দেশ: যুক্তরাজ্য
ভাষা: ইংরেজি
সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lamotrigine
GlaxoSmithKline UK Ltd
N03AX09
Lamotrigine
100mg
Dispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04080100; GTIN: 5010706004894
_ _ • a serious disorder of blood clotting, which can cause unexpected bleeding or bruising (_disseminated intravascular _ _coagulation_): _(see also_ _the information at the beginning of _ _Section 4)_ • haemophagocytic lymphohistiocytosis (HLH) (see Section 2: What you need to know before you take Lamictal). • changes which may show up in blood tests - including reduced numbers of red blood cells (_anaemia_), reduced numbers of white blood cells (_leucopenia, neutropenia, agranulocytosis_), reduced numbers of platelets (_thrombocytopenia_), reduced numbers of all these types of cell (_pancytopenia_) and a disorder of the bone marrow called _aplastic anaemia_ • hallucinations (‘seeing’ or ‘hearing’ things that aren’t really there) • confusion • feeling ‘wobbly’ or unsteady when you move about • uncontrollable body movements (_tics_), uncontrollable muscle spasms affecting the eyes, head and torso (_choreoathetosis_) or other unusual body movements such as jerking, shaking or stiffness • in people who already have epilepsy, seizures happening more often • in people who already have Parkinson’s disease, worsening of the symptoms. • lupus-like reaction (symptoms may include: back or joint pain which sometimes may be accompanied by fever and/or general ill health). 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. • inflammation of the kidney (_tubulointerstitial_ _nephritis_), or inflammation of both the kidney and the eye (_tubulointerstitial _ _nephritis and uveitis_ _syndrome_). • Nightmares. • Lower immunity because of lower levels of antibodies called immunoglobulins in the blood which help protect against infection. REPORTING OF SIDE EFFECTS If yo সম্পূর্ণ নথি পড়ুন
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 সম্পূর্ণ নথি পড়ুন