Quinine sulfate 300mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Quinine sulfate

Available from:

IVAX Pharmaceuticals UK Ltd

ATC code:

P01BC01

INN (International Name):

Quinine sulfate

Dosage:

300mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05040100

Patient Information leaflet

PATIENT INFORMATION LEAFLET
QUININE SULFATE 300MG 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
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
or pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section-4.
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 belongs to a group of medicines
called anti-protozoal agents and they are used to
treat:
x
malaria
x
and prevent night cramps in adults and the
elderly when sleep is regularly disrupted.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE QUININE SULFATE
DO NOT TAKE QUININE SULFATE IF YOU:
x
are
ALLERGIC
(hypersensitive) to
QUININE
or
any of the other ingredients of this medicine
(listed in section 6)
x
have
HAEMOLYTIC ANAEMIA
(tiredness caused
by the destruction of red blood cells)
x
have
TINNITUS
(ringing sound in the ears)
x
have
OPTIC NEURITIS
(loss of vision or
difficulty seeing)
x
have
HAEMOGLOBINURIA
(high concentration
of haemoglobin in urine)
x
have
MYASTHENIA GRAVIS
(suffer from muscle
weakness)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
these tablets if you:
x
have irregular
HEARTBEATS
or other heart
problems
x
have conduction defects of the heart (this is
where the heart cannot conduct electrical
signals properly)
x
have blood in your
URINE
x
suffer from
KIDNEY OR LIVER
problems
x
have had
MALARIA
for a long time
x
suffer from glucose-6-phosphate
dehydrogenase

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Quinine Sulfate Tablets 300mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tablet contains 300mg Quinine Sulfate.
Also contains lactose and sucrose. For the full list of excipients,
see section
6.1.
3
PHARMACEUTICAL FORM
Sugar coated tablets
White, round, biconvex sugar coated tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
a)
Treatment of uncomplicated attacks of falciparum malaria due to
chloroquine or
multi-drug resistant strains.
b)
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
FOR TREATMENT OF UNCOMPLICATED (FALCIPARUM) MALARIA:
ADULT (INCLUDING ELDERLY) AND CHILDREN AGED 12 YEARS AND OVER: 600mg
of
Quinine Sulfate 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: Equivalent of 10mg/kg Quinine
Sulfate
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 reassess the
benefit of
treatment.
_Method of Administration_
For oral administrati