1225 West Market St., Akron OH 44313 Phone: 330-869-0500, Fax: 330-869-0518 Safety Data Sheet Sovchem® TETD 1. CHEMICAL PRODUCT & COMPANY IDENTIFICATION Manufacturer: Emergency Contact: Sovereign Chemical Company Chemtrec: 1-800-424-9300 (continental USA) 1225 West Market Street
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Media.chemmart.com.auCONSUMER 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.
• 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
• 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.
• 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)
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.
children cannot reach it. A locked cupboard at least • Paraffin liquid.
one-and-a-half metres above the ground is a good • Dimethicone 100.
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.
temperature stays below 25°C.
• Benzyl alcohol.
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.
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.
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