Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nabilone
Meda Pharmaceuticals Ltd
A04AD11
Nabilone
1mg
Oral capsule
Oral
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04060000; GTIN: 5060035241019
J3640 F1020 1 Nabilone 1mg Capsule PIL F1020 400 x 148mm as shown n/a Dales Pharma Limited 19.11.13 1 21.11.13 2 10.05.14 3 20.05.14 4 tick box initial BLACK PANTONE CG10 PROFILE PANTONE 152 PANTONE 3125 PANTONE 3995 100mm Measurement Verification Bar PATIENT INFORMATION LEAFLET NABILONE 1 MG CAPSULES (nabilone) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you experience any side effect and this becomes serious, tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Nabilone is and what it is used for 2. Before you take Nabilone Capsules 3. How to take Nabilone Capsules 4. Possible side effects 5. How to store Nabilone Capsules 6. Further information 1. WHAT NABILONE IS AND WHAT IT IS USED FOR Nabilone is a medicine that helps to reduce nausea and vomiting caused by many anticancer medicines. Nabilone is often used when other medicines have not helped your nausea or vomiting. Nabilone is a man-made chemical known as a cannabinoid. It is not made from the Cannabis plant but it is similar to some marijuana extracts and can cause similar effects. 2. BEFORE YOU TAKE NABILONE CAPSULES DO NOT TAKE NABILONE • If you are allergic (hypersensitive) to any of the other ingredients of Nabilone Capsules (these are listed in section 6, “Further Information”). • If your nausea / vomiting is not due to anticancer treatment. • If you are under 18 years. Nabilone is not meant for children. TAKE SPECIAL CARE WITH NABILONE It is best if you take Nabilone Capsules in hospital, as you may experience side effects. Tell your doctor before you start treatment if you have any of the following problems or if you develop any of these during treatment: • Any liver problems. • High blood pressure or any other heart problem. • Any Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nabilone 1mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 1 mg of Nabilone. For excipients see section 6.1. 3 PHARMACEUTICAL FORM Capsules, hard. Opaque blue, size 2 hard gelatin capsule cap imprinted with “NAB 1” and opaque white body imprinted with “NAB 1” 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nabilone is indicated for the control of nausea and vomiting, caused by chemotherapeutic agents used in the treatment of cancer, in patients who have failed to respond adequately to conventional antiemetic treatments. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nabilone is for administration to adults only. It is not recommended for use in children younger than 18 years of age as safety and efficacy have not been established. The usual adult dosage is 1 mg or 2 mg twice a day. To minimise side-effects, it is recommended that the lower starting dose is used and that the dose is increased as necessary. The first dose should be administered the night before initiation of chemotherapy, and the second dose should be given one to three hours before the first dose of the oncolytic agent is administered. The maximum daily dose should not exceed 6 mg, given in three divided doses. Nabilone may be administered throughout each cycle of chemotherapy and, if necessary, for 48 hours after the last dose of each cycle. Data on the chronic use of nabilone are not available. _The elderly _as for adults (see ‘precautions’). 4.3 CONTRAINDICATIONS Nabilone is contra-indicated in patients with a known allergy to cannabinoid agents and when the nausea and vomiting arises from any cause other than cancer chemotherapy. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As nabilone is excreted primarily by the biliary route, the drug is not recommended for use in patients with severe liver dysfunction. Patients receiving nabilone should be closely observed, if possible, within an inpatient setting. This is especially important during th Read the complete document