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Daktarin Oral Gel (Miconazole)

What is your medicine?

The name of your medicine is Daktarin Oral Gel and its active ingredient is miconazole. Each gram of gel contains 20 mg of miconazole.

Other ingredients

This medicine also contains the following inactive ingredients: pregelatinised potato starch, alcohol, polysorbate 20 (E432), sodium saccharin, cocoa flavour, orange flavour, glycerol and water.

What should your medicine look like?

Daktarin Oral Gel is a white, sugar free gel with an orange taste and is supplied in tubes of 80 g. A 5 ml plastic spoon, marked with a 2.5 ml graduation is provided.

Daktarin Oral GelWhat type of medicine is Daktarin Oral Gel?

The product is one of a group of medicines called “antifungals” which are used to treat infections caused by fungi including yeasts, and some bacteria.

What is your medicine used for?

Daktarin Oral Gel is used to prevent and treat fungal and bacterial infections of lAJ the mouth, throat, gullet, stomach or intestine. It works by destroying the fungus and associated bacteria which may be present.

Remember-this medicine has been prescribed for you only. never give it to anyone else. it may harm them even if their symptoms are the same as yours.

When not to use your medicine

Do not use in infants less than 4 months of age because of the risk of choking. Do not use Daktarin Oral Gel if:

  • you have ever experienced an allergic reaction (hypersensitivity) to Daktarin Oral Gel, miconazole or any of the other ingredients in the past
  • you have any kind of liver disease.
  • you are taking any other prescription medicines unless you have advice from your doctor or pharmacist.

The effects and/or side effects of many prescription medicines can be increased if they are taken with Daktarin. If you are taking any other medicine, ask a doctor or pharmacist before you start Daktarin. If you need to take any other prescription medicine while you are using Daktarin, ask your doctor or pharmacist first. See ‘Other Medications’

Inform your doctor before taking the medicine if any of the above applies to you. Your doctor will then decide whether Daktarin Oral Gel is suitable for you.

Special precautions

Infants and small children-Daktarin Oral Gel is sticky. This ensures that it stays in the mouth as long as possible. Important: If giving Daktarin Oral Gel to a child, make sure that the gel does not close off the child’s throat as the child could choke on it.

You should therefore take the following precautions:

  • divide each application into smaller portions – never put the whole amount in the mouth of the child at once
  • place the gel in the front of the mouth – never put a large portion of gel in the back of the throat.

If the infant is premature or has slow development, your doctor may decide that they would be suitable for treatment when they are five or six months old, instead of four months.

Pregnancy and breast feeding

If you are pregnant, think you might be pregnant or are planning to become pregnant, you should talk to your doctor who will decide if you can use Daktarin Oral Gel.

If you are breast feeding ask your doctor for advice.

Other medicines

Always tell your doctor or pharmacist if you are taking any other medicines. Taking some medicines together can be harmful, and if certain drugs are taken at the same time, adaptations may have to be made (to the dose, for example)

You must not take Daktarin Oral Gel if you are using any of the following:

  • certain products for allergies (terfenadine, asternizole and mizolastine)
  • cisapride (a drug used for certain digestive problems)
  • certain drugs that lower your cholesterol, for example simvastatin and lovastatin
  • midazolam (by mouth) and triazolam, medicines that are taken for anxiety or to help you sleep (tranquillisers)
  • pimozide, and sertindole drugs for certain psychiatric disorders
  • certain medicines used to treat irregular heart beat rhythms, namely quinidine and dofetilide.
  • certain drugs used to treat migraine, such as ergot alkaloids

Combination with some other medicines may require additional monitoring or a dose change for either Daktarin Oral Gel or the other medicine. Examples are:

  • blood thinning agents taken by mouth (anticoagulants, eg warfarin)
  • certain AIDS drugs such as HIV protease inhibitors
  • certain drugs used in the treatment of cancer
  • some products that act on the heart and blood vessels (certain calcium-channel blockers)
  • medicines for diabetes which you take by mouth (eg chlorpropamide, glibenclamide)
  • phenytoin, a drug used for the treatment of epilepsy
  • cyclosporin or tacrolimus and sirolimus (= rapamycin), which are usually given after an organ transplant
  • certain anaesthetics used in hospital such as alfentanil
  • sildenafil, a drug to treat male impotence
  • certain drugs for anxiety or to help you sleep (tranquillisers)
  • certain drugs for tuberculosis
  • methylprednisolone, a drug given by mouth and injection for inflammations
  • trimetrexate, a drug used to treat a certain type of pneumonia
  • ebastine, a drug used for allergy
  • reboxetine, a drug used to treat depression.

If you are using any of these drugs, or any other prescription drugs please discuss the matter with you doctor or pharmacist. While taking Daktarin Oral Gel do not start a new medicine without first informing you doctor or pharmacist.

Driving or operating machinery

Daktarin Oral Gel should not affect your alertness or driving ability.

How to use your medicine

Each tube of gel is sealed. Use cap to pierce seal.

Always take Daktarin Oral Gel immediately after a meal.

How much should you take?

Your doctor will tell you how much Daktarin Oral Gel to take and for how long you should continue to take it. Always read the label on your medicine and follow your doctor’s instructions carefully. Ask your pharmacist if you are not sure about anything.

Your doctor will probably recommend the following treatment course:

Adults and elderly: One to two spoonfuls of gel four times a day ie after meals and at bedtime.

Children aged 6 years and over: One spoonful of gel four times a day.

Children aged 2-6 years: One spoonful of gel twice daily after meals.

Infants 4 months- 2 years: Half a spoonful of gel twice daily after meals. Each dose should be divided into smaller portions.

If the infant is premature or has slow development, your doctor may decide that they would be suitable for treatment when they are five or six months old, instead of four months.

The gel should not be swallowed immediately, but kept in the mouth as long as possible.

If the infection is localised in the mouth then the gel should be applied directly.

If you are wearing dentures, you should preferably remove them at bedtime and brush them with the gel. In this way you can prevent your dentures becoming infected too.

Relief from symptoms may occur quickly but it is important that you continue to use Daktarin Oral Gel for at least 2 days after all the symptoms have cleared.

If symptoms persist, consult your doctor.

What to do if you forget to use your medicine

If you forget to use your gel, do not take the missed dose, but take the next dose as usual and continue your course of medicine.

If you take too much of your medicine

In the unlikely event of anyone accidentally swallowing more Daktarin Oral Gel than is recommended, contact your doctor or nearest hospital casualty department immediately.

If you think your medicine makes you feel ill

Possible Side Effects

Like all medicines Daktarin oral gel can cause side effects, although not everybody gets them.

Stop using Daktarin 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. Hives (also known as nettle rash or urticaria), severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction.
  • Blistering of your skin, mouth, eyes and genitals
  • Light headedness, generalised itch, wheezing or difficulty breathing

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
  • Diarrhoea
  • Inflammation of the liver (hepatitis)
  • Sore mouth
  • Tongue discolouration
  • Rash
  • Serious skin reaction, with a widespread rash an peeling of the skin and blistering of the mouth, eyes and genitals (toxic epidermal necrolysis or Stevens-Johnson Syndrome)

If you have any of these side effects, or other side effects not listed in this leaflet, tell your doctor or pharmacist straight away.

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