QUINATE quinine sulfate dihydrate 300mg tablet jar (reformulation)

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

quinine sulfate dihydrate, Quantity: 300 mg

Dostopno od:

Arrotex Pharmaceuticals Pty Ltd

Farmacevtska oblika:

Tablet, film coated

Sestava:

Excipient Ingredients: lactose monohydrate; maize starch; povidone; sodium starch glycollate; magnesium stearate; titanium dioxide; hypromellose; macrogol 400

Pot uporabe:

Oral

Enote v paketu:

HDPE container 50 tablets

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Prevention and symptomatic relief of muscle cramps. Symptomatic relief of myotonia congenita. Suppression of malaria. INDICATIONS AS AT 21 JANUARY 2004. Suppression of malaria. INDICATIONS AS AT 26 APRIL 2004. Suppression of malaria.

Povzetek izdelek:

Visual Identification: White round biconvex film coated tablet; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

1994-11-22

Navodilo za uporabo

QUINATE
1
QUINATE®
_ _
Quinine Sulfate Dihydrate
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions about Quinate. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor or pharmacist has weighed
the risks of you taking Quinate against
the benefits they expect it will have for
you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT QUINATE IS USED FOR
Quinate contains quinine (as quinine
sulfate) as the active ingredient.
Quinate is used to treat malaria, an
infectious
disease
spread
by
female
mosquitoes. It belongs to a group of
medicines called antimalarials.
This medicine works by stopping the
growth of the organisms which cause
malaria.
ASK
YOUR
DOCTOR
IF
YOU
HAVE
ANY
QUESTIONS
ABOUT
WHY
QUINATE
HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another purpose
This medicine is only available with a
doctor’s prescription.
There is no evidence that it is addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE QUINATE IF YOU HAVE EVER
HAD AN ALLERGIC REACTION TO :
•
quinine sulfate
•
Any of the tablet ingredients listed
at the end of this leaflet.
Symptoms of an allergic reaction may
include shortness of breath, wheezing,
or difficulty in breathing; swelling of the
face, lips, tongue or any other parts of
the body; rash, itching or hives on the
skin.
DO NOT TAKE QUINATE IF YOU HAVE HAD
A REACTION TO IT BEFORE.
Highly
sensitive
reactions
to
quinine
can include bleeding or bruising more
easily
than
normal,
bloody diarrhoea
and stomach pains.
DO NOT TAKE QUINATE IF YOU HAVE:
•
myasthenia gravis, a disease of the
muscles.
•
_Glucose-6-phosphate _
_dehydrogenase, a genetic disorder _
_mainly affecting red blood cells _
•
_Tinnitus, ringing in the ears _
•
_Optic neuritis, an inflammation of _
_the opti

Lastnosti izdelka

QUINATE –Product Information Page 1 of 5
PRODUCT INFORMATION
QUINATE
®
Quinine sulfate
NAME OF THE MEDICINE
QUINATE (quinine sulfate).
DESCRIPTION
Quinine sulfate is the sulfate of an alkaloid obtained from the bark
of species of
_Cinchona_
. It contains not less that 99.0
per cent and not more that 101.0 per cent of total alkaloid salt,
calculated as (C
20
H
24
N
2
O
2
)
2
·H
2
SO
4
, on the anhydrous
basis. It is a white or almost white or colourless, fine, crystalline
solid. Quinine sulfate dihydrate has the following
structural formula:
Molecular weight: 783.0. CAS Registry Number: 6119-70-6.
QUINATE tablets contain 300 mg of quinine sulfate. They also contain
the excipients lactose monohydrate, maize
starch, povidone, sodium starch glycollate, magnesium stearate and
Opadry complete film coating system White Y-1-
7000.
PHARMACOLOGY
Quinine affects a large variety of biological systems. From the
therapeutic viewpoint, the following are most relevant.
_Central nervous system_
. Quinine exerts a slight antipyretic effect, and an analgesic action
resembling that of the
salicylate group, especially on joint and muscle pain. Although
Quinine acts centrally, it is ineffective against severe
pain.
_ _
_Cardiovascular system_
. Quinine acts in a similar qualitative manner on cardiac muscle as
does its isomer quinidine, the
anti-arrhythmic drug. However, therapeutic doses of quinine have
little or no effect on the normal cardiovascular
system in man.
_Smooth muscle._
Quinine has a mild stimulatory effect on the pregnant uterus which is
an oxytocic stimulation. It also
passes the placental barrier. Quinine may also cause the smooth muscle
in the spleen to contract producing
lymphocytosis, sometimes observed after therapeutic doses of the drug.
_Skeletal muscle_
. Quinine has a dual action in skeletal muscle: it acts directly on
the muscle fibre increases the tension
response, and also increases the refractory period; it affects
neuromuscular transmission by increasing the threshold of
excitability of the motor endpl