Botox® Cosmetic Information Sheet

Approved Uses

BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow’s feet lines, and frown lines between the eyebrows in adults. It can also be used for treatment of  Bruxism (teeth grinding), dimpled chin, marionette lines, platysmal folds in the neck, calf hypertrophy and to treat hyperhidrosis (excessive sweating). BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other Botulinum toxin product. 

IMPORTANT SAFETY INFORMATION

Overall Botox®  is a safe treatment. However, like any other drug BOTOX® Cosmetic treatment of the face and neck can have side effects, most common being bruising and eye brow droop. These side effects are temporary.  Rare side effect included eye lid droop that can require facial muscle exercises in combination with apraclonidine eye drops for a few weeks. Very rare effects that we have never encountered in our clinic from the last 14 years include:  

• Problems with swallowing, speaking, or breathing, due to weakening of associated muscles and can be severe. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months. 
• Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing. 

There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, and/or forehead lines. 

BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities. 

• Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint. 

Contraindications to receiving Botox: 

Absolute contraindications: 

1. Known hypersensitivity to Botox, or to any of the components in the formulation, including albumin and cow’s milk protein, because serious allergic reactions including anaphylactic shock can occur.
2. Allergy to any other Botulinum Toxin product such as Xeomin, Bocouture, Azzalure and Dysport.
3. History of botulism poisoning.
4. Pregnant women and nursing mothers: Safety has not been established but to date no teratogenicity has been attributed to Botox. There is no information on whether Botox is excreted in human milk. It is recommended to delay the Botox administration until pregnancy is complete and breast feeding has ended.
5. Peripheral motor neuropathic diseases, amyotrophic lateral sclerosis and neuromuscular junctional disorders (myasthenia gravis or Lambert-Eaton syndrome). There is Increased risk of severe dysphagia and respiratory compromise from typical doses of Botox.
6. Body dysmorphic disorder 

Relative Contraindications: 

1. Patients on medications that increase the risk of bruising such as antiplatelet drugs, anticoagulants, vitamin E, non-steroidal anti-inflammatory drugs and health supplements such as fish oil, krill oil or flax seed. 
2. Severe respiratory conditions such as severe asthma and COPD. Treatment with BoNTA may weaken neck muscles that serve as accessory muscles of ventilation resulting in a critical loss of breathing capacity in such patients. 
3. Plans for facial surgery. It is best to postpone treatment until complete recovery.
4. Infection at the injection sites.
5. Urinary tract infection or urinary retention.
6. Patients with unrealistic expectations.  Address the expectations and communicate the reality of the situation at the outset. 

Tell your doctor if you have any of the above: 

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past. 

Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum, recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners. 

For more information talk with your doctor. 

Contact details: Tel: 01234271682 / 02086802777 (Telephone lines open 7am -10 pm). 

For out of hours emergencies please contact 999