Quinine Sulphate 300mg Coated Tablets

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

QUININE SULFATE

Dostupné s:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC kód:

P01BC01

INN (Mezinárodní Name):

QUININE SULFATE 300 mg

Léková forma:

COATED TABLET

Složení:

QUININE SULFATE 300 mg

Druh předpisu:

POM

Terapeutické oblasti:

ANTIPROTOZOALS

Stav Autorizace:

Withdrawn

Datum autorizace:

2006-11-15

Informace pro uživatele

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• New regulatory text
WHAT IS IN THIS LEAFLET
1. What Quinine Sulfate Tablets are and what they are
used for
2. What you need to know before you take Quinine Sulfate
Tablets
3. How to take Quinine Sulfate Tablets
4. Possible side effects
5. How to store Quinine Sulfate Tablets
6. Contents of the pack and other information
1. WHAT QUININE SULFATE TABLETS ARE AND WHAT THEY
ARE USED FOR
The name of your medicine is Quinine Sulfate 300mg
Coated Tablets. Quinine Sulfate Tablets contain the
anti-malarial drug quinine sulfate and are used to treat a
type of malaria known as falciparum malaria (malignant
malaria). Malaria is a disease caused by infection with a
malaria parasite. This is carried by mosquitoes, which
flourish in tropical and subtropical countries. Human beings
become infected as a result of being bitten by malaria
carrying mosquitoes. Quinine sulfate has a relaxant action
on skeletal muscle. Your doctor may have prescribed this
medicine for the treatment of night leg cramps.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUININE
SULFATE TABLETS
DO NOT TAKE QUININE SULFATE TABLETS:
• if you are allergic to quinine or any of the other
ingredients of this medicine (listed in section 6)
• if you have problems with your eye sight
• if you suffer from tinnitus (ringing noises in the ear)
• if you have blood in the urine (or have had during a
previous attack of malaria)
• if you have been told you have haemolysis (a disorder
affecting the red blood cells)
• if you suffer from myasthenia gravis (a disease
characterised by weakness of certain groups of muscles)
• if you are pregnant or breast-feeding, unless the benefits
outweigh the risks
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking
Quinine Sulfate Tablets, if you suffer from, or have ever had:
• an enzyme deficiency, called glucose-6-phosphate
dehydrogenase deficiency
• your doctor has told you that you have

Charakteristika produktu

_ _
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Quinine Sulfate 300mg Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Quinine Sulfate 300mg
Excipients with known effect
Lactose and methyl hydroxyl benzoate (E218)
For the full list of excipients see 6.1
3
PHARMACEUTICAL FORM
Coated tablet for oral use.
White, biconvex, sugar-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
Posology
FOR THE TREATMENT OF FALCIPARUM MALARIA
_ _
_ _
_Adults_
600mg (two tablets) every eight hours for seven days.
_Paediatric population _
_Children:_10mg/kg bodyweight every eight hours for seven days.
FOR THE TREATMENT AND PREVENTION OF NOCTURNAL LEG CRAMPS
_ _
Page 2 of 8
_Adults (including elderly) _
_ _
The recommended dose is 200mg at bedtime. The maximum dose is 300mg.
_ _
_Paediatric population _
_ _
_Children under ten years:_ Not recommended
_ _
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 use.
4.3
CONTRAINDICATIONS
Quinine is contraindicated in patients with a history of
hypersensitivity to the
active substance or any of the excipients listed in section 6.1, in
tinnitus or
optic neuritis, in myasthenia gravis and in the presence of haemolysis
or
haemoglobinuria. As quinine has been implicated in precipitating
blackwater
fever_,_ it is generally contraindicated in patients who have already
suffered an
attack.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Before use for nocturnal