SPORANOX 100 mg Kapsułki Twarde

Treść ulotki

1. SPORANOX 10 mg/mL oral solution
   1. What is SPORANOX oral solution and what is it used for
   2. What you need to know before taking SPORANOX oral solution
   3. How to take SPORANOX oral solution
   4. Possible side effects
   5. How to store SPORANOX oral solution
   6. Contents of the pack and other information
2. SPORANOX 100 mg hard capsules
   1. What Sporanox capsules are and what they are used for
   2. Cosa deve sapere prima di usare Sporanox capsule
   3. How to use Sporanox capsules
   4. Possible side effects
   5. How to store Sporanox capsules
   6. Contents of the pack and other information

SPORANOX 10 mg/mL oral solution

(itraconazole)

Read this leaflet carefully before using this medicine because
it contains important information for you.

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

Contents of 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

1. What is SPORANOX oral solution and what is it used for

SPORANOX oral solution belongs to a group of medicines called “antifungals”.
These medicines are used to treat and resolve infections caused by fungi,
including yeasts.
SPORANOX oral solution is prescribed for:

• treating yeast infections in the mouth, throat or esophagus if you have a compromised immune system
• preventing some fungal infections if you have a compromised immune system due to blood diseases or bone marrow transplant.

2. What you need to know before taking SPORANOX oral solution

Do not use SPORANOX oral solution:

• If you are allergic (hypersensitive) to any of the other ingredients of SPORANOX oral solution (listed in section 6)
• If you are pregnant, suspect you may be pregnant, or are planning a pregnancy (see section “Pregnancy”)

Consult your doctor if you are taking any other medicines before taking
SPORANOX oral solution.

• Do not take SPORANOX oral solution ifyou are taking certain medicines, or within 2 weeks of stopping SPORANOX oral solution. The following list contains examples of medicines that you should not take with SPORANOX oral solution, or within 2 weeks of stopping SPORANOX oral solution:

Medicines for the treatment of heart, blood or
circulation problems

• 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 heartbeat)
• finerenone (for kidney problems in patients with type 2 diabetes)
• lomitapide, lovastatin or simvastatin (to reduce cholesterol)
• sildenafil (for pulmonary arterial hypertension) Medicines for the treatment of stomach problems or constipation
• cisapride (for stomach disorders)
• domperidone (for nausea and vomiting)
• naloxegol (for constipation due to opioid pain relievers) Medicines for the treatment of headaches, insomnia or mental
  health problems
• dihydroergotamine or ergotamine (ergot alkaloids for migraines)
• midazolam (by mouth) or triazolam (for sedation or to aid sleep)
• lurasidone, pimozide, quetiapine or sertindole (for schizophrenia, bipolar disorder or other mental health problems) Medicines for the treatment of urinary problems
• darifenacin (for urinary incontinence)
• fesoterodine or solifenacin (for bladder irritation) if used in patients with certain kidney or liver problems Medicines for the treatment of allergies
• astemizole, mizolastine or terfenadine (for allergies) Medicines for the treatment of erectile and ejaculation problems
• avanafil (for erectile dysfunction)
• dapoxetine (for premature ejaculation)
• vardenafil (for erectile dysfunction) if used in men over the age of 75 Other medicines containing:
• colchicine (for gout) if used in patients with kidney or liver problems
• ergot alkaloids, ergometrine (ergonovine) or methylergometrine (methylergonovine), used after childbirth
• eliglustat (for Gaucher's disease) if used in patients who cannot break down certain medicines in the body
• alofantrine (for malaria)
• irinotecan (for cancer)
• isavuconazole (for fungal infections)
• ombitasvir, paritaprevir, ritonavir with or without dasabuvir (for the treatment of hepatitis C)
• venetoclax (for chronic lymphocytic leukemia) when starting treatment or when taking increasing doses at the beginning of treatment
• voclosporin (for kidney problems related to lupus)

Note: do not take any of the medicines listed above for the 2 weeks
following the last treatment with SPORANOX oral solution.
This is not a complete list, so tell your doctor if you are taking or intend to take any of these medicines or other medicines.

Warnings and precautions
Stop taking SPORANOX oral solutionand contact
your doctor immediately if you experience any of the following serious liver disorders during treatment with the medicine:

• severe loss of appetite, feeling unwell, malaise, unusual fatigue, abdominal (stomach) pain, unusually dark urine or unusually pale stools.

Tell your doctor immediately:

• if you notice an unusual sensation of tingling, reduced sensitivity or weakness in your hands or feet during treatment with SPORANOX oral solution
• if you experience symptoms related to hearing loss. In very rare cases, patients taking SPORANOX oral solution have reported temporary or permanent hearing loss.

Tell your doctorif you have or have had any of the following conditions:

• an allergic reaction to other antifungal medicines
• heart problems, including heart failure (also called congestive heart failure or CHF) which SPORANOX oral solution may worsen. If your doctor decides to prescribe SPORANOX, you must be informed about the symptoms to watch out for, listed below. If you experience any of these symptoms, stop taking SPORANOX and contact your doctor immediately. These may be signs of heart failure:
• shortness of breath
• unexpected weight gain
• swelling of the legs or stomach
• unusual fatigue
• waking up at night with difficulty breathing
• liver problems, such as jaundice (yellowing of the skin): in this case the dose of SPORANOX may be changed. Your doctor will tell you the symptoms to watch out for. If you need to take SPORANOX continuously for more than a month, your doctor may want to check your liver function with blood tests. There may also be specific medicines that you may not be able to take
• kidney problems: in this case the dose of SPORANOX may be changed. There may also be specific medicines that you may not be able to take.
• cystic fibrosis (a genetic disease that affects the lungs, pancreas, liver, kidneys and intestines).

Other medicines and SPORANOX oral solution
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicines.
There are some medicines that you must not takeduring treatment with
SPORANOX. They are listed in the section “ Do not use SPORANOX oral
solution if:”
Some medicines are not recommended for use with SPORANOX
oral solution.
Your doctor will decide whether you must not take some medicines
at the same time or within 2 weeks of stopping
treatment with SPORANOX oral solution.
Examples of these medicines are:

Medicines for the treatment of heart, blood or
circulation problems

• apixaban, edoxaban, rivaroxaban or vorapaxar (for blood clots)
• atorvastatin (to reduce cholesterol)
• felodipine (for high blood pressure)
• riociguat or tadalafil (for pulmonary hypertension) Medicines for the treatment of epilepsy, headaches or mental
  health problems
• phenytoin, carbamazepine or phenobarbital (antiepileptics)
• eletriptan (for migraine)
• St. John's wort ( Hypericum perforatum) (a herbal remedy used for mental health problems) Medicines for the treatment of urinary problems
• tamsulosin (for male urinary incontinence)
• tolterodine (for bladder irritation) Medicines for the treatment of cancer
• axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, entrectinib, glasdegib, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, talazoparib, trabectedine, trastuzumab emtansine, venetoclax (when taking a stable dose of venetoclax for the treatment of chronic lymphocytic leukemia, or at any time during treatment for acute myeloid leukemia) or vinca alkaloids (e.g. vinflunine, vinorelbine) Medicines for the treatment of tuberculosis
• bedaquiline, isoniazid, rifabutin or rifampicin (for tuberculosis) Medicines for the treatment of 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 transplantation
• everolimus, rapamycin (also known as sirolimus), temsirolimus Medicines for the treatment of benign prostatic hyperplasia
• alfuzosin, silodosin Medicines for the treatment of lung problems or allergies
• ciclesonide (for inflammation, asthma and allergies)
• ebastine (for allergies)
• salmeterol (for asthma or chronic obstructive pulmonary disease, COPD) Medicines for the treatment of erectile and ejaculation problems
• tadalafil or vardenafil (if used in men aged 75 years or under) (for erectile dysfunction) Other medicines containing:
• colchicine (for gout)
• fentanyl (for pain)
• lumacaftor/ivacaftor (for cystic fibrosis)

Note: do not take any of the medicines listed above for the 2 weeks
following the last treatment with SPORANOX oral solution.
This is not a complete list, so tell your doctor if you are taking or plan to take any of these medicines or any other
medicine.

When SPORANOX oral solution is taken with certain other medicines caution is
needed
You may be more likely to experience undesirable effects or it may be necessary to change the dose of SPORANOX oral solution or the other
medicine. Examples of these medicines are:

Medicines for the treatment of heart, blood or circulation problems

• bosentan (for pulmonary hypertension)
• calcium channel blockers such as dihydropyridines, e.g. amlodipine, isradipine, nifedipine, nimodipine or diltiazem (for hypertension)
• or verapamil (for arterial hypertension)
• cilostazol (for circulatory problems)
• “coumarinic” drugs such as warfarin (for blood coagulation)
• digoxin (for atrial fibrillation)
• nadolol (for pulmonary hypertension or angina) Medicines for the treatment of stomach problems or diarrhea
• aprepitant or netupitant (for nausea and vomiting during cancer treatments)
• loperamide (for diarrhea)
• antacids such as aluminum, calcium, magnesium or sodium bicarbonate; H receptor antagonists such as cimetidine, ranitidine and proton pump inhibitors such as lansoprazole, omeprazole, rabeprazole (for the treatment of acid-related stomach problems) Medicines for the treatment of sleep or mental health problems
• alprazolam, brotizolam, buspirone or midazolam (intravenously) (for anxiety or to aid sleep)
• zopiclone (to aid 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 for the treatment of urinary problems
• imidafenacin, fesoterodine, oxybutynin, solifenacin (for urinary bladder irritation) Medicines for the treatment of tumors
• bortezomib, brentuximab vedotin, busulfan, erlotinib, gefitinib, idelalisib, imatinib, nintedanib, panobinostat, pemigatinib, ponatinib, ruxolitinib, sonidegib or tretinoin (oral) Medicines for the treatment of infections
• ciprofloxacin, clarithromycin or erythromycin (for bacterial infections)
• delamanid (for tuberculosis)
• artemether-lumefantrine or quinine (for the treatment of malaria)
• praziquantel (for trematodes and tapeworm) Medicines for the treatment of human immunodeficiency virus (HIV) or hepatitis
• cobicistat, boosted elvitegravir, maraviroc, ritonavir, darunavir boosted by ritonavir, fosamprenavir boosted by ritonavir, indinavir or saquinavir (for HIV)
• glecaprevir/pibrentasvir (for hepatitis) Medicines used following organ transplantation
• cyclosporine or tacrolimus Medicines for the treatment of benign prostatic hyperplasia
• dutasteride Medicines for the treatment of lung problems, allergies or inflammatory conditions
• bilastine or rupatadine (for allergies)
• methylprednisolone or dexamethasone (medicines administered orally or by injection for asthma, allergies or inflammatory conditions)
• budesonide or fluticasone (for asthma, allergies) Medicines for the treatment of erectile and ejaculation problems
• sildenafil (for erectile dysfunction) Medicines for the treatment of pain
• alfentanil, buprenorphine, oxycodone or sufentanil (for pain)
• meloxicam (for inflammation and joint pain) Other medicines containing:
• alitretinoin (administered orally) (for eczema)
• cabergoline (for Parkinson's disease)
• cannabinoid products including medicinal products (such as those for nausea and vomiting or for muscle spasms in patients with multiple sclerosis)
• cinacalcet (for hyperparathyroidism)
• dienogest or ulipristal (contraceptives)
• eliglustat (for Gaucher's disease) if used in patients unable to degrade certain medicines in the body
• ivacaftor (for cystic fibrosis)
• methadone (for the treatment of drug dependence)
• 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 medicine.

SPORANOX oral solution with food and beverages
Do not take SPORANOX with food or beverages because they may reduce your body's ability to absorb the medicine. Always take SPORANOX oral solution one hour before food or beverages, as this helps your body absorb the drug.

Children
SPORANOX is not normally given to children. Your doctor may prescribe it in particular cases.
SPORANOX contains cyclodextrin, propylene glycol and alcohol (ethanol). Do not use it in children under 2 years of age unless recommended by your doctor. If your child is under 5 years of age, talk to your doctor or pharmacist before giving this medicine, especially if your child is taking other medicines that contain cyclodextrin, propylene glycol or alcohol.

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

Pregnancy
Do not use SPORANOX if you are pregnant, unless your doctor has told you to take it. If you are of childbearing potential and may become pregnant, you must use adequate contraceptive measures to avoid pregnancy during treatment with this medicine. Since SPORANOX remains in the body for a period of time after stopping treatment, you must continue to use contraceptive measures until your next menstrual period after finishing treatment with SPORANOX.
If you become aware of being pregnant after a cycle of treatment with SPORANOX, stop taking Sporanox and contact your doctor immediately.
Before taking any medicine, always tell your doctor if you are pregnant, think you may be or intend to become pregnant.

Breastfeeding
If you are breastfeeding, do not take SPORANOX, as small amounts of the medicine may be present in breast milk. If your doctor recommends taking SPORANOX, you may have additional checks during the intake of this medicine.

Driving and operating machinery
SPORANOX can sometimes cause dizziness, blurred or double vision or hearing loss. If you experience these symptoms, do not drive or operate machinery.

SPORANOX oral solution contains sorbitol
This medicine contains 7,920 mg of sorbitol in a dose of 40 mL 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 metabolize fructose, talk to your doctor before you (or your child) take this medicine. Sorbitol is a source of fructose and can cause gastrointestinal discomfort and have a mild laxative effect.

SPORANOX oral solution contains propylene glycol
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, breastfeeding or suffer from liver or kidney disease, do not take this medicine unless recommended by your doctor.
Your doctor may request additional checks while you are taking this medicine.

SPORANOX oral solution contains cyclodextrin
This medicine contains 16,000 mg of cyclodextrins in each 40 mL which is equivalent to 400 mg/mL. Cyclodextrin can cause digestive disorders such as diarrhea.

SPORANOX oral solution contains alcohol (ethanol)
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 wine. The small amount of alcohol in this medicine will not produce significant effects.

SPORANOX oral solution contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) in a 40 mL dose, which is essentially “sodium-free”.

3. How to take SPORANOX oral solution

Always take SPORANOX oral solution one hour before each food or drink:
this will help to absorb the medicine.
Rinse your mouth with SPORANOX for about 20 seconds before swallowing it. Do not
rinse your mouth after taking the oral solution.
Always take SPORANOX exactly as recommended by your doctor. If you are
not sure, ask your doctor or pharmacist.
A graduated measuring cup indicating 10 mL is provided. Make sure to fill it up to the
10 mL mark.

How to take SPORANOX oral solution

• Treatment of oral, throat or esophageal yeast infectionsThe usual dose is 2 measuring cups (20 mL) per day for one week. They can be taken in a single administration or divided into two daily administrations. If the infection has not resolved after one week of treatment with SPORANOX, your doctor may decide to continue therapy for another week.
• Treatment of oral, throat or esophageal infections already treated withoutsuccess with other antifungals

The usual dose is 1-2 measuring cups (10-20 mL) twice a day for two weeks. The
treatment may be continued for another two weeks if the infection does not resolve within the
initial two weeks of treatment. For patients taking a dose of 400 mg (4
measuring cups) per day, treatment should be limited to 14 days, unless there are
signs of improvement during this period.

• Prevention of fungal infectionsThe dose is calculated based on your body weight (5 mg per kg) divided into two administrations. Your doctor will tell you exactly how much medicine to take.

Instructions for opening the bottle
The bottle comes with a child-resistant cap, which must be opened as
indicated: press the cap down and, at the same time, rotate it counterclockwise.

How to use the dosing cap
Use the dosing cap as it is placed on the bottle. Make sure the side with the graduated
marks (the smaller part) is facing up; that is the part to fill.
When the arrow points upwards, the correct side is the highest.

If you take more SPORANOX oral solution than you should
If you, or someone else, takes more SPORANOX than prescribed, contact
your doctor or the nearest hospital immediately.

If you forget to take SPORANOX oral solution
If you forget to take the medicine, take the next dose as usual and continue
to take the medicine as directed by your doctor. Do not take a double dose to
make up for a missed dose.
If you have any other questions about the use of SPORANOX oral solution, ask your doctor or
pharmacist.

4. Possible side effects

Like all medicines, SPORANOX oral solution can cause side effects
although not everybody gets them.
Medicines can cause serious allergic reactions.

Stop taking SPORANOX and contact your doctor immediatelyif
you notice any of the following:

• any sudden dizziness, difficulty breathing, swelling of the face, skin rash, itching (especially if it affects the whole body) or a severe skin disorder (characterised by widespread rashes with peeling of the skin and blisters on the mouth, eyes and genitals, or rashes characterised by small pustules or blisters).
• severe loss of appetite, feeling unwell or malaise, unusual tiredness, abdominal pain (in the stomach), unusually dark urine or pale stools. These may be symptoms of serious liver problems.

You should inform your doctor immediately if you experience any of the following
side effects:

• Symptoms suggestive of heart failure such as shortness of breath, unexpected weight gain, swelling of the legs, unusual tiredness, repeated night-time awakenings.
• A sensation of tingling, sensitivity to light, reduced sensitivity and weakness in the limbs.
• Blurred or double vision, ringing in the ears, incontinence or increased urge to urinate.
• If you experience symptoms of hearing loss
• Severe pain in the upper part of the stomach, often with nausea and vomiting due to inflammation of the pancreas (pancreatitis)

Other side effects include:
Side effects common(affect less than 1 in 10 people):

• headache
• stomach pain, feeling unwell (nausea), vomiting, diarrhoea, indigestion, unpleasant taste
• skin rash
• fever or high temperature
• shortness of breath
• dizziness
• cough

Side effects uncommon(affect less than 1 in 100 people):

• some blood disorders that can cause an increased risk of bleeding or bruising (possible symptoms due to low levels of platelets), or infections (possible symptoms due to low levels of white blood cells in the blood)
• constipation
• itching, hives
• generalised swelling
• muscle cramps or irregular heartbeat (possible symptoms due to low levels of potassium in the blood)
• muscle pain, joint pain
• abnormal menstrual bleeding
• reduction or alteration of sensitivity, especially in the skin

The following side effects have been reported in patients treated with SPORANOX with
an unknown frequency:

• excess triglycerides (fats) in the blood
• hair loss
• increased levels of creatine phosphokinase in the blood
• symptoms due to increased levels of the hormone “aldosterone” (such as high blood pressure or low levels of potassium in the blood), even if the level of “aldosterone” in the blood is normal or low

The following undesirable effects have been reported in patients treated with other
formulations of SPORANOX:

• upper respiratory tract infection
• nasal inflammation
• sinus inflammation
• some blood disorders that can increase the risk of infections (possible symptoms due to low levels of granulocytes)
• high blood sugar levels
• muscle cramps or irregular heartbeats (possible symptoms due to low levels of magnesium in the blood)
• muscle cramps or irregular heartbeats (possible symptoms due to high levels of potassium in the blood)
• confusion
• drowsiness
• tremors
• increased heart rate
• high blood pressure
• low blood pressure
• fluid in the lungs
• difficulty speaking
• excess gas in the intestinal tract
• increased levels of specific liver function parameters (increased liver enzymes)
• liver inflammation (hepatitis)
• yellowing of the skin (jaundice)
• excessive sweating
• kidney problems
• excessive urine production
• erectile dysfunction
• generalised swelling
• swelling of the face
• chest pain
• pain
• chills
• tiredness
• increased levels of urea in the blood
• abnormal urine tests

Reporting of side effects
If you get any side effects, even those not listed in this
leaflet, tell your doctor or pharmacist or nurse. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side
effects you can help provide more information on the safety of this
medicine.

5. How to store SPORANOX oral solution

Keep this medicine out of the sight and reach of children.
Store SPORANOX oral solution at a temperature not exceeding 25°C.
Do not use SPORANOX oral solution after the expiry date stated on the packaging
after EXP. The expiry date refers to the last day of the month.
The oral solution should not be used for more than 1 month from the first opening of the
bottle.
Always return any unused medicine to the pharmacist. Keep it only if indicated by your
doctor.

6. Contents of the pack and other information

What SPORANOX oral solution contains

• The active substance is itraconazole (10 mg of itraconazole per mL)
• The excipients are: hydroxypropyl-β (cyclodextrin) E420, sorbitol (non-crystallizing liquid), propylene glycol E1520, hydrochloric acid, cherry flavour 1 and 2 (contains ethanol), caramel flavour, sodium saccharin, sodium hydroxide and water.

Description of the appearance of SPORANOX oral solution and contents of the pack
SPORANOX oral solution is a clear solution, with a colour ranging from yellow to slightly amber. It is available in 150 mL bottles with a measuring dropper.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Janssen-Cilag SpA
Viale Fulvio Testi, 280/6
20126 Milano MI

Manufacturer
SPORANOX oral solution is manufactured by:
Janssen Pharmaceutica N.V.
Turnhoutseweg, 30
B-2340 Beerse
Belgium

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following denominations:
Austria: SPORANOX
Belgium: SPORANOX
Finland: SPORANOX
Germany: SEMPERA
Ireland: SPORANOX
Italy: SPORANOX
Luxembourg: SPORANOX
Netherlands: TRISPORAL
Portugal: SPORANOX
Sweden: SPORANOX
United Kingdom (Northern Ireland): SPORANOX
® registered trademark

SPORANOX 100 mg hard capsules

Itraconazole
Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Sporanox capsules are and what they are used for
• 2. What you need to know before you take Sporanox capsules
• 3. How to take Sporanox capsules
• 4. Possible side effects
• 5. How to store Sporanox capsules
• 6. Contents of the pack and other information

1. What Sporanox capsules are and what they are used for

Sporanox contains itraconazole which belongs to a group of medicines called
“systemic antimycotics” used for the following fungal infections (mycoses):

• Superficial mycoses:
• vulvovaginal candidiasis (infection of the female genital tract)
• pityriasis versicolor (skin infection characterized by light and dark spots)
• dermatophytosis (superficial skin infection)
• oral candidiasis (infection of the mouth)
• fungal keratitis (inflammation of the cornea on the front of the eye)
• Onychomycosis (nail infections) caused by fungi and/or yeasts.
• Systemic mycoses(infections caused by fungi that spread throughout the body):
• aspergillosis (infection caused by Aspergillus)
• candidiasis (infection caused by Candida)
• cryptococcosis (infection caused by Cryptococcus), including cryptococcal meningitis (inflammation of the meninges): in immunocompromised patients with cryptococcosis and in all patients with central nervous system cryptococcosis, Sporanox is indicated only when first-line treatment is considered inappropriate or has proven ineffective;
• histoplasmosis (infection caused by Histoplasma)
• sporotrichosis, including lymphocutaneous and cutaneous sporotrichosis (infection caused by Sporothrix)
• paracoccidioidomycosis (infection caused by Paracoccidioides Brasiliensis)
• blastomycosis (infection caused by Blastomyces Dermatitidis)
• other rare systemic mycoses.

2. Cosa deve sapere prima di usare Sporanox capsule

NON usi Sporanox capsule

• Se è allergico (ipersensibile) ad uno qualsiasi degli altri componenti di Sporanox capsule (elencati al paragrafo 6);
• Se è in corso una gravidanza, se sospetta o sta pianificando una gravidanza (vedere paragrafo su “Gravidanza”);
• Se ha problemi al cuore (disfunzione ventricolare), per esempio se ilcuore non riesce a pompare sangue (insufficienza cardiaca congestizia), ameno che il medico non valuti la necessità di trattare infezionipotenzialmente pericolose per la vita o altre gravi infezioni.

Informi il medico se sta assumendo dei medicinali prima di prendere Sporanox
capsule.

• Non prendaSporanox capsule se sta assumendo determinati medicinalioppure entro 2 settimane dall’interruzione di Sporanox capsule. L’elencoseguente contiene esempi di medicinali che non deve assumere conSporanox capsule, nè entro 2 settimane dall’interruzione di Sporanoxcapsule:

Medicinali usati per trattare problemi cardiaci, del sangue o della circolazione

• aliskiren, eplerenone, lercanidipina o nisoldipina (per la pressionesanguigna alta)
• bepridil ivabradina o ranolazina (per l’angina)
• dabigatran o tricagrelor (per i coaguli di sangue)
• disopiramide, dofetilide, dronedarone o chinidina (per il battitocardiaco irregolare)
• finerenone (per problemi renali in pazienti con diabete di tipo 2)
• lomitapide, lovastatina o simvastatina (per abbassare il colesterolo)
• sildenafil (per l’ipertensione arteriosa polmonare)Medicinali per trattare problemi di stomaco o costipazione
• cisapride (per i disturbi di stomaco)
• domperidone (per nausea e vomito)
• naloxegol(perlacostipazionecausatadall’assunzionediantidolorifici oppiacei)Medicinali per trattare mal di testa, problemi di sonno o di salute mentale
• diidroergotamina o ergotamina (alcaloidi dell’ergot usati per i maldi testa da emicrania
• midazolam (per via orale) o triazolam (per sedazione o per aiutarlaa dormire)
• lurasidone, pimozide, quetiapina o sertindolo (per schizofrenia,disturbi bipolari o altri problemi di salute mentale)Medicinali per trattare i problemi urinari
• darifenacina (per l’incontinenza urinaria)
• fesoterodina o solifenacina (per l’irritazione della vescica urinaria)quando utilizzata in pazienti con alcuni problemi renali o epaticiMedicinali per trattare le allergie
• astemizolo, mizolastina o terfenadina (per le allergie)Medicinali per trattare i problemi di erezione ed eiaculazione
• avanafil (per la disfunzione erettile)
• dapoxetina (per l’eiaculazione precoce)
• vardenafil (per la disfunzione erettile) quando usato in uomini di etàsuperiore a 75 anniAltri medicinali contenenti:
• colchicina (per la gotta) quando usata in pazienti con problemirenali o epatici
• ergometrina (ergonovina) o metilergometrina (metilergonovina),alcaloidi dell’ergot usati dopo il parto
• eliglustat (per la malattia di Gaucher) quando usato in pazienti chenon possono scomporre alcuni farmaci nell’organismo
• alofantrina (per la malaria)
• irinotecan (per il tumore)
• isavuconazolo (per infezioni fungine)
• ombitasvir, paritaprevir, ritonavir con o senza dasabuvir (pertrattare l’epatite C)
• venetoclax (per la leucemia linfocitica cronica) quando inizia iltrattamento o quando assume dosi crescenti all’inizio deltrattamento
• voclosporina (per trattare problemi renali associati a lupus)

Nota: non prenda nessuno dei farmaci riportati sopra per 2 settimane dopo il Suo ultimo
trattamento con Sporanox capsule.
Questo non è un elenco completo, pertanto informi il Suo medico se sta assumendo o ha
intenzione di assumere uno qualsiasi di questi medicinali o altri medicinali.
Avvertenze e precauzioni
Si rivolga al medico o al farmacista prima di prendere Sporanox capsule.
Interrompa il trattamento con Sporanox capsule e consulti immediatamente il suo medico qualora
dovessero insorgere sintomi quali:

• rifiuto del cibo (anoressia)
• nausea
• vomito
• debolezza (astenia)
• dolori addominali
• urine scure Se il medico ritiene necessaria l’assunzione di Sporanox capsule, le consiglierà di eseguire regolarmente esami del sangue. Ciò al fine di evidenziare precocemente eventuali problemi al fegato.

Contatti il medico se si verifica la perdita dell’udito e se soffre di acloridria (una malattia che causa
una riduzione dell’acidità dello stomaco).
Contatti immediatamente il medico in caso di:

• respiro corto
• inatteso aumento di peso
• gonfiore alle gambe o all’addome
• stanchezza insolita
• difficoltà a respirare di notte Questi potrebbero essere i sintomi di uno scompenso cardiaco, in tal caso il trattamento deve essere sospeso.
• formicolio
• intorpidimento
• debolezza agli arti
• altri problemi con i nervi delle braccia o delle gambe
• visione sfocata o vista doppia, in caso di ronzio alle orecchie, in caso di perdita di controllo della minzione.

Questi potrebbero essere i sintomi di una malattia nervosa (neuropatia), in tal caso il trattamento
deve essere sospeso.
Informi il medico se ha o ha avuto:

• problemi al fegato: potrebbe rendersi necessario un aggiustamento del dosaggio di Sporanox capsule;
• problemi al cuore;
• problemi ai reni: potrebbe rendersi necessario un aggiustamento del dosaggio di Sporanox capsule;
• fibrosi cistica (una malattia genetica);
• problemi al sistema nervoso periferico (neuropatia);
• neutropenia (riduzione del numero di globuli bianchi nel sangue) o AIDS o se è stato sottoposto ad un trapianto d’organo. Potrebbe rendersi necessario un aggiustamento del dosaggio di Sporanox capsule.

Se è un paziente anziano. Sporanox capsule non deve essere utilizzato nei pazienti anziani, salvo
diversa prescrizione medica.

Altri medicinali e Sporanox capsule
Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe
assumere qualsiasi altro medicinale.
Vi sono alcuni medicinali che non deve prenderese sta assumendo Sporanox capsule. Sono
elencati sopra al paragrafo “ Non usi Sporanox capsule se”:
L’uso di alcuni medicinali non è raccomandato con Sporanox capsule.
Il medico deciderà se Lei non deve prendere alcuni medicinali contemporaneamente a
Sporanox capsule o entro 2 settimane dall’interruzione diSporanox capsule.
Esempi di questi medicinali sono:

Medicinali per trattare problemi cardiaci, del sangue o della circolazione

• apixaban, edoxaban, rivaroxaban o vorapaxar (per i coaguli di sangue)
• atorvastatina (per abbassare il colesterolo)
• felodipina (per la pressione sanguigna alta)
• riociguat o tadalafil (per l’ipertensione polmonare) Medicinali per trattare epilessia, mal di testa o problemi di salute mentale
• fenitoina, carbamazepina o fenobarbital (anti-epilettici)
• eletriptan (per il mal di testa da emicrania)
• erba di San Giovanni (Hypericum perforatum) (un medicinale a base di erbe usato per problemi di salute mentale) Medicinali per trattare i problemi urinari
• tamsulosina (per l’incontinenza urinaria negli uomini)
• tolterodina (per l’irritazione della vescica urinaria) Medicinali per trattare il tumore
• axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, entrectinib, glasdegib, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, talazoparib, trabectedina, trastuzumab emtansina, venetoclax (quando sta assumendo una dose stabile di venetoclax per il trattamento della leucemia linfocitica cronica, o in qualsiasi momento del trattamento per leucemia mieloide acuta) o alcaloidi della vinca (ad es. vinflunina, vinorelbina) Medicinali per trattare la tubercolosi
• bedaquilina, isoniazid, rifabutina o rifampicina (per la tubercolosi)

Medicinali per trattare il virus da immunodeficienza umana (HIV) o l’epatite

• efavirenz o nevirapina (per HIV/AIDS),
• elbasvir/grazoprevir, tenofovir alafenamide fumarato (TAF), tenofovir disoproxil fumarato (TDF) (per HIV o epatite) Medicinali usati dopo il trapianto di organi
• everolimus, rapamicina (nota anche come sirolimus), temsirolimus Medicinali per trattare l’ipertrofia prostatica benigna
• alfuzosina, silodosina Medicinaliper trattare i problemi polmonari o le allergie
• ciclesonide (per infiammazione, asma e allergie)
• ebastina (per le allergie)
• salmeterolo (per asma o broncopneumopatia cronica ostruttiva - BPCO) Medicinali per trattare i problemi di erezione ed eiaculazione
• tadalafil o vardenafil (quando usato negli uomini di età pari o inferiore a 75 anni) (per la disfunzione erettile) Altri medicinali contenenti:
• colchicina (per la gotta)
• fentanil (per il dolore)
• lumacaftor/ivacaftor (per la fibrosi cistica) Nota: non prenda alcuno dei medicinali riportati sopra per le 2 settimane successive al Suoultimo trattamento con Sporanox capsule.Non si tratta di un elenco completo, quindi informi il Suo medico se sta assumendo o prevede di assumere uno di questi medicinali o qualsiasi altro medicinale.

Quando si assume Sporanox capsule con certi altri medicinali è necessario usare cautela
Lei potrebbe essere più incline ad incorrere in effetti indesiderati oppure potrebbe
essere necessario modificare la dose di Sporanox capsule o dell’altro medicinale. Esempi di questi
medicinali sono:

Medicinali per trattare problemi cardiaci, del sangue o della circolazione

• bosentan (per l’ipertensione polmonare)
• bloccanti del canale del calcio come diidropiridine, ad es. amlodipina, isradipina, nifedipina, nimodipina o diltiazem (per l’ipertensione)
• o verapamil (per la pressione sanguigna alta)
• cilostazolo (per problemi circolatori)
• coumarinici come warfarin (per i coaguli di sangue)
• digossina (per la fibrillazione atriale)
• nadololo (per l’ipertensione polmonare o l’angina) Medicinali per trattare problemi di stomaco o diarrea
• aprepitant o netupitant (per nausea e vomito durante il trattamento oncologico)
• loperamide (per la diarrea)
• antiacidi come alluminio, calcio, magnesio o bicarbonato di sodio, antagonisti del recettore H2 come cimetidina, ranitidina e inibitori della pompa protonica come lansoprazolo, omeprazolo, rabeprazolo (per trattare i problemi di acidità di stomaco) Medicinali per trattare i problemi di sonno o di salute mentale
• alprazolam, brotizolam, buspirone o midazolam (quando iniettato in vena) (per l’ansia o favorire il sonno)
• zopiclone (per favorire il sonno)
• reboxetina o venlafaxina (per depressione e ansia)
• ariprazolo, cariprazina, aloperidolo o risperidone (per schizofrenia, disturbo bipolare o altri problemi di salute mentale)
• galantamina (per la malattia di Alzheimer)
• guanfacina (per problemi di iperattività e deficit di attenzione)

Medicines to treat urinary problems

• imidafenacine, fesoterodine, oxybutynin, solifenacin (for urinary bladder irritation) Medicines to treat tumors
• 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 trematodes and tapeworm) Medicines to treat human immunodeficiency virus (HIV) or hepatitis
• cobicistat, boosted elvitegravir, maraviroc, ritonavir, darunavir boosted with ritonavir, fosamprenavir boosted with ritonavir, indinavir or saquinavir (for HIV)
• glecaprevir/pibrentasvir (for hepatitis) Medicines used after organ transplantation
• cyclosporine or tacrolimus Medicines to treat benign prostatic hyperplasia
• dutasteride Medicines to treat lung problems, allergies or inflammatory conditions
• bilastine or rupatadine (for allergies)
• methylprednisolone or dexamethasone (medicines administered orally or by injection for asthma, allergies or inflammatory conditions)
• budesonide or fluticasone (for asthma, allergies) Medicines to treat erectile 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 (administered orally) (for eczema)
• cabergoline (for Parkinson's disease)
• cannabis-based products, including medicinal products (such as those for nausea and vomiting or for muscle spasms in patients with multiple sclerosis)
• cinacalcet (for hyperparathyroidism)
• dienogest or ulipristal (contraceptives)
• eliglustat (for Gaucher's disease) when used in patients who are unable to 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 medicines or any other medicine.
Taking some medicines at the same time as Sporanox capsules may be harmful or may change the activity of Sporanox capsules.
The absorption of Sporanox capsules into the body occurs in the presence of sufficient acidity in the stomach. For this reason, medicines that neutralize stomach acidity (antacids) must be taken at least 1 hour before taking Sporanox capsules or must not be taken for at least 2 hours after taking Sporanox capsules.
For the same reason, if you are using medicines that inhibit the production of acid in the stomach, it is advisable to take Sporanox capsules with a cola-containing beverage.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Sporanox capsules are contraindicated in pregnancy unless the doctor assesses the need to treat infections potentially dangerous to life, where the expected benefit for the mother is greater than the potential risk to the fetus.

Breastfeeding
Avoid breastfeeding during treatment with Sporanox capsules, as small amounts of the medicine may pass into breast milk, unless the doctor assesses the potential risk in relation to the expected benefit.

Fertility
If you are a woman of childbearing potential and could become pregnant, talk to your doctor. You should use effective contraceptive measures to be sure you do not become pregnant during treatment with your medicine.
Consult your doctor if you have started therapy with Sporanox capsules without adopting adequate contraceptive measures.

Driving and operating machinery
When driving vehicles and operating machinery, the possibility that Sporanox capsules may cause dizziness, visual disturbances and hearing loss must be taken into consideration (see section Possible side effects).

Sporanox capsules contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to use Sporanox capsules

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Take Sporanox capsules immediately after one of the main meals, to ensure optimal absorption. Please note that:

• The capsule should not be opened and must be swallowed whole.
• The dose to be taken varies according to the infection to be treated.

Always carefully follow your doctor's instructions, who may adjust the treatment to your needs from time to time.

Treatment of superficial fungal infections

In skin infections, lesions disappear completely only 2-4 weeks after the end of treatment.
In onychomycosis (nail infections) it is necessary to wait for the regrowth of the nails, which occurs 6 to 9 months after the end of treatment.

Treatment of systemic fungal infections (infections of internal organs).

If you take more Sporanox capsules than you should
In case of accidental ingestion/intake of an excessive dose of Sporanox capsules, immediately inform your doctor or go to the nearest hospital.
In case of overdose, you may experience the side effects described in paragraph 4.

4. Possible side effects

Like all medicines, Sporanox capsules can cause side effects, although not everybody gets them.
The most commonly reported side effects during treatment with Sporanox capsules
reported are:

• Headache
• Abdominal pain
• Nausea. The more serious side effects are:
• Severe allergic reactions
• Heart failure and congestive heart failure (heart problems)
• Pulmonary edema (swelling due to fluid retention in the lungs)
• Pancreatitis (inflammation of the pancreas)
• Severe hepatotoxicity (harmful effect on the liver), including some cases of acute fatal hepatic failure (liver problems)
• Severe skin reactions.

Below are other side effects detected during clinical studies.

Common side effects (may affect up to 1 in 10 people) include:

• Headache
• Abdominal pain
• Nausea

Uncommon side effects (may affect up to 1 in 100 people) include:

• Sinusitis (inflammation of the paranasal mucous membranes)
• Upper respiratory tract infection
• Rhinitis (nasal congestion)
• Allergy (Hypersensitivity)*
• Dysgeusia (altered taste)
• Paresthesia (altered sensitivity of the limbs or other parts of the body)
• Confusion
• Diarrhea
• Vomiting
• Constipation
• Dyspepsia (difficult digestion)
• Flatulence (presence of gas in the stomach or intestines)
• Abnormal liver function
• Hyperbilirubinemia (increased bilirubin in the blood which can cause jaundice)
• Urticaria (Hives)
• Rash
• Pruritus (Itching)
• Alopecia (Hair loss)
• Menstrual disorders
• Edema (swelling)

Rare side effects (may affect up to 1 in 1,000 people) include:

• Leukopenia (decreased white blood cells)
• Serum sickness (allergy-like reaction)
• Angioedema (swelling of the face, mouth, lips and/or tongue)
• Anaphylactic reaction (severe allergic reaction)
• Hypertriglyceridemia (high concentration of triglycerides in the blood)
• Tremor
• Hypoesthesia (reduction of sensitivity and response to a given stimulus)
• Visual disturbances, including diplopia (double vision) and blurred vision
• Transient or permanent hearing loss*
• Tinnitus (ringing in the ears)
• Congestive heart failure (heart problems)*
• Dyspnea (difficulty breathing)
• Pancreatitis (inflammation of the pancreas)
• Severe hepatotoxicity (harmful effect on the liver), including some cases of acute fatal hepatic failure*
• Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) (Severe reaction of the skin and/or mucous membranes induced by the drug)
• Acute generalized exanthematous pustulosis (AGEP) (Sudden rash that manifests with the presence of pustules)
• Erythema multiforme (inflammation of blood vessels that causes allergic reaction)
• Exfoliative dermatitis (severe and widespread skin irritation that causes scaling of the skin)
• Leucocytoclastic vasculitis (inflammation of small blood vessels)
• Photosensitivity (abnormal and excessive reactivity of the skin to solar or artificial irradiation)
• Pollachiuria (frequent urination of small amounts of urine)
• Erectile dysfunction
• Fever
• Increased blood creatine phosphokinase (an enzyme present in the blood)

Side effects of unknown frequency (frequency cannot be estimated on the basis of the available data)
include:

• Symptoms from increased levels of the hormone "aldosterone" (such as increased blood pressure or reduced potassium levels in the blood), even if the level of "aldosterone" in the blood is normal or low.

*see paragraph “Warnings and precautions”
The following list of ADRs associated with itraconazole that have been reported in clinical studies
with SPORANOX oral solution and SPORANOX ev, excluding the term
“Inflammation at the injection site”, which is specific to the injectable route of administration.

Hematopoietic system disorders:granulocytopenia, thrombocytopenia

Immune system disorders:anaphylactoid reaction

Metabolism and nutrition disorders:hyperglycemia, hyperkalemia, hypokalemia,
hypomagnesemia

Psychiatric disorders:confusion

Nervous system disorders:peripheral neuropathy*, dizziness, drowsiness

Cardiac disorders:heart failure, left ventricular failure, tachycardia

Vascular disorders:hypertension, hypotension

Respiratory, thoracic and mediastinal disorders:pulmonary edema, dysphonia, cough, chest
pain

Gastrointestinal disorders:gastrointestinal disorders

Hepatobiliary disorders:hepatic failure*, hepatitis, jaundice

Skin and subcutaneous tissue disorders:erythematous rash, hyperhidrosis

Musculoskeletal and connective tissue disorders:myalgia, arthralgia

Renal and urinary disorders:renal failure, urinary incontinence

Systemic disorders and conditions related to the site of administration:generalized edema, facial edema, fever, pain, fatigue, chills

Diagnostic tests:increased levels of alanine aminotransferase, increased levels of
aspartate aminotransferase, increases in blood alkaline phosphatase levels, increased levels
of lactate dehydrogenase in the blood, increased blood urea levels, increased levels of
gamma-glutamyltransferase, increased liver enzymes, abnormal urine analysis.

Pediatric population
Based on safety data from clinical studies, the most
commonly reported side effects in pediatric patients are:

• Headache
• Vomiting
• Abdominal pain
• Diarrhea
• Abnormal liver function
• Hypotension (low blood pressure)
• Nausea
• Urticaria (Hives) In general, the side effects reported in pediatric patients are similar to those observed in adult subjects, but the frequency is higher in pediatric patients. Some cases of cardiac arrest have also been reported.

Side effects detected during the marketing of Sporanox capsules, whose
frequency is unknown

• Serum sickness (allergy-like reaction)
• Angioedema (swelling of the face, mouth, lips and/or tongue)
• Anaphylactic reaction (severe allergic reaction)
• Hypertriglyceridemia (increased triglycerides in the blood)
• Visual disturbances, including diplopia (double vision) and blurred vision
• Transient or permanent hearing loss
• Congestive heart failure (heart problems)
• Dyspnea (difficulty breathing)
• Pancreatitis (inflammation of the pancreas)
• Severe hepatotoxicity (harmful effect on the liver), including some cases of acute fatal hepatic failure
• Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) (severe reaction of the skin and/or mucous membranes induced by the drug)
• Acute generalized exanthematous pustulosis (AGEP) (sudden rash that manifests with the presence of pustules)
• Erythema multiforme (inflammation of blood vessels that causes allergic reaction)
• Exfoliative dermatitis (severe and widespread skin irritation that causes scaling of the skin)
• Leucocytoclastic vasculitis (inflammation of small blood vessels)
• Alopecia (hair loss)
• Photosensitivity (abnormal and excessive reactivity of the skin to solar or artificial irradiation)
• Increased blood creatine phosphokinase (an enzyme present in the blood)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Sporanox capsules

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is stated on the packaging after the
word Exp. The expiry date refers to the last day of that month. The expiry date
refers to the product in intact packaging, correctly stored.
Store at a temperature below 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sporanox capsules contain
The active ingredient is itraconazole. One capsule contains 100 mg of itraconazole.
The other ingredients are sugary granules as a support (composed of corn starch, purified water and sucrose), hypromellose, macrogol.
Capsule constituents: gelatin, titanium dioxide (E171), erythrosine (E127), indigotine (E132).

Description of the appearance of Sporanox capsules and contents of the pack
8 hard capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Janssen-Cilag SpA
Viale Fulvio Testi, 280/6
20126 Milano MI

Manufacturer
Janssen-Cilag SpA
Via C. Janssen - Latina