País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Buprenorphine
Accord-UK Ltd
N02AE01
Buprenorphine
52.5microgram/1hour
Transdermal patch
Transdermal
Schedule 3 (CD No Register)
Caution - AMP level prescribing advised
BNF: 04070200; GTIN: 5012617023629
HAPOCTASIN 35MICROGRAM/H, 52.5MICROGRAM/H AND 70MICROGRAM/H TRANSDERMAL PATCHES Buprenorphine _continued over page_ 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 or pharmacist. • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1 WHAT HAPOCTASIN IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU USE HAPOCTASIN 3 HOW TO USE HAPOCTASIN 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE HAPOCTASIN 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT HAPOCTASIN IS AND WHAT IT IS USED FOR Hapoctasin is an analgesic (a pain-relieving medicine) intended to relieve moderate to severe cancer pain and severe pain that has not responded to other types of painkillers. Hapoctasin acts through the skin. When the transdermal patch is applied to the skin, the active substance buprenorphine passes through the skin into the blood. Buprenorphine is an opioid (strong pain reliever), which reduces pain by acting on the central nervous system (specific nerve cells in the spinal cord and in the brain). The effect of the transdermal patch lasts for up to three days. Hapoctasin is not suitable for the treatment of acute (short-lasting) pain. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE HAPOCTASIN DO NOT USE HAPOCTASIN IF YOU: • are ALLERGIC to buprenorphine, soya, peanuts or any of the other ingredients of this medicine (listed in section 6) • are dependent on STRONG PAIN RELIEVERS (opiods) • suffer from a disease in which you have or may have GREAT DIFFICULTY BREATHING • are taking MONOAMINE OXIDASE (MAO) inhibitors (certain medicines used to treat depression) or you have taken this Leer el documento completo
OBJECT 1 HAPOCTASIN 52.5 MICROGRAM/H, TRANSDERMAL PATCHES Summary of Product Characteristics Updated 02-Aug-2016 | Accord-UK Ltd 1. Name of the medicinal product Hapoctasin 52.5 microgram/h, transdermal patches 2. Qualitative and quantitative composition Hapoctasin 52.5 microgram/h Each transdermal patch contains 30 mg buprenorphine. Area containing the active substance: 37.5 cm 2 Nominal release rate: 52.5 micrograms of buprenorphine per hour. Excipient with known effect: soya oil 24 mg For the full list of excipients, see section 6.1. 3. Pharmaceutical form Transdermal patch The patches are tan coloured, rectangular with four rounded edges and topped off corners and labelled with Buprenorphine 52.5 µg/h. Each patch is packed in single sealed sachets. 4. Clinical particulars 4.1 Therapeutic indications Moderate to severe cancer pain and severe pain which does not respond to non-opioid analgesics Hapoctasin is not suitable for the treatment of acute pain. 4.2 Posology and method of administration Posology Patients over 18 years of age The Hapoctasin dosage should be adapted to the condition of the individual patient (pain intensity, suffering, individual reaction). The lowest possible dosage providing adequate pain relief should be given. Three transdermal patch strengths are available to provide such adaptive treatment: Hapoctasin 35 microgram/h, Hapoctasin 52.5 microgram/h and Hapoctasin 70 microgram/h. Initial dose selection: Patients who have previously not received any analgesics should startwith the lowest transdermal patch strength Hapoctasin 35 microgram/h Patients previously given a WHO step-I analgesic (non-opioid) or a step-II analgesic (weak opioid) should also begin with Hapoctasin 35 microgram/h. According to the WHO recommendations, the administration of a non-opioid analgesic can be continued, depending on the patient's overall medical condition. When switching from a step-III analgesic (strong opioid) to Hapoctasin and choosing the initial transdermal patch strength, the nature of the previous m Leer el documento completo