Quinine bisulfate 300mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Quinine bisulfate

Available from:

Phoenix Healthcare Distribution Ltd

ATC code:

P01BC01

INN (International Name):

Quinine bisulfate

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

Dimension: 180 x 250 mm
Front Side
PACKAGE LEAFLET: INFORMATION FOR THE USER
QUININE BISULFATE TABLETS 300 MG
[Quinine Bisulfate]
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 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 side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Quinine Bisulfate Tablets are and what they are
used for
2. What you need to know before you take Quinine Bisulfate
Tablets
3. How to take Quinine Bisulfate Tablets
4. Possible side effects
5. How to store Quinine Bisulfate Tablets
6. Contents of the pack and other information
1. WHAT QUININE BISULFATE TABLETS ARE AND
WHAT THEY ARE USED FOR
Quinine Bisulfate is one of a group of medicines called
anti-protozoal agents.
Quinine Bisulfate Tablets are used to:
•
Treat malaria.
•
Treat and prevent nocturnal (night-time) leg cramps in
adults and the elderly.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
QUININE BISULFATE TABLETS
DO NOT TAKE QUININE BISULFATE IF YOU:
•
Are allergic to quinine or any other ingredients of this
medicine (listed in section 6).
•
Have problems with your eyes or difficulty seeing.
•
Suffer from tinnitus (ringing or buzzing in the ears).
•
Have blood in the urine (haemoglobinuria).
•
Suffer from muscle weakness (myasthenia gravis)..
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Quinine
Bisulfate Tablets if you:
•
Are sensitive to Quinine. See section 4 for possible
symptoms.
•
Have had malaria for a long time.
•
Have irregular heartbeats or other heart disease.
•
Have conduction defects of the heart (this is where the
heart cannot conduct el

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Quinine Bisulfate Tablets BP 300mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains quinine bisulfate 300mg
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet
A white, biconvex film-coated tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of falciparum malaria
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 falciparum malaria
Adults: the adult dosage regimen by mouth is 600mg of quinine sulfate
given every 8
hours for 7 days.
The elderly: as for adults
Children: the dosage regimen for children by mouth is 10mg of quinine
sulfate per kg
body weight given every 8 hours for 7 days.
Note
If quinine
resistance is known or suspected in the patient, then supplementary
treatment with another recommended antimalarial drug is necessary.
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 elderly):
The recommended dose is 300mg at bedtime.
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.
4.3
CONTRAINDICATIONS
-Hypersensitivity to the active substance(s) or to any of the
excipients listed in section
6.1.
-Optic neuritis
-Tinnitus
-Myasthenia gravis, quinine may cause severe respiratory distress and
dysphagia in
these patients
-Haemoglobinuria
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Cinchonism
Administration of quinine may give rise to cinchonism, which is
generally more
severe in overdose, but may also occur in no