Skip to Content

QUININE SULPHATE 300MG TABLETS

Active substance(s): QUININE SULPHATE / QUININE SULPHATE / QUININE SULPHATE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Quinine Sulphate 300mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Quinine Sulphate 300mg
For excipients, see section 6.1

3

PHARMACEUTICAL FORM
Film-coated tablet
White biconvex tablets. Engraved MP39 on one side.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
1.
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.
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 Section 4.4)

4.2

Posology and method of administration
1.
For the treatment of chloroquine-resistant malaria:
Adults including the elderly:
600 mg of quinine salt 8-hourly for 7 days.
Children:
10 mg of quinine salt per kg bodyweight 8-hourly for 7 days.
2.
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.

Route of administration: oral

4.3

Contraindications
Quinine is contra-indicated in patients with:
Hypersensitivity to quinine or to any of the excipient in the tablet
Haemoglobinuria during malaria
Tinnitus
Myasthenia gravis
Optic neuritis.

4.4

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
Section 4.6).
Quinine
may cause
unpredictable
serious
and
life-threatening
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
4.9).
Hypersensitivity to quinine may also occur with symptoms of cinchonism
together with urticaria, flushing, pruritis, rash, fever, angioedema, dyspnoea
and asthma.

4.5

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
phenytoin.
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
increased.
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
hypoglycaemia .
Quinine may cause hypoprothrombinaemia and enhance the effects of
anticoagulants.
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
falciparum malaria.

4.6

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
Malone).
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.
Lactation

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.

4.7

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.

4.8

Undesirable effects
MedDRA system organ class

Adverse Reaction

Blood and lymphatic
system disorders

Thrombocytopenia, intravascular coagulation,
hypoprothrombinaemia, haemoglobinuria, oliguria,
haemolytic-uremic syndrome, pancytopenia,
haemolysis, agranulocytosis, thrombocytopenic
purpura
Generalised hypersensitivity reactions including
angioneurotic oedema and fever

Immune system disorders
Metabolism and nutrition
disorders
Psychiatric disorders
Nervous system disorders

Hypoglycaemia
Agitation, confusion
Headache, vertigo

Blurred vision, defective colour perception, visual
field constriction
Ear and labyrinth disorders Tinnitus, impaired hearing

Eye disorders

Cardiac disorders
Respiratory, thoracic and
mediastinal disorders
Gastrointestinal disorders
Skin and subcutaneous
tissue disorders
Musculoskeletal and
connective tissue disorders
Renal and urinary
disorders

4.9

Atrioventricular conduction disturbances,
hypotension, prolongation of the QT interval,
widening of the QRS complex and T wave flattening
Bronchospasm
Nausea, vomiting, diarrhoea, abdominal pain
Flushing, rash, urticaria, eczematous dermatitis,
oedema, erythema, lichen planus, pruritis,
photosensitivity
Muscle weakness, aggravation of myasthenia gravis
Renal insufficiency, acute renal failure

Overdose
Symptoms
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.
Treatment
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
quinine elimination.
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.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
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.

5.2

Pharmacokinetic properties
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.

5.3

Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Core:
Maize starch
Sucrose
Povidone
Sodium starch glycollate
Talc
Magnesium stearate
Purified water
Coating:
Hypromellose
Ethylcellulose
Diethyl phthalate
Titanium dioxide
Saccharin sodium
Beeswax

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
36 months

6.4

Special precautions for storage
Do not store above 25°C. Keep the container tightly closed.

6.5

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.

6.6

Special precautions for disposal and other handling
Not applicable

7

MARKETING AUTHORISATION HOLDER
Genethics Europe Limited
41 - 43 Klimentos

Klimentos Tower
Nicosia 1061
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 42976/0061

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
13 July 2001

10

DATE OF REVISION OF THE TEXT
12/04/2016

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide