QUTENZA® PRESCRIBING INFORMATION. Refer to the Summary of Product Characteristics (SmPC) before prescribing. Presentation: QUTENZA (capsaicin) 179mg cutaneous patch. Each 280cm² cutaneous patch contains a total of 179mg of capsaicin or 640 micrograms of capsaicin per cm² of patch. Excipient with known effect: Each 50g tube of cleansing gel for QUTENZA contains 0.2mg/g butylhydroxyanisole (E320). Indications: QUTENZA is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for pain. Posology and method of administration: QUTENZA should be applied to the most painful skin areas (to a maximum of 4 patches). The QUTENZA cutaneous patch should be applied by a physician or a healthcare professional under a physician’s supervision in a well ventilated treatment area. The painful area should be determined by the physician and marked on the skin. Nitrile gloves should be worn at all times while handling QUTENZA and cleaning treatment areas. Latex gloves should NOT be worn as they do not provide adequate protection. Use of a mask and protective glasses is recommended, particularly during application and removal of the patch. The area may be pre-treated with a topical anaesthetic (e.g. topical lidocaine [4%] or lidocaine [2.5%]/prilocaine [2.5%]) or the patient may be administered an oral analgesic (e.g. 50mg of tramadol) prior to application of QUTENZA to reduce the potential of application related discomfort. The anaesthetic cream should be removed prior to applying QUTENZA and the skin washed and dried thoroughly. If necessary, hair should be clipped, not shaved. QUTENZA must be applied to intact (unbroken), non-irritated, dry skin, and allowed to remain in place for 30 minutes for the feet (e.g. HIV-associated neuropathy, painful diabetic peripheral neuropathy [PDPN]) and 60 minutes for other locations (e.g. post-herpetic neuralgia). When removing the patches they should be rolled inwards to minimise the risk of aerosolisation of capsaicin. Cleansing gel should be used to remove residual capsaicin and should be left on the area for at least one minute, wiped off and subsequently washed with soap and water. Acute pain during and following the procedure should be treated with local cooling and oral analgesics. QUTENZA treatments may be repeated every 90 days, as warranted by the persistence or return of pain. Paediatric population: QUTENZA is not recommended for use in children and adolescents (birth to 18 years) due to lack of data on safety and efficacy. Contraindications: Hypersensitivity to the&bbsp;active substance or to any of the excipients. Special warnings and precautions: Nitrile gloves should be worn at all times while handling QUTENZA and cleaning treatment areas. Dermal assessment: QUTENZA should be used only on dry, intact skin (unbroken) and not on the face, above the hairline of the scalp, and/or in proximity to the eyes or mucous membranes. In patients with PDPN, a careful visual examination of the feet should be undertaken prior to each application of QUTENZA and at subsequent clinic visits to detect skin lesions related to underlying neuropathy and vascular insufficiency. Sensory function: Reductions in sensory function have been reported following administration of QUTENZA. All patients with pre-existing sensory deficits should be clinically assessed for signs of sensory loss prior to each application of QUTENZA. Caution should be exercised in patients with reduced sensations in the feet and in those at increased risk for such changes in sensory function. If sensory loss is detected or worsens, QUTENZA treatment should be reconsidered. Application site reactions: Transient local application site burning, pain, erythema and pruritus are common/very common. In addition, cases of burns have been reported, including second degree burns in patients treated with capsaicin patches. In patients reporting severe pain, the patch should be removed and the skin examined for chemical burn. The cleansing gel for QUTENZA contains butylhydroxyanisole, which may cause local skin reactions (e.g. contact dermatitis) or irritation of eyes and mucous membranes. Unintended exposure: If QUTENZA comes in contact with skin not intended to be treated, cleansing gel should be applied. If burning of eyes, skin or airways,

remove affected individual from the vicinity of QUTENZA. Flush eyes or mucous membranes
with water. Treat shortness of breath with appropriate medical care. Cardiovascular: Blood
pressure should be monitored during the treatment procedure as transient increases (average <8.0mmHg) in blood pressure during and shortly after QUTENZA treatment may occur due to the treatment-related increase in pain. The risk of adverse cardiovascular reactions due to the potential stress of the procedure should be considered prior to using QUTENZA in patients with unstable or poorly controlled hypertension, history of cardiovascular events and particularly in diabetic patients with coronary artery disease, hypertension and cardiovascular autonomic neuropathy. Opioid tolerance: Patients using high doses of opioids may not respond to oral opioids when used for acute pain during and following treatment with QUTENZA. An alternative pain reduction strategy should be used when high opioid tolerance is suspected. Interactions: No formal interaction studies with other medicinal products have been performed as only transient low levels of systemic absorption have been shown to occur with QUTENZA. Pregnancy, lactation and breast feeding: Limited clinical data on exposed pregnancies are available. Since human pharmacokinetics show transient, low systemic exposure to capsaicin, the likelihood that QUTENZA increases the risk of developmental abnormalities when given to pregnant women is very low. However, caution should be exercised when prescribing to pregnant women. It is unknown whether capsaicin/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with QUTENZA. Effects on ability to drive or use machinery: QUTENZA has no or negligible influence on the ability to drive and use machines. Undesirable effects: Very common (≥ 1/10): application site pain, application site erythema. Common (≥ 1/100 to < 1/10): Application site: pruritus, papules, vesicles, oedema, swelling, dryness. Others: burning sensation, pain in extremity. Uncommon (≥ 1/1,000 to < 1/100): Application site: urticaria, paraesthesia, dermatitis, hyperaesthesia, inflammation, reaction, irritation, bruising, peripheral oedema. Others: muscle spasms, pruritus, nausea, cough, throat irritation, hypertension, first degree atrio-ventricular (AV) block, tachycardia, palpitations, eye irritation, dysgeusia, hypoaesthesia, herpes zoster, increased blood pressure (investigations). Not known: burns second degree, accidental exposure (including eye pain, eye and throat irritation and cough). Consult Summary of Product Characteristics for complete information on side effects. Overdose: In case of suspected overdose, the patches should be removed gently, cleansing gel should be applied for one minute and then wiped off with dry gauze and the area should be gently washed with soap and water. Supportive measures should be taken as clinically needed. There is no antidote to capsaicin. Basic NHS Cost: QUTENZA™ 179 mg cutaneous patch plus 50g tube cleansing gel £210 per pack. Legal Classification: POM. Marketing authorisation number(s): EU/1/09/524/001-002. Marketing authorisation holder: Grünenthal GmbH, Zieglerstraße6, 52078 Aachen, Germany. Date of preparation: March 2017.

UK/QUT17 0002