Quinine sulfate 300mg tablets

Country: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Quinine sulfate

থেকে পাওয়া:

Strides Pharma UK Ltd

এটিসি কোড:

P01BC01

INN (International Name):

Quinine sulfate

ডোজ:

300mg

ফার্মাসিউটিকাল ফর্ম:

Oral tablet

প্রশাসন রুট:

Oral

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 05040100; GTIN: 5031676004554

তথ্য লিফলেট

180 X 230 MM
FRONT SIDE
PACKAGE LEAFLET: INFORMATION FOR THE USER
QUININE SULFATE TABLETS 300 MG
[Quinine Sulfate]
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leafl et. You may need to read it again.
•
If you have any further questions, ask your doctor, or
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, pharmacist
or nurse. This includes any possible side effects not listed
in this leafl et. See section 4.
WHAT IS IN THIS LEAFL ET:
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
Quinine Sulfate is one of a group of medicines called anti-
protozoal agents.
Quinine Sulfate Tablets are used to:
•
Treat malaria.
•
Treat and prevent nocturnal (night-time) leg cramps in
adults and the elderly.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
QUININE SULFATE TABLETS
DO NOT TAKE QUININE SULFATE IF YOU:
•
Are allergic to quinine or any other ingredients of this
medicine (Listed in section 6).
•
Have problems with your eyes or diffi culty seeing.
•
Suffer from tinnitus (ringing or buzzing in the ears).
•
Have blood in the urine (haemoglobinuria).
•
Suffer from muscle weakness (myasthenia gravis).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Quinine Sulfate
Tablets if you:
•
Are
sensitive
to
Quinine.
See
section
4
for
possible
symptoms.
•
Have had malaria for a long time.
•
Have irregular heartbeats or other heart disease.
•
Have conduction defects of the heart (this is where the
heart cannot conduct electrical sign

পণ্য বৈশিষ্ট্য

1.
NAME OF THE MEDICINAL PRODUCT
Quinine Sulfate Tablets BP 300mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains quinine sulfate 300mg
Lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White, round, biconvex, film coated tablets marked “3” on one side
and plain on the other
side.
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
For falciparum malaria
Adults: the adult dosage regimen by mouth is 600mg of quinine sulfate
given every 8
hours for 7 days.
The elderly: as for adults
Children: the dosage regimen for children by mouth is 10mg of quinine
sulfate per kg
body weight given every 8 hours for 7 days.
Note
If quinine
resistance is known or suspected in the patient, then supplementary
treatment with another recommended antimalarial drug is necessary.
If part or all of the dose is vomited within 1 hour of administration,
then the same
amount must be administered immediately.
For the treatment and prevention of nocturnal leg cramps:
Adults (including elderly):
The recommended dose is 300mg 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.
4.3
CONTRAINDICATIONS
-Hypersensitivity to the active substance(s) or to any of the
excipients listed in section
6.1.
-Optic neuritis
-Tinnitus
-Myasthenia gravis, quinine may cause severe respiratory distress and
dysphagia in
these patients
-Haemoglobinuria 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Cinchonism
Administration of quinine may g