Risperidone 1mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Risperidone

متاح من:

Apotex UK Ltd

ATC رمز:

N05AX08

INN (الاسم الدولي):

Risperidone

جرعة:

1mg

الشكل الصيدلاني:

Oral tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 04020100; GTIN: 5060129470523 5060129470578

نشرة المعلومات

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

خصائص المنتج

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