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CONSUMER MEDICINE INFORMATION
Ask your doctor or pharmacist if you have any
• Any of the ingredients listed at the end of this leaflet.
questions about why Chemmart® Thrush one dose +
Some of the symptoms of an allergic reaction may
cream has been recommended for you. Your doctor
or pharmacist may have recommended Chemmart®
Thrush one dose + cream for another reason.
• Itching or hives
Chemmart® Thrush one dose + cream is not
• Swelling of the face
recommended for children under 18 years of age
• Lips or tongue which may cause difficulty in
One dose + cream
except under doctor supervision.
swallowing or breathing
There is no evidence that either component in
• Wheezing or shortness of breath
Chemmart® Thrush one dose + cream is addictive.
Do not use Chemmart® Thrush one dose + cream if
Fluconazole 150mg capsule
Chemmart® Thrush one dose + cream is a "Pharmacist
you are taking cisapride (Prepulsid), a medicine used
Only Medicine". It is available without a doctor's
to treat stomach problems. Combining Chemmart®
prescription but your pharmacist's advice is required.
Thrush one dose + cream with cisapride may cause
What is vaginal thrush?
serious side effects such as an abnormal heart rhythm. Do not use Chemmart® Thrush one dose + cream
Vaginal thrush is a common name for vaginal
if you are pregnant, suspect you may be pregnant
What is in this leaflet?
candidiasis and infection caused by a yeast-like
or if you may become pregnant during treatment.
This leaflet answers some common questions about
fungus called Candida albicans. Candida albicans
Chemmart® Thrush one dose + cream should not
Chemmart® Thrush one dose + cream.
is one of the many organisms that live in the vagina.
be used during pregnancy as it may affect your
Your body's natural balance (immune system)
It does not contain all the available information. It
developing baby.
normally keeps Candida albicans under control,
does not take the place of talking to your doctor
Do not use Chemmart® Thrush one dose + cream if
but when this balance is upset, Candida albicans
or pharmacist.
you are breastfeeding. Fluconazole passes into breast
can multiply and cause thrush symptoms. Common
All medicines have benefits and risks. Your doctor or
milk and may affect your baby.
symptoms of vaginal thrush include:
pharmacist has weighed the risks of you using this
Do not use Chemmart® Thrush one dose + cream if
medicine against the benefits expected for you.
the expiry date (EXP) printed on the pack has passed.
• Burning or soreness around the vagina
If you have any concerns about using the
Do not use Chemmart® Thrush one dose + cream if
• Cottage-cheese like discharge
medicine, talk to your doctor or pharmacist.
the packaging shows signs of tampering; the capsule
• Swelling or irritation of the infected area.
Keep this leaflet with your medicine. You may
does not look quite right or the cream tube shows
need to read it again.
Things that may help you to avoid
signs of tampering.
thrush in the future:
If you are not sure whether you should start using this medicine, talk to your doctor or pharmacist.
What Chemmart® Thrush one
• Wear cotton briefs, stockings and loose-fitting
clothing rather than tight synthetic clothing
dose + cream is used for?
Before you start to use it
• Wash regularly, but do not wash and dry yourself
Tell your doctor or pharmacist if you are allergic to any
Chemmart® Thrush one dose + cream is used to treat
other medicines, foods, dyes or preservatives.
a type of fungal infection called vaginal thrush.
• Avoid perfumed soaps, bath additives and vaginal
Tell your doctor or pharmacist, if you have or have
If this is the first time you have had these symptoms,
had, any medical conditions, especially the following:
talk to your doctor before using any treatment.
Your doctor or pharmacist may have more information
• Thrush more than twice in the last six months.
Chemmart® Thrush one dose + cream contains two
on things you can do to avoid thrush in the future.
• Liver problems.
Before you use Chemmart®
• Kidney problems.
Chemmart® Fluconazole is an oral capsule which
• Heart problems.
contains the active ingredient Fluconazole;
Thrush one dose + cream
• HIV infection or AIDS.
Chemmart® Clotrimazole cream contains the active
• Diabetes.
ingredient Clotrimazole, both of these ingredients
When you must not use it
belong to a group of medicines called azole antifungals.
Do not use Chemmart® Thrush one dose + cream if
Your doctor or pharmacist may want to take special care if you have any of these conditions.
Chemmart® Fluconazole capsule is taken by mouth
you are allergic to medicines containing:
and works from the inside to prevent the growth of
• Fluconazole.
Tell your doctor or pharmacist before using
the fungi causing your infection;
• Clotrimazole.
Chemmart® Thrush one dose + cream if you are
taking warfarin. (eg. Marevan, Coumadin), as bleeding
® Clotrimazole provides soothing relief from
• Other azole antifungals such as miconazole,
external itching and irritation.
or bruising may occur.
ketoconazole, itraconazole or econazole.
Tell your doctor or pharmacist
• Midazolam (e.g. Hypnovel) and triazolam (e.g Halcion),
Do this even if there are no signs of discomfort or
if you are experiencing any of
medicines used as sedatives or to treat anxiety.
poisoning. You may need urgent medical attention.
the following:
• Zidovudine (e.g. Retrovir), a medicine used to treat
While you are using Chemmart®
• Abnormal or irregular vaginal bleeding or blood
Thrush one dose + cream
stained discharge.
• Hydrochlorothiazide (e.g. Dithiazide), a medicine
used for treating fluid problems and high blood
• Foul smelling or unusual coloured discharge.
Things you must do
• Vulval or vaginal sores, ulcers or blisters.
• The contraceptive pill (birth control pill).
• Before starting any new medicine, tell your doctor
• Lower abdominal pain or burning when passing
or pharmacist that you are using or have used
Talk to your doctor about the need for additional method of contraception while using Chemmart®
Chemmart® Thrush one dose + cream.
• Fever or chills.
Thrush one dose + cream. Chemmart® Thrush one
• Tell your doctors, dentists and pharmacists who
If you have not told your doctor or pharmacist about
dose + cream may decrease the effectiveness of
are treating you that you are using or have used
any of the above, tell them before you start using
some birth control pills.
Chemmart® Thrush one dose + cream.
Chemmart® Thrush one dose + cream.
Your doctor can tell you what to do if you are taking
• Use effective contraception to prevent pregnancy
Using Chemmart® Clotrimazole Cream component
any of these medicines.
while using Chemmart® Thrush one dose + cream.
of Chemmart® Thrush one dose + cream may
If you are not sure whether you are taking any
• Immediately tell your doctor if you do become
reduce the effectiveness and safety of latex
of these medicines, check with your doctor or
pregnant while using Chemmart® Thrush one dose
products, such as condoms and diaphragms. This
pharmacist. Your doctor and pharmacist have more
effect is temporary and occurs only during treatment.
information on medicines to be careful with or avoid
If your symptoms do not improve after 3 days, tell
Taking other medicines
while using Chemmart® Thrush one dose + cream.
your doctor or pharmacist.
If you are taking cisapride (Prepulsid), a medicine
How to use Chemmart®
Things you must not do
used to treat stomach problems, do not use
Thrush one dose + cream?
Do no use Chemmart® Thrush one dose + cream
Chemmart® Thrush one dose + cream. Tell your
to treat any other conditions unless your doctor or
doctor or pharmacist if you are taking anyother
Follow all directions given to you by your doctor
pharmacist tells you to.
medicines, including any that you buy without a
and pharmacist carefully. They may differ from the
Do not give Chemmart® Thrush one dose + cream
prescription from a pharmacy, supermarket or health
information contained in this leaflet.
to anyone else, even if they have the same condition
If you do not understand the instructions on the pack,
Some medicines may be affected by Chemmart®
ask your doctor or pharmacist.
Things to be careful of
Thrush one dose + cream or may affect how well it
How to use it
works. These include:
Tell your doctor immediately if you develop a rash
• Warfarin (e.g. Marevan, Coumadin), a medicine
For vaginal thrush in adults, only a single dose (1
while using Chemmart® Thrush one dose + cream.
used to prevent blood clots.
capsule) is needed.
People with AIDS or a weak immune system may be more prone to serious side effects of the skin.
• Phenytoin (e.g. Dilantin), a medicine used to treat
Swallow the capsule whole with a glass of water. The
capsule can be taken with or without food.
Side effects
• Cyclosporin (e.g. Neoral) or tacrolimus (e.g.
Use the cream on the external irritated area 2-3 times
Prograf), medicines used to prevent organ
a day to relieve the symptoms for as long as they last,
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Chemmart®
transplant system rejection or to treat certain
usually not more than 3 days.
Thrush one dose + cream.
problems with the immune system.
Do not give Chemmart® Thrush one dose + cream to
• Certain medicines used to treat diabetes such
children under 18 years of age except under doctor
Chemmart® Thrush one dose + cream helps most
as: glibenclamide (e.g. Daonil, Glimel), glipizide
people and is generally well tolerated. However it may have unwanted side effects in some people.
(e.g. Minidiab, Melizide),glimepiride (e.g. Amaryl),
If you use too much Chemmart®
gliclazide (e.g. Diamicron, Glyade) pioglitazone
All medicines can have side effects. Sometimes they are
Thrush one dose + cream (overdose)
(e.g. Actos).
serious, most of the time they are not. You may need
Immediately telephone your doctor, or the Poisons
• Rosiglitazone (e.g. Avandia) rifampicin (e.g. Rifadin,
medical treatment if you get some of the side effects.
Information Centre (telephone 13 11 26 –Aust
Rimycin) or rifabutin (e.g. Mycobutin), antibiotics
Do not be alarmed by this list of possible side effects.
or 0800 764 766 – N.Z.), or go to Accident and
used to treat infections.
You may not experience any of them.
Emergency at the nearest hospital, if you think you
• Theophylline (e.g. Nuelin), a medicine used to treat
Ask your doctor or pharmacist to answer any
or anyone else may have used too much Chemmart®
questions you may have.
Thrush one dose + cream.
Tell your doctor or pharmacist if you notice any of the
After using Chemmart®
The cream also contains:
following and they worry you:
• Propylene glycol.
• Nausea (feeling sick).
Thrush one dose + cream
• Cetostearyl alcohol.
• Vomiting.
• Disodium edetate.
• Stomach pains.
Keep Chemmart® Thrush one dose + cream where
• Cetomacrogol 1000.
• Indigestion.
children cannot reach it. A locked cupboard at least
• Paraffin liquid.
• Diarrhoea.
one-and-a-half metres above the ground is a good
• Dimethicone 100.
• Headache.
place to store medicines.
• Paraffin soft white.
• Mild burning, stinging or irritation immediately
Keep your medicines in a cool dry place where the
• Glyceryl monostearate self-emulsifying.
after application.
temperature stays below 25°C.
• Benzyl alcohol.
• Pruritus.
Do not store Chemmart® Thrush one dose + cream or
• Purified water.
The side effects listed above are common and
any other medicine in the bathroom or near a sink.
This medicine does not contain sucrose, gluten,
usually mild.
Do not leave your medicine in the car or on
tartrazine or any other azo dyes.
Tell your doctor as soon as possible if you notice any
of the following:
Heat and dampness can destroy some medicines.
• Unusual muscle stiffness causing poor control of
Symbion Pharmacy Services Pty Ltd.
ABN 25 000 875 034.48-58 Overseas Drive,
• Frequent infections such as fever, severe chills,
If your doctor or pharmacist tells you to stop using
Noble Park North, VIC 3174, Australia.
sore throat or mouth ulcers.
Chemmart® Thrush one dose + cream, or your
• Bleeding or bruising more easily than normal.
medicine has passed its expiry date, ask your
Chemmart® is a registered trade mark of Symbion Pharmacy Services Pty Ltd.
• Passing more urine than normal, kidney pain (pain
pharmacist what to do.
on the sides of the body).
Made in India.
• Symptoms of liver disease such as yellowing of
the skin or eyes; dark urine, pale stools; loss of
What Chemmart® Thrush one dose + cream looks like–
appetite; unusual tiredness.
Chemmart® Thrush one dose + cream contains two
This leaflet was prepared in July 2010.
• An irregular heart beat or palpitations.
These side effects are serious and need medical
Chemmart® Fluconazole 1 capsule is a hard gelatine
capsule with sky blue opaque body and cap.
Tell your doctor immediately or go to Accident and
Each pack contains 1 capsule.
Emergency at the nearest hospital if you notice any
Chemmart® Clotrimazole Cream is a tube with a
of the following;
screw-cap containing 10g of a white cream.
• Signs of an allergic reaction such as skin rash,
itching or hives; swelling of the face, lips or tongue which may cause difficulty in swallowing or
The active ingredient in the Chemmart® Fluconazole 1
breathing; wheezing or shortness of breath.
capsule is Fluconazole 150mg.
• Severe blisters and bleeding of the lips, eyes,
Each capsule also contains the following inactive
mouth, nose and genitals.
• A severe rash with skin peeling, fever, chills and
• Gelatin.
aching muscles.
• Lactose.
These side effects are rare, but very serious and
• Starch maize.
require urgent medical attention or hospitalisation.
• Silicon colloidal anhydrous.
Tell your doctor or pharmacist if you notice anything
• Sodium lauryl sulphate.
that makes you feel unwell. Other side effects not
• Titanium dioxide.
listed above may occur in some people.
• Talc purified.
• Patent blue V.
• Tekprint SW-9008 Black Ink.
The active ingredient in Chemmart® clotrimazole cream is 10mg Clotrimazole per gram of cream as the active ingredient.
Source: http://media.chemmart.com.au/cmi/363677.pdf
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TABLE OF CONTENTS 1. LICENSE AND CERTIFICATION AGREEMENT . 4 2. CERTIFICATION BODY APPROVAL PROCESS . 4 2.1 CB APPROVAL BY GLOBALG.A.P. 4 2.2 EXTENSION OF SCOPES, SUB-SCOPES, APPROVED MODIFIED CHECKLISTS AND BENCHMARKED 2.3 ACCREDITATION BODY REQUIREMENTS . 6 2.4 TERMINATION OF APPROVAL . 7