Quinine sulfate 300mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Quinine sulfate

Предлага се от:

Teva UK Ltd

АТС код:

P01BC01

INN (Международно Name):

Quinine sulfate

дозиране:

300mg

Лекарствена форма:

Oral tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 05040100; GTIN: 5017007120766

Листовка

CHILDREN UNDER 12 YEARS - 10 mg per kg of
body weight every eight hours for 7 days.
PATIENTS WITH KIDNEY OR LIVER PROBLEMS
A lower dose than the usual adult dose or
increased time between doses should be
used if you have kidney or liver problems.
IF YOU TAKE MORE QUININE SULFATE THAN YOU
SHOULD
If you (or someone else) swallow a lot of the
tablets all together, or if you think a child
has accidentally swallowed any of the
tablets, CONTACT YOUR NEAREST HOSPITAL
CASUALTY DEPARTMENT OR YOUR DOCTOR
IMMEDIATELY.
An overdose of Quinine Sulfate may cause
‘cinchonism’. Early symptoms are:
• tinnitus (ringing in the ears), impaired
hearing and vision, headache, feeling sick,
being sick, fits
• rashes, confusion, hot and flushed skin.
More severe symptoms include:
• nervous system disorders, stomach
problems, shallow breathing, loss of
consciousness
• severe eyesight problems including
blindness
• effects on the heart, kidney and brain
• shock, low blood sugar.
Large doses can cause abortion.
Please take this leaflet, any remaining
tablets, and the container with you to the
hospital or doctor so that they know which
tablets were consumed.
IF YOU FORGET TO TAKE QUININE SULFATE
If you forget to take a tablet, take one as
soon as you remember, unless it is nearly
time to take the next one. Do not take a
double dose to make up for a forgotten dose.
Take the remaining doses at the correct time
.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
If any of the following happen, stop taking
the tablets and tell your doctor immediately
or go to the casualty department at your
nearest hospital:
• an allergic reaction (swelling of the lips,
face or neck leading to severe difficulty
in breathing; skin rash or hives)
• unexplained bruising or bleeding.
These are very serious but rare side effects.
You may need urgent medical attention or
hospitalisation.
CONTAC

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Quinine Sulphate 300 mg Tablets BP.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg quinine sulphate equivalent to 248 mg
anhydrous quinine
base.
Excipient(s) with known effect:
Sucrose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablet.
White, biconvex, sugar-coated tablets, plain or marked APS on one side
and
coded "300 1206" on the reverse; or alternatively plain on one side
and coded
APS over "1206" on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prevention of nocturnal leg cramps in adults and the
elderly, when
cramps cause regular disruption of sleep (see section 4.2 and section
4.4).
Treatment of chloroquine-resistant malaria.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults_
For the treatment and prevention of nocturnal leg cramps
_ _
_ _
_ _
_Adults (including elderly): _
The recommended dose is 200mg at bedtime. The maximum dose is 300mg.
A reduction in frequency of leg cramps may take up to 4 weeks to
become apparent.
Patients should be monitored closely during the early stages of
treatment for adverse
effects. After an initial trial of 4 weeks, treatment should be
stopped if there is no
benefit. Treatment should be interrupted at approximately three
monthly intervals to
reassess the benefit of treatment.
Treatment of Chloroquine-Resistant Malaria
_Adults (including elderly) and children aged 12 years and over:
_600mg every eight
hours for 7 days. The dose may depend upon the size of the patient,
severity of
infection, and evidence of renal or liver disease (when the intervals
should be
increased), due to a prolonged half-life of the drug.
If quinine resistance is known or suspected on completion of the
course additional
treatment may be given. This may be one of the following:
1.
doxycycline 200mg daily (as a single dose or in 2 divided doses) for
at least 7 days.
2.
clindamycin 300mg four times daily for 5 days.
_ _
_Children_
Tre