorbate 80 (E433), L tryptophan and water for injections (see section 2 Relfydess contains potassium, sodium and polysorbate).

Relfydess is a clear, colourless to pale yellow solution for injection (injection).

It comes in pack size of 1 or 10 glass vials containing 1.5 mL solution for injection.

Not all pack sizes may be marketed.