Quinine Sulphate 300 mg film coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Quinine sulfate

Available from:

Teva B.V.

ATC code:

P01BC; P01BC01

INN (International Name):

Quinine sulfate

Dosage:

300 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Not applicable

Therapeutic area:

Methanolquinolines; quinine

Authorization status:

Marketed

Authorization date:

1985-07-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
QUININE SULPHATE 300 MG FILM-COATED TABLETS
quinine sulphate
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 SULPHATE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUININE SULPHATE
3.
HOW TO TAKE QUININE SULPHATE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE QUININE SULPHATE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT QUININE SULPHATE IS AND WHAT IT IS USED FOR
Quinine sulphate belongs to a group of medicines called anti-protozoal
agents and they are used to:
• treat malaria
• treat and prevent nocturnal (night time) leg cramps in the adults
and the elderly when sleep is
regularly disrupted.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUININE SULPHATE
DO NOT TAKE QUININE SULPHATE:

if you are allergic to quinine sulphate or any of the other
ingredients of this medicine (listed in
section 6)

if you have BLOOD IN YOUR URINE

if you have RINGING OR BUZZING IN YOUR EARS (tinnitus)

if you have PROBLEMS WITH YOUR EYES or difficulty seeing

if you have muscle weakness (MYASTHENIA GRAVIS)

if you have a history of decreased levels of platelets
(thrombocytopenia). If you are elderly
and develop thrombocytopenia you are at risk of a brain haemorrhage

if you have a history of cardiac arrhythmias (irregular heart rate or
rhythm)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Quinine Sulphate

if you have IRREGULAR HEART BEATS or other HEART DISEASE

if

Summary of Product characteristics

Health Products Regulatory Authority
09 May 2023
CRN00DJDZ
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Quinine Sulphate 300 mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg Quinine Sulphate.
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 QD embossed on one face..
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1) In the treatment of malignant tertian malaria including treatment
of chloroquine resistant 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 4.4 and 4.8).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_For the treatment of falciparum malaria:_
_ _
_Adults (including elderly) and children over 12 years:_
600 mg 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 200 mg daily (as a single dose or in two divided doses)
for at least 7 days.
2.
clindamycin 300 mg four times daily for 5 days.
_Children under 12 years:_
10 mg/kg every eight hours for 7 days.
_For the treatment and prevention of nocturnal leg cramps:_
_Adults (including elderly):_
300 mg at bedtime. The maximum dose is 300 mg.
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.
_Children and adoles