Consumer Medicine Information 
This page answers some common questions about PRIMACIN™
(primaquine) TABLETS. Please read this carefully before you start taking the
tablets. The page does not contain all the information available on this
medicine. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of
you taking PRIMACIN™ against the benefits he expects it will have for you. If
you have concerns about taking this medicine, ask your doctor or your pharmacist
for further information. Keep this information with your medicine. You may need
to read it again.
Identification
PRIMACIN™ tablets contain primaquine phosphate 13.2mg equivalent to 7.5mg
of primaquine. The excipients (inactive ingredients) contained in the tablets
are lactose, wheat starch, purified talc, gelatin, povidone, magnesium stearate
and glycerol.
What primaquine is used for
Primaquine is registered in Australia for two uses:
- to treat the vivax and ovale form of malaria following
an attack
- to aid in the treatment of falciparum malaria by
treating the malaria parasites in patients resident in areas receptive to
malaria
Before you use primaquine
Contraindications - Do not take primaquine if you have an
allergic reaction to the drug. Tell your doctor if you are pregnant or intend to
become pregnant. Tell your doctor if you are breastfeeding or are intending to
breastfeed. If you have a condition known as glucose-6-phosphate dehydrogenase
deficiency (G6PD deficiency) tell your doctor. You may not know if you have this
deficiency but your doctor can give you a quick blood test to check this out. If
you have a serious disease, for example, rheumatoid arthritis or lupus, please
tell your doctor. The tablets contain small amounts of two inactive ingredients
which some people are allergic to - lactose and wheat starch (gluten). If you
are allergic to these substances please tell your doctor.
Warning: If the tablets show visible signs of deterioration do not use them.
Do not use the medicine after the expiry date.
Taking other medicines
Tell your doctor if you are taking proguanil or are
allergic to proguanil (Paludrine). Tell your doctor all the medicines you are
taking including medicines you buy without a prescription from your pharmacy,
supermarket or health food shop. Some medicines may interfere with primaquine.
Your doctor will need to know this to ensure that there are no interactions.
These drugs include ketoconazole - a drug used to treat fugal infections.
How it works
Primacin works by killing the malarial parasite at different stages of its
life cycle, both in the blood and in the liver.
How to use primaquine properly
To treat malaria: if you have an attack of malaria following a stay in a
malaria area, there are a number of methods used to kill the parasite injected
into your body. The treatment and dose will depend upon the area in which you
stayed. In some areas, South East Asia and the Pacific region close to Australia
(Papua New Guinea, Vanuatu, Solomon Islands), there are parasites that live in
the mosquito which are more resistant to treatment. If your stay has been in one
of these areas, the treatment may include an increased dose of primaquine or the
use of primaquine over a longer period of time. The general treatment is usually
one of the following:
Dosage and administration
Primaquine should be taken with food Radical treatment Your doctor will
tell you how many tablets to take. The general treatment is usually one of the
following:
 | 15mg for 14 days |
| up to 30mg daily for 14 days in areas where resistant malaria strains
occur or where treatment has failed with lower doses. |
| The WHO advises that the treatment period of 21 days should be employed to
achieve radical cure in most of South East Asia and the Pacific regions.
Other antimalarial agents may be used concomitantly. |
| Paediatric dose 0.3mg/kg/day. For the reduction of gametocytes of P.
falciparum 0.7 to 1.0mg/kg |
| For patients with G6PD deficiency. Up to 45mg once weekly for 8 weeks with
monitoring for the development of haemolysis |
| Reduction of gametocytes of P. falciparum 45mg as a single dose for adults
and 0.7 - 1.0 mg/kg for children |
Ensure that you take the complete course of tablets. If you feel chilly or
have a fever following return from a malaria area, see your doctor even if you
have taken a course of tablets. In a small proportion of cases, relapses may
occur.
What to do if one or more doses are not taken
PRIMACIN™ tablets must be taken regularly - try to take the tablets at
about the same time each day with a meal. If you miss a dose one day, do not
increase the dose the next day but continue with the usual dose. If you miss
more than one dose, consult your doctor.
In case of overdose
Please contact your nearest Poisons Centre (13 11 26) or doctor immediately
or go to casualty at your nearest hospital immediately if you think that you or
anyone else may have taken too much Primacin. Do this even if there are no signs
of discomfort or poisoning. You may need urgent medical attention.
Unwanted effects
Generally, the side effects of primaquine are few. You may not experience the
reactions listed below and the list is not exhaustive. Ensure that you take your
tablets with food or an upset stomach may occur. If you feel unwell or feverish
while taking the tablets, see your doctor even if the side effect is not listed
below.
Common: abdominal cramps and pains, nausea, vomiting, dizziness &
headache. Effects on the blood may occur in susceptible individuals. These occur
more commonly in patients taking very high doses - 120 mg daily.
Storage conditions
Keep your tablets in a cool place below 25 degrees. The expiry date of
the tablets is on the label. Do not use the product after this date.
Where to go for further information
Further
information is available from your pharmacist or doctor
Product description
PRIMACIN™
Tablets comply with the requirements of the British Pharmacopoeia 1988 but do
not comply with you European Pharmacopoeia 1997. Primaquine has been used for
more than 40 years in malaria but has not undergone the same long-term animal
safety testing as drugs, which have been developed more recently. PRIMACIN™
tablets are pink/orange in colour and contain 7.5mg primaquine.
Aust R 63856
Sponsor
Boucher & Muir, 118-124
Willoughby Road, Crows Nest, NSW 2065 Australia
Date of
information
April 1998
Please note that Boucher & Muir Pty Ltd
cannot be held responsible for the accuracy of this text. As the information on
this screen may not contain the latest information on this product, we recommend
that alternative sources of information be consulted, particularly when
confirmation of indications and dosages is required.
Phone: (612) 9431 6333
Fax: (612) 9906 7147
Email: primacin@bnmgroup.com
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