What Mycoheal® oral gel is and what it is used for Mycoheal® oral gel is a medicine which is used to treat fungal and bacterial 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. 2. What you need to know before you use this product 1. Before you use Mycoheal® oral gel Do not use Mycoheal® - If you are allergic to anything in Mycoheal® oral gel. - If you suffer 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. If you are not sure, talk to your doctor or pharmacist before using Mycoheal® oral gel. Take special care with Mycoheal® - Mycoheal® 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 Mycoheal® oral gel, and you are breast-feeding, 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) or 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, herbal or dietary supplements 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 use 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 affecting thoughts, feelings and behaviour - Medicines for an irregular heart beat called quinidine or dofetilide - Ergotamine-used to treat migraine Do not start using Mycoheal® oral gel and tell your doctor if you are taking any of the above. Tell your doctor 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 channel-blockers’ 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 inflammation (given by mouth or injection) - Ebastine - for allergy - Reboxetine - for depression - Sulphonylureas such as chlorpropamide and glibenclamide (medicines for diabetes taken by mouth) - Sildenafil – for erection problems - Trimetrexate – for a type of pneumonia Tell your doctor 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 Mycoheal® oral gel if you are pregnant, think you may be pregnant or might become pregnant. You may still be able to use Mycoheal® 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 Mycoheal® oral gel is not likely to affect you being able to drive or use any tools or machines. 3. How to use this product. 1. How to use Mycoheal® oral gel Always use Mycoheal® exactly as your doctor has told you. If you are not sure check with your doctor or pharmacist. 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 How much gel to use Your doctor will tell you how much Mycoheal® oral gel to use and for how long you should use 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, 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 Mycoheal® 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 take more Mycoheal® oral gel than you should If you use more Mycoheal® 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 forget to take Mycoheal® oral gel - 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 have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Mycoheal® oral gel may cause side effects, although not everybody gets them. Stop using Mycoheal® 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. 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 discoloration - Rash with pus filled pimples/blisters (acute generalised exanthematous pustulosis) If any of the side effects gets serious or if you have any side effects not listed in this leaflet; please tell your doctor or pharmacist. 5. How to store this product Keep out of the reach and sight of children. Do not use Mycoheal® after the expiry date which is stated on the carton. The expiry date refers to the last day of that month Do not store above 30 °C. Discard unused content 7 days after first breaking tube seal. 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 to protect the environment.