Qutenza · 4.1 Therapeutic indications · 1

HOS-095020 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most commonly reported adverse reactions were transient local application site burning, pain, erythema and pruritus. 5 Tabulated list of adverse reactions In Table 1 below all adverse reactions, which occurred at an incidence greater than control and in more than one patient in controlled clinical trials in patients with postherpetic neuralgia (PHN), painful Human Imunodeficiency Virus – Associated Neuropathy (HIV-AN) and painful diabetic peripheral neuropathy, are listed by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1: Tabulated list of adverse reactions System organ class and Adverse reaction frequency Infections and infestations Uncommon Herpes zoster Nervous system disorders Common Burning sensation Uncommon Dysgeusia, hypoaesthesia Eye disorders Uncommon Eye irritation Cardiac disorders Uncommon First degree atrio-ventricular (AV) block, tachycardia, palpitations Vascular disorders Common Hypertension Respiratory, thoracic and mediastinal disorders Common Cough Uncommon Throat irritation Gastrointestinal disorders Common Nausea Skin and subcutaneous tissue disorders Common Pruritus Musculoskeletal and connective tissue disorders Common Pain in extremity, muscle spasms General disorders and administration site conditions Very common Application site pain, application site erythema Application site pruritus, application site papules, application site vesicles, Common application site oedema, application site swelling, application site dryness, peripheral oedema Application site urticaria, application site paraesthesia, application site Uncommon dermatitis, application site hyperaesthesia, application site inflammation,

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HOS-095016 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-095015 · has-indication-information · PDF-Seite 2

Qutenza is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for the treatment of pain.

HOS-095018 · has-interaction-information · PDF-Seite 5

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.

HOS-095019 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no or limited amount of data from the use of capsaicin in pregnant women. Based on human pharmacokinetics, which 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. Breast-feeding It is unknown whether capsaicin/metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of capsaicin/metabolites in milk (for details see 5.3). A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with Qutenza. Fertility There is no data in humans available on fertility. A reproductive toxicology study in rats showed a reduction in the number and percent of motile sperm and the number of pregnancies (see section 5.3).

HOS-095017 · has-warning-information · PDF-Seite 4

Dermal assessment Qutenza must be used only on dry, intact (unbroken) skin and not on the face, above the hairline of the scalp, and/or in proximity to mucous membranes. In patients with painful diabetic peripheral neuropathy, 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. Decreases in sensory functions are generally minor and temporary (including to thermal and sharp stimuli), however, a single case of persistent hypoesthesia has been reported in clinical studies in painful diabetic neuropathy. For this case a relationship with Qutenza could not be excluded. Caution should be exercised in patients with reduced sensation in the feet and in those at increased risk for such changes in sensory function. All patients with pre-existing sensory deficits should be clinically assessed for signs of sensory loss to prior to each application of Qutenza. If sensory loss is detected or worsens, Qutenza treatment should be reconsidered. Monitoring and management of application site reactions Application site reactions, such as transient local applications site burning, pain, erythema and pruritus are common or very common. In addition, there have been reported cases of burns, including second- and third-degree burns, in patients treated with capsaicin patches (see section 4.8). In patients reporting severe pain, the patch should be removed and the skin examined for chemical burn. Unintended exposure Unintended exposure to capsaicin may cause irritation of eyes, mucous membranes, respiratory tract, and skin in patients and healthcare professionals. Healthcare professionals should ensure that the recommended protective measures as outlined in Section 4.2 are applied appropriately. If Qutenza comes in contact with skin not intended to be treated, cleansing gel should be applied for one minute and wiped off with dry gauze to remove any remaining capsaicin from the skin surface. After the cleansing gel has been wiped off, the area should be gently washed with soap and water. If capsaicin comes in contact with eyes or mucous membranes, these should be flushed or rinsed with cold water. If irritation of airways, eyes, or mucous membranes occurs, the affected individual should leave the Qutenza treatment

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