Itraconazole Alter 100 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Itraconazol Alter 100 mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because 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 must not be given to other people, 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 such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Itraconazol Alter 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 taking Itraconazol Alter

Do not take Itraconazol Alter 100 mg capsules

• if you are allergic to itraconazole or to any of the other ingredients of this medicine (listed in section 6).
• 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 them immediately if you experience shortness of breath, unexpected weight gain, swollen legs, unusual fatigue, or begin 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 age, you must use adequate contraceptive measures to avoid becoming pregnant 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.

• Itraconazol Alter cannot be used together with certain medicines. Many medicines interact with Itraconazol Alter; see section “Other medicines and Itraconazol Alter” and the list below.

Before taking Itraconazol Alter, inform your doctor if you are taking any medicine.

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

Medicines used to treat 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)
• 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 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)

Medicines to treat urinary problems

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

Medicines to treat allergies

• astemizole, mizolastine, or terfenadine (for allergies)

Medicines to treat erectile dysfunction and premature ejaculation

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

Other medicines containing:

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

Remember: do not take any of the above medicines within 2 weeks after your last dose of Itraconazol Alter.

Warnings and precautions

Take special care with Itraconazol Alter

• if you have heart problems, consult your doctor. Inform your doctor immediately if you develop difficulty breathing, unexpected weight gain, leg swelling, unusual fatigue, or insomnia, as these may be symptoms of heart failure.
• if you have liver problems. The dose of this medicine may need to be adjusted. If any of the following symptoms occur during treatment, stop taking the medicine and contact your doctor immediately: loss of appetite, nausea, vomiting, fatigue, abdominal pain, jaundice (yellowing of the skin, eyes, mucous membranes, and secretions), dark urine, or pale stools. If you are undergoing treatment with itraconazole, your doctor may regularly order blood tests, as liver disorders, although very rare, have been reported.
• if you have 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, you experience a severe allergic reaction (characterized by severe skin rash, itching, hives, difficulty breathing, and/or facial swelling).
• stop taking this medicine and contact your doctor immediately if you become overly sensitive to sunlight.
• stop taking itraconazole and contact your doctor immediately if you develop a serious skin disorder, such as widespread rash with skin peeling and blisters in the mouth, eyes, or 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 had an allergic reaction to itraconazole or to another medicine used to treat fungal infections (medicines known as azoles), consult your doctor. A hypersensitivity reaction may present, for example, as skin rash, itching, hives, shortness of breath, or difficulty breathing, and/or facial swelling. If you experience a severe allergic reaction, contact your doctor immediately.
• if you have cystic fibrosis, consult your doctor before taking itraconazole.
• stop taking itraconazole and contact 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 more than usual.
• this medicine is not recommended for elderly patients. It may only be prescribed by a doctor in exceptional cases.

Other medicines and Itraconazol Alter

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine, including those obtained without a prescription.

There are medicines that you must not take while taking Itraconazol Alter. These medicines are listed above under the heading “Do not use Itraconazol Alter”.

Use of certain medicines with Itraconazol Alter is not recommended

Your doctor may decide that you should not take certain medicines at the same time as Itraconazol Alter or within 2 weeks after stopping it.

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 to treat epilepsy, headaches, or mental health problems

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

Medicines to treat urinary problems

• tamsulosin (for male urinary incontinence)
• tolterodine (for 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 (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 to treat benign enlargement of the prostate

• alfuzosin, silodosin

Medicines to treat lung problems or allergies

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

Medicines to treat erectile dysfunction and premature ejaculation

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

Other medicines containing:

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

Remember: do not take any of the above medicines within 2 weeks after your last dose of Itraconazol Alter.

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 Itraconazol Alter 100 mg with certain medicines.

You may be more likely to experience adverse effects, or the dose of Itraconazol Alter or the other medicine may need to be adjusted. 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 high blood pressure)
• verapamil (for high blood pressure)
• cilostazol (for circulatory problems)
• “coumarins” such as warfarin (for blood clots)
• digoxin (for atrial fibrillation)
• nadolol (for pulmonary hypertension or angina)

Medicines to treat stomach problems or diarrhea

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

Medicines to treat sleep or mental health disorders

• alprazolam, brotizolam, buspirone, or midazolam (when injected intravenously) (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 to treat urinary problems

• imidafenacina, 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 (for treating malaria)
• praziquantel (for worms and tapeworms)

Medicines to treat 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 organ transplant

• ciclosporin or tacrolimus

Medicines to treat benign enlargement of the prostate

• dutasteride

Medicines to treat lung problems, allergies, or inflammatory conditions

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

Medicines to treat erectile dysfunction and premature ejaculation

• sildenafil (for erectile dysfunction)

Medicines to treat pain

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

Other medicines containing:

• alitretinoin (oral) (for eczema)
• cabergoline (for Parkinson’s disease)
• cannabis-based products, including medicines (for nausea and vomiting or muscle spasms in multiple sclerosis patients)
• cinacalcet (for overactive parathyroid function)
• dienogest or ulipristal (contraceptives)
• eliglustat (for Gaucher disease) when used in patients who cannot metabolize certain medicines
• ivacaftor (for cystic fibrosis)
• methadone (for drug addiction)
• repaglinide or saxagliptin (for diabetes)

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, so appropriate measures can be taken.

Sufficient stomach acidity is required to ensure the absorption of Itraconazol Alter capsules. Therefore, medicines that neutralize stomach acid should be taken at least 2 hours before or at least 2 hours after taking itraconazole. For the same reason, if you are taking medicines that regulate stomach acid production, take Itraconazol Alter with a cola drink (see section 3 “How to take Itraconazol Alter”).

If in doubt, consult your doctor or pharmacist.

Taking Itraconazol Alter with food and drinks

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

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

Pregnancy and breastfeeding

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

Pregnancy

Itraconazol Alter will not be used during pregnancy.

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 Itraconazol Alter 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 Alter”).

Breastfeeding

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

Driving and using machines

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

Itraconazol Alter contains sucrose

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

3. How to take Itraconazol Alter

Follow exactly the administration instructions for Itraconazol Alter provided by your doctor. Consult your doctor or pharmacist if you have any doubts. Remember to take your medication.

Your doctor will indicate how long your treatment with this medicine should last. Do not stop treatment early. If you feel the effect of the medicine is too strong or too weak, inform your doctor or pharmacist.

You should take Itraconazol Alter immediately after meals, as this ensures better 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 much itraconazole you should take.

Sufficient stomach acidity is required to ensure proper absorption of this medicine. Therefore, medications that neutralize stomach acidity should be taken either two hours after taking this medicine or two hours before taking Itraconazol Alter capsules. For the same reason, if you are taking medications that regulate acid production in the stomach, take Itraconazol Alter with a cola drink.

The following doses are the most common:

TYPE OF INFECTION	CAPSULES PER DAY	DURATION
Vaginal infection	2 capsules twice daily or 2 capsules once daily	1 day 3 days
Skin infection	2 capsules once daily or 1 capsule once daily	7 days 2 weeks
If palms of hands or soles of feet are affected, 2 capsules twice daily for 7 days or 1 capsule once daily for 1 month may be required.
Oral infections	1 capsule once daily	2 weeks
Eye infections	2 capsules once daily	3 weeks
Internal infections	1 to 4 capsules daily	longer periods

• Nail infections: depending on your individual needs, your doctor will choose either 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 two capsules twice daily for 1 week, followed by discontinuation of itraconazole capsules for 3 weeks. Then repeat the cycle once for fingernails and twice for toenails (with or without fingernail infection). (See the following table)

	Week 1	Week 2	Week 3	Week 4	Week 5	Week 6	Week 7	Week 8	Week 9	Week 10
Nails of the feet, with or without fingernail involvement	Take 2 capsules twice a day	No treatment with Itraconazole Alter capsules	Take 2 capsules twice a day	No treatment with Itraconazole Alter capsules	Take 2 capsules twice a day	Interrupt treatment	Interrupt treatment	Interrupt treatment	Interrupt treatment	Interrupt treatment
Fingernails only	Take 2 capsules twice a day	No treatment with Itraconazole Alter capsules	Take 2 capsules twice a day	No treatment with Itraconazole Alter capsules	Interrupt treatment	Interrupt treatment	Interrupt treatment	Interrupt treatment	Interrupt treatment	Interrupt treatment

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

Nail lesions will disappear 6 to 9 months after completion of treatment, since the medication 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 medication 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 capsules should not be used in children. Only in exceptional cases may it be prescribed by a physician.

If you take more Itraconazol Alter than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or contact the Toxicology Information Service, telephone 91 562 04 20, indicating the medication and amount taken.

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

If you forget to take Itraconazol Alter

If you forget to take the medication, take the next scheduled dose and continue treatment as directed by your doctor. Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Itraconazol Alter

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

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

4. Possible adverse effects

Like all medicines, Itraconazol Alter may 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 adverse reactions listed below have been observed during post-marketing surveillance and clinical trials of the medicine.

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

Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 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: leucopenia

• 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 urticaria, fluid accumulation, joint pain, fever, and extreme exhaustion), angioneurotic edema (fluid accumulation causing swelling that may affect the mouth and upper respiratory tract)

• Metabolism and nutrition disorders

Rare: increased triglycerides

• Nervous system disorders

Common: headache
Rare: tremor, tingling sensation in limbs (paresthesia), reduced sensitivity (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, gas accumulation in the intestine (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 disease characterized by skin rash and the appearance of blisters and peeling), Stevens-Johnson syndrome (severe erythema of the skin, mucous membranes, and eyes), a serious skin disorder (generalized 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 the appearance of vesicles, blisters, etc.), exfoliative dermatitis (a skin disease characterized by 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)

?Additional investigations

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

Description of selected adverse effects

Listed below are adverse effects associated with itraconazole reported in clinical trials of oral and/or intravenous itraconazole solution, excluding the adverse effect "injection site inflammation," as this effect is specific to the injectable route of administration.

Blood and lymphatic system disorders: granulocytopenia, thrombocytopenia (reduction 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 damage causing 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: reddish 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

Additional 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 data from clinical trials 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 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 via 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 Alter

Keep this medicine out of the sight and reach of children.

Do not use Itraconazole Alter after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are in doubt, please ask your pharmacist how to properly discard unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Itraconazol Alter

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

Sugar spheres (corn starch and sucrose), poloxamer 188, hypromellose.

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

Appearance of the product and pack contents

Itraconazol Alter 100 mg capsules are available in packs of 7, 14 or 100 (hospital pack) hard capsules in aluminum/aluminum blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Laboratorios Alter, S.A
C/ Mateo Inurria, 30
28036 Madrid
Spain

Manufacturer:

Laboratorios Liconsa, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

Date of the most recent revision of this leaflet: July 2021

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/