QUININE SULPHATE 300MG TABLETS
Active substance(s): QUININE SULPHATE
NAME OF THE MEDICINAL PRODUCT
Quinine Sulphate 300mg Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Quinine Sulphate 300mg
For excipients, see section 6.1
White biconvex tablets. Engraved MP39 on one side.
Quinine is a highly active blood schizonticide and suppresses the
asexual cycle of development of malaria parasites in the erythrocytes.
It is now mainly used in the treatment of P falciparum malaria resistant
to other antimalarial drugs.
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)
Posology and method of administration
For the treatment of chloroquine-resistant malaria:
Adults including the elderly:
600 mg of quinine salt 8-hourly for 7 days.
10 mg of quinine salt per kg bodyweight 8-hourly 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
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.
Route of administration: oral
Quinine is contra-indicated in patients with:
Hypersensitivity to quinine or to any of the excipient in the tablet
Haemoglobinuria during malaria
Special warnings and precautions for use
Before use for nocturnal leg cramps, the risks, which include significant
adverse effects and interactions (see sections 4.5 and 4.8), should be carefully
considered relative to the potential benefits. These risks are likely to be of
particular concern in the elderly. Quinine should only be considered when
cramps are very painful or frequent, when other treatable causes of cramp have
been ruled out, and when non-pharmacological measures have not worked.
Quinine sulphate should not be used for this indication during pregnancy (see
thrombocytopenia, which is thought to be an idiosyncratic hypersensitivity
reaction. Quinine should not be prescribed or administered to patients who have
previously experienced any adverse reaction to quinine, including that in tonic
water or other beverages. Patients should be instructed to stop treatment and
consult a physician if signs of thrombocytopenia such as unexplained bruising
or bleeding occur.
Quinine should be used with caution in patients with atrial fibrillation or other
serious heart disease. It may cause hypoprothrombinaemia.
Patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency may
develop acute haemolytic anaemia.
Administration of quinine may give rise to cinchonism, which is generally
more severe in overdose, but may also occur in normal therapeutic doses.
Patients should be warned not to exceed the prescribed dose, because of the
possibility of serious, irreversible side effects in overdose. Treatment for night
cramps should be stopped if symptoms of cinchonism emerge. Such symptoms
include tinnitus, impaired hearing, headache, nausea, vomiting abdominal
pain, diarrhea, vertigo, blindness and disturbed vision (see section 4.8 and
Hypersensitivity to quinine may also occur with symptoms of cinchonism
together with urticaria, flushing, pruritis, rash, fever, angioedema, dyspnoea
Interaction with other medicinal products and other forms of interaction
Effect of other drugs on quinine
Quinine is metabolised via hepatic oxidative cytochrome P450 pathways,
predominantly by CYP3A4. There is the potential for increased quinine
toxicity with concurrent use of potent CYP3A4 inhibitors, which include azole
antifungal drugs and HIV protease inhibitors.
Sub-optimal quinine serum levels may result from concomitant use of
CYP3A4 inducers, which include rifampicin, barbiturates, carbamazepine and
Care should be taken when quinine is used in combination with other CYP3A4
substrates, especially those causing prolongation of the QT interval.
Effect of quinine on other drugs
The plasma concentration of flecainide, digoxin and mefloquine may be
Quinine can decrease plasma concentrations of ciclosporin.
Other drug interactions
There is an increased risk of ventricular arrhythmias with other drugs which
prolong the QT interval, including amiodarone, moxifloxacin, pimozide,
thioridazine and halofantrine.
Concurrent use with oral hypoglycaemics may increase the risk of
Quinine may cause hypoprothrombinaemia and enhance the effects of
Quinine enhances the neuromuscular effects of suxamethonium.
Concomitant use of quinidine may increase the possibility of cinchonism.
Chloroquine and quinine appear to be antagonistic when given together for P
Fertility, Pregnancy and lactation
Quinine may cause congenital abnormalities of the CNS and extremities. Following
administration of large doses during pregnancy, phototoxicity and deafness have been
reported in neonates. Quinine sulphate should not be used during pregnancy unless
the benefits outweigh the risks (e.g. when the mother is treated for Malignant Tertian
Treatment of chlorquine-resistant strains of falciparium malaria.
Pregnancy in a patient with malaria is not generally regarded as a contra-indication to
the use of quinine. As malaria infection is potentially serious during pregnancy and
poses a threat to the mother and foetus, there appears to be little justification in
withholding treatment in the absence of a suitable alternative.
Prophylaxis of nocturnal leg-cramps.
Qunine sulphate should not be used during pregnancy to treat cramps.
Quinine sulphate is excreted in breast milk, but no problems in humans have been
reported. However, quinine sulphate should not be given to nursing mothers unless
the benefits outweigh the risks.
Effects on ability to drive and use machines
Quinine may cause visual disturbances and vertigo, hence patients should be advised
that if affected they should not drive or operate machinery.
MedDRA system organ class
Blood and lymphatic
Thrombocytopenia, intravascular coagulation,
hypoprothrombinaemia, haemoglobinuria, oliguria,
haemolytic-uremic syndrome, pancytopenia,
haemolysis, agranulocytosis, thrombocytopenic
Generalised hypersensitivity reactions including
angioneurotic oedema and fever
Immune system disorders
Metabolism and nutrition
Nervous system disorders
Blurred vision, defective colour perception, visual
Ear and labyrinth disorders Tinnitus, impaired hearing
Respiratory, thoracic and
Skin and subcutaneous
connective tissue disorders
Renal and urinary
Atrioventricular conduction disturbances,
hypotension, prolongation of the QT interval,
widening of the QRS complex and T wave flattening
Nausea, vomiting, diarrhoea, abdominal pain
Flushing, rash, urticaria, eczematous dermatitis,
oedema, erythema, lichen planus, pruritis,
Muscle weakness, aggravation of myasthenia gravis
Renal insufficiency, acute renal failure
Quinine overdosage may lead to serious side effects including irreversible visual loss,
and can be fatal.
Symptoms include vomiting, tinnitus, deafness, headache, and visual disturbance.
Features of a significant overdose include convulsions, impairment of consciousness,
respiratory depression, QT prolongation, ventricular arrhythmia, cardiogenic shock
and renal failure. High doses of quinine are tetrogenic and may cause miscarriage.
Hypokalaemia and hypoglycaemia may also occur.
Children (< 5 years) who have ingested any amount should be referred to hospital.
Older children and adults should be referred to hospital if more than 30 mg/kg of
quinine base has been taken.
Consider activated charcoal (50 g for adults; 1 g/kg for children) if the patient
presents within 1 hour of ingestion of more than 30 mg/kg quinine base or any
amount in a child under 5 years. Multiple dose activated charcoal will enhance
Observe patients for at least 12 hours after ingestion. Monitor cardiac conduction and
rhythm, serum electrolytes, blood glucose and visual acuity.
Other treatment is symptomatic to maintain blood pressure, respiration, renal function
and to treat arrhythmia, convulsions, hypoglycaemia and acidosis.
Note: each 300mg tablet is equivalent to 178mg quinine base.
Quinine is a highly active blood schizonticide and suppresses the asexual cycle of
development of malaria parasites in the erythrocytes. It is considered to act by
interfering with DNA.
Quinine is almost completely absorbed from the gastro-intestinal tract. Peak
concentrations in the circulation is attained about 1-3 hours after ingestion and about
70% is bound to proteins in the plasma. Quinine is readily diffused across the
placenta. It is degraded in the body, mainly in the liver, and only a small proportion is
excreted in the urine unchanged.
The plasma half-life is 11 hours.
Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.
List of excipients
Sodium starch glycollate
Special precautions for storage
Do not store above 25°C. Keep the container tightly closed.
Nature and contents of container
High density polystyrene containers with polythene lids and/or polypropylene
containers with polythene lids and polyurethane or polythene inserts.
Containers of 100, 250 and 500 tablets.
Special precautions for disposal and other handling
MARKETING AUTHORISATION HOLDER
Genethics Europe Limited
41 - 43 Klimentos
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
13 July 2001
DATE OF REVISION OF THE TEXT