NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
APOHEALTH THRUSH TREATMENT DUO
Contains the active ingredientfluconazole and clotrimazole
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about APOHEALTH THRUSH TREATMENT DUO.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor or pharmacist has weighed the risks of you using this medicine against the benefits expected for you.
If you have any concerns about using this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What APOHEALTH THRUSH TREATMENT DUO is used for
APOHEALTH THRUSH TREATMENT DUO is used to treat a type of fungal infection called vaginal thrush.
If this is the first time you have had these symptoms, talk to your doctor before using any treatment.
APOHEALTH THRUSH TREATMENT DUO contains two components:
APOHEALTH Fluconazole One is an oral capsule which contains the active ingredient fluconazole;
APOHEALTH Clotrimazole Cream contains the active ingredient clotrimazole, both of these ingredients belong to a group of medicines called azole antifungals.
APOHEALTH Fluconazole
One capsule is taken by mouth and works from the inside to prevent the growth of the fungi causing your infection; APOHEALTH Clotrimazole Cream provides soothing relief from external itching and irritation.
One capsule is taken by mouth and works from the inside to prevent the growth of the fungi causing your infection; APOHEALTH Clotrimazole Cream provides soothing relief from external itching and irritation.
Ask your doctor or pharmacist if you have any questions about why APOHEALTH THRUSH TREATMENT DUO has been recommended for you. Your doctor or pharmacist may have recommended APOHEALTH THRUSH TREATMENT DUO for another reason.
APOHEALTH THRUSH TREATMENT DUO is not recommended for children under 18 years of age except under doctor supervision.
There is no evidence that either component in APOHEALTH THRUSH TREATMENT DUO is addictive.
APOHEALTH THRUSH TREATMENT DUO is a “Pharmacist Only Medicine”. It is available without a doctor’s prescription but your pharmacist’s advice is required.
What is vaginal thrush
Vaginal thrush is a common name for vaginal candidiasis, an infection caused by a yeast-like fungus called Candida albicans.
Candida albicans is one of many organisms that live in the vagina.
Your body’s natural balance (immune system) normally keeps Candida albicans under control, but when this natural balance is upset, Candida albicans can multiply and can cause thrush symptoms.
Common symptoms of vaginal thrush include:
itching, burning or soreness around the vagina
cottage-cheese like discharge
swelling or irritation of the infected area.
Things that may help you to avoid thrush in the future:
wear cotton briefs, stockings and loose-fitting clothing rather than tight synthetic clothing
wash regularly, but do not wash and dry yourself harshly
avoid perfumed soaps, bath additives and vaginal deodorants.
Your doctor or pharmacist may have more information on things you can do to avoid thrush in the future.
Before you use APOHEALTH THRUSH TREATMENT DUO
When you must not use it
Do not use APOHEALTH THRUSH TREATMENT DUO if you are allergic to medicines containing:
fluconazole
clotrimazole
other azole antifungals such as miconazole, ketoconazole, itraconazole, econazole; or
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
skin rash,
itching or hives;
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing;
wheezing or shortness of breath.
Do not use APOHEALTH THRUSH TREATMENT DUO if you are taking cisapride (Prepulsid), a medicine used to treat stomach problems, or erythromycin (an antibiotic used to treat certain infections).
Combining APOHEALTH THRUSH TREATMENT DUO with cisapride may cause serious side effects such as an abnormal heart rhythm.
Do not use APOHEALTH THRUSH TREATMENT DUO if you are pregnant, suspect you may be pregnant or if you may become pregnant during treatment.
APOHEALTH THRUSH TREATMENT DUO should not be used during pregnancy as it may affect your developing baby. Sufficient methods of contraception should be used throughout treatment and for at least 1 week after the final dose.
Do not use APOHEALTH THRUSH TREATMENT DUO if you are breastfeeding. Fluconazole passes into breast milk and may affect your baby.
Do not use APOHEALTH THRUSH TREATMENT DUO if the expiry date (EXP) printed on the pack has passed.
Do not use APOHEALTH THRUSH TREATMENT DUO if the packaging shows signs of tampering; the capsule does not look quite right or the cream tube shows signs of tampering.
If you are not sure whether you should start using this medicine, talk to your doctor or pharmacist.
Before you start to use it
Tell your doctor or pharmacist if you are allergic to any other medicines, foods, dyes or preservatives.
Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:
thrush more than twice in the last six months
liver problems
kidney problems
heart problems
HIV infection or AIDS
diabetes
Your doctor or pharmacist may want to take special care if you have any of these conditions.
Tell your doctor or pharmacist before using APOHEALTH THRUSH TREATMENT DUO if you are taking warfarin (eg. Marevan, Coumadin), as bleeding or bruising may occur.
Tell your doctor or pharmacist if you are experiencing any of the following:
abnormal, irregular vaginal bleeding or blood stained discharge
foul smelling or unusually coloured discharge
vulval or vaginal sores, ulcers or blisters
lower abdominal pain or burning when passing urine
fever or chills
If you have not told your doctor or pharmacist about any of the above, tell them before you start using APOHEALTH THRUSH TREATMENT DUO.
Using the APOHEALTH Clotrimazole Cream component of APOHEALTH THRUSH TREATMENT DUO may reduce the effectiveness and safety of latex products, such as condoms and diaphragms.
This effect is temporary and occurs only during treatment.
Taking other medicines
If you are taking cisapride (Prepulsid), a medicine used to treat stomach problems, do not use APOHEALTH THRUSH TREATMENT DUO.
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may be affected by APOHEALTH THRUSH TREATMENT DUO, or may affect how well it works. These include:
warfarin (e.g. Marevan, Coumadin), a medicine, used to prevent blood clots
amiodarone, used to treat certain heart arrhythmias
amlodipine, nifedipine, verapamil or felodipine, medicines used to treat certain heart disorders such as blood pressure
carbamazepine or phenytoin (e.g. Dilantin), a medicine used to treat epilepsy
non-steroidal anti-inflammatory drugs (NSAIDs) such as celecoxib
some statins, used to lower cholesterol levels, such as atorvastatin or simvastatin
cyclosporin (e.g. Neoral); or
tacrolimus (e.g. Prograf), medicines used to prevent organ transplant rejection or to treat certain problems with the immune system;
certain medicines use to treat diabetes such as: glibenclamide (e.g. Daonil, Glimel), glipizide (e.g. Minidiab, Melizide), glimepiride (e.g. Amaryl), gliclazide (e.g. Diamicron, Glyade), pioglitazone (e.g. Actos)
rosiglitazone (e.g. Avandia), rifampicin (e.g. Rifadin, Rimycin) or rifabutin (e.g. Mycobutin);
antibiotics used to treat infections;
theophylline (e.g. Nuelin), a medicine used to treat asthma;
midazolam (e.g. hypnovel) and triazolam (e.g. Halcion), medicines used as sedatives or to treat anxiety
amitriptyline or nortriptyline, used to treat some mood disorders
zidovudine (e.g. Retrovir), a medicine used to treat AIDS;
hydrochlorothiazide (e.g. Dithiazide), a medicine used for treating fluid problems and high blood pressure
certain strong pain-killers such as fentanyl or methadone
the contraceptive pill (birth control pill) – talk to your doctor about the need for an additional method of contraception while using APOHEALTH THRUSH TREATMENT DUO. APOHEALTH THRUSH TREATMENT DUO may decrease the effectiveness of some birth control pills.
Your doctor can tell you what to do if you are taking any of these medicines.
If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while using
APOHEALTH THRUSH TREATMENT DUO.
How to use APOHEALTH THRUSH TREATMENT DUO
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist.
How to use it
For vaginal thrush in adults, only a single dose (1 capsule) is needed.
Swallow the capsule whole with a glass of water. The capsule can be taken with or without food.
Use the cream on the external irritated area 2-3 times a day to relieve the symptoms for as long as they last, usually not more than 3 days.
Do not give APOHEALTH THRUSH TREATMENT DUO to children under 18 years of age except under doctor supervision.
If you take too much APOHEALTH THRUSH TREATMENT DUO (overdose)
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26 – Aust. or 0800 764 766 – N.Z.), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have used too much APOHEALTH THRUSH TREATMENT DUO.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
While you are using APOHEALTH THRUSH TREATMENT DUO
Things you must do
Before starting any new medicine, tell your doctor or pharmacist that you are using or have used
APOHEALTH THRUSH TREATMENT DUO.
Tell all the doctors, dentists and pharmacists who are treating you that you are using or have used
APOHEALTH THRUSH TREATMENT DUO.
Use effective contraception to prevent pregnancy while using APOHEALTH THRUSH TREATMENT DUO.
Immediately tell your doctor if you do become pregnant while using
APOHEALTH THRUSH TREATMENT DUO.
If your symptoms do not improve after 3 days, tell your doctor or pharmacist.
Things you must not do
Do not use APOHEALTH THRUSH TREATMENT DUO to treat any other conditions unless your doctor or pharmacist tells you to.
Do not give APOHEALTH THRUSH TREATMENT DUO to anyone else, even if they have the same condition as you.
Things to be careful of
Tell your doctor immediately if you develop a rash while using APOHEALTH THRUSH TREATMENT DUO. People with AIDS or a weak immune system may be more prone to serious side effects of the skin.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using APOHEALTH THRUSH TREATMENT DUO.
APOHEALTH THRUSH TREATMENT DUO helps most people and is generally well tolerated. However it may have unwanted side effects in some people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
nausea (feeling sick) or vomiting
stomach pain or indigestion
diarrhoea
headache
mild burning, stinging or irritation immediately after application
pruritis
The side effects listed above are common and usually mild.
Tell your doctor as soon as possible if you notice any of the following:
unusual muscle stiffness causing poor control of movement
frequent infections such as fever, severe chills, sore throat or mouth ulcers
bleeding or bruising more easily than normal
passing more urine than normal or kidney pain (pain on the sides of the body)
symptoms of liver disease such as yellowing of the skin or eyes; dark urine, pale stools; loss of appetite; unusual tiredness
an irregular heartbeat or palpitations.
These side effects are serious and need medical attention.
Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:
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 breathing;
wheezing or shortness of breath
severe blisters and bleeding of the lips, eyes, mouth, nose and genitals
a severe rash with skin peeling, fever, chills and aching muscles.
These side effects are rare, but very serious and require urgent medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
After using APOHEALTH THRUSH TREATMENT DUO
Storage
Keep APOHEALTH THRUSH TREATMENT DUO where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store APOHEALTH THRUSH TREATMENT DUO or any other medicine in the bathroom or near a sink.
Do not leave your medicine in the car or on windowsills.
Heat and dampness can destroy some medicines.
Disposal
If your doctor or pharmacist tells you to stop using
APOHEALTH THRUSH TREATMENT DUO, or your medicine has passed its expiry date, ask your pharmacist what to do.
Product description
What APOHEALTH THRUSH TREATMENT DUO looks like
APOHEALTH THRUSH TREATMENT DUO contains two components:
APOHEALTH Fluconazole One capsule is a hard gelatin capsule with sky blue opaque body and cap.
Each pack contains 1 capsule.
APOHEALTH Clotrimazole Cream is a tube with a screw – cap containing 10 g of a white cream.
AUST R 229520
Ingredients
The active ingredient in the APOHEALTH Fluconazole One capsule is fluconazole 150 mg.
Each capsule also contains the following inactive ingredients:
gelatin
lactose monohydrate
maize starch
colloidal anhydrous silica
sodium lauryl sulfate
titanium dioxide
purified talc
patent blue V
APOHEALTH Fluconazole One capsule also contains sugars (as lactose) and sulfites (from gelatin).
The active ingredient in APOHEALTH Clotrimazole Cream is 10 mg clotrimazole per gram of cream as the active ingredient.
The cream also contains:
propylene glycol
cetostearyl alcohol
disodium edetate
cetomacrogol 1000
liquid Paraffin
dimeticone 100
white soft paraffin
self-emulsifying glyceryl monostearate
benzyl alcohol (as preservative)
purified water
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
Supplier
APOHEALTH THRUSH TREATMENT DUO is supplied in Australia by:
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
Australia
Tel: +61 2 8877 8333
Web: www1.apotex.com/au
APOHEALTH is a trademark used under license.
This leaflet was prepared in November 2019
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