PROSPECTO: INFORMATION FOR THE USER

Itraconazole TecniGen100 mg hard capsules EFG

Itraconazole

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. Seesection 4.

1. What isItraconazole TecniGen100 mg hard capsules EFG and for what it is used

2. What you need to know before starting to takeItraconazole TecniGen100 mg hard capsules EFG

3. How to takeItraconazole TecniGen100 mg hard capsules EFG

4. Possible adverse effects

5. Storage ofItraconazole TecniGen100 mg hard capsules EFG

6. Contents of the package and additional information

ItraconazolTecniGenbelongs 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 takeItraconazoleTecniGen:

•if you are allergic to the active ingredient or any of the other components of this medication (including in section 6).

•do not useItraconazoleTecniGencapsules with some medications, see section “Use of other medications”, “Do not useItraconazoleTecniGencapsules with the following medications”.

•if you have a condition called heart failure (also called congestive heart failure or CHF). This medication may worsen it.

If your doctor considers that you should take this medication, 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 evaluate whether you should take this medication.

•if you are fertile, you should take appropriate contraceptive measures to avoid becoming pregnant during treatment. Since this medication may remain in the body for a long time, you should extend contraceptive measures until the next menstrual period after completing treatment with this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeItraconazoleTecniGencapsules.

•if you have heart problems, consult your doctor. If he decides to prescribeItraconazoleTecniGencapsules, he should give you instructions on the symptoms that may appear, such as difficulty breathing, unexpected weight gain, leg swelling, unusual fatigue, or insomnia, so that you can contact him immediately.

•if you have any liver problems. The dose of this medication may need to be adjusted. If any of the following symptoms appear during treatment with this medication, stop taking it and consult your doctor immediately: loss of appetite, nausea, vomiting, fatigue, abdominal pain, jaundice (yellow discoloration of the skin, mucous membranes, and secretions), very dark urine, or pale stools. If you are taking a treatment withItraconazoleTecniGencapsules, it is very likely that your doctor will send you regular blood tests, as liver disorders have occurred in very rare cases.

•if you have any kidney problems, consult your doctor. The dose of this medication may need to be adjusted.

•contact your doctor if you have neutropenia, AIDS, or have received an organ transplant. The dose of this medication may need to be adjusted.

•if in the past you have suffered any allergic reaction due to another medication used to treat fungal infections (medications known as azoles), consult your doctor. An allergic reaction can be recognized, for example, by the appearance of skin rash, itching, hives, shortness of breath, or difficulty breathing, and/or facial swelling. If you suffer a severe allergic reaction, consult your doctor immediately.

•if during treatment withItraconazoleTecniGencapsules you feel unusual tingling, numbness, or weakness in your feet or hands (neuropathy), consult your doctor immediately.

•stop taking this medication and contact your doctor immediately if you do not hear correctly. In very rare cases, temporary or permanent hearing loss has occurred.

•do not recommend taking this medication in elderly patients. Only in exceptional cases can it be prescribed by the doctor.

Administration ofItraconazoleTecniGen100 mg hard capsules EFG with other medications

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication.

Some medications should not be taken at the same time or if certain medications are taken, the dose may need to be adjusted.

Do not takeItraconazoleTecniGen100 mg hard capsules EFG with the following medications:

•certain medications for treating allergies, mainly terfenadine, astemizol, and mizolastina.

•certain medications used to treat angina pectoris (oppressive chest pain) and high blood pressure, such as bepridilo and nisoldipino.

•cisaprida, a medication used for digestive problems.

•levacetilmetadol, a medication used in opioid dependence treatment.

•certain medications used to treat irregular heart rhythms, mainly quinidina and dofetilida.

•certain medications used to lower cholesterol, such as atorvastatina, simvastatina, and lovastatina.

•medications used to treat anxiety or to induce sleep, such as midazolam oral and triazolam.

•pimozida and sertindol, medications used for psychotic disorders.

•alkaloids of ergot, such as dihidroergotamina and ergotamina used in the treatment of migraines.

•eletriptán, a medication used to treat migraines.

•alkaloids of ergot, such as ergometrina (ergonovina) and metilergometrina (metilergonovina) used in the control of bleeding and maintenance of uterine contractions after delivery.

Antacids should not be taken until two hours after takingItraconazoleTecniGen(see section 3 “How to takeItraconazoleTecniGen100 mg capsules”).

Certain medications may decrease the action ofItraconazoleTecniGencapsules. This may apply particularly to some medications used to treat epilepsy (for example, carbamacepina, fenitoína, and fenobarbital) and tuberculosis (for example, rifampicina and isoniazida) and St. John's Wort. Therefore, you should always inform your doctor if you are using any of these medications so that they can take the necessary measures.

The combination with other medications may require an adjustment of the dose, either of this medication, or of the other medications. Examples are:

• some antibiotics called claritromicina, eritromicina, rifabutina;
• blood thinners;
• some HIV protease inhibitors;
• some medications used to treat cancer;
• ciclosporina, tacrolimus, and rapamicina (also known as sirolimus), which are usually used after an organ transplant;
• metilprednisolona, budesonida, fluticasona, and dexametasona, medications that can be administered orally, by injection, or by inhalation for conditions such as inflammation, asthma, and allergies;
• some medications that act on the heart and blood vessels (digoxina, disopiramida, some calcium channel blockers, cilostazol);
• some medications used to treat anxiety or to induce sleep (tranquilizers), mainly buspirona, alprazolam, and brotizolam;
• ebastina, a medication for allergies;
• reboxetina, a medication used to treat depression;
• fentanilo, a very strong medication for pain relief;
• halofantrina, a medication used to treat malaria;
• repaglinida, a medication used to treat diabetes.

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

There should be enough acidity in the stomach to ensure the absorption ofItraconazoleTecniGencapsules. Therefore, antacids should be used after two hours of taking this medication. For the same reason, if you are taking medications that regulate the production of acid in the stomach, takeItraconazoleTecniGencapsules with a cola drink.

Administration ofItraconazoleTecniGen100 mg capsules with food and drinks

Take this medication immediately after finishing one of the main meals. If you are taking any medication that regulates the production of acid in the stomach, it is recommended to take this medication with a cola drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy

This medication will not be used in case of pregnancy.

If you are fertile, you should take appropriate contraceptive measures to avoid becoming pregnant during treatment. SinceItraconazole TecniGencapsules may remain in the body for a long time, you should extend contraceptive measures until the next menstrual period after completing treatment with this medication. (See section 2 “Do not takeItraconazoleTecniGen100 mg capsules”).

Breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are breastfeeding, consult your doctor before takingItraconazoleTecniGen, as small amounts of the medication may appear in the milk.

Driving and operating machinery

There is no problem driving or operating machinery, unless you feel dizzy, blurred/double vision, or hearing loss. If you feel any of these symptoms, do not drive or operate machinery.

ItraconazoleTecniGen100 mg capsules contain saccharose

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Do not discontinue treatment beforehand. If you think the medication's action is too strong or too weak, inform your doctor or pharmacist.

You must takeitraconazolecapsules immediately after meals, as this is when it is best absorbed. Swallow the capsules whole with a little water. The number of capsules you must take and for how long depends on the type of fungus and the location of the infection. Your doctor will tell you exactly how muchitraconazolecapsules 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 taken two hours after taking this medication. For the same reason, if you are taking medications that regulate stomach acid production, takeitraconazolecapsules with a cola drink.

The following doses are the most common:

• Nail infections: depending on your personal needs, your doctor will choose a continuous or pulsatile treatment.

• Continuous treatment for foot nail infections:

• Pulsatile treatment for nails:

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

Lesions on the skin 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 grows.

Nail lesions will disappear from 6 to 9 months after completing treatment, as the medication only eliminates the fungus itself. The nail has to 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 stop 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 TecniGencapsules should not be used in children. Only in exceptional cases can it be prescribed by the doctor.

If you take moreItraconazole TecniGen100 mg hard capsules EFG 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. They may also perform stomach lavage within the hour after ingestion or administer activated charcoal if considered appropriate. Itraconazole is not eliminated by hemodialysis. No specific antidotes are known.

If you forget to takeItraconazole TecniGen100 mg hard capsules EFG

Ifyouforgettotakethemedication,takethenextdosethatcorrespondstoyouandcontinuethetreatmentasindicatedbyyourdoctor.Do not take a double dose to compensate for the missed doses.

If you discontinue treatment withItraconazole TecniGen100 mg hard capsules EFG

Do not discontinue treatment withItraconazole TecniGenwithout consulting your doctor, as your symptoms may worsen or reappear.

If you have any other questions 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 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: affects more than 1 in 10 patients

Common: affects between 1 and 10 in 100 patients

Uncommon: affects between 1 and 10 in 1,000 patients

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

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

Frequency not known: cannot be estimated with available data

•Blood and lymphatic system disorders

Rare: leucopenia

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

•Immune system disorders

Uncommon: excessive and allergic hypersensitivity reactions.

Frequency not known: anaphylactic and anaphylactoid 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 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), increase in triglycerides.

•Nervous system disorders

Uncommon: paresthesia (tingling sensation in the extremities), 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 noise in the ear.

Frequency not known: permanent or temporary hearing loss.

•Cardiac disorders

Frequency not known: congestive heart failure.

•Respiratory, thoracic, and mediastinal disorders

Rare: labored breathing, difficulty breathing (dyspnea)

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

•Gastrointestinal disorders

Common: abdominal pain, nausea

Uncommon: vomiting, discomfort associated with meals, diarrhea, constipation, unpleasant taste (bad taste in the mouth), accumulation of gas in the intestine (flatulence). Frequency not known: pancreatitis.

•Hepatobiliary disorders:

Uncommon: elevated bilirubin in the blood (hyperbilirubinemia), increased alanine aminotransferase and aspartate aminotransferase, liver function parameters.

Rare: reversible increase in liver enzymes

Frequency not known: acute liver failure, severe hepatotoxicity (including cases of severe acute liver failure), hepatitis, abnormal liver function.

•Skin and subcutaneous tissue disorders

Common: rash.

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

Frequency not known: 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 rash with skin peeling and blisters in the mouth, eyes, and genitals, or generalized rash with small pustules or blisters), erythema multiforme (skin disease characterized by the appearance of vesicles, blisters, etc.), exfoliative dermatitis (skin disease characterized by peeling), leukocytoclastic vasculitis (inflammation of the blood vessel walls), photosensitivity (exaggered 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 frequency of urination

Frequency not known: loss of urine.

•Reproductive and breast disorders

Uncommon: menstrual disorders

Frequency not known: erectile dysfunction.

•General disorders and administration site conditions

Uncommon: edema (fluid accumulation) Rare: fever.

•Injury, poisoning, and procedural complications

Frequency not known: injury.

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 that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: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. Store in the original packaging to protect it from moisture.

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

CompositionofItraconazol TecniGen100 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 coating: indigo carmine (E 132), yellow of quinoline (E 104), titanium dioxide (E 171) and gelatin.

Appearanceof the product and contents of the packaging

The product is available in blister packaging of 7 and 14 hard capsules.
Only some sizes of packaging may be commercially marketed.

Holderof the marketing authorization and responsible for manufacturing: Holder of the marketing authorization:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Arroyo de la Vega Industrial Estate,

28108 Alcobendas (Madrid) Spain

Responsible for manufacturing:

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

Miralcampo Industrial Estate

19200 Azuqueca de Henares (Guadalajara) SPAIN

This leaflet was approved inJune 2014.

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