Quinine sulfate 200mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Quinine sulfate

Verfügbar ab:

Accord-UK Ltd

ATC-Code:

P01BC01

INN (Internationale Bezeichnung):

Quinine sulfate

Dosierung:

200mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 05040100; GTIN: 5012617009982

Gebrauchsinformation

148x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Quinine sulfate, Tablets, 200mg,
28s - UK
148x210 (Reel Fed)
51016395
Leaflet for Blisters
1459
RH
31-10-22
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QUININE SULFATE 200MG 28 TABLETS PIL - UK
Black
Profile
BBBB5908
S.Anson
01.11.2022
03.11.2022
S.Anson
148 x 210
7pt
Accord Barnstaple
n/a
n/a
2
Version 7
12.02.2020
German GTIN 14
(incorporating PZN):
Cartons and label leaflets only
(labels only when specified)
QUININE SULFATE 200MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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, pharmacist or nurse.
•
This medicine has been prescribed for you
only. 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, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
WHAT QUININE SULFATE TABLETS ARE AND
WHAT THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
QUININE SULFATE TABLETS
3 HOW TO TAKE QUININE SULFATE TABLETS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE QUININE SULFATE TABLETS
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT QUININE SULFATE TABLETS ARE AND
WHAT THEY ARE USED FOR
Quinine sulfate belongs to a group of medicines called anti-
protozoa

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
QUININE SULFATE TABLETS BP 200mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg Quinine Sulfate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White, circular, biconvex film-coated tablets with the identifying
letters “QC”
embossed on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1) Treatment of falciparum (malignant tertian) malaria.
2) 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).
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
Posology
_ _
_FOR THE TREATMENT OF FALCIPARUM (MALIGNANT TERTIAN) 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 aged 11 years and under: _10mg/kg every eight hours for 7
days.
_ _
_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 assess the need for
continuation of
treatment with quinine.
Method of Administration
For oral administration.
4