দেশ: যুক্তরাজ্য
ভাষা: ইংরেজি
সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)
Risperidone
Actavis UK Ltd
N05AX08
Risperidone
1mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5012617015747 5012617015730
4 Shaking of the head Glaucoma (increased pressure within the eyeball), Problems with movement of your eyes, Eye rolling, Eyelid margin crusting Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken Risperdal ® Tablets. If you need to have cataract surgery, be sure to tell your eye doctor if you take or have taken this medicine. Dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood Severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure Dangerously excessive intake of water Irregular heart beat Sleep walking Sleep-related eating disorder Blood clot in the legs, Blood clot in the lungs Trouble breathing during sleep (sleep apnea), Fast, shallow breathing Inflammation of the pancreas, A blockage in the bowels Swollen tongue, Chapped lips, Rash on skin related to drug Dandruff Breakdown of muscle fibers and pain in muscles (rhabdomyolysis) A delay in menstrual periods, Enlargement of the glands in your breasts, Breast enlargement, Discharge from the breasts Increased insulin (a hormone that controls blood sugar levels) in your blood Priapism (a prolonged penile erection that may require surgical treatment) Hardening of the skin Decreased body temperature, Coldness in arms and legs Symptoms of drug withdrawal Yellowing of the skin and the eyes (jaundice). VERY RARE (MAY AFFECT UP TO 1 IN 10,000 PEOPLE): Life threatening complications of uncontrolled diabetes. Serious allergic reaction with swelling that may involve the throat and lead to difficulty breathing. Lack of bowel muscle movement that causes blockage. The following side effect has been seen with the use of another medicine called paliperidone that is very similar to risperidone, so these can also be ex সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Risperidone 1mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 mg risperidone Excipient(s) with known effect: Each film-coated tablet contains 49.88 mg lactose (as lactose monohydrate). 3 PHARMACEUTICAL FORM Film-coated tablet White, oval film-coated tablets with breaking notch and embossed with “1” on one side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Risperidone is indicated for the treatment of schizophrenia. Risperidone is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders. Risperidone is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer’s dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others. Risperidone is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with sub-average intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment. Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and educational intervention. It is recommended that risperidone be prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the treatment of conduct disorder of children and adolescents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Schizophrenia _Adults _ Risperidone may be given once daily or twice daily. Patients should start with 2 mg/day risperidone. The dosage may be increased on the second day to 4 mg. Subsequently, the dosage can be maintained unchanged, or further individualised, if needed. Most patients will benefit f সম্পূর্ণ নথি পড়ুন