• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

1. What SPORANOX oral solution is and what it is used for
2. What you need to know before you use SPORANOX oral solution
3. How to use SPORANOX oral solution
4. Possible side effects
5. How to store SPORANOX oral solution
6. Contents of the pack and other information

• If you are allergic (hypersensitive) to any of the ingredients in SPORANOX oral solution (listed in Section 6)
• If you are pregnant, think you might be pregnant or could become pregnant (see the section on Pregnancy)

Tell your doctor if you are taking any medicines, before you use SPORANOX oral solution.

• You must not use SPORANOX oral solution if you are taking certain medicines, or within 2 weeks of stopping SPORANOX oral solution. The following list contains examples of medicines you must not take with SPORANOX oral solution, or within 2 weeks of stopping SPORANOX oral solution:

Medicines to treat problems with the heart, blood or circulation

• aliskiren, eplerenone, lercanidipine or nisoldipine (for high blood pressure)
• bepridil, ivabradine or ranolazine – (for angina)
• dabigatran or ticagrelor (for blood clots)
• disopyramide, dofetilide, dronedarone or quinidine (for irregular heart beat rhythms)
• finerenone (for kidney problems in patients with type 2 diabetes)
• lomitapide, lovastatin or simvastatin (to lower cholesterol)
• sildenafil (for pulmonary arterial hypertension)

Medicines to treat stomach problems or constipation

• cisapride (for stomach upsets)
• domperidone (for nausea and vomiting)
• naloxegol (for constipation caused by taking opioid painkillers)

Medicines to treat headaches, sleep or mental health problems

• dihydroergotamine or ergotamine (ergot alkaloids used for migraine headaches)
• midazolam (taken by mouth) or triazolam (for sedation or to help you sleep)
• lurasidone, pimozide, quetiapine or sertindole (for schizophrenia, bipolar disorder or other mental health problems)

Medicines to treat urinary problems

• darifenacin (for urinary incontinence)
• fesoterodine or solifenacin (for irritated urinary bladder) when used in patients with certain kidney or liver problems

Medicines to treat allergies

• astemizole, mizolastine or terfenadine (for allergies)

Medicines to treat erection and ejaculation problems

• avanafil (for erectile dysfunction)
• dapoxetine (for premature ejaculation)
• vardenafil (for erectile dysfunction) when used in men older than 75 years of age

Other medicines containing:

• colchicine (for gout) when used in patients with kidney or liver problems
• ergometrine (ergonovine) or methylergometrine (methylergonovine) ergot alkaloids used after giving birth
• eliglustat (for Gaucher’s disease) when used in patients that cannot break down certain medicines in the body
• halofantrine (for malaria)
• irinotecan (for cancer)
• isavuconazole (for fungal infections)
• ombitasvir, paritaprevir, ritonavir with or without dasabuvir – (to treat hepatitis C)
• venetoclax (for chronic lymphocytic leukaemia) when you newly start venetoclax or take increasing doses at beginning of treatment
• voclosporin (to treat lupus-related kidney problems)

Remember – do not take any of the medicines above for 2 weeks after your last treatment with SPORANOX oral solution.

This is not a complete list, so tell your doctor if you are taking or planning to take any of these medicines, or any other medicines.

Stop taking SPORANOX 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 SPORANOX.
• If you experience any hearing loss symptoms. In very rare cases patients taking SPORANOX 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), SPORANOX could make it worse. If your doctor decides to give you SPORANOX, you should be told about the symptoms listed below to watch out for. If you get any of the following stop taking SPORANOX and tell your doctor straight away. These may be signs of heart failure:
  • shortness of breath
  • unexpected weight gain
  • swelling of your legs or stomach
  • feel unusually tired
  • wake up short of breath at night
• a liver problem, such as jaundice (yellowing of the skin) as your dose of SPORANOX may have to be changed. Your doctor should give you instructions on symptoms to watch out for. If you have to take SPORANOX 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 SPORANOX may have to be changed. In addition, there may be specific medication you may not be able to take.
• Cystic fibrosis (a genetic disease affecting the lungs, pancreas, liver, kidneys and intestines).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. There are some medicines that you should not take whilst taking SPORANOX. These are listed above under the heading “Do not use SPORANOX oral solution if you are:”

Certain medicines are not recommended for use with SPORANOX oral solution.

Your doctor may decide that you should not take some medicines at the same time as, or within 2 weeks of stopping SPORANOX oral solution.

Examples of these medicines are:

Medicines to treat problems with the heart, blood or circulation

• apixaban, edoxaban, rivaroxaban or vorapaxar (for blood clots)
• atorvastatin (to lower cholesterol)
• felodipine (for high blood pressure)
• riociguat or tadalafil (for pulmonary hypertension)

Medicines to treat epilepsy, headaches or mental health problems

• phenytoin, carbamazepine or phenobarbital (anti-epileptics)
• eletriptan (for migraine headaches)
• St. John’s Wort (Hypericum perforatum) (a herbal medicine used for mental health problems)

Medicines to treat urinary problems

• tamsulosin (for male urinary incontinence)
• tolterodine (for irritated urinary bladder)

Medicines to treat cancer

• axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, entrectinib, glasdegib, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, talazoparib, trabectedin, trastuzumab emtansine, venetoclax (when you are on a stable dose of venetoclax for chronic lymphocytic leukaemia, or at any time of treatment for acute myeloid leukaemia) or vinca alkaloids (e.g., vinflunine, vinorelbine)

Medicines to treat tuberculosis

• bedaquiline, isoniazid, rifabutin or rifampicin (for tuberculosis)

Medicines to treat human immunodeficiency virus (HIV) or hepatitis

• efavirenz or nevirapine (for HIV/AIDS)
  elbasvir/grazoprevir, tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) (for HIV or hepatitis)

Medicines used after organ transplant

• everolimus, rapamycin (also known as sirolimus), temsirolimus

Medicines to treat benign prostatic enlargement

• alfuzosin, silodosin

Medicines to treat lung problems or allergies

• ciclesonide (for inflammation, asthma and allergies)
• ebastine (for allergies)
• salmeterol (for asthma or chronic obstructive pulmonary disease -COPD)

Medicines to treat erection and ejaculation problems

• tadalafil or vardenafil (when used in men 75 years of age and younger) (for erectile dysfunction)

Other medicines containing:

• colchicine (for gout)
• fentanyl (for pain)
• lumacaftor/ivacaftor (for cystic fibrosis)

Remember - do not take any of the medicines above for 2 weeks after your last treatment with SPORANOX oral solution.

This is not a complete list, so tell your doctor if you are taking or planning to take any of these medicines, or any other medicines.

Care needs to be taken when using SPORANOX oral solution with certain other medicines

You may be more likely to get side effects, or the dose of SPORANOX oral solution or the other medicine might need to be changed. Examples of these medicines are:

Medicines to treat problems with the heart, blood or circulation

• bosentan (for pulmonary hypertension)
• calcium channel blockers such as, dihydropyridines such as amlodipine, isradipine, nifedipine, nimodipine or diltiazem (for hypertension)
• or verapamil (for high blood pressure)
• cilostazol (for circulatory problems)
• ‘coumarins’ such as warfarin (for blood clots)
• digoxin (for atrial fibrillation)
• nadolol (for pulmonary hypertension or angina)

Medicines to treat stomach problems or diarrhoea

• aprepitant or netupitant (for nausea and vomiting during cancer treatment)
• loperamide (for diarrhoea)
• antacids such as aluminium, calcium, magnesium, or sodium bicarbonate; H2-receptor antagonists such as cimetidine, ranitidine and proton pump inhibitors such as lansoprazole, omeprazole, rabeprazole (to treat stomach acid problems)

Medicines to treat sleep problems or mental health problems

• Alprazolam, brotizolam, buspirone, or midazolam (when injected into a vein) (for anxiety or to help you sleep)
• zopiclone (to help you sleep)
• reboxetine or venlafaxine (for depression and anxiety)
• aripiprazole, cariprazine, haloperidol or risperidone (for schizophrenia, bipolar disorder or other mental health problems)
• galantamine (for Alzheimer’s disease)
• guanfacine (for attention deficit hyperactivity disorder)

Medicines to treat urinary problems

• imidafenacin, fesoterodine, oxybutynin, solifenacin (for irritated urinary bladder)

Medicines to treat cancer

• bortezomib, brentuximab vedotin busulfan, erlotinib, gefitinib, idelalisib, imatinib, nintedanib, panobinostat, pemigatinib, ponatinib, ruxolitinib, sonidegib or tretinoin (oral)

Medicines to treat infections

• ciprofloxacin, clarithromycin, or erythromycin (for bacterial infections)
• delamanid (for tuberculosis)
• artemether-lumefantrine or quinine (to treat malaria)
• praziquantel (for fluke and tapeworms)

Medicines to treat human immunodeficiency virus (HIV) or hepatitis

• cobicistat, boosted elvitegravir, maraviroc, ritonavir, ritonavir-boosted darunavir, ritonavir-boosted fosamprenavir, indinavir or saquinavir (for HIV)
• glecaprevir/pibrentasvir (for hepatitis)

Medicines used after organ transplant

• cyclosporine or tacrolimus

Medicines to treat benign prostatic enlargement

• dutasteride

Medicines to treat lung problems, allergies or inflammatory conditions

• bilastine or rupatadine (for allergy)
• methylprednisolone or dexamethasone, (medicines given by mouth or injection for asthma, allergies or inflammatory conditions)
• budesonide or fluticasone (for asthma, allergies)

Medicines to treat erection and ejaculation problems

• sildenafil (for erectile dysfunction)

Medicines to treat pain

• alfentanil, buprenorphine, oxycodone or sufentanil (for pain)
• meloxicam (for joint inflammation and pain)

Other medicines containing:

• alitretinoin (given by mouth) (for eczema)
• cabergoline (for Parkinson’s disease)
• cannabis based products including medicines (such as for nausea and vomiting or muscle spasms in patients with multiple sclerosis)
• cinacalcet (for an over active parathyroid)
• dienogest or ulipristal (contraceptives)
• eliglustat (for Gaucher’s disease) when used in patients that cannot break down certain medicines in the body
• ivacaftor; (for cystic fibrosis)
• methadone (to treat drug addiction)
• repaglinide or saxagliptin (for diabetes)

This is not a complete list, so tell your doctor if you are taking or planning to take any of these medicines, or any other medicines.

Do not take SPORANOX with food or drink as it reduces your body’s ability to absorb the medicine. Always take SPORANOX oral solution one hour before any food or drink as this helps the body absorb the medicine.

SPORANOX is not normally given to children. Your doctor may prescribe it in special cases.

SPORANOX contains cyclodextrin, propylene glycol and alcohol (ethanol). Do not use in children less than 2 years old unless recommended by your doctor. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if the child is given other medicines that contain cyclodextrin, propylene glycol or alcohol.

SPORANOX is not normally given to the elderly. Your doctor may prescribe it in special cases.

Do not take SPORANOX if you are pregnant, unless your doctor has told you to. If you are of child bearing age and could become pregnant, talk to your doctor. You should use effective contraceptives to make sure that you do not become pregnant while you are taking your medicine. As SPORANOX 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 with SPORANOX has finished.

If you do find that you are pregnant after starting a course of SPORANOX, 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.

If you are breast-feeding do not take SPORANOX, as small amounts of the medicine could be present in your breast milk. If, your doctor recommends taking SPORANOX they may carry out extra checks while you are taking this medicine.

SPORANOX can sometimes cause dizziness, blurred/double vision or hearing loss. If you have these symptoms, do not drive or use machines.

This medicine contains 7 920 mg sorbitol in a 40 mL dose which is equivalent to 198 mg in each mL. 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 this medicine. Sorbitol is a source of fructose and may cause gastrointestinal discomfort and mild laxative effect.

This medicine contains 4.2 g of propylene glycol in each 40 mL dose which is equivalent to 104 mg/mL. If you are pregnant, breast-feeding or 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.

This medicine contains 16 000 mg cyclodextrin (s) in each 40 mL which is equivalent to 400 mg/mL. Cyclodextrin may cause digestive problems such as diarrhoea.

This medicine contains 0.2 mg of alcohol (ethanol) in each 40 mL dose which is equivalent to 0.005 mg/mL. The amount in 40 mL of this medicine is equivalent to less than 1 mL of beer or 1 mL wine. The small amount of alcohol in this medicine will not have any noticeable effects.

This medicine contains less than 1 mmol sodium (23 mg) per 40 mL, that is to say essentially ‘sodium-free’.

• Treatment of yeast infections of the mouth, throat or gullet

The usual dose is 2 measuring cups (20 mL) per day for one week. This may be taken either all at once or in two divided doses during the day.

If after one week of using SPORANOX, your infection has not cleared, your doctor may decide to continue your treatment for one more week.

• Treatment of yeast infections of the mouth, throat or gullet, that have already been treated with another antifungal but have still not cleared

The usual dose is 1-2 measuring cups (10-20 mL) twice daily for two weeks. The treatment may be continued for an additional two weeks, if the infection does not clear in the initial two weeks of treatment. For patients on the higher dose of 400 mg (4 measuring cups) daily, treatment should be limited to 14 days, if there are no signs of improvement during this time.

• Prevention of fungal infections

The dose is calculated according to your body weight (5 mg per kg) given in two divided doses. Your doctor will tell you exactly how much you should take.

The bottle comes with a child-proof cap, and should be opened as follows: push the plastic screw cap down, while turning it counter clockwise.

Use the measuring cup just as it sits on the bottle. Make sure that the side with the graduations (the side that holds less) is uppermost; that is the side you have to fill. When the arrow on the side points up, the correct side is uppermost.

If you, or anyone else, take more SPORANOX than you were told to, contact your doctor or local hospital without delay.

If you forget to take your medicine, take the next dose as usual and continue your medicine as directed by your doctor. Do not take a double dose.

• The active ingredient is itraconazole (10 mg of itraconazole per mL).
• The other ingredients are hydroxypropyl-β (cyclodextrin) E 420, sorbitol (liquid non crystallising), propylene glycol E 1520, hydrochloric acid, cherry flavour 1 and 2 (contains ethanol), caramel flavour, sodium saccharin, sodium hydroxide and water.

SPORANOX oral solution is a clear, yellow to slightly amber solution. It is available in bottles containing 150 mL together with a measuring cup.

SPORANOX oral solution is manufactured by: