ITRACONAZOLE TECNIGEN 100 mg HARD CAPSULES

2. What you need to know before you take Itraconazole TecniGen 100 mg hard capsules EFG

Do not takeItraconazoleTecniGenif:

• you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• Itraconazole TecniGen capsules must not be taken with some medicines, see section “Using other medicines”, “Itraconazole TecniGen capsules must not be taken with the following medicines”.
• you have a condition called heart failure (also called congestive heart failure or CHF). This medicine could make it worse.

If your doctor decides that 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, your doctor will decide whether you should take this medicine.
• if you are of childbearing age, you should take adequate contraceptive measures to avoid becoming pregnant during treatment. Because this medicine can stay in your body for some time, you should continue to use contraceptive measures until your next menstrual period after finishing treatment with this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Itraconazole TecniGen capsules.

• if you have heart problems, consult your doctor. If he decides to prescribe Itraconazole TecniGen capsules, he will give you instructions on symptoms that may appear, such as shortness of breath, unexpected weight gain, leg swelling, unusual fatigue, or insomnia, so that you can contact him immediately.
• if you have any liver problems. It may be necessary 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, mucous membranes, and secretions), dark urine, or pale stools. If you are taking Itraconazole TecniGen capsules, it is likely that your doctor will order regular blood tests, as liver disorders have occurred in very rare cases.
• if you have any 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 had an allergic reaction to other medicines used to treat fungal infections (medicines 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 swelling of the face. If you experience a severe allergic reaction, consult your doctor immediately.
• if during treatment with Itraconazole TecniGen capsules you feel unusual tingling, numbness, or weakness in your feet or hands (neuropathy), consult your doctor immediately.
• stop taking this medicine and contact your doctor immediately if you experience any hearing problems. In very rare cases, temporary or permanent hearing loss has occurred.
• this medicine is not recommended for elderly patients. It can only be prescribed by a doctor in exceptional cases.

Taking Itraconazole TecniGen 100 mg hard capsules EFG with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Some medicines should not be taken at the same time or the dose of one of the medicines may need to be adjusted.

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

• certain medicines for treating allergies, mainly terfenadine, astemizole, and mizolastine.
• certain medicines used to treat angina pectoris (chest pain) and high blood pressure, such as bepridil and nisoldipine.
• cisapride, a medicine used for digestive problems.
• levacetilmetadol, a medicine used to treat opioid dependence.
• certain medicines used to treat irregular heart rhythms, mainly quinidine and dofetilide.
• certain medicines used to lower cholesterol, such as atorvastatin, simvastatin, and lovastatin.
• medicines used to treat anxiety or to help you sleep, such as midazolam oral and triazolam.
• pimozide and sertindole, medicines used for psychotic disorders.
• ergot alkaloids, such as dihydroergotamine and ergotamine, used to treat migraines.
• 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 acid should not be taken until at least 2 hours after taking Itraconazole TecniGen (see section 3 “How to take Itraconazole TecniGen 100 mg capsules”).

Certain medicines may reduce the effect of Itraconazole TecniGen capsules. This may apply particularly to some products used to treat epilepsy (e.g., carbamazepine, phenytoin, and phenobarbital) and tuberculosis (e.g., rifampicin and isoniazid) and St. John's Wort. Therefore, you should always inform your doctor if you are using any of these medicines so that the necessary measures can be taken.

The combination with other medicines may require a dose adjustment, either of this medicine or of the other medicines. Examples include:

• certain antibiotics called clarithromycin, erythromycin, and rifabutin;
• medicines that slow down blood clot formation;
• certain HIV protease inhibitors;
• certain medicines used to treat cancer;
• cyclosporine, tacrolimus, and rapamycin (also known as sirolimus), which are usually used after organ transplantation;
• methylprednisolone, budesonide, fluticasone, and dexamethasone, which can be administered orally, by injection, or by inhalation for disorders such as inflammation, asthma, and allergies;
• certain medicines that act on the heart and blood vessels (digoxin, disopyramide, some calcium channel blockers, cilostazol);
• certain medicines used to treat anxiety or to help you sleep (tranquilizers), mainly buspirone, alprazolam, and brotizolam;
• ebastine, a medicine for allergies;
• reboxetine, a medicine used to treat depression;
• fentanyl, a strong pain reliever;
• halofantrine, a medicine used to treat malaria;
• repaglinide, a medicine used to treat diabetes.

If you are using any of these medicines, inform your doctor. In case of doubt, consult your doctor or pharmacist.

There must be enough acidity in the stomach to ensure the absorption of Itraconazole TecniGen capsules. Therefore, medicines that neutralize stomach acid should be used after 2 hours of taking this medicine. For the same reason, if you are taking medicines that regulate stomach acid production, take Itraconazole TecniGen capsules with a cola drink.

Taking Itraconazole TecniGen 100 mg hard capsules EFG 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Itraconazole TecniGen should not be used during pregnancy.

If you are of childbearing age, you should take adequate contraceptive measures to ensure you do not become pregnant while taking the medicine. Because Itraconazole TecniGen capsules can stay in your body for some time, you should continue to use contraceptive measures until your next menstrual period after finishing treatment with this medicine. (See section 2 “Do not take Itraconazole TecniGen 100 mg capsules”).

Breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

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

Driving and using machines

There are no problems with driving or using machines, unless you feel dizzy, have blurred or double vision, or experience hearing loss. If you experience any of these symptoms, do not drive or use machines.

Itraconazole TecniGen 100 mg hard capsules EFG contains sucrose

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

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Do not stop treatment early. If you think the effect of the medicine is too strong or too weak, talk to your doctor or pharmacist.

You should take itraconazole capsules immediately after meals, as they are better absorbed. 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 many itraconazole capsules you should take.

There must be enough acidity in the stomach to ensure the absorption of this medicine. Therefore, medicines that neutralize stomach acid should be used after 2 hours of taking this medicine. For the same reason, if you are taking medicines that regulate stomach acid production, take itraconazole capsules with a cola drink.

The following doses are the most common:

• Nail 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:

It 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 hand nails and twice for foot nails (with or without nail infection). (See the following table)

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

Nail lesions will disappear 6 to 9 months after finishing treatment, as the medicine only eliminates the fungus itself. The nail has to grow, and this takes several months. Therefore, do not worry if you do not notice any improvement during treatment: the medicine stays in your nails for several months and fulfills its mission. Therefore, you should stop treatment when your doctor tells you to, even if you do not see any improvement.

Internal organ infections:Higher doses and longer treatment periods may be necessary.

Always follow your doctor's instructions, as he will adapt the treatment to your needs.

Use in children

Itraconazole TecniGen capsules should not be used in children. It can only be prescribed by a doctor in exceptional cases.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or the Toxicology Information Service, Telephone 91 562 04 20, indicating the medicine and the amount used.

In case of accidental overdose, your doctor will apply supportive measures. He may also perform stomach lavage within the hour following ingestion or administer activated charcoal if deemed appropriate. Itraconazole is not eliminated by hemodialysis. No specific antidotes are known.

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

If you forget to take the medicine, take the next dose that corresponds to you and continue treatment as indicated by your doctor. Do not take a double dose to make up for forgotten doses.

If you stop taking Itraconazole TecniGen 100 mg hard capsules EFG

Do not stop treatment with Itraconazole TecniGen without consulting your doctor, as your symptoms may reappear or worsen.

If you have any other 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 all people suffer from them.

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

The following adverse effects were seen during the marketing of the medicine and clinical trials.

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

Very frequent: affecting more than 1 in 10 patients

Frequent: affecting between 1 and 10 in 100 patients

Infrequent: affecting between 1 and 10 in 1,000 patients

Rare: affecting between 1 and 10 in 10,000 patients

Very rare: affecting less than 1 in 10,000 patients

Frequency not known: cannot be estimated with the available data

• Blood and lymphatic system disorders

Rare: leukopenia

Frequency not known: neutropenia, thrombocytopenia (decrease in some blood cells)

• Immune system disorders

Infrequent: exaggerated hypersensitivity and allergic reaction.

Frequency not known: anaphylactic reactions and anaphylactoid reactions, serum disease (allergy that appears after the injection of some sera and is characterized by the appearance of urticaria, fluid accumulation, joint pain, fever, and extreme exhaustion), angioneurotic edema (swelling due to fluid accumulation that can affect the mouth and upper respiratory tract).

• Metabolism and nutrition disorders

Frequency not known: hypokalemia (decrease in potassium in the blood), increased triglycerides.

• Nervous system disorders

Infrequent: tingling sensation in the extremities (paresthesia), headache, and dizziness. Rare: decreased sensitivity (hypoesthesia)

Frequency not known: peripheral nerve damage

• Eye disorders

Rare: visual disturbances.

Frequency not known: blurred vision and double vision.

• Ear and labyrinth disorders

Rare: subjective sensation of noises 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: shortness of breath, difficulty breathing (dyspnea)

Frequency not known: pulmonary edema, rhinitis (inflammation of the nasal mucosa that occurs with the production of watery mucus and frequent sneezing), upper respiratory tract infection, sinusitis (irritation and swelling of the nasal sinuses).

• Gastrointestinal disorders

Frequent: abdominal pain, nausea

Infrequent: vomiting, meal-related discomfort, diarrhea, and constipation, unpleasant taste (bad taste in the mouth), gas accumulation in the intestine (flatulence). Frequency not known: pancreatitis

• Hepatobiliary disorders:

Infrequent: elevated bilirubin levels in the blood (hyperbilirubinemia), increased alanine aminotransferase and aspartate aminotransferase, parameters that measure 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

Frequent: rash.

Rare: urticaria, alopecia (hair loss), itching.

Frequency not known: toxic epidermal necrolysis (a serious skin disease characterized by a skin rash and the appearance of blisters and scales), Stevens-Johnson syndrome (severe skin, mucous membrane, and eye erythema), a severe skin disorder (widespread 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 skin peeling), leukocytoclastic vasculitis (inflammation of the blood vessel wall), photosensitivity (exaggerated skin response to sunlight), skin redness.

• Musculoskeletal and connective tissue disorders

Frequency not known: muscle pain or weakness, joint pain.

• Renal and urinary disorders

Rare: increased urination frequency

Frequency not known: urine loss.

• Reproductive system and breast disorders

Infrequent: menstrual disorders

Frequency not known: erectile dysfunction.

• General disorders and administration site conditions

Infrequent: edema (fluid accumulation) Rare: fever.

• Traumatic injuries, poisonings, and complications of therapeutic procedures

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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Itraconazol TecniGen 100 mg Hard Capsules EFG

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

Do not use this medicine 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. Store in the original packaging to protect it from moisture.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Itraconazol TecniGen 100 mg Hard Capsules EFG

• The active ingredient is itraconazole. Each capsule contains 100 mg of itraconazole.
• The other components are: sugar spheres (cornstarch 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 Packaging Contents

The product is available in blister packs of 7 and 14 hard capsules. Only some 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 prospectus was approved in June 2014.

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