Quinine sulfate 300mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Quinine sulfate

Sẵn có từ:

Wockhardt UK Ltd

Mã ATC:

P01BC01

INN (Tên quốc tế):

Quinine sulfate

Liều dùng:

300mg

Dạng dược phẩm:

Oral tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 05040100; GTIN: 5012727903057

Tờ rơi thông tin

PATIENT INFORMATION LEAFLET
QUININE SULFATE 300MG TABLETS
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 or pharmacist.
‡
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 or nurse. This includes any
possible side effects not listed in this leaflet.
See section-4.
IN THIS LEAFLET:
1. What Quinine Sulfate is and what it is used
for
2. What you need to know before you take
Quinine Sulfate
3. How to take Quinine Sulfate
4. Possible side effects
5. How to store Quinine Sulfate
6. Contents of the pack and other information
1. WHAT QUININE SULFATE IS AND WHAT IT IS
USED FOR
Quinine Sulfate belongs to a group of medicines
called anti-protozoal agents and they are used to
treat:
x
malaria
x
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
DO NOT TAKE QUININE SULFATE IF YOU:
x
are
ALLERGIC
(hypersensitive) to
QUININE
or
any of the other ingredients of this medicine
(listed in section 6)
x
have
HAEMOLYTIC ANAEMIA
(tiredness caused
by the destruction of red blood cells)
x
have
TINNITUS
(ringing sound in the ears)
x
have
OPTIC NEURITIS
(loss of vision or
difficulty seeing)
x
have
HAEMOGLOBINURIA
(high concentration
of haemoglobin in urine)
x
have
MYASTHENIA GRAVIS
(suffer from muscle
weakness)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
these tablets if you:
x
have irregular
HEARTBEATS
or other heart
problems
x
have conduction defects of the heart (this is
where the heart cannot conduct electrical
signals properly)
x
have blood in your
URINE
x
suffer from
KIDNEY OR LIVER
problems
x
have had
MALARIA
for a long time
x
suffer from glucose-6-phosphate
dehydrogenase

Đặc tính sản phẩm

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
_ _
_ _
_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 leg cramps, the risks,