Itraconazole Tecnigen 100 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

1. What Itraconazol TecniGen 100 mg hard capsules EFG is and what it is used for

Itraconazol TecniGen 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.

2. What you need to know before starting Itraconazol TecniGen 100 mg hard capsules EFG

Do not take Itraconazol TecniGen:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• Itraconazol TecniGen capsules must not be used together with certain medicines; see section “Use of other medicines”, “Itraconazol TecniGen capsules must not be used together with the following medicines”.
• if you have a condition called heart failure (also known as congestive heart failure or CHF). This medicine could worsen it.

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

• if you are pregnant, 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.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Itraconazol TecniGen capsules.

• if you have heart problems, consult your doctor. If he/she decides to prescribe Itraconazol TecniGen capsules, he/she will give you instructions about symptoms that may occur, such as difficulty breathing, unexpected weight gain, leg swelling, unusual fatigue, or insomnia, so that you can contact him/her immediately.
• if you have liver problems. It may be necessary to adjust the dose of this medicine. If any of the following symptoms occur during treatment with this medicine, stop taking it and contact your doctor immediately: loss of appetite, nausea, vomiting, tiredness, abdominal pain, jaundice (yellowing of the skin, mucous membranes, and secretions), very dark urine, or pale stools. If you are undergoing treatment with Itraconazol TecniGen capsules, your doctor may request regular blood tests, as liver disorders have occurred, although very rarely.
• if you have kidney problems, consult your doctor. It may be necessary to adjust the dose of this medicine.
• contact your doctor if you have neutropenia, AIDS, or have received an organ transplant. The dose of this medicine may need to be adjusted.
• if you have previously experienced an allergic reaction to another antifungal medicine (medicines known as azoles), consult your doctor. A hypersensitivity reaction may be recognized, for example, by the appearance of skin rash, itching, hives, shortness of breath, or difficulty breathing, and/or facial swelling. If you experience a severe allergic reaction, contact your doctor immediately.
• if during treatment with Itraconazol TecniGen capsules you experience unusual tingling, numbness, or weakness in your feet or hands (neuropathy), contact your doctor immediately.
• 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.
• the use of this medicine is not recommended in elderly patients. It may be prescribed by a doctor only in exceptional cases.

Taking Itraconazol TecniGen 100 mg hard capsules EFG with other medicines

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

Some medicines must not be taken at the same time, or the dose may need to be adjusted when certain medicines are taken.

Itraconazol TecniGen 100 mg hard capsules EFG must not be taken together with the following medicines:

• certain medicines used to treat allergies, mainly terfenadine, astemizole, and mizolastine.
• certain medicines used to treat angina pectoris (chest tightness) and high blood pressure, such as bepridil and nisoldipine.
• cisapride, a medicine used for digestive problems.
• levacetylmethadol, a medicine used in the treatment of opioid dependence.
• certain medicines used to treat irregular heartbeat, mainly quinidine and dofetilide.
• certain medicines used to lower cholesterol, such as atorvastatin, simvastatin, and lovastatin.
• medicines used to treat anxiety or help sleep, such as oral midazolam and triazolam.
• pimozide and sertindole, medicines used for psychotic disorders.
• ergot alkaloids, such as dihydroergotamine and ergotamine, used to treat migraine.
• eletriptan, a medicine used to treat migraines.
• ergot alkaloids, such as ergometrine (ergonovine) and methylergometrine (methylergonovine), used to control bleeding and maintain uterine contractions after childbirth.

Medicines that neutralize stomach acidity should not be taken until at least two hours after taking Itraconazol TecniGen (see section 3 “How to take Itraconazol TecniGen 100 mg capsules”).

Certain medicines may reduce the effect of Itraconazol TecniGen capsules. This particularly applies to some medicines used to treat epilepsy (e.g., carbamazepine, phenytoin, and phenobarbital) and tuberculosis (e.g., rifampicin and isoniazid), as well as St. John’s wort. Therefore, always inform your doctor if you are taking any of these medicines so that appropriate measures can be taken.

Combining with other medicines may require dose adjustments, either for this medicine or for the other medicines. Examples include:

• certain antibiotics called clarithromycin, erythromycin, rifabutin;
• drugs that slow blood clotting;
• certain HIV protease inhibitors;
• certain medicines used in cancer treatment;
• ciclosporin, tacrolimus, and rapamycin (also known as sirolimus), usually used after organ transplantation;
• methylprednisolone, budesonide, fluticasone, and dexamethasone, drugs that may be administered orally, by injection, or by inhalation for conditions such as inflammation, asthma, and allergies;
• certain drugs acting on the heart and blood vessels (digoxin, disopyramide, some calcium channel blockers, cilostazol);
• certain medicines used to treat anxiety or help sleep (tranquilizers), mainly buspirone, alprazolam, and brotizolam;
• ebastine, an antiallergy medicine;
• reboxetine, a medicine used to treat depression;
• fentanyl, a very strong pain-relieving medicine;
• halofantrine, a medicine used to treat malaria;
• repaglinide, a medicine used to treat diabetes.

If you are taking any of these medicines, inform your doctor. If in doubt, consult your doctor or pharmacist.

Sufficient stomach acidity is required to ensure absorption of Itraconazol TecniGen capsules. Therefore, medicines that neutralize stomach acidity should be taken at least two hours after taking this medicine. For the same reason, if you are taking medicines that regulate stomach acid production, take Itraconazol TecniGen capsules with a cola drink.

Taking Itraconazol TecniGen 100 mg capsules 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 may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Itraconazol TecniGen will not be used during pregnancy.

If you are of childbearing age, you must take adequate contraceptive precautions to avoid becoming pregnant while taking this medicine. Because Itraconazol TecniGen capsules may remain in the body for some time, you should continue contraceptive measures until your next menstrual period after completing treatment with this medicine. (See section 2 “Do not take Itraconazol TecniGen 100 mg capsules”).

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Driving and using machines

There are no problems with driving or operating machinery unless you experience dizziness, blurred/double vision, or hearing loss. If you experience any of these symptoms, do not drive or operate machinery.

Itraconazol TecniGen 100 mg capsules contain sucrose

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

3. How to take Itraconazol TecniGen 100 mg hard capsules EFG

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Do not stop treatment prematurely. If you think that the effect of the medicine is too strong or too weak, inform your doctor or pharmacist.

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

Sufficient stomach acidity is required to ensure proper absorption of this medicine. Therefore, medicines that neutralize stomach acidity should be taken at least two hours after this medicine. For the same reason, if you are taking medicines that regulate acid production in the stomach, take itraconazol capsules together with a cola drink.

The following doses are the most common:

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

• Continuous treatment for nail infections of the feet:

• Pulsed therapy for nails:

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

In skin infections, lesions will disappear a few weeks after completing 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 completing treatment, as 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 and prolonged treatment may be required.

Always follow your doctor's instructions; he or she will adapt the treatment to your needs.

Use in Children

Itraconazol TecniGen capsules must not be used in children. It may only be prescribed by a physician in exceptional cases.

If you take more Itraconazol TecniGen 100 mg hard capsules EFG than you should

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

In case of accidental overdose, your doctor will implement supportive measures. Gastric lavage may be performed within the first hour after ingestion, or activated charcoal may be administered if deemed appropriate. Itraconazol is not eliminated by hemodialysis. Specific antidotes are not known.

If you forget to take Itraconazol TecniGen 100 mg hard capsules EFG

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 missed doses.

If you interrupt treatment with Itraconazol TecniGen 100 mg hard capsules EFG

Do not interrupt treatment with Itraconazol TecniGen without consulting your doctor, as symptoms of your condition may recur or worsen.

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

4. Possible adverse effects

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

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

The following are adverse effects reported during the marketing of the medicine and clinical trials.

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

Very common: affects more than 1 in 10 patients
Common: affects 1 to 10 in 100 patients
Uncommon: affects 1 to 10 in 1,000 patients
Rare: affects 1 to 10 in 10,000 patients
Very rare: affects less than 1 in 10,000 patients
Frequency not known: cannot be estimated from available data

• Blood and lymphatic system disorders

Rare: leucopenia
Frequency not known: neutropenia, thrombocytopenia (reduction in certain blood cells)

• Immune system disorders

Uncommon: hypersensitivity and allergic reactions
Frequency not known: anaphylactic and anaphylactoid reactions, serum sickness (an allergic reaction occurring after injection of certain sera, characterized by urticaria, fluid accumulation, joint pain, fever, and extreme exhaustion), angioneurotic edema (swelling due to fluid accumulation that may affect the mouth and upper respiratory tract)

• Metabolism and nutrition disorders

Frequency not known: hypokalaemia (decreased potassium in blood), increased triglycerides

• Nervous system disorders

Uncommon: tingling sensation in the extremities (paraesthesia), headache, dizziness
Rare: decreased sensation (hypoesthesia)
Frequency not known: peripheral nerve involvement

• Eye disorders

Rare: visual disturbances
Frequency not known: blurred vision, double vision

• Ear and labyrinth disorders

Rare: subjective sensation of ringing in the ear
Frequency not known: permanent or transient hearing loss

• Cardiac disorders

Frequency not known: congestive heart failure

• Respiratory, thoracic and mediastinal disorders

Rare: interrupted breathing, difficulty breathing (dyspnoea)
Frequency not known: pulmonary oedema, rhinitis (inflammation of the nasal mucosa causing watery mucus discharge and frequent sneezing), upper respiratory tract infection, sinusitis (irritation and swelling of the nasal sinuses)

• Gastrointestinal disorders

Common: abdominal pain, nausea
Uncommon: vomiting, discomfort associated with meals, diarrhoea and constipation, unpleasant taste (dysgeusia), accumulation of gas in the intestine (flatulence)
Frequency not known: pancreatitis

• Hepatobiliary disorders

Uncommon: elevated levels of bilirubin in blood (hyperbilirubinaemia), increased alanine aminotransferase and aspartate aminotransferase, parameters measuring liver function
Rare: reversible increase in liver enzymes
Frequency not known: acute liver failure, severe hepatotoxicity (including cases of very severe acute liver failure), hepatitis, abnormal liver function

• Skin and subcutaneous tissue disorders

Common: rash
Rare: urticaria, alopecia (hair loss), pruritus (itching)
Frequency not known: toxic epidermal necrolysis (a serious skin disease characterized by skin rash, 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 the walls of blood vessels), photosensitivity (exaggerated skin response to sunlight), redness of the skin

• Musculoskeletal and connective tissue disorders

Frequency not known: muscle pain or weakness, joint pain

• Renal and urinary disorders

Rare: increased frequency of urination
Frequency not known: urinary incontinence

• Reproductive system and breast disorders

Uncommon: menstrual disorders
Frequency not known: erectile dysfunction

• General disorders and administration site conditions

Uncommon: oedema (fluid accumulation)
Rare: fever

• Injury, poisoning and procedural complications

Frequency not known: injury

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 System for Pharmacovigilance of 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 TecniGen 100 mg hard capsules EFG

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

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 store above 30°C. Keep in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Package contents and other information

Composition of Itraconazol TecniGen 100 mg hard capsules EFG

• 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

The product is available in blister packs containing 7 and 14 hard capsules. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.
Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,
28108 Alcobendas (Madrid), Spain

Manufacturer:

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

This leaflet was approved in June 2014.

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