Prospecto: Information for the User

Itraconazol Alter 100 mg Hard Capsules EFG

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Itraconazol Alter belongs to the group of medicines called “antifungals”.

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

Do not take Itraconazol Alter 100 mg capsules

If your doctor thinks you should take this medicine, contact him immediately if you notice that you are short of breath, gain weight unexpectedly, have swollen legs, feel unusually tired, or start waking up at night.

• if you are fertile, you should take appropriate contraceptive measures to avoid becoming pregnant during treatment. Because this medicine may remain in the body for a long time, you should prolong contraceptive measures until the next menstrual period after completing treatment with this medicine.
• do not use Itraconazol Alter with some medicines. There are many medicines that interact with Itraconazol Alter, see section “Other medicines and Itraconazol Alter” and the list below.

Inform your doctor if you are taking any other medicine.

Do not use Itraconazol Alter ifyou are taking any of the following medicines, or within 2 weeks of the end of Itraconazol Alter treatment:

Medicines used to treat heart, blood, or circulation problems

Medicines to treat stomach or constipation problems

Medicines to treat headache, sleep, or mental health problems

Medicines to treat urinary problems

Medicines to treat allergies

• astemizole, mizolastine, or terfenadine (for allergies)

Medicines to treat erection and ejaculation problems

Other medicines that contain:

Remember: do not take any of the above medicines during 2 weeks after your last treatment with Itraconazol Alter.

Warnings and precautions

Be especially careful with Itraconazol Alter

• if you have heart problems, consult your doctor. Inform your doctor immediately if you experience shortness of breath, unexpected weight gain, swollen legs, unusual fatigue, or insomnia, as they 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 appear 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), dark urine, or pale stools. If you continue treatment with itraconazole, it is very likely that your doctor will send you regular blood tests, as rare cases of liver disorders have occurred.
• if you have any kidney problems, consult your doctor. The dose of this medicine may need to be adjusted.
• consult your doctor or seek medical attention immediately if, while taking itraconazole, you experience a severe allergic reaction (characterized by a pronounced skin rash, itching, hives, difficulty breathing, and/or facial swelling).
• stop taking this medicine and consult your doctor immediately if you become too sensitive to sunlight.
• stop taking itraconazole and consult your doctor immediately if you experience a severe skin disorder, such as a generalized 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, HIV/AIDS, or have received an organ transplant. The dose of this medicine may need to be adjusted.
• if you have had an allergic reaction due to itraconazole or another antifungal medicine (known as azoles), consult your doctor. A hypersensitivity reaction can be recognized, for example, by the appearance of a 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.
• stop taking itraconazole and consult your doctor immediately if you experience any numbness, tingling, decreased sensitivity, or weakness in the arms and legs (neuropathy).
• stop taking this medicine and contact your doctor immediately if you do not hear correctly. In rare cases, temporary or permanent hearing loss has occurred.
• inform your doctor if your vision becomes blurry or double, if you hear a buzzing in your ears, if you lose control of your urine, or urinate more than usual.
• do not recommend taking this medicine in elderly patients. Only in exceptional cases can it be prescribed by your doctor.

Other medicines and Itraconazol Alter

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

There are medicines thatshould not be takenwhile takingItraconazol Alter. These medicines are listed above under the heading “Do not use Itraconazol Alter”

Do not use certain medicines with Itraconazol Alter

Your doctor may decide thatyou should not take some medicines at the same time as Itraconazol Alter or within 2 weeks after its completion.

Examples of these medicines are:

Medicines used to treat heart, blood, or circulation problems

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

Medicines to treat epilepsy, headache, or mental health problems

Medicines to treat urinary problems

Medicines to treat cancer

Medicines to treat tuberculosis

Medicines to treat HIV or hepatitis

Medicines used after organ transplantation

Medicines to treat benign prostatic hyperplasia

Medicines to treat respiratory, allergy, or inflammatory problems

Medicines to treat erection and ejaculation problems

Other medicines that contain:

Remember: do not take any of the above medicines during 2 weeks after your last treatment with Itraconazol Alter.

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

Be careful when using Itraconazol Alter 100 mg with certain medicines.

You may be more likely to experience side effects or the dose of Itraconazol Alter or the other medicine may need to be adjusted. Examples of these medicines are:

Medicines used to treat heart, blood, or circulation problems

• calcium channel blockers such as dihydropyridines, such as amlodipine, isradipine, nifedipine, nimodipine, or diltiazem (for hypertension)
• verapamil (for hypertension)
• 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 or diarrhea problems

• 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, or proton pump inhibitors such as lansoprazole, omeprazole, or rabeprazole (for acid reflux)

Medicines to treat sleep or mental health problems

• 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 disorders)
• galantamine (for Alzheimer's disease)
• guanfacine (for attention deficit hyperactivity disorder)

Medicines to treat urinary problems

• imidafenacin, fesoterodine, oxybutynin, or solifenacin (for irritated 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 malaria)
• praziquantel (for tapeworms and tapeworms)

Medicines to treat HIV or hepatitis

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

Medicines used after organ transplantation

• ciclosporin or tacrolimus

Medicines to treat benign prostatic hyperplasia

• dutasteride

Medicines to treat respiratory, allergy, or inflammatory problems

• bilastine, or rupatadine (for allergies)
• prednisolone or dexamethasone (oral or injectable medicines for asthma, allergies, or inflammatory disorders)
• budesonide or fluticasone (for asthma, allergies)

Medicines to treat erection and ejaculation problems

• sildenafil (for erectile dysfunction)

Medicines to treat pain

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

Other medicines that contain:

• alitretinoin (oral) (for eczema)
• • cabergoline (for Parkinson's disease)
  • products containing cannabis, including medicines (for nausea and vomiting or muscle spasms in patients with multiple sclerosis)
  • cinacalcet (for hyperparathyroidism)
  • dienogest or ulipristal (contraceptives)
  • eliglustat (for Gaucher's disease) when used in patients who cannot break down certain medicines in the body
  • ivacaftor (for cystic fibrosis)
  • methadone (for opioid addiction)
  • repaglinide or saxagliptin (for diabetes)

This list is not exhaustive, so you should 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.

You should have enough acidity in the stomach to ensure the absorption of Itraconazol Alter capsules. Therefore, medicines that neutralize stomach acidity should be taken at least 2 hours before taking itraconazole or 2 hours after taking this medicine. 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”).

In case of doubt, consult your doctor or pharmacist.

Taking Itraconazol Alter with food and drinks

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

If you are taking any 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, or think you may 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 fertile and may become pregnant, consult your doctor. You should use effective contraceptive measures to avoid becoming pregnant during treatment. Because Itraconazol Alter may remain in the body for a long time, you should prolong contraceptive measures until the 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 appear in milk.

Driving and operating machinery

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

Itraconazol Alter contains saccharose

This medicine contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

Your doctor will indicate the duration of your treatment with this medication. Do not suspend the treatment before. If you estimate that the medication's action is too strong or weak, inform your doctor or pharmacist.

You must take Itraconazol Alter immediately after meals, as it is absorbed better. Swallow the capsules whole with a little water. The number of capsules you should take and for how long depends on the type of fungus and the location of the infection. Your doctor will tell you exactly how much itraconazole you should take.

There must be enough acidity in the stomach to ensure the absorption of this medication. Therefore, medications that neutralize stomach acidity should be used two hours after taking this medication 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 frequent:

• Fingernail infections: Depending on your personal needs, your doctor will choose between continuous or pulsatile treatment.

-Continuous treatment for foot nail infections:

-Pulsatile treatment for nails:

This consists of 2 capsules twice a day for 1 week; then stop taking itraconazole capsules for 3 weeks. The cycle is then repeated, once for the hands and twice for the feet (with or without infection in the hands).(See the following table)

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

Fingernail lesions will disappear from 6 to 9 months after treatment is completed, as the medication only eliminates the fungus itself. The nail must grow, which takes several months. Therefore, do not worry if you do not notice improvement during treatment: the medication remains in your nails for several months and fulfills its mission. Therefore, you must interrupt treatment at the time indicated by your doctor, even if you do not see any improvement.

Internal organ infections:Higher doses may be needed and for a long time. Always follow your doctor's instructions, as they will adapt the treatment to your needs.

Use in Children

Itraconazole capsules should not be used in children. Only in exceptional cases can it be prescribed by the doctor.

If you take more Itraconazol Alter than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or the Toxicological Information Service, Teléfono 91 562 04 20, indicating the medication and the amount used.

In case of accidental overdose, your doctor will apply supportive measures. Itraconazole is not eliminated by hemodialysis. No specific antidotes are known.

If you forget to take Itraconazol Alter

If you forget to take the medication, take the next dose that corresponds to you and continue treatment as indicated by your doctor. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Itraconazol Alter

Do not interrupt treatment with itraconazole without consulting your doctor, as the symptoms of your disease may reappear or worsen.

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

Like all medicines, Itraconazol Alter may cause side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

The following side effects have been seen during the marketing of the medicine and clinical trials.

Adverse reactions were classified by 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

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

Rare: leucopenia

Uncommon: hypersensitivity and allergic reactions

Rare: anaphylactic reactions (allergic reactions), serum sickness (allergy that appears after the injection of some sera, characterized by the appearance of urticaria, accumulation of fluid, joint pain, fever, and extreme exhaustion), angioneuritic edema (swelling due to fluid accumulation that may affect the mouth and upper respiratory tract)

Rare: increased triglycerides

Common: headache

Rare: tremor, sensation of numbness in the extremities (paresthesia), decreased sensitivity (hypoaesthesia), unpleasant taste (bad taste)

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

Rare: permanent or temporary hearing loss, subjective sensation of noise in the ear

Rare: congestive heart failure

Rare: dyspnea (shortness of breath), difficulty breathing

Common: abdominal pain, nausea

Uncommon: vomiting, discomfort associated with meals, diarrhea, constipation, flatulence (accumulation of gas in the intestine)

Rare: pancreatitis (inflammation of the pancreas)

Uncommon: abnormal liver function

Rare: elevated bilirubin in blood (hyperbilirubinemia), severe hepatotoxicity (including cases of acute severe liver failure)

Uncommon: urticaria, rash, pruritus

Rare: toxic epidermal necrolysis (severe skin disease characterized by skin rash and the appearance of blisters and scales), Stevens-Johnson syndrome (severe skin, mucous membrane, and eye inflammation), a severe skin disorder (generalized exfoliative dermatitis with skin peeling and blisters in the mouth, eyes, and genitals, or generalized exfoliative dermatitis with small pustules or blisters), erythema multiforme (skin disease characterized by the appearance of vesicles, blisters, etc.), dermatitis exfoliativa (skin disease characterized by peeling), leukocytoclastic vasculitis (inflammation of the blood vessel walls), alopecia (hair loss), photosensitivity (exaggered skin response to sunlight)

Rare: increased frequency of urination

Uncommon: menstrual disorders

Rare: erectile dysfunction

Rare: edema (fluid accumulation)

Rare: increased creatine phosphokinase in blood (parameter that measures liver function)

Description of certain side effects

The following side effects are associated with itraconazole notified in clinical trials of itraconazole oral solution and/or intravenous, excluding the side effect "inflammation at the injection site" since this side effect is specific to the intravenous administration route.

Immune system disorders: anaphylactoid reaction

Psychiatric disorders: sensation of confusion or disorientation

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

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

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

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

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

Side effects in the pediatric population

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

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

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

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

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

Do not use Itraconazol Alter after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Itraconazol Alter

Sugar spheres (cornstarch and sucrose), poloxamer 188, hypromellose.

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

Appearance of the product and contents of the packaging

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

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer responsible: Marketing authorization holder:

Laboratorios Alter, S.A

C/ Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer responsible:

Laboratorios Liconsa, S.A. Avda. Miralcampo, Nº 7, Industrial Estate Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet: July 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/