Package Leaflet: Information for the User

itraconazol cinfa 100 mg hard capsules EFG

Read this leaflet carefully before you start to take 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. Do 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 belongs to a 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 itraconazole cinfa:

• If you are allergic to itraconazole or 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 may worsen it.

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 pregnant,think you may be pregnant or could become pregnant(see section “Pregnancy and breastfeeding”) your doctor will assess whether you should take this medicine.
• 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 some time, you should prolong contraceptive measures until the next menstrual period after completing treatment with this medicine.
• This medicine cannot be used with some medicines. There are many medicines that interact with itraconazole, see section “Other medicines and itraconazole cinfa” and the list below.

Inform your doctor if you are taking any other medicine.

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

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:

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 itraconazole.

Warnings and precautions

Consult your doctor or pharmacist before starting to take itraconazole cinfa:

• 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 these may be symptoms of heart failure.
• If you have any liver problems. Your doctor may need to adjust the dose of this medicine. 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 to take this medicine, it is likely that your doctor will ask you to have regular blood tests, as rare cases of liver disorders have occurred.
• If you have any kidney problems, consult your doctor. Your doctor may need to adjust the dose of this medicine.
• Consult your doctor or seek medical attention immediately if you experience a severe allergic reaction (characterized by a pronounced skin rash, itching, hives, difficulty breathing, and/or facial swelling) while taking itraconazole.
• 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 this medicine and consult your doctor immediately if you experience any numbness, tingling, decreased sensitivity, or weakness in your 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.
• This medicine is not recommended for elderly patients. It may only be prescribed by your doctor in exceptional cases.

Other medicines and itraconazole cinfa

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 taking itraconazole. These medicines are listed above under the heading“Do not take itraconazole cinfa”.

It is not recommended to use certain medicines with itraconazole.

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

Examples of these medicines are:

Medicines used to treat heart, blood, or circulation problems:

Medicines to treat epilepsy, headaches, 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:

Medicines to treat pain:

Other medicines that contain:

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.

You should be careful when using itraconazole with certain medicines.It is possible that you may be more likely to experience side effects or that the dose of itraconazole or the other medicine may need to be adjusted. Examples of these medicines are:

Medicines used to treat heart, blood, or circulation problems:

Medicines to treat stomach or diarrhea problems:

Medicines to treat sleep or mental health problems:

Medicines to treat urinary problems:

Medicines to treat cancer:

Medicines to treat infections:

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:

Medicines to treat pain:

Other medicines that contain:

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 this medicine. Therefore, medicines that neutralize stomach acid should be taken at least 2 hours before taking itraconazole or 2 hours after taking it. For the same reason, if you are taking medicines that regulate stomach acid production, take itraconazole with a cola drink (see section 3 “How to take itraconazole cinfa”).

If in doubt, consult your doctor or pharmacist.

Taking itraconazole cinfa 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 could become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Consult your doctor or pharmacist before using any medicine.

This medicine 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 while taking the medicine. Because this medicine may remain in the body for some time, you should prolong contraceptive measures until the next menstrual period after completing treatment with this medicine (see section 2 “Do not take itraconazole cinfa”).

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Driving and operating machinery

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

itraconazole cinfa 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 this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

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

You must take this medication 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 itraconazole. For the same reason, if you are taking medications that regulate acid production in the stomach, take itraconazole 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 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)

For 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.

Nail 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 should interrupt treatment at the time your doctor indicates, 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 he will adapt the treatment to your needs.

Use in children

This medication should not be used in children. It can only be prescribed by a doctor in exceptional cases.

If you take more itraconazole cinfa than you should

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

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

If you forgot to take itraconazole cinfa

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 itraconazole cinfa

Do not stop 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, this medicine can cause side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are serious 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).

Infections and infestations

• Uncommon: sinusitis (irritation and swelling of the nasal sinuses), upper respiratory tract infection, rhinitis (inflammation of the nasal mucosa that is accompanied by the production of watery mucus and frequent sneezing).

Blood and lymphatic system disorders

• Rare: leucopenia.

Immune system disorders

• Uncommon: excessive and allergic hypersensitivity reactions.
• • Rare: anaphylactic reactions (allergic reactions), serum disease (allergy that appears after the injection of some sera and is characterized by the appearance of urticaria, accumulation of fluids, joint pains, fever, and extreme exhaustion), angioneuritic edema (swelling due to the accumulation of fluids that can affect the mouth and upper respiratory tract).

Metabolism and nutrition disorders

Nervous system disorders

Eye disorders

Ear and labyrinth disorders

Cardiac disorders

Respiratory, thoracic and mediastinal disorders

Gastrointestinal disorders

Hepatobiliary disorders

Skin and subcutaneous tissue disorders

Renal and urinary disorders

Reproductive and breast disorders

General disorders and administration site conditions

Investigations

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

Description of certain side effects

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

Blood and lymphatic system disorders:granulocytopenia, thrombocytopenia (decreased platelet count).

Immune system disorders:anaphylactoid reaction.

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

Mental and behavioral disorders:sensation of confusion or disorientation.

Nervous system disorders:peripheral neuropathy (affecting peripheral nerves with a sensation of tingling, numbness, or weakness in the extremities), dizziness, somnolence.

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

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

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

Gastrointestinal disorders:gastrointestinal disorder.

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

Skin and subcutaneous tissue disorders:erythematous rash (exanthema eritematoso), excessive sweating.

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

Renal and urinary disorders:renal insufficiency, urinary incontinence (urine loss).

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

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

Other side effects in children

Based on data from pediatric clinical trials, 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.

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 mentioned in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products 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 this medication after the expiration date that appears on the packaging after CAD. 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 packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of itraconazole cinfa

• The active ingredient is itraconazole. Each capsule contains 100 mg of itraconazole.
• The other components (excipients) are:

Contents of the capsule: sugar spheres (containing saccharose, cornstarch and purified water), poloxamer 188 and hypromellose.

Capsule coating: gelatin, purified water, blue FD & C2, indigotin, cochineal extract (E-132), quinoline yellow (E-104) and titanium dioxide (E-171).

Appearance of the product and contents of the packaging

Hard gelatin capsules, with green opaque cap and body, containing beige-yellow microspheres.

It is presented in Aluminio/Aluminio blisters. Each package contains 7, 14 or 100 (clinical package) capsules.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Responsible manufacturer:

LICONSA, S.A.

Avda. Miralcampo, Nº 7 Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara), Spain

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: July 2021

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/65773/P_65773.html

QR code to: https://cima.aemps.es/cima/dochtml/p/65773/P_65773.html