Quinine sulfate 300mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Quinine sulfate

זמין מ:

Bristol Laboratories Ltd

קוד ATC:

P01BC01

INN (שם בינלאומי):

Quinine sulfate

כמות:

300mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 05040100; GTIN: 5060013940682 5060013940309

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
QUININE SULFATE 300MG TABLETS
QUININE SULFATE
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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
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 tablets BP 300mg.
The active ingredient is Quinine Sulfate.
Quinine Sulfate belongs to a group of medicines called anti-
protozoal agents and they are used to treat:
•
malaria
•
and prevent night cramps in adults and the elderly when sleep
is regularly disrupted.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
QUININE SULFATE TABLETS
DO NOT TAKE Quinine Sulfate tablets and tell your doctor if you
have:
•
an allergy to quinine (including that in tonic waters or other
beverages), quinoline or any of the other ingredients of this
medicine (listed in section 6)
•
BLOOD IN YOUR URINE
•
RINGING IN YOUR EARS
•
suffer from muscle weakness (MYASTHENIA GRAVIS)
•
problems with your EYES or difficulty seeing
•
been told you have a disorder affecting the red blood cells
(HAEMOLYSIS)
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST before taking Quinine Sulfate
tablets if you:
•
have IRREGULAR HEART BEATS or other HEART DISEASE
•
have had MALARIA for a long time
•

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Quinine Sulfate Tablets BP 300 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg of Quinine Sulfate.
Excipients of known effect: Also contains 34mg of lactose and 156mg of
sucrose.
For the full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Tablet
White, bi-convex, sugar coated tablets
4.1.
THERAPEUTIC INDICATIONS
1) Treatment of falciparum (malignant tertian) 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 section
4.4)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology: _ _FOR THE TREATMENT OF FALCIPARUM (MALIGNANT TERTIAN) MALARIA _
_ _
_Adults (including the elderly) and children aged 12 years and over:_
Two tablets (600
mg) to be taken every 8 hours for a period of 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 aged 10-12 years_: Dosage is dependent on bodyweight as
follows- 10 mg/kg
to be taken every 8 hours for a period of 7 days.
_Children under 10 years:_ Not recommended
_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