ITRACONAZOL 250 mg Concentrate For Solution For Infusion

Prospect: information for the patient

Itraconazole Altan 10 mg/ml concentrate and solvent for solution for infusion EFG

Read this prospect carefully before starting to use this medication,because it contains
important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult yourdoctor, pharmacist or nurse.
• This medication has been prescribedonlyto you, and you must not give it to other people even ifthey havethe same symptomsas you,as it may harm them.
• If you experience any adverse effects,consult your doctor, pharmacist or nurse, evenifthey are not listed in this prospect. See section 4.

1.What isItraconazole Altanand for what it is used

2.What you need to know before starting to use Itraconazole Altan

3.How to use Itraconazole Altan

4.Possible adverse effects

5.Storage of Itraconazole Altan

6.Contents of the package and additional information

Itraconazol Altanbelongs to a group of medicines called “antifungals”. These medicines are indicated for treating infections caused by fungi including yeasts.Itraconazol Altanis indicated for the treatment of internal organ infections caused by fungi.

No use Itraconazol Altan

• If you are allergic (hypersensitive) to any of the components of Itraconazol Altan 10 mg/ml (see section 6 for more information).
• If you are pregnant, think you may be pregnant, or are trying to become pregnant (see pregnancy section).
• If you have a severe kidney disease.
• If you cannot receive sodium chloride by injection.
• If you are taking any of the following medications:
• • Terfenadine, astemizole, or mizolastine (antihistamines for allergies).
  • Bepridil, a medication for the treatment of angina (chest pain).
  • Nisoldipine (used for high blood pressure).
  • Cisapride (for digestive problems).
  • Midazolam oral or triazolam (used to help fall asleep or for anxiety).

anxiety).

Warnings and precautions

Consult your doctor or nurse before starting to useItraconazol Altan

Inform your doctor immediately:

• If you feel unusual tingling, numbness, or weakness in your feet or hands while using Itraconazol Altan.
• If you experience symptoms of hearing loss. In very rare cases, permanent or temporary hearing loss has been reported in patients taking Itraconazol Altan.

Before using Itraconazol Altan, inform your doctor if you have or have had any of the following conditions:

• You have any liver problems or jaundice (yellowing of the skin). If your doctor decides to prescribe Itraconazol Altan, it may be necessary to adjust the dose. Your doctor should give you instructions on the symptoms that may appear and perform blood tests.
• You have an allergy to any medication used to treat fungal infections.
• You have any heart problems, including congestive heart failure (also known as congestive heart failure or CHF) as Itraconazol Altan 10 mg/ml may worsen it. If your doctor decides to prescribe Itraconazol Altan 10 mg/ml, they should give you instructions on the symptoms that may appear. If you have any of the following symptoms, stop using Itraconazol Altan and inform your doctor immediately. They may be signs of congestive heart failure:
• • Difficulty breathing
  • Unexplained weight gain
  • Swelling of legs or stomach
  • Unusual fatigue
  • Waking up with a feeling of suffocation at night

• Follow a low-sodium diet.
• You have any kidney problems, it may be necessary to adjust the dose of Itraconazol Altan or perform more thorough monitoring.

Children and elderly population

Itraconazol Altanis usually not given to children or the elderly population. Only in exceptional cases can it be prescribed by a doctor.

Use of Itraconazol Altan with other medications

Inform your doctor or pharmacist that you are using, have used recentlyor may need to use any other medication.

There are some medications that you should not take while usingItraconazol Altan. These medications are included in the section “Do not useItraconazol Altanif:”

Inform your doctor if you are takingany of the following medications, as they may reduce the action ofItraconazol Altan:

• Rifampicin, rifabutin, and isoniazid (antibiotics used to treat tuberculosis).
• Phenytoin, carbamazepine, and phenobarbital (antiepileptic medications).
• St. John's Wort (a medicinal plant).

Do not useItraconazol Altanuntil 2 weeks after taking these medications.

Inform your doctor before using any of the following medications, as it may require an adjustment of the dose, either ofItraconazol Altanor of the other medications:

• Clarithromycin and erythromycin (antibiotics for infection).
• Certain medications that act on the heart and blood vessels (digoxin, disopyramide, and some calcium channel blockers such as dihydropyridines, verapamil, and cilostazol).
• Certain medications that slow down blood clotting or circulation, such as warfarin.
• Prednisolone, budesonide, fluticasone, and dexamethasone, medications administered orally and injectable for the treatment of inflammatory processes, asthma, and allergies.
• Ciclosporin, tacrolimus, and rapamycin (also known as sirolimus) used after organ transplantation.
• Certain medications used to treat HIV, such as ritonavir, indinavir, and saquinavir.
• Certain medications used in cancer treatment (such as busulfan, docetaxel, trimetroxate, and the group of medications known as vinca alkaloids).
• Alfentanil and fentanyl (used for pain).
• Buspirone, alprazolam, brotizolam, and midazolam, when administered by intravenous injection (for the treatment of anxiety or to induce sleep).
• Reboxetine (for depression)
• Antihistamine containing ebastine.
• Halofantrine (for malaria).
• Repaglinide (for diabetes).
• Cerivastatin (to lower cholesterol levels).

Please inform your doctor or pharmacist if you are using or have used recently other medications, even those acquired without a prescription or medicinal plants.

Pregnancy

Do not use Itraconazol Altan if you are pregnant and before consulting your doctor.

If you are of childbearing age and may become pregnant, you should take adequate contraceptive precautions to ensure you do not become pregnant while taking the medication.

As Itraconazol Altan remains in the body for some time after treatment is stopped, once treatment with Itraconazol Altan is completed, some form of effective contraception should be continued until the next menstrual period.

If you become pregnant after starting treatment with Itraconazol Altan, consult your doctor immediately.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consultyour doctor before using this medication.

Lactation

You shouldstopbreastfeedingbeforestartingtreatmentwithItraconazolAltan,assmallamountsofthemedicationmayappearinthemilk.

Driving and operating machinery

Itraconazol Altan may cause dizziness, blurred vision/double vision, or hearing loss in some cases. If you experience any of these symptoms, do not drive or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor.In case of doubt, consult your doctor again.

This medication must be administered by your doctor or nursing staff.Itraconazol Altanis mixed in the bag with thesodium chloride 9 mg/ml (0.9%) solution for injectionand administered by slow intravenous injection. This preparation is called intravenous perfusion (IV) and is normally administered over one hour.During the first two days, you will be administered two perfusions each day.From day 3 onwards, you will receive one perfusion per day.

The recommended doseisas follows:

Adults:

During day 1 and 2 of treatment: Two 60-milliliter perfusions of 1 hour duration each day will be administered, containing 200 milligrams of Itraconazol Altan 10 mg/ml.

From day 3 onwards: One 60-milliliter perfusion of 1 hour duration each day will be administered, containing 200 milligrams of Itraconazol Altan.

Children:

Use in children is not recommended.

Geriatric patients:

Use in elderly populations is not recommended.

If you forgot to use the medication or were administered more Itraconazol Altan than you should have.

Since the medication is administered by your doctor or nursing staff, it is difficult for you to be administered more than you should or for a dose to be missed. However, if you have any doubts, consult your doctor or nurse.

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 used.

Like all medicines, Itraconazol Altan can cause side effects, although not everyone will experience them.

Medicines can cause serious allergic reactions.

Stop using Itraconazol Altan and contact your doctor immediatelyif you experience:

• Some wheezing when breathing, difficulty breathing, facial inflammation, rash, itching (all over the body) or a severe skin disorder including blisters and skin peeling.
• Severe loss of appetite, nausea, vomiting, unusual fatigue, abdominal pain (stomach), dark urine or pale stools. These may be symptoms of serious liver problems.

Inform your doctor immediately if you experience any of the following side effects:

• Cardiovascular circulation-related symptoms such as difficulty breathing, unexpected weight gain, leg swelling, unusual fatigue (tiredness) and difficulty sleeping all night uninterrupted.
• Tingling sensation, light sensitivity and numbness or weakness in the extremities.
• Blurred vision or seeing double, if you hear a ringing in your ears, if you lose your ability to control urination or urinate more than usual.
• If you experience symptoms of hearing loss.

Other side effects that may occur are:

Side effectsveryfrequent(occur in more than 1 in 10 patients):

• Nausea.

Side effectscommon(occur in less than 1 in 10 patients):

• Muscle weakness (possible symptom of low potassium levels in the blood).
• Headache, dizziness.
• Abdominal pain, vomiting, diarrhea, constipation.
• Increased levels of specific liver function (liver enzyme), liver inflammation (hepatitis), yellow discoloration of the skin (jaundice).
• Rash, itching.
• General swelling.
• Fever or high temperature
• Labored breathing, difficulty breathing

Side effectsinfrequent(occur in less than 1 in 100 patients) are:

• Increased blood sugar levels.
• Unpleasant taste.
• Muscle pain.

The following side effects have occurred in patients after administration of Itraconazol Altan with an unknown frequency:

• Certain blood abnormalities that may increase the risk of bleeding, bruising or infections.
• Excess triglycerides in the blood.
• High blood pressure
• Indigestion
• Hair loss.
• Joint pain.
• Menstrual irregularities.
• Erectile dysfunction.
• Severe pain in the upper part of the stomach, often accompanied by nausea and vomiting due to pancreatitis (inflammation of the pancreas)

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Itraconazol Altan 10 mg/ml must be stored in the hospital pharmacy service.

Do not usethis medicationafter the expiration date that appears onthe boxaftertheCAD.The expiration date is the last day of the month indicated.

Do not store Itraconazol Altan at a temperature above 30 °C. Store in the original packaging.

Do not store the sodium chloride bag above 30 °C.

Protect the mixture of the solution from direct light. Once the mixture is obtained, it must be administered immediately.

The physical and chemical stability of the product has been demonstrated once diluted for a maximum of 24 hours stored between 2 and 8 °C. From a microbiological point of view, it is recommended to use the product immediately once reconstituted; otherwise, the storage conditions and duration are the responsibility of the user.

Medicines should not be thrown away through the drains or in the trash. Ask your pharmacisthow to dispose ofthepackaging and of themedicines that you no longerneed.By doing so, you will help protect the environment.

Itraconazol Altan Composition

• The active ingredient is itraconazole 10 mg (milligrams) of itraconazole per ml (milliliter).
• The other components (excipients) are hydroxypropyl-β-cyclodextrin, propylene glycol, concentrated hydrochloric acid, sodium hydroxide, and water for injection.

Composition of the SolutionSodium Chloride 9 mg/ml (0.9%) solution for injection

• Sodium chloride, water for injection.

Appearance of the Product and Contents of the Package

Itraconazol Altanis presented in a kit composed of a concentrated transparent and colorless solution for intravenous infusion (IV), which needs to be diluted before use.

Itraconazol Altancomes in a 25 milliliter (ml) vial, along with a bag containing a transparent and colorless solution of sodium chloride and a extension set. These two solutions will be mixed, resulting in a transparent and colorless solution before being injected directly into a vein.

One milliliter ofItraconazol Altancontains 10 milligrams (mg) of itraconazole. Once Itraconazol Altan is mixed with the sodium chloride bag, each milliliter of the resulting solution contains 3.33 milligrams of itraconazole.

The sodium chloride bag is a polypropylene plastic bag containing 50 milliliters of injectable sodium chloride solution. One milliliter of the solution contains 9 milligrams of sodium chloride, which is used to diluteItraconazol Altanmaking its administration easier.

Marketing Authorization Holder

Altan Pharmaceuticals, S.A.

C/ Cólquide, 6. Portal 2. 1st floor. Office F

Edificio Prisma

28230 Las Rozas (Madrid) Spain

Responsible for Manufacturing

Altan Pharmaceuticals, S.A.

Avda de la Constitución 198 - 199, Industrial Estate Monte Boyal

45950 Casarrubios del Monte (Toledo) Spain

or

Altan Pharmaceuticals, S.A.

Industrial Estate of Bernedo s/n

01118 Bernedo (Álava)

Last Review Date of this Leaflet:February 2014

For detailed and updated information on this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/.