Itraconazole Stada 100 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Itraconazole Stada 100 mg hard capsules EFG

Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Itraconazole Stada is and what it is used for.
2. What you need to know before taking Itraconazole Stada.
3. How to take Itraconazole Stada.
4. Possible adverse effects.
5. How to store Itraconazole Stada.
6. Contents of the pack and other information.

1. What Itraconazol Stada is and what it is used for

Itraconazol Stada belongs to a group of medicines called "antifungals".

It is indicated for the treatment of fungal infections of the vagina, skin, mouth, eyes, nails, or internal organs.

2. What you need to know before starting Itraconazol Stada

Do not take Itraconazol Stada

• if you are allergic to itraconazole or to any of the other ingredients of this medicine (listed in section 6, “Contents of the pack and other information”).
• if you have a condition called heart failure (also known as congestive heart failure or CHF). This medicine could worsen it.

If your doctor decides you should take this medicine, contact him or her immediately if you experience shortness of breath, unexpected weight gain, swelling in the legs, unusual fatigue, or start waking up at night.

• if you are pregnant, think you might be pregnant, or could become pregnant (see pregnancy section), your doctor will assess whether you should take this medicine.
• if you are of childbearing potential, you must use adequate contraceptive measures to avoid pregnancy during treatment. Because this medicine may remain in the body for some time, you should continue contraceptive measures until your next menstrual period after completing treatment with this medicine.
• itraconazole capsules cannot be used together with certain medicines. Many medicines interact with itraconazole capsules; see section “Taking other medicines and Itraconazol Stada” and the list below.

Before taking itraconazole capsules, inform your doctor if you are taking any medicine.

Do not use itraconazole 100 mg capsules if you are taking any of the following medicines, or within 2 weeks after stopping Itraconazol:

Medicines used to treat heart, blood, or circulation problems

• aliskiren, eplerenone, lercanidipine, or nisoldipine (for hypertension)
• 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)
• sildenafil (for pulmonary arterial hypertension)

Medicines to treat stomach problems or constipation

• cisapride (for stomach disorders)
• 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 migraines)
• midazolam (oral) or triazolam (for sedation or sleep induction)
• lurasidone, pimozide, quetiapine, or sertindole (for schizophrenia, bipolar disorder, or other mental health disorders)

Medications for treating urinary problems

• darifenacin (for urinary incontinence)
• fesoterodine or solifenacin (for overactive bladder) when used in patients with certain renal or hepatic impairments

Medicines for treating allergies

• astemizole, mizolastine, or terfenadine (for allergies)

Medications for treating erectile and ejaculation problems

• avanafil (for erectile dysfunction)
• dapoxetine (for premature ejaculation)
• vardenafil (for erectile dysfunction) when used in males over 75 years of age

Other medicines that contain:

• colchicine (for gout) when used in patients with renal or hepatic problems
• ergometrine (ergonovine) or methylergometrine (methylergonovine), ergot alkaloids used after childbirth
• eliglustat (for Gaucher disease) when used in patients who cannot metabolize certain drugs in the body
• halofantrine (for malaria)
• irinotecan (for cancer)
• isavuconazole (for fungal infections)
• ombitasvir, paritaprevir, ritonavir with or without dasabuvir (for the treatment of hepatitis C)

Remember: do not take any of the above medicines during the 2 weeks following your last treatment with itraconazole capsules.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take itraconazol:

• if you have heart problems, consult your doctor. Inform your doctor immediately if you develop shortness of breath, unexpected weight gain, swelling of the legs, unusual fatigue, or insomnia, as these may be symptoms of heart failure.

• if you have any liver problems. The dose of this medicine may need to be adjusted. If any of the following symptoms occur during treatment with this medicine, stop taking it and consult your doctor immediately: loss of appetite, nausea, vomiting, fatigue, abdominal pain, jaundice (yellowing of the skin, eyes, mucous membranes, and secretions), very dark urine, or pale stools. If you are undergoing treatment with itraconazole capsules, your doctor may regularly order blood tests, as liver disorders have occurred in very rare cases.

• if you have any kidney problems, consult your doctor. The dose of this medicine may need to be adjusted.

• consult your doctor or seek immediate medical attention if, while taking itraconazole capsules, you experience a severe allergic reaction (characterized by severe skin rash, itching, hives, difficulty breathing, and/or swelling of the face).

• stop taking this medicine and consult your doctor immediately if you become overly sensitive to sunlight.

• stop taking itraconazole capsules and consult your doctor immediately if you develop a serious skin disorder, such as a widespread rash with skin peeling and blisters in the mouth, eyes, and genitals, or a rash with small pustules or blisters.

• contact your doctor if you have neutropenia, AIDS, or have received an organ transplant. The dose of this medicine may need to be adjusted.

• if you have previously experienced an allergic reaction to itraconazole capsules or to another medicine used to treat fungal infections (medicines known as azoles), consult your doctor. A hypersensitivity reaction may be recognized, for example, by the appearance of skin rash, itching, hives, shortness of breath, or difficulty breathing, and/or facial swelling. If you experience a severe allergic reaction, consult your doctor immediately.

• if you have cystic fibrosis, consult your doctor before taking itraconazole capsules.

• stop taking itraconazole capsules and consult your doctor immediately if you experience tingling, numbness, reduced sensation, or weakness in the limbs or other nerve problems in the arms and legs (neuropathy).

• stop taking this medicine and contact your doctor immediately if you experience hearing problems. In very rare cases, temporary or permanent hearing loss has occurred.

• inform your doctor if your vision becomes blurred or you see double, if you hear ringing in your ears, if you lose control of your urine, or if you urinate much more than usual.

• the use of this medicine is not recommended in elderly patients. It may be prescribed by a doctor only in exceptional cases.

Other medicines and itraconazol stada

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

There are medicines that must not be taken while you are taking itraconazole. These medicines are listed above under the heading "Do not use Itraconazol 100 mg capsules".

The use of certain medicines with Itraconazole 100 mg capsules is not recommended.

Your doctor may decide that you should not take certain medicines at the same time as itraconazole capsules or within the 2 weeks following the end of treatment.

Examples of these medicines are:

Medicines to treat heart, blood, or circulation problems

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

Medicines for treating epilepsy, headaches, or mental health conditions

• phenytoin, carbamazepine, or phenobarbital (antiepileptics)
• eletriptan (for migraines)
• St. John’s wort (Hypericum perforatum) (a herbal medicine used for mental health conditions)

Medicines for treating urinary problems

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

Medicines for treating cancer

• axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, trabectedin, trastuzumab emtansine, 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, simeprevir, 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 for treating benign enlargement of the prostate

• alfuzosin, silodosin

Medications for treating lung problems or allergies

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

Medications for treating erection and ejaculation problems

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

Other 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 itraconazole capsules.

This list is not complete, so you must inform your doctor if you are taking or plan to take any of these medicines or any other medicine.

Caution is required when using itraconazole 100 mg capsules with certain medicines. You may be more likely to experience adverse effects, or it may be necessary to adjust the dose of itraconazole capsules or the other medicine. Examples of these medicines are:

Medicines to treat heart, blood, or circulation problems

• bosentan (for pulmonary hypertension)
• calcium channel blockers such as dihydropyridines, including amlodipine, isradipine, nifedipine, nimodipine, or diltiazem (for hypertension)
• or verapamil (for hypertension)
• cilostazol (for circulation problems)
• "coumarins" such as warfarin (for blood clots)
• digoxin (for atrial fibrillation)
• nadolol (for pulmonary hypertension or 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; H2-receptor antagonists such as cimetidine, ranitidine; and proton pump inhibitors such as lansoprazole, omeprazole, rabeprazole (to treat stomach acid problems)

Medicines for treating sleep or mental health disorders

• alprazolam, brotizolam, buspirone, or midazolam (when injected into a vein) (for anxiety or sleep induction)
• zopiclone (for sleep induction)
• 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 treating urinary 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 infections

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

Medicines for treating human immunodeficiency virus (HIV) or hepatitis

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

Medicines used after an organ transplant

• cyclosporine or tacrolimus

Medicines for treating benign enlargement of the prostate

• dutasteride

Medications for treating pulmonary problems, allergies, or inflammatory conditions

• bilastine, or rupatadine (for allergies)
• methylprednisolone or dexamethasone (oral or injectable medications for asthma, allergies, or inflammatory conditions)
• budesonide or fluticasone (for asthma, allergies)

Medications for treating erectile and ejaculation problems

• sildenafil (for erectile dysfunction)

Medications for treating pain

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

Other medicines that contain:

• alitretinoin (administered orally) (for eczema)
• cabergoline (for Parkinson's disease)
• cannabis-based products, including medicines (for nausea and vomiting or muscle spasms in patients with multiple sclerosis)
• cinacalcet (for excessive parathyroid activity)
• dienogest or ulipristal (contraceptives)
• eliglustat (for Gaucher disease) when used in patients who cannot break down certain drugs in the body
• ivacaftor (for cystic fibrosis)
• methadone (for treating drug addiction)
• repaglinide or saxagliptin (for diabetes)

This list is not exhaustive, so you must inform your doctor if you are taking or plan to take any of these medicines, or any other medicine, so that appropriate measures can be taken.

There must be sufficient stomach acidity to ensure absorption of itraconazole capsules. Therefore, medicines that neutralize stomach acid should be taken at least two hours before taking itraconazole capsules, or at least two hours after taking this medicine. For the same reason, if you are taking medicines that regulate stomach acid production, take itraconazole capsules together with a cola drink (see section 3 “How to take Itraconazol Stada”).

If in doubt, consult your doctor or pharmacist.

Taking Itraconazol Stada with food, drinks and alcohol

Take this medicine immediately after completing one of your main meals.

If you are taking any medicine that regulates stomach acid production, it is recommended to take this medicine together with a cola drink.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Itraconazole must not be used during pregnancy.

Breastfeeding

If you are breastfeeding, consult your doctor before taking itraconazole, as small amounts of the medicine may pass into breast milk.

Fertility

If you are of childbearing age and could become pregnant, consult your doctor. You must use effective contraception to ensure you do not become pregnant while taking this medicine. Because itraconazole capsules may remain in the body for some time, you should continue contraceptive measures until your next menstrual period after completing treatment with this medicine (see section 2 “Do not take Itraconazol Stada”).

Driving and use of machines

Itraconazole may sometimes cause dizziness, blurred/double vision or hearing loss. If you experience any of these symptoms, do not drive or operate machinery.

Itraconazol Stada contains sucrose

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Itraconazol Stada

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will tell you how long to take this medicine. Do not stop treatment early.

If you think the effect of the medicine is too strong or too weak, inform your doctor or pharmacist.

You should take itraconazol capsules immediately after meals, as this improves absorption. Swallow the capsules whole with a little water. The number of capsules you need to take and the duration of treatment depend on the type of fungus and the location of the infection. Your doctor will tell you exactly how many itraconazol capsules to take.

There must be sufficient stomach acidity to ensure proper absorption of this medicine. Therefore, medicines that neutralize stomach acidity should be taken either two hours after taking this medicine or two hours before taking itraconazol capsules. For the same reason, if you are taking medicines that regulate acid production in the stomach, take itraconazol capsules with a cola drink.

The following doses are the most common:

Type of infection	Capsules per day	Duration
Vaginal infection	2 capsules twice a day or 2 capsules once a day	1 day 3 days
Skin infection	2 capsules once a day or 1 capsule once a day	7 days 2 weeks
If palms of hands or soles of feet are affected, 2 capsules twice a day for 7 days or 1 capsule once a day for 1 month may be required.
Oral infections	1 capsule once a day	2 weeks
Eye infections	2 capsules once a day	3 weeks
Internal infections	1 to 4 capsules daily	longer periods

• Nail infections: depending on your individual needs, your doctor will choose a continuous or pulsed treatment.

• Continuous treatment for toenail infections:

Type of infection	Capsules per day	Duration
Continuous treatment for nails	2 capsules once daily	3 months

• Pulsed therapy for nails:

Consists of 2 capsules twice daily for 1 week; then stop taking itraconazole capsules for 3 weeks. The cycle is then repeated, once for fingernails and twice for toenails (with or without infection in the fingernails). (See the following table)

	Week 1	Week 2	Week 3	Week 4	Week 5	Week 6	Week 7	Week 8	Week 9	Week 10
Toenails, with or without fingernail involvement	Take 2 capsules twice daily	No itraconazole treatment	Take 2 capsules twice daily	No itraconazole treatment	Take 2 capsules twice daily	Interrupt treatment	Interrupt treatment	Interrupt treatment	Interrupt treatment	Interrupt treatment
Fingernails only	Take 2 capsules twice daily	No itraconazole treatment	Take 2 capsules twice daily	Interrupt treatment	Interrupt treatment	Interrupt treatment	Interrupt treatment	Interrupt treatment	Interrupt treatment	Interrupt treatment

In skin infections, lesions will disappear a few weeks after completing treatment. This is characteristic of fungal spots: the medicine eliminates the fungus itself, but the lesion does not disappear until new skin grows.

Nail lesions will disappear 6 to 9 months after completing treatment, as the medicine only eliminates the fungus itself. The nail must regrow, which takes several months. Therefore, do not be concerned if you do not notice improvement during treatment: the medicine remains in your nails for several months and fulfills its purpose. Thus, you must stop treatment at the time indicated by your doctor, even if you do not see any improvement.

• Internal organ infections: Higher doses for prolonged periods may be required. Always follow your doctor's instructions; he or she will adapt the treatment to your needs.

Use in children

Itraconazol should not be used in children. Only in exceptional cases may it be prescribed by a doctor.

If you take more Itraconazol Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, Telephone: 91 562 04 20, stating the medication and amount ingested. It is recommended to bring the medication package and leaflet to the healthcare professional.

In case of accidental overdose, your doctor will apply supportive measures. Itraconazol is not removed by hemodialysis. Specific antidotes are not known.

If you forget to take Itraconazol Stada

Do not take a double dose to make up for forgotten doses.

If you forget to take the medication, take the next scheduled dose and continue treatment as directed by your doctor.

If you stop treatment with Itraconazol Stada

Do not interrupt treatment with itraconazol without consulting your doctor, as symptoms of your illness may reappear or worsen.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, itraconazole can cause adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

The following are adverse reactions reported during clinical trials and post-marketing experience with the medicine.

Adverse reactions are classified by frequency according to the following convention:

Very common: may affect more than 1 in 10 people
Common: may affect between 1 and 10 in 100 people
Uncommon: may affect between 1 and 10 in 1,000 people
Rare: may affect between 1 and 10 in 10,000 people
Very rare: may affect fewer than 1 in 10,000 people
Frequency not known: cannot be estimated from available data

• Infections and infestations

Uncommon: sinusitis (irritation and swelling of the nasal sinuses), upper respiratory tract infection, rhinitis (inflammation of the nasal mucosa causing watery mucus discharge and frequent sneezing)

• Blood and lymphatic system disorders

Rare: leukopenia

• Immune system disorders

Uncommon: hypersensitivity and allergic reactions
Rare: anaphylactic reactions (allergic), serum sickness (an allergic reaction occurring after injection of certain sera, characterized by hives, fluid accumulation, joint pain, fever, and extreme exhaustion), angioneurotic edema (fluid accumulation causing swelling that may affect the mouth and upper airways)

• Metabolism and nutrition disorders

Rare: increased triglycerides

• Nervous system disorders

Common: headache
Rare: tremor, tingling sensation in the limbs (paresthesia), reduced sensation (hypoesthesia), unpleasant taste (dysgeusia)

• Eye disorders

Rare: visual disturbances (including blurred vision and double vision)

• Ear and labyrinth disorders

Rare: permanent or transient hearing loss, subjective sensation of ringing in the ears (tinnitus)

• Cardiac disorders

Rare: congestive heart failure

• Respiratory, thoracic and mediastinal disorders

Rare: shortness of breath, difficulty breathing (dyspnea)

• Gastrointestinal disorders

Common: abdominal pain, nausea
Uncommon: vomiting, discomfort associated with meals, diarrhea and constipation, intestinal gas accumulation (flatulence)
Rare: pancreatitis (inflammation of the pancreas)

• Hepatobiliary disorders

Uncommon: abnormal liver function
Rare: elevated blood bilirubin levels (hyperbilirubinemia), severe hepatotoxicity (including cases of very severe acute liver failure)

• Skin and subcutaneous tissue disorders

Uncommon: urticaria, rash, itching
Rare: toxic epidermal necrolysis (a serious skin condition characterized by rash, blisters, and skin peeling), Stevens-Johnson syndrome (severe erythema of the skin, mucous membranes, and eyes), a serious skin disorder (widespread rash with skin peeling and blisters in the mouth, eyes, and genitals, or rash with small pustules or blisters), erythema multiforme (a skin disease characterized by vesicles, blisters, etc.), exfoliative dermatitis (skin condition characterized by skin peeling), leukocytoclastic vasculitis (inflammation of blood vessel walls), alopecia (hair loss), photosensitivity (exaggerated skin response to sunlight)

• Renal and urinary disorders

Rare: increased frequency of urination

• Reproductive system and breast disorders

Uncommon: menstrual disorders
Rare: erectile dysfunction

• General disorders and administration site conditions

Rare: edema (fluid accumulation)

• Investigations

Rare: increased blood creatine phosphokinase (a parameter measuring liver function)

Description of certain adverse effects

The following adverse effects associated with itraconazole have been reported in clinical trials of oral and/or intravenous itraconazole solution, excluding the adverse effect "injection site inflammation," which is specific to the injectable route of administration.

Blood and lymphatic system disorders: granulocytopenia, thrombocytopenia (decrease in certain blood cells)

Immune system disorders: anaphylactoid reaction

Metabolism and nutrition disorders: hyperglycemia (increased blood sugar), hyperkalemia (increased blood potassium), hypokalemia (decreased blood potassium), hypomagnesemia (decreased blood magnesium)

Psychiatric disorders: feeling of confusion or disorientation

Nervous system disorders: peripheral neuropathy (peripheral nerve involvement with tingling, numbness, or weakness in the limbs), dizziness, somnolence

Cardiac disorders: heart failure, left ventricular failure, tachycardia (rapid heart rate)

Vascular disorders: high blood pressure (hypertension), low blood pressure (hypotension)

Respiratory, thoracic and mediastinal disorders: pulmonary edema, hoarseness, cough

Gastrointestinal disorders: gastrointestinal disorder

Hepatobiliary disorders: liver failure, hepatitis, jaundice (yellowing of the skin, eyes, mucous membranes, and secretions)

Skin and subcutaneous tissue disorders: red skin rash (erythematous exanthema), excessive sweating

Musculoskeletal and connective tissue disorders: muscle pain or weakness (myalgia), joint pain (arthralgia)

Renal and urinary disorders: renal failure, urinary incontinence (urine leakage)

General disorders and administration site conditions: excessive fluid accumulation in body tissues (generalized edema), fluid accumulation in the face (facial edema), chest pain, fever, pain, fatigue, chills

Investigations: increased alanine aminotransferase, increased aspartate aminotransferase, increased alkaline phosphatase in blood, increased lactate dehydrogenase in blood, increased blood urea, increased gamma-glutamyltransferase, increased liver enzymes, abnormal urine analysis

Adverse effects in the pediatric population

Based on clinical trial data in pediatric patients, the most frequently reported adverse effects were: headache, vomiting, abdominal pain, diarrhea, abnormal liver function, low blood pressure, nausea, and urticaria.

In general, the nature of the adverse effects is similar to that observed in adult patients, although the incidence is higher in pediatric patients.

If you experience any of these adverse effects, consult your doctor.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Itraconazole Stada

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Itraconazole STADA

Itraconazole STADA is presented in the form of hard gelatin capsules containing microgranules.

• The active substance is itraconazole. Each capsule contains 100 mg of itraconazole.
• The other components are:

Capsule contents: sugar spheres (corn starch and sucrose), poloxamer 188 and hypromellose 6 cP.

Capsule coating: indigo carmine (E 132), quinoline yellow (E 104), titanium dioxide (E 171) and gelatin.

Appearance of the product and pack contents

The product is available in blister packs containing 6, 7, 14, 18 or 100 capsules, with the largest pack size intended for hospital use.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, No. 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the most recent review of this package leaflet: May 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.