Micozol

Main information

  • Trade name:
  • Micozol Oral Gel
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Micozol Oral Gel
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL06011687
  • Last update:
  • 28-05-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Consumer Medication Information Leaflet(RiMUP)

MICOZOL ORAL GEL

Miconazole nitrate (2%w/w)

1

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

holder

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

present.

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

smaller amounts.

- Safety for use in pregnancy and during

breastfeeding has not been established.

- Tell your doctor if you are on warfarin

therapy.

- 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

docetaxel, trimetrexate,)

- verapamil and dihydropyridines (for

hypertension)

- 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

(antihistamine)

- 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

pharmacist.

- How long to use it

You should check with your doctor or

pharmacist.

- 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.

Side effects

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

(Public

Reporting Medicinal Problems /

Side Effects / AEFI / Vaccine Safety).

Storage and Disposal of Micozol

- Storage

Store in a cool, dry place below 30

Protect from light. Keep out of reach of

children.

- Disposal

Ask your pharmacist how to dispose of

medicines no longer required.

Product description

- What it looks like

White flavoured gel.

- Ingredients:

- Active ingredient: miconazole nitrate

- Inactive ingredients: popylene glycol,

polyethylene glycol, cremophor RH-40,

methyl parabens, propyl parabens,

polyvinylpyrrolidone, maltodextrin,

sodium saccharin, silbione 70460,

buttermilk flavour, sodium citrate, sodium

chloride, sugar and purified water.

- MAL number:

MAL06011687AZ

Manufacturer and Product Registration

Holder

Prime Pharmaceutical Sdn. Bhd.

1505, Lorong Perusahaan Utama 1

Taman Perindustrian Bukit Tengah

14000 Bukit Mertajam, Penang, Malaysia.

Date of revision

09/10/2017

Serial number

NPRA(R4/1)051017/00265