Oral treatment of fungal infections of the oropharynx and gastrointestinal tract
Miconazole gel is for use in adults, children and infants 4 months and older.

For oral administration.
1 measuring spoon (provided) is equivalent to 124 mg Miconazole per 5 mL gel.
Oropharyngeal candidosis
Infants: 4-24 months:
1.25 mL (1/4 measuring spoon) of gel, applied four times a day after meals. Each dose should be
divided into smaller portions and the gel should be applied to the affected area(s) with a clean
finger. The gel should not be applied to the back of the throat due to possible choking. The gel
should not be swallowed immediately, but kept in the mouth as long as possible.

Adults and children 2 years of age and older:
2.5 mL (1/2 measuring spoon) of gel, applied four times a day after meals.
The gel should not be swallowed immediately, but kept in the mouth as long as possible.
The treatment should be continued for at least a week after the symptoms have disappeared.
For oral candidosis, dental prostheses should be removed at night and brushed with the gel.
Gastrointestinal tract candidosis.
The gel may be used for infants (≥ 4 months of age), children, and adults who have difficulty
swallowing tablets. The dosage is 20 mg per kg body weight per day, administered in four divided
doses. The daily dose should not exceed 250 mg (10 mL Oral Gel) four times a day.
The treatment should be continued for at least a week after the symptoms have disappeared.

Known hypersensitivity to Miconazole, other imidazole derivatives or to any of the excipients listed in section 6.1. In infants less than 4 months of age or in those whose swallowing reflex is not yet sufficiently developed (see section 4.4) In patients with liver dysfunction. Coadministration of the following drugs that are subject to metabolism by CYP3A4: (See Section 4.5 Interactions with Other Medicinal Products and Other Forms of Interaction) - Substrates known to prolong the QT-interval e.g., astemizole, cisapride, dofetilide, mizolastine, pimozide, quinidine, sertindole and terfenadine. - Ergot alkaloids - HMG-CoA reductase inhibitors such as simvastatin and lovastatin - Triazolam and oral midazolam

If the concomitant use of Miragel and anticoagulants is envisaged, the anticoagulant effect should
be carefully monitored and titrated (see section 4.5)
It is advisable to monitor Miconazole and phenytoin levels, if these two drugs are used
concomitantly.
In patients using certain oral hypoglycaemics such as sulphonylureas, an enhanced therapeutic
effect leading to hypoglycaemia may occur during concomitant treatment with Miconazole and
appropriate measures should be considered (See Section 4.5 Interactions with Other Medicinal
Products and Other Forms of Interaction).
Choking in infants and young children
Particularly in infants and young children (aged 4 months – 2 years), caution is required, to ensure
that the gel does not obstruct the throat. Hence, the gel should not be applied to the back of the
throat. Each dose should be divided into smaller portions and applied into the mouth with a clean
finger. Observe the patient for possible choking. Also due to the risk of choking, the gel must not
be applied to the nipple of a breast-feeding woman for administration to an infant.
It is important to take into consideration the variability of the maturation of the swallowing
function in infants, especially when giving Miconazole gel to infants between the ages of 4-6
months. The lower age limit should be increased to 5-6 months of age for infants who are preterm,
or infants exhibiting slow neuromuscular development.
This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per dose.

When using any concomitant medication the corresponding label should be consulted for
information on the route of metabolism. Miconazole can inhibit the metabolism of drugs
metabolised by the CYP3A4 and CYP2C9 enzyme systems. This can result in an increase and/or
prolongation of their effects, including adverse effects.
Oral Miconazole is contraindicated with the coadministration of the following drugs that are
subject to metabolism by CYP3A4 (See Section 4.3 Contraindications):
- Substrates known to prolong the QT-interval e.g., astemizole, cisapride, dofetilide, mizolastine,
pimozide, quinidine, sertindole and terfenadine
- Ergot alkaloids
- HMG-CoA reductase inhibitors such as simvastatin and lovastatin
- Triazolam and oral midazolam
When coadministered with oral miconazole the following drugs should be used with caution
because of a possible increase or prolongation of the therapeutic outcome and/or adverse events. If
necessary, their dosage should be reduced and, where appropriate, plasma levels monitored:
Drugs subject to metabolism by CYP2C9 (see Section 4.4 Special Warnings and Precautions for
Use);
- Oral anticoagulants such as warfarin
- Oral hypoglycaemics such as sulphonylureas
- Phenytoin
Other drugs subject to metabolism by CYP3A4;
- HIV Protease Inhibitors such as saquinavir;
- Certain antineoplastic agents such as vinca alkaloids, busulfan and docetaxel;
- Certain calcium channel blockers such as dihydropyridines and verapamil;

Certain immunosuppressive agents: cyclosporin, tacrolimus, sirolimus (= rapamycin)
- Others: carbamazepine, cilostazol, disopyramide, buspirone, alfentanil, sildenafil, alprazolam,
brotizolam, midazolam IV, rifabutin, methylprednisolone, trimetrexate, ebastine and reboxetine.

In animals, miconazole has shown no teratogenic effects but is foetotoxic at high oral doses. The
significance of this to man is unknown. However, as with other imidazoles, Miragel Oral Gel
should be avoided in pregnant women if possible.
The potential hazards should be balanced against the possible benefits.
It is not known whether miconazole is excreted in human milk. Caution should be exercised when
prescribing Miragel Oral Gel to nursing mothers.

Miragel Oral Gel should not affect alertness or driving ability.
 

The safety of Miragel Oral Gel was evaluated in 111 patients with oral candidiasis or oral
mycoses who participated in 5 clinical trials. Of these 111 patients, 88 were adults with oral
candidiasis or oral mycoses who participated in 1 randomised, active-controlled, double-blind
clinical trial and 3 open-label clinical trials. The other 23 patients were paediatric patients with
oral candidiasis who participated in 1 randomised, active-controlled, open-label clinical trial in
paediatric patients (aged ≤1 month to 10.7 years). These patients took at least one dose of Miragel
Oral Gel and provided safety data.

Based on the pooled safety data from these 5 clinical trials (adult and paediatric), the most
commonly reported (≥1% incidence) adverse reactions were nausea (6.3%), product taste
abnormal (3.6%), vomiting (3.6%), oral discomfort (2.7%), regurgitation (1.8%), and dry mouth
(1.8%). Dysgeusia was reported in 0.9% of patients.
Adult Patients
Based on the pooled safety data from the 4 clinical trials in adults, common adverse reactions
reported included nausea (4.5%), product taste abnormal (4.5%), oral discomfort (3.4%), dry
mouth (2.3%), dysgeusia (1.1%), and vomiting (1.1%).
Paediatric Patients
In the 1 paediatric clinical trial, the frequency of nausea (13.0%) and vomiting (13.0%) was very
common, and regurgitation (8.7%) was common. As identified through post-marketing
experience, choking may occur in infants and young children (See Section 4.3 Contraindications
and Section 4.4 Special Warnings and Special Precautions). The frequency, type, and severity of
other adverse reactions in children are expected to be similar to that in adults.
Table A includes all identified adverse reactions, including those that that have been reported
from post-marketing experience.
The frequency categories use the following convention: very common (≥1/10); common (≥1/100
to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000);
and not known (cannot be estimated from the available clinical trial data).

Table A: Adverse Drug Reactions in Patients Treated with MIRAGEL Oral Gel

System Organ Class Adverse Drug Reactions
Frequency Category
Common
(≥1/100 to <1/10)
Uncommon
(≥1/1,000 to <1/100)
Not Known
Immune System
Disorders
Anaphylactic
reaction,
Angioedema,
Hypersensitivity
Nervous System
Disorders
Dysgeusia
Respiratory,
Thoracic and
Mediastinal
Disorders
Choking
Gastrointestinal
Disorders
Dry mouth, Nausea,
Oral discomfort,
Vomiting,
Regurgitation
Diarrhoea, Stomatitis,
Tongue
discolouration
Hepatobiliary
Disorders
Hepatitis
Skin and
Subcutaneous
Tissue Disorders
Toxic epidermal
necrolysis, Stevens-
Johnson syndrome,
Urticaria, Rash, Acute
Generalized
exanthematous
pustulosis, Drug
reaction with
eosinophilia and
systemic symptoms
General Disorders
and
Administration Site
Conditions
Product taste
abnormal
Reporting of suspected adverse reactions reporting suspected adverse reactions after
authorization of the medicinal product is important. It allows continued monitoring of the
benefit/risk balance of the medicinal product.

To report any side effects please contact National Pharmacovigilance and Drug Safety Center
(NPC) details below:
The National Pharmacovigilance and Drug Safety Centre (NPC)
• Fax: +966-11-205-7662
• Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
• Toll free phone: 8002490000
• E-mail: npc.drug@sfda.gov.sa
• Website: www.sfda.gov.sa/npc
• Other GCC States:
− Please contact the relevant competent authority

 

Symptoms:
In the event of accidental overdose, vomiting and diarrhoea may occur.
Treatment:
Treatment is symptomatic and supportive. A specific antidote is not available.

ATC Code: A01AB09
Miconazole possesses an antifungal activity against the common dermatophytes and yeasts as well
as an antibacterial activity against certain gram-positive bacilli and cocci.

Its activity is based on the inhibition of the ergosterol biosynthesis in fungi and the change in the
composition of the lipid components in the membrane, resulting in fungal cell necrosis.

Absorption:
Miconazole is systemically absorbed after administration as the oral gel. Administration of a 60 mg
dose of Miconazole as the oral gel results in peak plasma concentrations of 31 to 49 ng/mL,
occurring approximately two hours post-dose.
Distribution:
Absorbed Miconazole is bound to plasma proteins (88.2%), primarily to serum albumin and red
blood cells (10.6%).
Metabolism and Elimination:
The absorbed portion of Miconazole is largely metabolized; less than 1% of an administered dose is
excreted unchanged in the urine. The terminal half-life of plasma Miconazole is 20 to 25 hours in
most patients. The elimination half-life of Miconazole is similar in renally impaired patients.
Plasma concentrations of Miconazole are moderately reduced (approximately 50%) during
hemodialysis. About 50% of an oral dose may be excreted in the faeces partly metabolized and
partly unchanged.

Preclinical data reveal no special hazard for humans based on conventional studies of local
irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.

Potato starch Pregelatinized
Saccharin Sodium
Glycerol
Polysorbate 80
Purified water
Orange flavour
 

None known.

2 years

Do not store above 30 °C.
Discard the tube after 3 months from opening.

Immediate Container: 40g collapsible aluminium tube 29.4 mm diameters, double lacquered,
latex end seal, membrane nozzle.
Cap: High density (HDPE) with piercing end.
Outer Individual Carton: 260g/m2 grammage paper, dimension 34 mm x 45 mm x 149 mm,
printed.
Insert/Leaflet: Dimension 180 x 290 mm, both sides printed.

Not applicable