100 mg hard capsules
Itraconazole
What Sporanox capsules are and what they are used for
Sporanox belongs to a group of medicines called “antimycotics” (medicines against fungal infections). These medicines are used to treat and prevent infections caused by fungi including yeasts.
Sporanox has an inhibitory effect on, among other things, disease-causing yeasts, by preventing the fungus from building up a normal cell wall. Without a well-functioning cell wall, the fungus dies.
Sporanox is used against fungal infections in the vagina, skin, nails, and internal organs.
The itraconazole found in Sporanox may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Sporanox capsules
Do not use Sporanox capsules:
- if you are allergic (hypersensitive) to itraconazole or any other ingredient in this medicine (specified in section 6, Contents of the pack and other information).
- if you are pregnant, think you may be pregnant or may become pregnant (see Pregnancy section).
Tell your doctor if you are taking other medicines before using Sporanox capsules.
- Do not use Sporanox capsules if you are taking any of the following medicines. Also, do not use the following medicines for 2 weeks after you have finished treatment with Sporanox capsules:
Medicines to treat problems with the heart, blood, or blood 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 rhythm)
- lomitapide, lovastatin, or simvastatin (to lower cholesterol, etc)
- sildenafil (for pulmonary arterial hypertension which means high blood pressure in the blood vessels of the lungs)Medicines to treat stomach problems or constipation
- cisapride (for upset stomach)
- domperidone (for nausea and vomiting)
- naloxegol (for constipation caused by painkillers containing opioids )Medicines to treat headaches sleep problems, or mental illness
- dihydroergotamine or ergotamine (ergot alkaloids used for migraine headaches)
- midazolam took by mouth or triazolam (sedative or for insomnia)
- lurasidone, pimozide, quetiapine, or sertindole (for schizophrenia, bipolar disorder, or other mental illnesses)Medicines to treat urinary tract problems
- darifenacin (for urinary incontinence)
- fesoterodine or solifenacin (for overactive bladder ) when used in patients with certain types of kidney or liver problems medicines to treat allergies
- astemizole, mizolastine, or terfenadine (for allergies )Medicines to treat erectile problems or problems with ejaculation
- avanafil (for erectile dysfunction)
- dapoxetine (for premature ejaculation)
- vardenafil (for erectile dysfunction) when used in men over 75 years of age breathe medicines that contain:
- colchicine (for gout ) when used in patients with kidney or liver problems
- ergometrine (ergonovine) or methylergometrine (methylergonovine) ergot alkaloids used after delivery
- eliglustat (for Gaucher’s disease ) when used in patients who 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)
Remember – do not take any of the above medicines for 2 weeks after your last treatment with Sporanox capsules.
Warnings and precautions
Talk to your doctor or pharmacist before using Sporanox.
Stop taking Sporanox and see a doctor immediately if any of the following symptoms of serious liver problems occur during treatment:
- severe loss of appetite, nausea, vomiting, unusual tiredness, stomach pain, unusually dark urine, or light stools.
Tell your doctor immediately :
- if you experience unusual tingling, numbness, or weakness in your hands or feet while taking Sporanox.
- if you experience that your hearing is deteriorating. 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 agents
- have heart problems, including heart failure. Sporanox can make it worse. If your doctor decides to give you Sporanox, you should be informed of the symptoms listed below that you should be aware of. If you experience any of the following, stop taking Sporanox and tell your doctor immediately. These symptoms may be signs of heart failure:
- shortness of breath
- unexpected weight gain
- swelling of the legs or abdomen
- you feel unusually tired
- you wake up short of breath at night
- have liver problems, such as jaundice (yellowing of the skin), as your dose of Sporanox may need to be changed. Your doctor should give you information about the symptoms you should be aware of. If you have to take Sporanox continuously for more than a month, your doctor may want to check your liver by taking some blood tests. In addition, there may be certain medicines that you cannot take.
- have kidney disease, as your dose of Sporanox may need to be changed. In addition, there may be certain medicines that you cannot take.
Other medicines and Sporanox capsules
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
There are certain medicines that you should not take while taking Sporanox. These are listed above under the heading ” Do not use Sporanox capsules “.
Some medicines are not recommended for use with Sporanox capsules.
The doctor may decide that you should not take certain medicines at the same time as, or for 2 weeks after you have stopped taking Sporanox capsules.
Examples of these medicines are:
Medicines to treat problems with the heart, blood, or blood circulation
- apixaban, rivaroxaban or vorapaxar (for blood clots)
- atorvastatin (to lower cholesterol etc)
- felodipine (for high blood pressure )
- riociguat or tadalafil (for pulmonary hypertension which means high blood pressure in the blood vessels in the lungs)
Medicines to treat epilepsy, headaches, or mental illness
- phenytoin, carbamazepine, or phenobarbital (for epilepsy )
- eletriptan (for migraine headaches)
- St. John’s wort ( Hypericum perforatum, a herbal medicine used to treat mental illness)
Medicines to treat urinary tract problems
- tamsulosin (for urinary incontinence in men)
- tolterodine (for overactive bladder )
Medicines to treat cancer
- axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, trabectedin, trastuzumab emtansine or vinca alkaloids (eg, 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, simeprevir, tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) (for HIV or hepatitis )
Medicines used after organ transplantation
- everolimus, rapamycin (also called sirolimus), temsirolimus
Medicines to treat benign prostatic hyperplasia
- alfuzosin, silodosin
Medicines to treat lung problems or allergies
- ciclesonide (against inflammation, asthma, and allergies )
- ebastine (for allergies )
- salmeterol (for asthma or chronic obstructive pulmonary disease – COPD)
Medicines to treat erectile problems or problems with ejaculation
- tadalafil or vardenafil when used in men aged 75 and under (for erectile dysfunction)
Breathe medicines that contain:
- colchicine (for gout )
- fentanyl (for pain)
- lumacaftor/ivacaftor (for cystic fibrosis )
Remember – do not take any of the above medicines for 2 weeks after your last treatment with Sporanox capsules.
This is not a complete list, so tell your doctor if you are taking or plan to take any of these or other medicines.
Care must be taken when using Sporanox capsules with certain other medicines
It may be more likely that you will have side effects, or that the dose of Sporanox capsules or other medicines may need to be changed. Examples of these medicines are:
Medicines to treat problems with the heart, blood, or blood circulation
- bosentan (for pulmonary hypertension, which means high blood pressure in the blood vessels in the lungs)
- calcium channel blockers such as dihydropyridines such as amlodipine, isradipine, nifedipine, nimodipine or diltiazem (for high blood pressure ) or verapamil (for high blood pressure )
- cilostazol (for circulation problems)
- coumarins such as warfarin (for blood clots)
- digoxin (for atrial fibrillation )
- nadolol (for pulmonary hypertension, which means high blood pressure in the blood vessels in the lungs, or for angina)
Medicines to treat stomach problems or diarrhea
- aprepitant or netupitant (for nausea and vomiting during cancer treatment)
- loperamide (for diarrhea)
- antacids such as aluminum, calcium, magnesium, or sodium bicarbonate; H 2 -receptor antagonists such as cimetidine, ranitidine, and proton pump inhibitors such as lansoprazole, omeprazole, rabeprazole (to treat problems with stomach acid)
Medicines to treat sleep problems or mental illness
- alprazolam, brotizolam, buspirone, or midazolam when given by injection into a vein (for anxiety or sleep problems)
- zopiclone (for insomnia)
- reboxetine or venlafaxine (for depression and anxiety)
- aripiprazole, cariprazine, haloperidol, or risperidone (for schizophrenia, bipolar disorder, or other mental illness)
- galantamine (for Alzheimer’s disease )
- guanfacine (for ADHD )
Medicines to treat urinary tract problems
- imidafenacin, fesoterodine, oxybutynin, solifenacin (for overactive bladder )
Medicines to treat cancer
- bortezomib, brentuximab vedotin, busulfan, erlotinib, gefitinib, idelalisib, imatinib, nintedanib, panobinostat, ponatinib, ruxolitinib, or sonidegib
Medicines to treat infection
- ciprofloxacin, clarithromycin, or erythromycin (for bacterial infections)
- delamanid (for tuberculosis )
- artemether and lumefantrine or quinine (to treat malaria )
- praziquantel (against liver fluke and tapeworm)
Medicines to treat human immunodeficiency virus ( HIV ) or hepatitis
- cobicistat, boosted (boosted) elvitegravir, maraviroc, ritonavir, darunavir boosted with (boosted by) ritonavir, fosamprenavir boosted with (boosted by) ritonavir, indinavir or saquinavir (anti- HIV )
- glecaprevir/pibrentasvir (for hepatitis )
Medicines used after organ transplantation
- ciclosporin or tacrolimus
Medicines to treat benign prostatic hyperplasia
- dutasteride
Medicines to treat lung problems, allergies, or inflammatory conditions
- bilastine or rupatadine (for allergy )
- methylprednisolone or dexamethasone (medicines given orally or by injection for asthma, allergies, or inflammatory conditions)
- budesonide or fluticasone (for asthma and allergies )
Medicines to treat erectile problems or problems with ejaculation
- sildenafil (for erectile dysfunction)
Medicines to treat pain
- alfentanil, buprenorphine, oxycodone, or sufentanil (for pain)
- meloxicam (for joint inflammation and pain)
Breathe medicines that contain:
- alitretinoin gave by mouth (for eczema )
- cabergoline (for Parkinson’s disease )
- products including medicinal products containing cannabis (for nausea and vomiting or muscle spasms in patients with multiple sclerosis )
- cinacalcet (for an overactive parathyroid gland )
- dienogest or ulipristal (contraceptives)
- eliglustat (against Gaucher’s disease ) when used in patients who cannot break down certain drugs 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 plan to take any of these or other medicines.
Sporanox capsules with food and drink
Take Sporanox capsules immediately after a meal. The capsules should be swallowed whole.
Talk to your doctor if you use drugs that neutralize stomach acid or if you have AIDS. You may be able to take Sporanox capsules with an acid-containing liquid (e.g. a normal cola drink, not a diet).
Children and the elderly
Sporanox is not normally given to children or the elderly. Your doctor can prescribe the drug in special cases.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not take Sporanox if you are pregnant unless your doctor has told you to.
Talk to your doctor if you are of childbearing age and could become pregnant. You must use effective contraception to make sure you do not become pregnant while taking this medicine. Because 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 treatment with Sporanox has ended.
If you discover that you are pregnant after starting a course of treatment with Sporanox, stop taking the medicine and inform your doctor immediately.
Breast-feeding
If you are breastfeeding, you should not take Sporanox, as small amounts of the drug may be present in breast milk.
Driving ability and use of machinery
Sporanox can sometimes cause dizziness, blurred or double vision, or hearing loss. If you have these symptoms, you should not drive a motor vehicle or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Sporanox contains sucrose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
How to use Sporanox capsules
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The capsules should be swallowed whole.
Take Sporanox capsules immediately after a meal so they are more easily absorbed by the body.
The dose is determined by the doctor who adjusts it individually for you. The recommended dose for adults varies between 1-4 capsules daily. The usual treatment time for fungal infections of the skin is 15-30 days. In case of fungal infections in the nails, either continuous treatment or so-called pulse treatment is given. For continuous treatment, Sporanox capsules are given for 3 months. In pulse treatment, two or three pulses are given. Each pulse is given for one week and is separated by 3 weeks of treatment freedom. In case of infection in internal organs, the treatment time is individually adjusted.
Use for children and adolescents
Sporanox capsules should only be used in children on the advice of a doctor.
If you have used too much Sporanox
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Sporanox
Do not take a double dose to make up for a missed dose.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly reported side effects of Sporanox capsules were headache, stomachache, and nausea. The most serious side effects were severe allergic reactions, heart failure / pulmonary edema, inflammation of the pancreas, severe hepatotoxicity (including some cases of fatal acute liver failure), and severe skin reactions, see below.
The following side effects have been reported:
Common side effects ( affects more than 1 in 100 users):
- headache
- stomach pain, nausea
Uncommon side effects ( affects less than 1 in 100 users):
- inflammation of the sinuses
- upper respiratory tract infection
- inflammation of the nose
- hypersensitivity
- diarrhea, vomiting, indigestion, constipation, flatulence
- impact on liver function and laboratory test values
- urticaria, rash, itching
- menstrual disorders
Rare side effects ( affects less than 1 in 1,000 users):
- decreased number of white blood cells
- serum sickness (causes symptoms such as fever, hives, and joint pain)
- angioedema (swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing) or severe allergic hypersensitivity reaction
- excess of a certain type of fat in the blood ( triglycerides )
- and crawls
- decreased sensitivity to touch
- unpleasant taste
- trembling or shaking ( tremor )
- visual disturbances (including blurred vision, and double vision)
- temporary or permanent hearing loss
- tinnitus (ringing in the ears)
- heart failure with symptoms such as shortness of breath, unexpected weight gain, swollen legs, unusual tiredness
severe pain in the upper abdomen, often accompanied by nausea and vomiting due to inflammation of the pancreas ( pancreatitis ) - severe hepatotoxicity (in some cases with fatal outcome)
- severe, extensive skin damage, changes in skin and mucous membranes (eg toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, leukocytoclastic vasculitis, erythema multiforme, acute generalized exanthematous pustulosis )
- hair loss
- photosensitivity of the skin
- increased need to urinate
- disorders of sexual ability in men
- fluid retention ( edema )
- increased levels of creatine phosphokinase in the blood
In addition, the following side effects have been reported for Sporanox oral solution and Sporanox for intravenous use:
- decrease in white blood cells and platelets
- increase in blood sugar
- high or low potassium levels in the blood
- low magnesium levels in the blood
- confusion
- numbness or muscle weakness in the arms or legs
- dizziness
- somnolence
- increased heart rate
- high or low blood pressure
- fluid accumulation in the lungs
- changed voice
- cough
- stomach problems
- liver problems
- hepatitis, jaundice
- vasculitis
- excessive sweating
- muscle and joint pain
- impaired kidney function
- impaired ability to control urine
- general swelling, swelling of the face
- chest pain
- fever
- pain
- fatigue
- overindulge
- changed laboratory values for blood and urine tests
How to store Sporanox capsules
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Use before the expiry date stated on the packaging after “EXP”. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is itraconazole.
- Other ingredients are sugar spheres (corn starch and sucrose), hypromellose, and macrogol. The capsule shell contains dyes (erythrosine/E 127, indigo carmine/E 132, titanium dixoid/E 171) and gelatin.
Appearance and package sizes of the medicine
Blisters of 4, 15, and 28 pcs.
The Sporanox capsules have a blue opaque upper part and a pink transparent lower part.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Janssen-Cilag AB
Box 4042
SE‑169 04 Solna
Phone: +46 8 626 50 00
Manufacturer
Janssen-Cilag SpA, Via C. Janssen, 04100 Borgo San Michele, Latina, Italy.