Quinine sulfate 200mg tablets

Country: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Quinine sulfate

Disponibbli minn:

Alliance Healthcare (Distribution) Ltd

Kodiċi ATC:

P01BC01

INN (Isem Internazzjonali):

Quinine sulfate

Dożaġġ:

200mg

Għamla farmaċewtika:

Oral tablet

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 05040100

Fuljett ta 'informazzjoni

Dimension: 180 x 270 mm
Front Side
PACKAGE LEAFLET: INFORMATION FOR THE USER
QUININE SULFATE 200 MG TABLETS
[Quinine Sulfate]
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 is one of a group of medicines called
antiprotozoal agents.
Quinine Sulfate Tablets are used to:
•
Treat malaria
•
Treat and prevent nocturnal (night-time) leg cramps in
adults and the elderly when sleep is regularly disturbed.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUININE
SULFATE TABLETS
DO NOT TAKE QUININE SULFATE TABLETS IF YOU:
•
Are allergic to quinine or any of the other ingredients of
this medicine (listed in section 6)
•
Suffer from tinnitus (ringing or buzzing in the ears)
•
Have problems with your eyes or difficulty seeing
•
Suffer from inflammation of the optic nerve causing
problems with your eye sight
•
Have blood in the urine (haemoglobinuria)
•
Suffer from a particular type of muscle weakness
(myasthenia gravis).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Quinine
Sulfate Tablets if you:
•
Are sensitive to Quinine. See section 4 for possible
symptoms
•
Have had malaria for a long time
�

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Quinine Sulfate 200mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains quinine sulfate 200mg
Excipient(s) with known effect
Lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
A white, biconvex film-coated tablet, plain on both sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of chloroquine resistant falciparum malaria in
adults and children
aged 5 years or older (and
≥
20kg)
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
Treatment of chloroquine resistant falciparum malaria
_Adults (including the elderly) and children aged 12 years and over:_
600mg of quinine
sulfate given every 8 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.
_Note _
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.
If part or all of the dose is vomited within 1 hour of administration,
then the same
amount must be administered immediately.
For the treatment and prevention of nocturnal leg cramps
_Adults (including the elderly): _
The recommended dose is 200mg at bedtime. 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
reass