Product Details

Product Information of Itraconazole Oral Solution

WHAT YOU NEED TO KNOW BEFORE YOU TAKE ITRACONAZOLE ORAL SOLUTION

DO NOT TAKE Itraconazole Oral Solution if you: • are allergic (hypersensitive) to itraconazole or any of the other ingredients (listed in section 6) • have, or have a history of, congestive heart failure, unless you have a very serious fungal infection (see under ‘Take special care’) • are pregnant, think you might be pregnant or could become pregnant (see the section on Pregnancy) • are taking any of the following medicines: • terfenadine, astemizole or mizolastine (antihistamine for allergies) • bepridil, ivabradine or ranolazine used to treat angina (crushing chest pain) • nisoldipine, lercanidipine or eplerenone (used for high blood pressure) • cisapride (used for stomach upsets) • domperidone (for nausea and vomiting) • midazolam by mouth or triazolam (used to help you sleep or for anxiety) • lovastatin or simvastatin (used to lower cholesterol) • lurasidone, pimozide or sertindole (for conditions affecting thoughts, feelings and/or behaviour) • levacetylmethadol (used for treatment of drug abuse (opioiddependency)) • dihydroergotamine and ergotamine (used for migraine headaches) • ergometrine (ergonovine) and methylergometrine (methylergonovine) used after giving birth • disopyramide, dronedarone, quinidine and dofetilide (used for irregular heart beat rhythms) • telithromycin (for pneumonia) when used in patients with severe kidney or liver problems • colchicine (for gout) when used in patients with kidney or liver problems • halofantrine (for malaria) • irinotecan (for cancer) • dabigatran (for blood thinning) • ticagrelor (for blood clots) • quetiapine (for psychosis) • aliskiren (for hypertension) • darifenacin (for urinary incontinence) • fesoterodine (for irritated urinary bladder) when used in patients with certain kidney or liver problems • sildenafil (for pulmonary arterial hypertension) • solifenacin (for irritated urinary bladder) when used in patients with certain kidney or liver problems • vardenafil (for erectile dysfunction) when used in men older than 75 years of age Also, upon completing your course of Itraconazole Oral Solution, do not take any of the medicines listed above for 2 weeks. Warnings and precautions Stop taking Itraconazole Oral Solution and see your doctor immediately if any of the following symptoms of severe liver problems appear during your course of treatment: • severe lack of appetite, feeling sick, being sick, unusual tiredness, abdominal (stomach) pain, unusually dark urine or pale stools. Tell your doctor immediately if you: • have any unusual feelings of tingling, numbness or weakness in your hands or feet whilst taking Itraconazole Oral Solution • experience any hearing loss symptoms. In very rare cases patients taking itraconazole have reported temporary or permanent hearing loss. Tell your doctor if you have: • had an allergic reaction to any other antifungal medicines • a heart problem, including heart failure (also called congestive heart failure or CHF), Itraconazole Oral Solution could make it worse. If your doctor decides to give you Itraconazole, you should be told to watch out for any of the symptoms listed below. If you get any of the following stop taking Itraconazole Oral Solution and tell your doctor straight away. These may be signs of heart failure: o shortness of breath o unexpected weight gain o swelling of your legs or stomach o feel unusually tired o wake up short of breath at night • a liver problem, such as jaundice (yellowing of the skin), as your dose of Itraconazole may have to be changed. Your doctor should give you instructions on symptoms to watch out for. If you have to take Itraconazole Oral Solution continuously for more than one month, your doctor may want to check your liver by doing blood tests. In addition, there may be specific medication you may not be able to take. • a kidney disorder, as your dose of Itraconazole may have to be changed. In addition, there may be specific medication you may not be able to take. • a gastro-intestinal disorder that causes slow passage of food through your body. In addition, there may be specific medication you may not be able to take. OTHER MEDICINES AND ITRACONAZOLE ORAL SOLUTION There are some medicines that you should not take whilst taking Itraconazole Oral Solution. These are listed under the heading “Do not take Itraconazole Oral Solution if you: • are taking any of the following medicines” Tell your doctor if you are using the following medicines as they may stop itraconazole from working properly: • rifampicin, rifabutin and isoniazid (antibiotics used for tuberculosis) • phenytoin, carbamazepine and phenobarbital (anti-epileptics) • efavirenz or nevirapine (medicines used for HIV/AIDS) • St. John’s wort (a herbal medicine). Do not use Itraconazole Oral Solution within 2 weeks of taking these medicines. Tell your doctor if you are using the following medicines as they are not recommended with Itraconazole Oral Solution unless your doctor feels it is necessary: • medicines for cancer (namely axitinib, dabrafenib, dasatinib, ibrutinib, lapatinib, nilotinib, sunitinib or trabectedin) • simeprevir (for hepatitis C) • riociguat, when used to treat pulmonary hypertension (increased blood pressure in the blood vessels in the lungs) • rifabutin (for tuberculosis) • carbamazepine (for epilepsy) • colchicine (for gout) • everolimus or temsirolimus (given after an organ transplant) • fentanyl (for pain) • apixaban (for blood clots) • rivaroxaban (for blood clots) • salmeterol (for breathing problems) • tamsulosin (for male urinary incontinence) • vardenafil (for erectile dysfunction) when used in men 75 years of age and younger • atorvastatin (for lowering levels of cholesterol) • ciclesonide (for inflammation, asthma and allergies) • ebastine (for allergies) • eletriptan (for migraine headaches) • tolterodine (for irritated urinary bladder) • felodipine (for the heart or blood vessels) Also, upon completing your course of Itraconazole Oral Solution, do not take any of the medicines listed above for 2 weeks. Tell your doctor before taking any of the following medicines as the dose of Itraconazole Oral Solution or other treatments may need to be altered: • ciprofloxacin, clarithromycin and erythromycin (antibiotics for infections) • medicines that act on the heart and blood vessels (bosentan, digoxin, nadolol and calcium channel-blockers such as dihydropyridines and verapamil) • telithromycin (for pneumonia) • drugs that slow down blood clotting or thin the blood, such as the coumarins (e.g. warfarin) and cilostazol • methylprednisolone, budesonide, fluticasone and dexamethasone, medicines for inflammation, asthma and allergies • ciclosporin, tacrolimus and rapamycin (also known as sirolimus), which are usually given after an organ transplant • medicines used in HIV-infected patients, such as maraviroc, ritonavir, ritonavir-boosted darunavir, ritonavir-boosted fosamprenavir, indinavir and saquinavir • telaprevir, used in the treatment of Hepatitis C Virus • medicines for cancer (such as bortezomib, busulphan, docetaxel, erlotinib, gefitinib, imatinib, ixabepilone, ponatinib, trimetrexate and a group of medicines known as vinca alkaloids) • alfentanil, buprenorphine, sufentanil or oxycodone (for pain) • methadone for treatment of drug abuse (opioid-dependency) • buspirone, alprazolam, brotizolam, perospirone and midazolam when given by injection into a vein (for anxiety or to help you sleep) • reboxetine (for depression) • loperamide (for diarrhoea) • repaglinide or saxagliptin (for diabetes) • aripiprazole, haloperidol or risperidone (for psychosis) • aprepitant (for nausea and vomiting) • fesoterodine, oxybutynin or solifenacin (for irritated urinary bladder) • sildenafil or tadalafil (for erectile dysfunction) • praziquantel (for fluke and tapeworms) • bilastine (for allergies) • meloxicam (for joint inflammation and pain) • cinacalcet (for an over active parathyroid) • tolvaptan (for low blood sodium levels) • alitretinoin (oral) (for eczema) Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Itraconazole Oral Solution with food and drink • Do not take Itraconazole Oral Solution with food or drink as it reduces your body’s ability to absorb the medicine. • Always take it one hour before any food or drink as this helps the body absorb the medicine. PREGNANCY AND BREAST-FEEDING Pregnancy • If you are pregnant, do not take this medicine unless recommended by your doctor. • If you are of child bearing age and could become pregnant, you should use contraceptives to make sure that you do not become pregnant while you are taking your medicine. • As itraconazole remains in the body for some time after you stop taking it, you should continue to use some form of contraception until your next period after your treatment has finished. • If you become pregnant after starting a course of Itraconazole Oral Solution, stop taking it and tell your doctor straight away. • Before taking any medicine – always tell your doctor if you are pregnant, think you might be pregnant or are trying to become pregnant. Breast-feeding If you are breast-feeding, do not take Itraconazole Oral Solution as small amounts of the medicine could be present in your breast milk. DRIVING AND USING MACHINES Itraconazole can sometimes cause dizziness, blurred/double vision or hearing loss. Do not drive or use machines if you have these symptoms. Itraconazole Oral Solution contains sorbitol (E420) This medicine contains 5662 mg sorbitol in each 20ml dose which is equivalent to 283.1 mg/ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. Itraconazole Oral Solution contains propylene glycol (E1520) This medicine contains 2072 mg propylene glycol in each 20ml dose which is equivalent to 103.6 mg/ml. If you are pregnant or breast-feeding, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine. 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. Itraconazole Oral Solution contains Ethanol This medicinal product contains a small amount of ethanol (alcohol) less than 100mg per 20ml. This medicine contains less than 1 mmol sodium (23 mg) per 20ml, that is to say essentially ‘sodium-free’.