Daktarin Oral 20 mg Gel

DAKTARIN is a medicine used for treating and preventing infection by fungi including yeasts (such as Candida). DAKTARIN oral gel is used for candida infections of the mouth.

Do not use DAKTARIN ORAL GEL:

• Due to risk of choking, do not use DAKTARIN oral gel in infants less than 4 months of age or in infants less than 6 months of age if the infant is pre – term or has problems swallowing.
• if you or your child are allergic to miconazole, similar antifungal medicines or any of the other ingredients of DAKTARIN oral gel. (see WHAT DAKTARIN ORAL GEL CONTAINS)
• if you or your child have any kind of liver disease
• if you are taking any other medication(s) unless you have advice from your healthcare provider. (see below: Taking other medicines with DAKTARIN oral gel)

Take special care with DAKTARIN oral gel

• Avoid contact with eyes
• Infants and small children: DAKTARIN oral gel is sticky. This ensures that it stays in the mouth as long as possible. Important: 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 in smaller portions (never put the whole amount in the mouth of the child at once;
• apply the gel to the affected areas of the mouth (white patches) and ulcers (sores) with a clean finger and according to the advice from your doctor or pharmacist;
• never put a large portion of gel in the back of the throat.
• If you are breastfeeding, your infant never apply the gel to your nipple to treat the baby.
• DAKTARIN ORAL GEL can cause severe allergic reactions. You must be aware of the signs of an allergic reaction while you are taking DAKTARIN ORAL GEL. (See POSSIBLE SIDE EFFECTS)

If you take any of the following medications:

1. the blood thinning medicine, warfarin;
2. certain medicines that are taken by mouth for the treatment of diabetes;
3. phenytoin, a medicine used for the treatment of epilepsy; additional monitoring or a dose change of either DAKTARIN oral gel or the other medicine may be required

Do not share medicines prescribed for you with any other person. Recommended dosages: Adults and children 2 years and older: ½ measuring spoonful (2.5 ml) of gel; Children 4 months to 2 years: ¼ measuring spoonful (1.25 ml) The gel should not be swallowed immediately, but kept in the mouth as long as possible. Using a clean finger, spread the gel evenly over the affected areas taking care to properly cover oral ulcerations and other lesions. Apply three to four times daily depending on the severity of the infection. Apply the gel regularly until all signs of the infection have disappeared. If you are wearing dentures, you should remove them at bedtime and brush them with the gel. In this way, you can prevent your dentures from becoming infected too. Continue using for another two days after the infection has cleared. If you use more DAKTARIN oral gel than you should: If you have taken too much DAKTARIN oral gel, you might suffer from vomiting and diarrhoea. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control center.

DAKTARIN oral gel may cause side effects. Severe allergic reactions have been reported with DAKTARIN ORAL GEL. The signs of a severe allergic reaction may include:

• A swollen face, lips, mouth tongue or throat
• Difficulty in swallowing or breathing
• Itchy rash (hives)

Stop using DAKTARIN ORAL GEL and get emergency medical help straight away if you notice or suspect any of these side effects. Tell your doctor if you notice any of the following:

• nausea (feeling sick),
• vomiting,
• regurgitation, (bringing up stomach contents into the mouth)
• loss of or abnormal taste,
• dry mouth,
• mouth discomfort
• diarrhoea,
• inflammation of the mouth,
• sores in the mouth
• tongue discolouration

as the above may occur frequently. If any of the following happen, stop taking DAKTARIN oral gel and tell your doctor immediately or go to the casualty department at your nearest hospital:

• choking
• liver problems
• Life-threatening rash with blisters and peeling skin over much of the body (toxic epidermal necrolysis)
• Severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• skin rash, itching, hives
• Red rash covered with small pus-filled bumps that can spread over the body, sometimes with a fever (acute generalised exanthematous pustulosis)
• Severe rash over the body, usually with fever and swollen lymph nodes, and effects on blood cells and organs (drug reaction with eosinophilia and systemic symptoms)

These are all very serious side effects. If you have them, you may have a serious allergic reaction to DAKTARIN oral gel. You may need urgent medical attention or hospitalisation. All of these very serious side effects are very rare. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• lack of appetite, nausea, vomiting, tiredness, abdominal pain, jaundice, very dark urine and pale stools as these may be signs of inflammation of the liver.

These are all serious side effects. You may need urgent medical attention. Serious side effects are rare. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Not all side effects reported for DAKTARIN ORAL GEL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DAKTARIN oral gel, please consult your doctor, pharmacist or other health care professional for advice.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via “6.04 Adverse Drug Reaction Reporting Form” found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/index/8. By reporting side effects, you can help provide more information on the safety of GYNO-DAKTARIN VC.

Keep well closed. Store below 30 °C. Do not freeze. This medicine can be kept for only a limited period. Do not use DAKTARIN oral gel after the date (month and year) printed after “EXP”, even if it has been stored properly. You are advised to return old medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets) STORE ALL MEDICINES OUT OF THE REACH OF CHILDREN.