国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lamotrigine
DE Pharmaceuticals
N03AX09
Lamotrigine
100mg
Dispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04080100
_ _ OTHER SIDE EFFECTS Other side effects have occurred in a small number of people but their exact frequency is unknown: There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term anti-epileptic medication, have a history of osteoporosis or take steroids Nightmares Lower immunity because of lower levels of antibodies called immunoglobulins in the blood which help protect against infection. REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed on this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the GOOGLE PLAY or APPLE APP STORE. By reporting side effects, you can help provide more information on the safety of this medicine. 5 HOW TO STORE LAMICTAL KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Do not store above 30°C. Store in a dry place. Protect from light. Do not use after the expiry date printed on the carton label or blister strip. If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to. If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do. If you have any unwanted Lamictal tablets, don’t dispose of them in your waste water or your household rubbish. Take them back to your pharmacist, who will dispose of them in a way that won’t harm the environment. 6 CONTENTS OF THE PACK AND OTHER INFORMATION WHAT LAMICTAL CONTAINS Each 100mg dispersible tablet contains 100mg lamotrigine. Lamictal Dispersible also contain the following inactive ingredients: calcium carbonate, low substituted hydroxypropylcellulose, aluminium magnesium silicate, sodium starch glycollate, pov 阅读完整的文件
PRODUCT SUMMARY 1. NAME OF THE MEDICINAL PRODUCT Not applicable 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Not applicable 3. PHARMACEUTICAL FORM Not applicable 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Not applicable 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Not applicable 4.3. CONTRAINDICATIONS Not applicable 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Not applicable 4.5. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Not applicable 4.6. PREGNANCY AND LACTATION Not applicable 4.7. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not applicable 4.8. UNDESIRABLE EFFECTS Not applicable 4.9. OVERDOSE Not applicable 5. PHARMACOLOGICAL PROPERTIES 5.1. PHARMACODYNAMIC PROPERTIES Not applicable 5.2. PHARMACOKINETIC PROPERTIES Not applicable 5.3. PRECLINICAL SAFETY DATA Not applicable 6. PHARMACEUTICAL PARTICULARS 6.1. LIST OF EXCIPIENTS Not applicable 6.2. INCOMPATIBILITIES Not applicable 6.3. SHELF LIFE Not applicable 6.4. SPECIAL PRECAUTIONS FOR STORAGE Not applicable 6.5. NATURE AND CONTENTS OF CONTAINER Not applicable 6.6. INSTRUCTION FOR USE AND HANDLING (, AND DISPOSAL) Not applicable No Data Held ADMINISTRATIVE DATA 7. Marketing Authorisation Holder Not applicable 8. MARKETING AUTHORISATION NUMBER Not applicable 9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION Not applicable 10. DATE OF (PARTIAL) REVISION OF TEXT Not applicable 阅读完整的文件