PATIENT INFORMATION SHEET Botulinum Toxin- Informed Consent Hyperhidrosis

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PATIENT INFORMATION SHEETBotulinum Toxin- Informed Consent HyperhidrosisBotox is indicated and licensed for the treatment of severe primary axillary hyperhidrosis thatis inadequately managed with topical agents. Its safety and efficacy have not been establishedfor the treatment of hyperhidrosis on the hands, feet, scalp or face.Botulinum toxin injection is generally a safe and effective treatment method. Nevertheless,certain side effects can occur;Common side effects, associated with the injection include; Pain or stinging sensation when the injection is performed. Localized swelling, redness, tenderness Bleeding at the sites of injection Bruising Numbness or itching of the area following injection.The above usually resolve spontaneously within hours or days but may persist for longer.Rare side effects (3-10%) include; Compensatory sweating from other areas of the body.Aching or weakness in the upper arms, which is temporaryInfectionPharyngitisFlu syndromeHeadacheFeverAnxietyNeck or back painAllergic reactions have not been reported with this treatment; Symptoms of allergyinclude; itching, rash, red itchy welts, wheezing, asthma symptoms, dizziness or feeling faint. Get medical help immediately if you have any breathing problems.Weakness of hand muscles and drooping of the eye lids may occur in patients whoreceive BOTOX for palmar hyperhidrosis and facial hyperhidrosis, respectively.

In general, adverse reactions occur within the first week following injection and while generallytemporary, may have a duration of several months, or longer.Successful treatment can significantly reduce sweating in the treatment area for a period of 612 months. The successful outcome varies by degree and how long it lasts from one individualto another and cannot be guaranteed. Treatment may be repeated once the therapeutic effecthas worn off.Material information provided:I understand that whilst I have been advised as to a probable result, this should not be interpreted as a guarantee.Alternative treatments I have been advised I may consider:I confirm that the medical health history form has been completed truthfully and I am fullyaware that withholding medical information may be detrimental to the safe and optimal outcome of any treatment that the practitioner agrees to undertake.If there are any changes in my medical history, I must inform the practitioner.I confirm the procedure has been explained comprehensively and that the possible risks andside effects associated with the treatment have been fully discussed and understood. I understand that though complications are uncommon, they do sometimes occur. It is possiblethat side effects not described may occur and indeed that a complication not previously reported or experienced may occur for the first time.I confirm that I understand this is an elective non-surgical cosmetic procedure. I have beenadvised that there are alternatives to this procedure available, including the acceptance of mypresent condition.I have had the opportunity to have any questions answered and the time to process and consider the information provided before making a decision to proceed with the agreed treatmentplan.I confirm that I have been provided with verbal and written information about this treatmentwhich includes aftercare and follow up advice.I agree to follow the aftercare advice and understand this reduces risk of adverse reactionsand helps ensure optimum results.I understand information about me will be confidential and access to it restricted in accordance with the Data Protection Act. Pre and post treatment photographs may be taken as partof my treatment record and kept in my personal medical file. Any such photographs will notbe used without my consent for any other purpose.

I understand if I suffer any adverse reactions that are not expected, or concern me, I mustcontact the clinic. An appointment will be made for me to be seen. The clinic cannot takeresponsibility for complications or results that have not been reported, assessed, documentedand managed in a timely fashion.The main reason for this treatment is For physical benefit, personal & psychological reasonsPatients Signature Date. .Print Name .Practitioners Signature Date

What is Hyperhidrosis?In some people, the body’s mechanism for cooling itself down is over active- so over activethat they may sweat four or five times more than is necessary, or normal. When sweating isthis extreme it can be embarrassing, uncomfortable, anxiety inducing and life inhibiting. It candisrupt all aspects of a person’s life, from career choices and recreational activities to relationships, emotional wellbeing and self-image. This kind of excessive sweating is a medical condition called hyperhidrosis.‘Hyperhidrosis affects approximately 3% of the population, but due to lack of awareness, more than half of sufferers are never diagnosed or treated for their symptoms.’What causes Hyperhidrosis?Excessive sweating can be a symptom of certain medical conditions or a side effect of somemedications. You should not have treatment for your hyperhidrosis without first consultingyour GP to exclude any underlying medical condition which requires treatment.Your GP will check for potential causes of secondary hyperhidrosis to avoid symptomatictreatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.The cause of primary hyperhidrosis is not known.What Treatments are Available?There are a range of treatments available for hyperhidrosis, many are available on prescription. They includeantiperspirants, creams and lotions, iontophoresis, medications, laser, surgery and injectionsof Botox.There is a wealth of information available on the internet, not all of it responsible, factual orimpartial. We recommend you visit the website of The International Hyperhidrosis Society;www.SweatHelp.org for useful and reliable information.

Botox has been licensed to treat underarm sweating since 2004. Research has shown thattreating excessive sweating of the armpits, hands, feet, and face with Botox (Botulinum ToxinA) is safe and effective. In one clinical study involving 322 patients with severe underarmsweating, 81% of the patients receiving botulinum toxin injections achieved a greater than50% reduction in sweating. And, 50% of the patients had their excessive sweating relieved forat least 201 days (nearly 7 months).How Does Botox work?Botox is a natural, purified protein with the ability to temporarily block the secretion of thechemical that is responsible for "turning on" the body's sweat glands. By blocking, or interrupting, this chemical messenger, botulinum toxin "turns off" sweating at the area where it hasbeen injected.While sweating is an essential body function for temperature-control, the underarms houseless than 2% of the body’s sweat glands. The treatment of these sweat glands has no effecton body temperature regulation and compensatory sweating (sweating on other body parts),has not shown itself to be a concern.Botox is injected into the skin to treat the symptoms of severe underarm sweating (severeprimary axillary hyperhidrosis) when medicines used on the skin (topical) do not work wellenough.Am I suitable for treatment with Botox ?If you have seen your GP, your diagnosis is confirmed and you have tried and failed to getalong with alternative topical treatments, then it is likely, subject to your medical history, thatBotox would be an appropriate treatment for you.The clinician will take a full medical history to confirm you have no medical contraindicationsto Botox .You may not be suitable for Botox treatment if you have any of the following: cin) A neuromuscular transmission disorder such as Myasthenia gravis or Eaton LambertSyndrome.Aminoglycoside antibiotics within the last 3 days (Gentamycin, Clindamycin, TobramyIf you are pregnant (or might be) or are breast feeding.If you have a skin infection at the site for treatment.If you have had previous adverse, sensitivity reactions to any botulinum toxin.What does the treatment involve?The clinician will first identify where the sweat glands are most active. This is done by applyingiodine solution to the treatment area, then dusting with starch powder. The area turnsblue/black where there is sweat.

The area is marked with a surgical pen, then cleaned prior to injection.Injections are spaced approximately 2cm apart to treat the area. The needles are tiny, theinjections are not deep and most patients report tolerable discomfort rather than pain.Be Prepared Please shave underarms and avoid using over the counter antiperspirants or deodorants 24 hours before.It is advisable to avoid aspirin and non-steroidal medication, vitamin E, gingko bilobaand St. John’s Wort for at least 24 hours prior to treatment as these may increase therisk of bleeding and bruising.If you have been prescribed aspirin for a medical reason, it is best to continue this. Ifyou have a bleeding disorder, or are taking Warfarin, discuss this with the nurse priorto receiving botulinum treatment.Wear a dark, loose top, preferably an old one to the appointment. You may bleed alittle and iodine may stain clothing.After TreatmentThe treatment area may feel sore and or tender for the first 24 hours. Some patients describean achiness, tiredness or heaviness of the arms which usually resolves within a few days fromoccurring.Results are gradual and may be judged at 2-3 weeks. You are invited for a review appointmentto record the effectiveness of treatment and modify your treatment plan if necessary. Sometimes an additional treatment is required to achieve optimal results.Keep the area clean. You may apply antiperspirants as soon as the skin has recovered fromthe injections- usually within 4-12 hours.Avoid vigorous exercise or extreme heat for 48 hours after treatment.Should you experience any unpleasant side effects that you are not expecting, or suffer symptoms that concern you, please do not hesitate to contact the clinic and an appointment will bemade for you to be seen.The treatment may not completely stop any sweating, but we expect the sweating to be significantly reduced. Treatment results are expected to last approximately 6 months. For someindividuals this may be shorter, or even longer.Once the Botox wears off, your condition will return to its previous state, there is no permanent effect on your condition, either for the better, or for the worse.If you have any further questions, before, during or after the treatment, do not hesitate to askyour practitioner.

Botulinum Toxin- Informed Consent Hyperhidrosis Botox is indicated and licensed for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents. Its safety and efficacy have not been established . I confirm that the medical health history form has been completed truthfully and I am fully