Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Morphine sulfate
Napp Pharmaceuticals Ltd
N02AA01
Morphine sulfate
60mg
Modified-release capsule
Oral
Schedule 2 (CD)
Caution - AMP level prescribing advised
BNF: 04070200; GTIN: 5012854076549
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _MXL_ _®_ 30 MG, 60 MG, 90 MG, 120 MG, 150 MG AND 200 MG PROLONGED-RELEASE CAPSULES Morphine sulfate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 _MXL _ capsules are and what they are used for 2. What you need to know before you take _MXL _ capsules 3. How to take _MXL _ capsules 4. Possible side effects 5. How to store _MXL _ capsules 6. Contents of the pack and other information 1. WHAT _MXL _CAPSULES ARE AND WHAT THEY ARE USED FOR These capsules have been prescribed for you by your doctor to relieve severe pain over a period of 24 hours. They contain the active ingredient morphine which belongs to a group of medicines called strong analgesics or ‘painkillers’. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _MXL_ CAPSULES DO NOT TAKE _MXL _CAPSULES IF: • you are allergic to morphine or any of the other ingredients of the capsules (see section 6); • you have breathing problems, such as obstructive airways disease, respiratory depression, or severe asthma. Your doctor will have told you if you have these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected; • you have a head injury that causes a severe headache or makes you feel sick. This is because the capsules may make these symptoms worse or hide the extent of the head injury; • you have a condition where the small bowel (part of your gut) does not work properly (paralytic ileus), your stomach empties more slowly than it sho Belgenin tamamını okuyun
OBJECT 1 MXL capsules 60 mg Summary of Product Characteristics Updated 21-May-2021 | Napp Pharmaceuticals Limited • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product MXL 30 mg 60 mg, 90 mg, 120 mg, 150 mg, 200 mg prolonged release capsules 2. Qualitative and quantitative composition Each 30 mg prolonged-release capsule contains Morphine Sulfate 30 mg. Each 60 mg prolonged-release capsule contains Morphine Sulfate 60 mg Each 90 mg prolonged-release capsule contains Morphine Sulfate 90 mg Each 120 mg prolonged-release capsule contains Morphine Sulfate 120 mg Each 150 mg prolonged-release capsule contains Morphine Sulfate 150 mg Each 200 mg prolonged-release capsule contains Morphine Sulfate 200 mg Excipient with known effect: Each 30 mg prolonged-release capsule contains 0.006 mg of sodium (sodium dodecyl sulfate) Each 60 mg prolonged-release capsule contains 0.008 mg of sodium (sodium dodecyl sulfate) Each 90 mg prolonged-release capsule contains 0.010 mg of sodium (sodium do Belgenin tamamını okuyun