Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
capsaicin
Grunenthal GmbH
N01BX04
capsaicin
Anesthetics
Neuralgia
Qutenza is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for pain.
Revision: 19
Authorised
2009-05-15
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE USER QUTENZA 179 MG CUTANEOUS PATCH capsaicin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Qutenza is and what it is used for 2. What you need to know before Qutenza is used 3. How to use Qutenza 4. Possible side effects 5. How to store Qutenza 6. Contents of the pack and other information 1. WHAT QUTENZA IS AND WHAT IT IS USED FOR Qutenza contains capsaicin and belongs to a group of medicines called anaesthetics. Qutenza is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicines for the treatment of pain. Qutenza is used to relieve pain in people who have nerve pain due to damaged nerves in the skin. Damaged nerves in your skin may occur as a result of a variety of diseases such as shingles, HIV infection, diabetes, certain medicines and other conditions. You may experience pain relief between 1 and 3 weeks after treatment. 2. WHAT YOU NEED TO KNOW BEFORE QUTENZA IS USED DO NOT USE QUTENZA if you are allergic to capsaicin (also present in chili peppers) or any other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before using Qutenza Do not use Qutenza on any part of your head or face. Do not use Qutenza on broken skin or open wounds. Do not touch Qutenza or other materials that have come in contact with the treated areas as it may cause burning and stinging. Do not touch your eyes, mouth or other sensitive areas as it may cause irritat Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Qutenza 179 mg cutaneous patch 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 280 cm 2 cutaneous patch contains a total of 179 mg of capsaicin or 640 micrograms of capsaicin per cm 2 of patch. Excipient with known effect Each 50 g tube of cleansing gel for Qutenza contains 0.2 mg/g butylhydroxyanisole (E320). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cutaneous patch. Each patch is 14 cm x 20 cm (280 cm 2 ) and consists of an adhesive side containing the active substance and an outer surface backing layer. The adhesive side is covered with a removable, clear, unprinted, diagonally cut, release liner. The outer surface of the backing layer is imprinted with ‘capsaicin 8%’. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The Qutenza cutaneous patch should be applied by a physician or by a health care professional under the supervision of a physician. Posology The cutaneous patch should be applied to the most painful skin areas (using up to a maximum of 4 patches). The painful area should be determined by the physician or by a health care professional and marked on the skin. Qutenza must be applied to intact, 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) and 60 minutes for other locations (e.g. postherpetic neuralgia). Qutenza treatments may be repeated every 90 days, as warranted by the persistence or return of pain. Re-treatment after less than 90 days can be considered for individual patients only after a careful assessment by the physician (see also section 5.1). A minimum interval of 60 days between treatments is to be observed. It is recommended to treat sufficiently long and t Прочетете целия документ