Quinine bisulfate 300mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Quinine bisulfate

Dostopno od:

Teva UK Ltd

Koda artikla:

P01BC01

INN (mednarodno ime):

Quinine bisulfate

Odmerek:

300mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 05040100; GTIN: 5017007120254

Navodilo za uporabo

Talk to your doctor if you are taking any of the
following:
•
anticoagulants (to stop your blood from
clotting)
•
cardiac glycosides (for your heart such as
digoxin)
•
amiodarone, quinidine or flecainide (used to
treat an irregular heartbeat)
•
pimozide or thioridazine (used in the
treatment of mental illness)
•
terfenadine (used in the treatment of allergies)
•
moxifloxacin or rifampicin (antibiotics)
•
antifungals (to treat infections)
•
ciclosporin (used to prevent transplant
rejection)
•
halofantrine, chloroquine, mefloquine or
artemether with lumefantrine or primaquine
(also to treat malaria)
•
cimetidine (to treat stomach ulcers or acid
reflux and indigestion)
•
amantadine (to treat Parkinsons Disease or
some viral infections)
•
suxamethonium (a muscle relaxant)
•
carbamazepine or phenytoin
(anticonvulsants)
•
antifungal medicines, e.g. fluconazole,
itraconazole, ketoconazole
•
barbiturates, e.g. phenobarbital (medicines
to treat epilepsy)
•
medicines to prevent blood clots forming,
e.g. warfarin
•
medicines to treat diabetes e.g. metformin,
tolbutamide, glimepiride
•
medicines used in the treatment of HIV e.g.
ritonavir, indinavir, nelfinavir
•
medicines which are known to cause
disturbances in heart rhythm.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
PREGNANCY, BREAST-FEEDING AND FERTILITY
You should not take Quinine Bisulfate tablets if
you are pregnant, planning to become
pregnant or breast-feeding unless advised to
by your doctor.
QUININE BISULFATE IS NOT RECOMMENDED FOR USE
DURING PREGNANCY FOR THE PREVENTION OF NIGHT
CRAMPS.
DRIVING AND USING MACHINES
Quinine Bisulfate may affect your vision or
cause vertigo (a feeling of dizziness or
“spinning”). If you are affected, DO NOT drive
or operate machinery.
QUININE BISULFATE CONTAINS SUCROSE
Patients who are intolerant to SUCROSE should
note that Quinine Bisulfate tablets contain a
small amount of sucrose.

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Quinine Bisulfate 300 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg quinine bisulphate equivalent to 178 mg
anhydrous
quinine base.
Excipient(s) with known effect:
Sucrose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablet.
White, biconvex, sugar-coated tablets, plain or marked APS on one side
and
coded "300 over "1202" on reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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).
Treatment of chloroquine-resistant malaria.
_4.2. _
_POSOLOGY AND METHOD OF ADMINISTRATION _
Posology
Adults
For the treatment and prevention of nocturnal leg cramps
Adults (including elderly):
The recommended dose is 300 mg 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.
Treatment of Chloroquine-Resistant Malaria
Adults (including elderly) and children aged 12 years and over: 600mg
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 200mg daily (as a single dose or in 2 divided doses) for
at least 7 days.
2.
clindamycin 300mg four times daily for 5 days.
Children
Treatment of Chloroquine-Resistant Malaria
10 mg/kg every 8 hours for 7 days.
Method of administration
For oral administration