Quinine sulfate 200mg 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:

200mg

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: 5017007120759

Листовка

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
QUININE SULFATE 200 MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their signs of illness
are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
WHAT QUININE SULFATE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUININE SULFATE
3.
HOW TO TAKE QUININE SULFATE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE QUININE SULFATE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT QUININE SULFATE IS AND WHAT IT IS USED FOR
Quinine Sulfate is an antimalarial drug also used for muscle
disorders.
Quinine Sulfate is used:
•
to prevent night cramps
•
for the treatment of chloroquine-resistant malaria.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUININE SULFATE
DO NOT TAKE QUININE SULFATE:
•
if you are allergic to quinine sulfate or any
of the other ingredients of this medicine (listed in
section 6).
•
if you have kidney problems resulting in the presence of blood in your
urine
•
if you have inflammation of the optic nerve causing problems with your
eye sight
•
if you suffer from tinnitus (ringing in the ears)
•
if you have myasthenia gravis (a disorder in which the muscles are
weak and tire easily)
•
if you have problems with your eyes or difficulty seeing.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Quinine Sulfate.
Tell your doctor before you start to take this medicine:
•
if you suffer from heart, kidney or liver problems
•
if you have irregular heart beats or other heart disease
•
if you have had malaria for a long time
2
•
if you suffer from glucose 6-phosphat

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Quinine Sulphate 200 mg Tablets BP.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg quinine sulphate equivalent to 165 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 “200 1205” on the reverse; or alternatively plain on one
side and coded
APS over “1205” 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.
_ _
_Chil