Daktarin 20mg/g Oral Gel 40g
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Daktarin oral gel is a medicine which is used to treat fungal infections of the mouth, throat, gullet, stomach or gut. 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.
Daktarin Oral Gel is a medicine which is used to treat superficial fungal infections of the mouth and throat. The gel contains miconazole which works by destroying the fungus. Daktarin Oral Gel may also be used to prevent and treat fungal infections of the gastrointestinal tract, in children and adults who have difficulty swallowing tablets.
You should check with your doctor or pharmacist if you are not sure. 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 aff ected area with a clean fi nger •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 How much gel to use Your doctor will tell you how much Daktarin oral gel to take and for how long you should take it. 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. Infections of the stomach and gut: •Adults,Always use Daktarin oral gel exactly as your doctor has told you. Children and infants over 4 months: 20 mg per kg of body weight per day. Divided into four doses a day. Maximum dose is 10 ml of gel four times a day. 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
When to stop using Daktarin oral gel Keep using the gel for at least a week after all the symptoms have gone away. This will stop the symptoms from coming back. If you forget a dose •Do not apply the missed dose of gel •Apply the next dose of gel as usual and keep using it as your doctor has told you •Do not use a double dose of gel to make up for a missed dose If you use more Daktarin oral gel than you should If you use more Daktarin oral gel than you were told to or if someone else has taken any, talk to a doctor or go to the nearest hospital casualty department straight away. If you have any further questions on the use of this product, ask your doctor or pharmacist.
The active substance in Daktarin oral gel is miconazole. Each gram (g) of Daktarin oral gel contains 20 milligrams (mg) of miconazole.
The other ingredients are pregelatinised potato starch, alcohol, polysorbate 20 (E432), sodium saccharin, cocoa fl avour, orange fl avour, glycerol and water.
Daktarin oral gel comes in a tube containing 80 g of a white, sugar free gel with an orange fl avour. A 5 ml plastic spoon, marked with a 2.5 ml graduation is provided
Daktarin oral gel contains small amounts of ethanol (alcohol), less than 100 mg per dose
Do not use Daktarin oral gel: •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 suff er from liver problems •If it is for an infant under 4 months of age because of risk of choking. Do not use this medicine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Daktarin oral gel. Take special care with Daktarin oral gel Daktarin oral gel is sticky. This ensures that it stays in the mouth for as long as possible. 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 Daktarin oral gel, and you are breastfeeding, do not apply the gel to your nipple in order to give the gel to your infant. Blood tests 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. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines. In particular, do not take this medicine and tell your doctor if you are taking any of the following medicines: •Medicines for hay fever or allergy called terfenadine, astemizole or mizolastine •Cisapride –for digestive problems •Medicines to lower cholesterol called lovastatin or simvastatin •Midazolam (by mouth) or triazolam - for anxiety or to help you sleep •Pimozide or sertindole - for conditions aff ecting thoughts, feelings and behaviour •Medicines for an irregular heart beat called quinidine or dofetilide •Ergotamine - used to treat migraine. Do not start using Daktarin oral gel and tell your doctor if you are taking any of the above. Tell your doctor or dentist before taking, or if you are already taking, any of the following medicines: •Medicines to thin the blood (anticoagulants) such as warfarin. •Medicines for HIV infection such as saquinivir. They are called ‘antiviral protease inhibitors’•Medicines used in the treatment of cancer such as busulfan, docetaxel and a group of medicines known as ‘vinca alkaloids’•Medicines that act on the heart and blood vessels called ‘calcium channelblockers’such as dihydropyridines and verapamil •Medicines that are usually given after an organ transplant called cyclosporin, tacrolimus or rapamycin. Another name for rapamycin is sirolimus •Medicines for epilepsy called phenytoin or carbamazepine •Alfentanil - for pain •Medicines used for anxiety or to help you sleep (tranquillisers), such as buspirone, alprazolam or brotizolam •Midazolam - to help you relax or sleep when given into a vein •Rifabutin - for tuberculosis •Methylprednisolone - for infl ammation (given by mouth or injection) •Ebastine - for allergy •Reboxetine - for depression •Sulphonylureas such as chlorpropamide and glibenclamide (medicines for diabetes taken by mouth) •Sildenafi l –for erection problems •Trimetrexate –for a type of pneumonia Tell your doctor or dentist before taking, or if you are already taking any of the above. They may need to alter your treatment. Pregnancy and breast-feeding Please tell your doctor before using Daktarin oral gel if you are pregnant, think you may be pregnant or might become pregnant. You may still be able to use Daktarin oral gel if your doctor thinks you need to. Talk to your doctor before using this medicine if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. Driving and using machines Daktarin oral gel is not likely to aff ect you being able to drive or use any tools or machines. Important information about some of the ingredients of Daktarin oral gel •Daktarin oral gel contains small amounts of ethanol (alcohol), less than 100 mg per dose
Like all medicines, Daktarin oral gel can cause side eff ects, 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;diffi culty swallowing;hives (also known as nettle rash or urticaria) and breathing diffi culties (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 diffi culty 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 coff ee ground vomit. Other side eff ects which may occur: Common (aff ects 1 to 10 users in 100) •Dry mouth •Feeling sick (nausea) •Being sick (vomiting) •Mouth discomfort •Regurgitation •Product tastes abnormal Uncommon (aff ects 1 to 10 users in 1,000) •Loss or abnormal sense of taste The following side eff ects were also seen in a small number of patients •Choking •Diarrhoea •Infl ammation of the liver (hepatitis) •Sore mouth •Tongue discolouration •Rash with pus fi lled pimples/blisters (acute generalised exanthematous pustulosis) Reporting of side eff ects If you get any side eff ects, talk to your doctor, pharmacist or nurse. This includes any possible side eff ects not listed in this leafl et. You can also report side eff ects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side eff ects you can help provide more information on the safety of this medicine.
Keep out of the reach and sight of children. Store the gel in its original packaging. Do not store above 30°C. Do not use Daktarin oral gel after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
Johnson & Johnson
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