Consumer Medication Information Leaflet(RiMUP)
MICOZOL ORAL GEL
Miconazole nitrate (2%w/w)
What is in this leaflet
1. What Micozol is used for
2. How Micozol works
3. Before you use Micozol
4. How to use Micozol
5. While you are using Micozol
6. Side effects
7. Storage and Disposal of Micozol
8. Product description
9. Manufacturer and Product Registration
10.Date of revision
What Micozol is used for
It is used for the treatment and prevention of
fungal infections of the mouth, throat,
stomach or intestines.
How Micozol works
Micozol destroys both the fungus that
causes the infection and some of the
associated bacteria which may also be
Before you use Micozol
- When you must not use it
- allergic to miconazole or other
ingredients of Micozol
- liver problems
- Before you start to use it
- Be careful when applying gel on infants
or young children, so as not to cause
choking. Doses should be divided to
- Safety for use in pregnancy and during
breastfeeding has not been established.
- Tell your doctor if you are on warfarin
- Taking other medicines
Medicines used below must be monitored:
- oral anticoagulants (prevent blood clot)
- saquinavir, tacrolimus, cyclosporin and
sirolimus (for HIV)
- anticancers (busulfan, vinca alkaloids and
- verapamil and dihydropyridines (for
- oral hypoglycemic (for diabetes)
- phenytoin, carbamazepine (for seizures)
- buspirone, alprazolam, brotizolam,
reboxetine ( mood disorders)
- alfentanil (for intense pain)
- sildenafil (for impotence)
- rifabutin (antibiotic)
- methylprednisolone (steroid)
- ebastine (antihistamine)
Medicines below should not be used:
- simvastatin and lovastatin (for cholesterol)
- terfenadine, astemizole, mizolastine
- cisapride (for gastric motility)
- triazolam, midazolam (for anxiety)
- dofetilide (for irregular heartbeat)
- quinidine (for malaria)
- pimozide (for brain disorder)
How to use Micozol
- How much to use
Apply over affected area 4 times daily. Gel
should be kept in the mouth longest
possible and treatment should be continued
for at least a week after symptoms
disappear. Oral candidosis – dental
protheses should be removed and brushed
with gel at night.
- When to use it
Please follow the advice of the doctor or
- How long to use it
You should check with your doctor or
- If you forget to use it
If you forget to use this medicine, use it as
soon as you remember. Then continue
using it at your usual time.
- If you use too much (overdose)
If you have used too much Micozol,
contact your doctor, an emergency
department or a poison center immediately.
Vomiting and diarrhoea may occur.
While you are using Micozol
- Things you must do
Inform your doctor of all the medications
you are taking.
- Things you must not do
Do not stop using medication although you
feel better after a few days, until the
prescribed course is finished.
- Things to be careful of
If you are pregnant, become pregnant, or
are breastfeeding, you should not use
Micozol unless advised by your doctor.
Local irritations and sensitivity reactions
due to allergy may occur. Mild
gastrointestinal disturbances may occur if
taken by mouth
You may report any side effects or adverse
drug reactions directly to the National
Centre for Adverse Drug Reaction
Monitoring by calling Tel: 03-78835550, or
visiting the website npra.moh.gov.my
Reporting Medicinal Problems /
Side Effects / AEFI / Vaccine Safety).
Storage and Disposal of Micozol
Store in a cool, dry place below 30
Protect from light. Keep out of reach of
Ask your pharmacist how to dispose of
medicines no longer required.
- What it looks like
White flavoured gel.
- Active ingredient: miconazole nitrate
- Inactive ingredients: popylene glycol,
polyethylene glycol, cremophor RH-40,
methyl parabens, propyl parabens,
sodium saccharin, silbione 70460,
buttermilk flavour, sodium citrate, sodium
chloride, sugar and purified water.
- MAL number:
Manufacturer and Product Registration
Prime Pharmaceutical Sdn. Bhd.
1505, Lorong Perusahaan Utama 1
Taman Perindustrian Bukit Tengah
14000 Bukit Mertajam, Penang, Malaysia.
Date of revision