Miconaz Antifungal oral gel 2% 20 g

Miconaz Antifungal oral gel 2% 20 g

Indications:

Miconaz Oral Gel is a medicine which is used to treat fungal infections of the mouth, throat and gullet. The gel contains miconazole which works by destroying the fungus that is present.

This medicine is for use in adults and children aged 4 months and over.

Composition:

Each gram (g) of Miconaz Oral Gel contains 20 milligrams (mg) of miconazole.

The other ingredients are Sodium saccharine, Carbopol 974 P, Sodium hydroxide, Propylene glycol, methyl paraben, Aroma (Menthol / Eucalyptus E103784), Glycerol and purified water. 

How to use:

 How to apply the gel

 -Each tube of the gel is sealed - use the cap to  pierce the seal

 -For oral use only

 -Keep the gel in the mouth as long as possible. Do not swallow it straight away

 -If the infection is just in the mouth, apply directly to the affected area with a clean finger

 -If you are wearing dentures, remove them at bedtime and rub them with the gel. This helps stop your dentures becoming infected too

 -Do not use more than the stated dose

 -Use after meals

 -If you are giving the gel to a child or infant aged 4 months or over, make sure that the gel does not become a choking hazard by making sure you place the gel at the front of the mouth.

Your doctor will probably suggest the following  treatment course

Infections of the mouth and throat: 

-Adults and Children over 2 years: 2.5 ml (half a 5ml spoonful) of gel applied four times a day after food. 

-Infants 4 months - 2 years: 1.25 ml (one quarter of a 5 ml spoonful) of gel applied four times a day after food. Each application should be divided into smaller portions. If the infant is 4-6 months old, and is premature or has slow development, check with your doctor before using this medicine. If symptoms persist, talk to your doctor.

Side effects:

Like all medicines, Miconaz Oral Gel can cause side effects, although not everybody gets them.

Stop using Miconaz Oral Gel and tell your doctor straight away if you notice the following. You may need medical treatment.

 -Sudden swelling of the face, lips, tongue or throat; difficulty swallowing; hives (also known as nettle rash or urticaria) and breathing difficulties (angioedema, anaphylactic reactions); severe irritation, reddening or blistering of your skin.

These may be signs of a severe allergic reaction.

-Severe skin disorders with peeling and/or rashes with small pus-containing pimples (with a fever)  or blistering of your skin, mouth, eyes and genitals (toxic epidermal necrolysis or Stevens - Johnson syndrome)

 -Light headedness, generalised itch, wheezing or difficulty breathing.

-If you are taking medicines to thin the blood (anticoagulants), such as warfarin: unexpected bleeding or bruising, nosebleeds, coughing up blood, blood in the urine, black tarry stools or coffee ground vomit.

Other side effects which may occur:

 Common (affects 1 to 10 users in 100)

  -Dry mouth

 -Feeling sick (nausea)

 -Being sick (vomiting)

 -Mouth discomfort

 -Regurgitation

 -Product tastes abnormal

 Uncommon (affects 1 to 10 users in 1,000)

 -Loss or abnormal sense of taste

 The following side effects were also seen in a small number of patients

 -Choking

 -Diarrhea

 -Inflammation of the liver (hepatitis)

 -Sore mouth

 -Tongue discoloration

 -Rash with pus filled pimples/blisters (acute generalised exanthematous pustulosis)

 Contraindications:

 -If you are allergic to miconazole, any of the other ingredients of this medicine (listed in section 6) or   to other similar antifungal medicines

 - If you suffer from liver problems

 - If it is for an infant under 4 months of age  because of risk of choking.

Precautions:

-If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol.

-If you are pregnant or breast-feeding, do not take this medicine unless recommended by your doctor. 

-If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine. 

-Miconaz Oral Gel contains methyl hydroxybenzoate (methyl paraben), Methyl paraben may cause allergic reactions (possibly delayed). 

-If you are giving the gel to a child or infant, make sure that the gel does not close off the child's or infant's throat as they could choke on it. You should place the gel at the front of the mouth – never put it at the back of the throat.

-If your infant is being treated with Miconaz Oral Gel, and you are breastfeeding, do not apply the gel to your nipple in order to give the gel to your infant.

-If you are also taking medicines to thin the blood (anticoagulants, such as warfarin) or if you are taking phenytoin (a medicine for epilepsy), your doctor may want to check the level of the medicines in your body by testing your blood.

Pregnancy and breast-feeding:

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Storage Method:

- Keep this medicine out of the sight and reach of children.

- Do not use this medicine after the expiry date which is stated on the tube and the outer packaging. 

- Do not store above 30ºC.

Package:

Miconaz Oral Gel comes in a printed aluminum tube containing 30 g of a white, sugar free with Menthol taste and odor gel, packed in a carton.