Itraconazole Tarbis 100 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Itraconazol Tarbis 100 mg hard capsules EFG

Itraconazole

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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Itraconazol Tarbis 100 mg hard capsules is and what it is used for
2. What you need to know before taking Itraconazol Tarbis 100 mg hard capsules
3. How to take Itraconazol Tarbis 100 mg hard capsules
4. Possible side effects
5. How to store Itraconazol Tarbis 100 mg hard capsules
6. Contents of the pack and other information

1. What Itraconazol Tarbis 100 mg capsules is and what it is used for

The active substance in Itraconazol Tarbis capsules is itraconazole, which belongs to a group of medicines called antifungals.

Itraconazole is indicated for the treatment of infections caused by yeasts and fungi. It is used for:

• Infections in the mouth or vagina causing "candidiasis"
• Skin infections
• Infections affecting other parts of the body

Damaged areas of the skin may take several weeks to fully regain their normal appearance after completion of treatment with itraconazole capsules. Fingernails and toenails may take several months to completely recover. This is because the skin or nails will only look normal again once new skin or nail has grown, even though the medicine has killed the fungus causing the infection.

2. What you need to know before taking Itraconazol Tarbis 100 mg capsules

Do not take Itraconazol Tarbis 100 mg capsules

• if you are allergic (hypersensitive) to itraconazole or to any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant, think you may be pregnant, or could become pregnant unless your doctor has instructed you otherwise (see Pregnancy and Breast-feeding)
• you have a serious heart condition called heart failure (also known as congestive heart failure or CHF) unless your doctor has instructed you otherwise (see 'Take special care with itraconazole capsules' below).

Do not use this medicine if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before using itraconazole capsules.

Tell your doctor if you are taking any medicine before taking itraconazole.

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

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 heart rhythms)
• finerenone (for kidney problems in patients with type 2 diabetes)
• lomitapide, lovastatin, or simvastatin (to lower cholesterol)
• sildenafil (for pulmonary arterial hypertension)

Medicines to treat stomach problems or constipation

• cisapride (for stomach discomfort)
• domperidone (for nausea and vomiting)
• naloxegol (for constipation caused by opioid painkillers)

Medicines to treat headaches, sleep problems, or mental health conditions

• dihydroergotamine or ergotamine (ergot alkaloids used for migraines)
• midazolam (oral) or triazolam (for sedation or to help you sleep)
• lurasidone, pimozide, quetiapine, or sertindole (for schizophrenia, bipolar disorder, or other mental health problems)

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 and ejaculation problems

• 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 break down certain medicines in the body
• halofantrine (for malaria)
• irinotecan (for cancer)
• isavuconazole (for fungal infections)
• ombitasvir, paritaprevir, ritonavir with or without dasabuvir – (to treat hepatitis C)
• venetoclax (for chronic lymphocytic leukemia) when starting venetoclax for the first time or taking increasing doses at the beginning of treatment.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Itraconazol Tarbis 100 mg capsules if:

• You have ever had kidney problems. Your dose of itraconazole may need to be adjusted.
• You have ever had liver problems such as yellowing of the skin (jaundice). Your dose of itraconazole may need to be adjusted. If after taking this medicine you develop severe loss of appetite, feel unwell (nausea), are sick (vomiting), feel unusually tired, have abdominal pain, muscle weakness, yellowing of the skin and whites of the eyes, unusually dark urine, pale stools, or hair loss, stop taking itraconazole capsules and consult your doctor immediately.
• You have ever had heart problems including heart failure (congestive heart failure or CHF). Itraconazole capsules could worsen it. If after taking this medicine you experience shortness of breath, unexpected weight gain, swollen legs, unusual fatigue, or start waking up at night, stop taking itraconazole capsules and consult your doctor immediately. These may be signs of heart failure.
• You have Acquired Immunodeficiency Syndrome (AIDS) or your immune system does not function properly.
• You have ever had an allergic reaction to another antifungal medicine.
• Itraconazole capsules are normally not given to elderly people. However, your doctor may prescribe it in special cases.
• If you have cystic fibrosis, consult your doctor before taking itraconazole.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before taking itraconazole capsules.

Children and adolescents

Itraconazole capsules should not be given to children or adolescents under 18 years of age. However, your doctor may prescribe it in special cases.

Elderly

Itraconazole is normally not given to elderly people. However, your doctor may prescribe it in special cases.

Blood tests

If you take itraconazole capsules for more than one month, your doctor may want to check your liver function with a blood test.

Taking Itraconazol Tarbis 100 mg capsules with other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines you can buy without a prescription or herbal remedies. There are some medicines you must not take while using itraconazole. These are listed under the heading "Do not use Itraconazole capsules if".

Use of certain medicines with itraconazole capsules is not recommended. Your doctor may decide that you should not take some medicines at the same time or within 2 weeks after stopping itraconazole.

Examples of such medicines are:

Medicines to treat heart, blood, or circulation problems

• apixaban, edoxaban, 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, entrectinib, glasdegib, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, talazoparib, trabectedin, trastuzumab emtansine, venetoclax (when taking a stable dose of venetoclax for chronic lymphocytic leukemia or at any time during treatment for acute myeloid leukemia), 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, 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 to treat benign prostatic hyperplasia

• 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 and ejaculation problems

• tadalafil or vardenafil (when used in men aged 75 years and 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 itraconazole capsules.

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

Care should be taken when using itraconazole with certain other medicines.

You may be more likely to experience side effects, or it may be necessary to adjust the dose of itraconazole or the other medicine. Examples of such medicines are:

Medicines to treat heart, blood, or circulation problems

• bosentan (for pulmonary hypertension)
• calcium channel blockers such as dihydropyridines like amlodipine, isradipine, nifedipine, nimodipine, or diltiazem (for hypertension)
• or 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 diarrhoea

• aprepitant or netupitant (for nausea and vomiting during cancer treatment)
• loperamide (for diarrhoea)
• 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 problems or mental health conditions

• alprazolam, brotizolam, buspirone, or midazolam (when injected intravenously) (for anxiety or to help you sleep)
• zopiclone (to help you 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 to treat urinary problems

• imidafenacin, fesoterodine, oxybutynin, solifenacin (for overactive bladder)

Medicines to treat cancer

• bortezomib, brentuximab vedotin, busulfan, erlotinib, gefitinib, idelalisib, imatinib, nintedanib, panobinostat, pemigatinib, ponatinib, ruxolitinib, sonidegib, or oral tretinoin

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 tapeworms)

Medicines to treat human immunodeficiency virus (HIV) or hepatitis

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

Medicines used after organ transplantation

• ciclosporin or tacrolimus

Medicines to treat benign prostatic hyperplasia

• dutasteride

Medicines to treat lung problems, allergies, or inflammatory conditions

• bilastine or rupatadine (for allergy)
• methylprednisolone or dexamethasone (oral or injectable medicines 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 inflammation and joint pain)

Other medicines containing:

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

This is not a complete list, so inform your doctor if you are taking or plan to take any of these medicines or any other medicine. Dose adjustments of itraconazole capsules or your other medicine may be necessary.

Taking Itraconazol Tarbis 100 mg capsules with food and drinks:

Always take your dose of itraconazole after a meal, as this helps your body absorb the medicine.

Pregnancy and breast-feeding

• Do not take itraconazole capsules if you are pregnant unless your doctor tells you to. You must use adequate contraceptive measures to ensure you do not become pregnant while being treated with this medicine.
• Itraconazole remains in the body for some time after stopping treatment. After completing treatment with itraconazole, you should continue using an effective contraceptive method until your next menstrual period. Consult your doctor about which contraceptive method to use.
• If you become pregnant after starting treatment with itraconazole capsules, stop taking it and consult your doctor immediately.
• Do not breast-feed while taking itraconazole capsules, as small amounts of the medicine pass into breast milk. Consult your doctor.

Consult your doctor or pharmacist before taking any medicine if you are pregnant or breast-feeding.

If you are of childbearing age and could become pregnant, consult your doctor. You should use effective contraception to ensure you do not become pregnant while taking this medicine.

Driving and using machines

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

Itraconazol Tarbis 100 mg capsules contains sucrose (sugar)

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

3. How to take Itraconazol Tarbis 100 mg capsules

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

Taking Itraconazol capsules:

• Itraconazol should be taken immediately after a meal for optimal absorption.
• The capsules should be swallowed with a small amount of water.
• There must be sufficient acid in the stomach to ensure that the medicine can be properly absorbed by the body. Medicines for indigestion, stomach ulcers, or stomach acidity may affect stomach acid production. For this reason, you should wait two hours after taking itraconazol capsules before taking any of these other medicines.
• If you are taking medicines that suppress gastric acid production, you should take the itraconazol capsules with a non-diet cola drink.

Your doctor will tell you how many itraconazol capsules you should take and for how long. The recommended dose in adults is:

Indications	Dosage
Vaginal fungal infections (Candidiasis)	2 capsules in the morning and two capsules 12 hours later for one day, or 2 capsules daily for 3 days.
Oral fungal infections (Oral Candidiasis)	1 capsule daily for 14 days
Fungal skin infections	Dosage depends on the infection. Your doctor will recommend one of the following: 2 capsules daily for 7 days, or 1 capsule daily for 14 days, or 1 capsule daily for 28 days.
Fungal infections in other parts of the body	Your doctor will indicate how many itraconazole capsules to take and for how long, depending on the infection.

If you take more Itraconazol Tarbis 100 mg capsules than you should

Inform your doctor immediately if you have taken more Itraconazol Tarbis capsules than you should.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, Telephone 91 562 04 20.

If you forget to take Itraconazol Tarbis 100 mg capsules

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and follow your regular dosing schedule. Do not take a double dose to make up for the missed one.

If you stop taking Itraconazol Tarbis 100 mg capsules

Continue taking itraconazole for the length of time prescribed by your doctor. Do not stop the treatment even if you feel better.

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

4. Possible adverse effects

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

Stop taking itraconazole capsules and consult your doctor immediately if you notice or suspect any of the following effects. You may need urgent medical treatment.

• Sudden signs of allergy such as rashes, hives, severe skin irritation, swelling of the face, lips, tongue, or other parts of the body. This may be a sign of a serious allergic reaction. This occurs only in a very small number of people.
• Severe skin reactions with peeling and/or hives with small pustules (with fever) or blistering of the skin, mouth, eyes, and genitals, accompanied by fever, chills, muscle pain, and generally feeling unwell (the exact frequency of these effects is unknown).
• Tingling sensation, numbness, or weakness in the limbs (the exact frequency of these effects is unknown).
• Severe loss of appetite, feeling sick (nausea), being sick (vomiting), feeling unusually tired, abdominal pain, muscle weakness, yellowing of the skin and whites of the eyes (jaundice), unusually dark urine, pale stools, or hair loss. These may be signs of a liver problem. This occurs only in a very small number of people.
• Severe shortness of breath, unexpected weight gain, swollen legs, feeling unusually fatigued, or waking up at night with breathing difficulties. These may be signs of heart failure. Shortness of breath may also be a sign of fluid in the lungs (this occurs only in a very small number of people).

Consult your doctor or pharmacist if you notice any of the following adverse effects:

Frequent (may affect up to 1 in 10 people)

• Stomach pain and feeling sick (nausea).
• Headache.

Uncommon (may affect up to 1 in 100 people)

• Menstrual disorders.
• Sinusitis, nasal congestion, cough, and colds.
• Constipation, diarrhea, gas, being sick (vomiting), indigestion.

Rare (may affect up to 1 in 1,000 people)

• Increase in liver function tests (shown by blood tests).
• Unexpected loss of urine or need to urinate more frequently.
• Vision problems, including blurred vision or double vision.
• Altered taste.
• Certain blood disorders, which may increase the risk of bleeding, bruising, or infection.
• Ringing in the ears.
• Hearing loss (may be permanent).
• Severe pain in the upper abdomen, often with nausea and vomiting (inflammation of the pancreas).
• Swelling due to fluid accumulation under the skin.
• Unusual hair loss or thinning (alopecia).
• Red, itchy, peeling, or flaking skin.
• High levels of triglycerides in the blood (shown by blood tests).
• Skin sensitivity to light.
• Difficulty achieving or maintaining an erection.
• Tremor.
• Fever or high temperature.

The following adverse effects have been reported; however, their exact frequency cannot be determined and therefore their frequency is classified as unknown:

• Muscle pain and joint pain.
• Low levels of potassium in the blood (shown by blood tests).

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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Itraconazole Tarbis 100 mg capsules

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

Do not store above 25°C.

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

Do not use this medicine if you notice any visible signs of deterioration.

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

6. Package contents and other information

Composition of Itraconazole Tarbis 100 mg capsules

Itraconazole Tarbis 100 mg capsules are presented as 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.
• Capsule shell: indigo carmine (E 132), quinoline yellow (E 104), titanium dioxide (E 171) and gelatin.

Appearance of the medicine and contents of the pack

Itraconazole Tarbis 100 mg capsules are presented as hard gelatin capsules containing microgranules. The product is available in blister packs containing 4, 6, 7, 14, 15, 16, 18, 28, 32, 60 or 100 capsules, with the largest pack size intended for hospital use.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer:

LABORATORIOS LICONSA, S.A.

Avda. Miralcampo, No. 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares – Guadalajara (SPAIN)

This medicine is authorized in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Austria: Itraconazol Universal Farma 100 mg Hartkapseln

Portugal: Itraconazol Unisens 100 mg cápsulas MG

Spain: Itraconazol Tarbis 100 mg hard capsules EFG

United Kingdom (Northern Ireland): Itraconazole 100 mg hard capsules

Date of the most recent review of this leaflet: 04/2023

Other sources of information

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