Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Capsaicin
Grunenthal Ltd
Capsaicin
179mg
Cutaneous patch
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 10030200; GTIN: 5013346098582
1 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 medicinal products for 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, chilli 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 irritation and pain. Sniffing or inhaling close to the Lees het volledige document
OBJECT 1 QUTENZA 179MG CUTANEOUS PATCH Summary of Product Characteristics Updated 12-May-2017 | Grunenthal Ltd 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 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 Qutenza 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 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. The treatment area may be pre-treated with a topical anaesthetic or the patient may be administered an oral analgesic prior to application of Qutenza to reduce potential application related discomfort. The topical anaesthetic should be applied to cover the entire Qutenza Lees het volledige document