POSACONAZOL ALTAN 300 MG CONCENTRATE FOR INFUSION SOLUTION

Introduction

Patient Information Leaflet

Posaconazole Altan 300 mg concentrate for solution for infusion EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Posaconazole Altan and what is it used for
2. What you need to know before you use Posaconazol Altan
3. How to use Posaconazole Altan
4. Possible side effects
5. Storage of Posaconazole Altan
6. Contents of the pack and other information

1. What is Posaconazole Altan and what is it used for

Posaconazole Altan contains a medicine called posaconazole, which belongs to a group of medicines called "antifungals". Posaconazole is used to prevent and treat many different fungal infections.

Posaconazole works by killing or stopping the growth of some types of fungi that can cause infections.

This medicine can be used in adults to treat fungal infections caused by fungi of the Aspergillusfamily.

This medicine can be used in adults and children from 2 years of age to treat the following types of fungal infections:

? infections caused by fungi of the Aspergillusfamily that have not improved during treatment with the antifungal medicines amphotericin B or itraconazole, or when treatment with these medicines has had to be stopped;

? infections caused by fungi of the Fusariumfamily that have not improved during treatment with amphotericin B, or when treatment with amphotericin B has had to be stopped;

? infections caused by fungi that cause diseases known as "chromoblastomycosis" and "mycetoma" that have not improved during treatment with itraconazole, or when treatment with itraconazole has had to be stopped;

? infections caused by a fungus called Coccidioidesthat have not improved during treatment with one or more medicines, amphotericin B, itraconazole, or fluconazole, or when treatment with these medicines has had to be stopped.

Posaconazole can also be used to prevent fungal infections in adults and children from 2 years of age who are at high risk of getting a fungal infection, such as:

? patients who have a weakened immune system as a result of having received chemotherapy for "acute myeloid leukaemia" (AML) or "myelodysplastic syndromes" (MDS)

? patients who are receiving "high-dose immunosuppressive treatment" after a "haematopoietic stem cell transplant" (HSCT).

2. What you need to know before you use Posaconazole Altan

Do not use Posaconazole Altan

? if you are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6).

? if you are taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicine that contains "ergot alkaloids", such as ergotamine or dihydroergotamine, or a "statin", such as simvastatin, atorvastatin, or lovastatin.

• if you have just started taking venetoclax or your dose of venetoclax is being slowly increased for the treatment of chronic lymphocytic leukaemia (CLL).

Do not use Posaconazole Altan if you are in any of the above situations. If in doubt, consult your doctor or pharmacist before taking this medicine.

See the section "Using Posaconazole Altan with other medicines" below for information about other medicines that may interact with Posaconazole Altan.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking Posaconazole Altan if:

? you have had an allergic reaction to another antifungal medicine, such as ketoconazole, fluconazole, itraconazole, or voriconazole.

? you have had or currently have liver problems. You may need to have blood tests while you are taking this medicine.

? you have an abnormal heart rhythm (ECG) that shows a problem called QTc interval prolongation.

? you have weakness of the heart muscle or heart failure.

? you have a very slow heart rate.

? you have any heart rhythm problems.

? you have any problems with the levels of potassium, magnesium, or calcium in your blood.

? you are taking vincristine, vinblastine, and other "vinca alkaloids" (medicines used to treat cancer).

• you are taking venetoclax (a medicine used to treat cancer).

You should avoid exposure to the sun while you are taking this medicine. It is important to cover areas of skin that are exposed to the sun with protective clothing and use a high sun protection factor (SPF) sunscreen, as you may be more sensitive to the UV rays of the sun.

If you are in any of the above situations (or if in doubt), talk to your doctor, pharmacist, or nurse before using Posaconazole Altan.

Children

Posaconazole Altan should not be used in children under 2 years of age.

Using Posaconazole Altan with other medicines

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

Do not take Posaconazole Altan if you are taking any of the following medicines:

? terfenadine (used to treat allergies)

? astemizole (used to treat allergies)

? cisapride (used to treat stomach problems)

? pimozide (used to treat symptoms of Tourette's syndrome and mental illnesses)

? halofantrine (used to treat malaria)

? quinidine (used to treat heart rhythm problems).

Posaconazole can increase the levels of these medicines in your blood, which could lead to serious changes in your heart rhythm.

? any medicine that contains "ergot alkaloids", such as ergotamine or dihydroergotamine, used to treat migraines. Posaconazole can increase the levels of these medicines in your blood, which could lead to a serious decrease in blood flow to your fingers or toes and damage them.

? a "statin", such as simvastatin, atorvastatin, or lovastatin, used to treat high cholesterol levels.

• venetoclax when used at the start of treatment for a type of cancer, chronic lymphocytic leukaemia (CLL).

Do not take this medicine if you are in any of the above situations. If in doubt, consult your doctor or pharmacist before taking Posaconazole Altan.

Other medicines

See the list provided earlier of medicines that you should not use while taking Posaconazole Altan. In addition to the medicines mentioned earlier, there are other medicines that may increase the risk of heart rhythm problems, which may be greater when taken with posaconazole. Make sure to tell your doctor about all the medicines you are taking (with or without a prescription).

Some medicines may increase the risk of side effects of Posaconazole Altan by increasing its levels in your blood.

The following medicines may decrease the effectiveness of Posaconazole Altan by reducing its levels in your blood:

? rifabutin and rifampicin (used to treat certain infections). If you are already taking rifabutin, you will need to have a blood test, as well as be aware of some possible side effects of rifabutin.

? some medicines used to treat or prevent seizures, including: phenytoin, carbamazepine, phenobarbital, or primidone.

? efavirenz and fosamprenavir, used to treat HIV infection.

? flucloxacillin (an antibiotic used to treat bacterial infections).

Posaconazole may increase the risk of side effects of other medicines by increasing their levels in your blood. These medicines include:

? vincristine, vinblastine, and other "vinca alkaloids" (used to treat cancer)

• venetoclax (used to treat cancer)

? ciclosporin (used during or after transplants)

? tacrolimus and sirolimus (used during or after transplants)

? rifabutin (used to treat certain infections)

? medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir, which are given with ritonavir)

? midazolam, triazolam, alprazolam, or other "benzodiazepines" (used as sedatives or muscle relaxants)

? diltiazem, verapamil, nifedipine, nisoldipine, or other "calcium channel blockers" (used to treat high blood pressure)

? digoxin (used to treat heart failure)

? glipizide or other "sulphonylureas" (used to treat high blood sugar levels).

• all-trans retinoic acid (ATRA), also called tretinoin (used to treat some blood cancers).

If you are in any of the above situations (or if in doubt), consult your doctor or pharmacist before taking this medicine.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or think you may be pregnant before you start taking Posaconazole Altan. Do not use this medicine if you are pregnant, unless your doctor tells you to.

If you are a woman who can become pregnant, you must use effective contraception while you are using Posaconazole Altan. If you become pregnant while using this medicine, contact your doctor immediately.

Do not breast-feed while you are using Posaconazole Altan, as small amounts may pass into breast milk.

Driving and using machines

You may feel dizzy, sleepy, or have blurred vision while you are taking Posaconazole Altan, which may affect your ability to drive or use tools or machines. If this happens, do not drive or use any tools or machines and contact your doctor.

Posaconazole Altan contains sodium

This medicine contains up to 477 mg of sodium (a major component of cooking/table salt) in each vial. This is equivalent to 23.8% of the maximum recommended daily intake of sodium for an adult.

Consult your pharmacist or doctor if you need Posaconazole Altan 300 mg concentrate for solution for infusion every day for a prolonged period, especially if you have been advised to follow a low-salt diet.

Posaconazole Altan contains cyclodextrin(s)

This medicine contains 6,680 mg of cyclodextrin(s) in each vial, which is equivalent to 6,680 mg/16.7 ml.

3. How to use Posaconazole Altan

Follow exactly the instructions given to you by your doctor or pharmacist. If you are not sure, talk to your doctor or pharmacist again.

The recommended dose for adults is 300 mg twice a day on the first day and then 300 mg once a day.

The recommended dose for children from 2 years to less than 18 years is 6 mg/kg up to a maximum of 300 mg twice a day on the first day and then 6 mg/kg up to a maximum of 300 mg once a day.

Your pharmacist or nurse will dilute posaconazole to the correct concentration.

This medicine will always be prepared and given to you by a healthcare professional.

You will be given posaconazole:

? through a plastic tube inserted into a vein (intravenous infusion)

? usually over 90 minutes

The length of treatment may depend on the type of infection you have or the period of time during which your immune system is not working properly, and may be adjusted individually for you by your doctor. Do not change your dose yourself before talking to your doctor, or change your treatment schedule.

If you miss a dose of Posaconazole Altan

Since this medicine is given under close medical supervision, it is unlikely that you will miss a dose. However, if you think you may have missed a dose, tell your doctor or pharmacist.

If your doctor stops your treatment with Posaconazole Altan, you should not experience any effects.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Severe Adverse Effects

Inform your doctor, pharmacist, or nurse immediately if you notice any of the following severe adverse effects; you may need urgent medical treatment:

? Nausea or vomiting (feeling or being sick), diarrhea

? Signs of liver problems, including yellowing of the skin or the whites of the eyes, unusually dark urine or pale stools, feeling sick without an apparent reason, stomach problems, loss of appetite, or unusual fatigue or weakness, an increase in liver enzymes detected in blood tests

? Allergic reaction

Other Adverse Effects

Inform your doctor, pharmacist, or nurse if you notice any of the following adverse effects:

Frequent: the following may affect up to 1 in 10 patients

? A change in blood salt levels detected in blood tests, whose signs include a feeling of confusion or weakness

? Abnormal sensations in the skin, such as numbness, tingling, itching, crawling, pinching, or burning

? Swelling, redness, and pain along the vein where Posaconazole was administered

? Headache

? Low potassium levels, detected in blood tests

? Low magnesium levels, detected in blood tests

? High blood pressure

? Loss of appetite, stomach pain, or stomach discomfort, flatulence, dry mouth, changes in taste

? Heartburn (a burning sensation in the chest that rises to the throat)

? Low levels of "neutrophils," a type of white blood cell (neutropenia), which can make you more prone to infections and are detected in blood tests

? Fever

? Feeling of weakness, dizziness, fatigue, or drowsiness

? Rash

? Itching

? Constipation

? Rectal discomfort

Infrequent: the following may affect up to 1 in 100 patients

? Anemia, whose signs include headaches, feeling of fatigue or dizziness, difficult breathing, or paleness, and low hemoglobin levels detected in blood tests

? Low platelet levels (thrombocytopenia), detected in blood tests. This can cause bleeding

? Low levels of "leukocytes," a type of white blood cell (leukopenia), detected in blood tests. This can make you more susceptible to infections

? High levels of "eosinophils," a type of white blood cell (eosinophilia). This can appear if you have an inflammatory process

? Inflammation of blood vessels

? Heart rhythm problems

? Seizures (convulsions)

? Nerve damage (neuropathy)

? Abnormal heart rhythm, detected in an electrocardiogram (ECG), palpitations, slow or fast heartbeat, high or low blood pressure

? Low blood pressure

? Inflammation of the pancreas (pancreatitis). This can cause severe stomach pain

? Interruption of oxygen supply to the spleen (splenic infarction), which can cause severe stomach pain

? Severe kidney problems, whose signs include increased or decreased urination with urine that has a different color than usual

? High blood creatinine levels, detected in blood tests

? Cough, hiccups

? Nosebleeds

? Sharp and intense chest pain when breathing (pleuritic pain)

? Inflammation of the lymph nodes (lymphadenopathy)

? Decreased sensitivity, especially in the skin

? Tremors

? High or low blood sugar levels

? Blurred vision, sensitivity to light

? Hair loss (alopecia)

? Mouth ulcers

? Chills, feeling of discomfort

? Pain, back pain, or neck pain, pain in arms or legs

? Fluid retention (edema)

? Menstrual problems (abnormal vaginal bleeding)

? Inability to sleep (insomnia)

? Inability to speak, total or partial

? Mouth swelling

? Abnormal dreams or sleep problems

? Coordination or balance problems

? Mucosal inflammation

? Nasal congestion

? Breathing difficulties

? Chest discomfort

? Feeling bloated

? Nausea, vomiting, cramps, and diarrhea, from mild to severe, usually caused by a virus, stomach pain

? Belching

? Feeling of restlessness

? Inflammation or pain at the injection site

Rare: the following may affect up to 1 in 1,000 patients

? Pneumonia, whose signs include shortness of breath and production of discolored phlegm

? High blood pressure in the blood vessels of the lungs (pulmonary hypertension), which can cause serious damage to the lungs and heart

? Blood problems, such as unusual blood clotting or prolonged bleeding

? Severe allergic reactions, including widespread skin rash with blisters and skin peeling

? Mental problems, such as hearing voices or seeing things that are not there

? Fainting

? Problems thinking or speaking, sudden movements, especially in the hands, that cannot be controlled

? Stroke, whose signs include pain, weakness, numbness, or tingling in the limbs

? Presence of a blind spot or dark spot in the field of vision

? Heart failure or heart attack, which can cause cardiac arrest and death, heart rhythm problems with sudden death

? Blood clots in the legs (deep vein thrombosis), whose signs include intense pain or swelling of the legs

? Blood clots in the lungs (pulmonary embolism), whose signs include shortness of breath or pain when breathing

? Bleeding in the stomach or intestine, whose signs include vomiting blood or blood in the stool

? A blockage of the intestine (intestinal obstruction), especially of the "ileum." This blockage prevents the contents of the intestine from passing through the colon and whose signs include a feeling of bloating, vomiting, severe constipation, loss of appetite, and cramps

? "Hemolytic uremic syndrome" that appears when there is destruction of red blood cells (hemolysis), which can occur with or without kidney failure

? "Pancytopenia," low levels of all blood cells (red, white, and platelets), detected in blood tests

? Large purple spots on the skin (thrombocytopenic purpura)

? Inflammation of the face or tongue

? Depression

? Double vision

? Breast pain

? Inadequate functioning of the adrenal glands, which can cause weakness, fatigue, loss of appetite, skin discoloration

? Inadequate functioning of the pituitary gland, which can cause low blood levels of some hormones that affect the function of male or female sexual organs

? Hearing problems

• Pseudoaldosteronism, which causes high blood pressure with low potassium levels (appears in blood tests)

Frequency not known: cannot be estimated from the available data

? Some patients have also reported feeling confused after taking Posaconazole

? Redness of the skin

Inform your doctor, pharmacist, or nurse if you experience any of the adverse effects described above.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Posaconazole Altan

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 and label, after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Once prepared, the medicine must be used immediately. If it is not used immediately, the storage times and conditions prior to use are the responsibility of the user and should not normally exceed 24 hours between 2°C and 8°C, unless the reconstitution/dilution has been carried out in controlled and validated aseptic conditions.

This medicine is for single use, and any unused solution must be discarded.

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Posaconazole Altan

The active ingredient is posaconazole. Each vial contains 300 mg of posaconazole.

The other components are: sulfobutylether beta-cyclodextrin sodium (SBECD), disodium edetate, hydrochloric acid, sodium hydroxide, water for injectable preparations.

Appearance of the Product and Package Contents

Clear liquid, colorless to slightly yellowish.

Color variations within this range do not affect the quality of the medicine.

This medicine is available in a 20 ml type I amber glass vial for single use, closed with a bromobutyl rubber stopper and an aluminum cap, containing 16.7 ml of solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Altan Pharma Ltd

Lennox Building, 50 South Richmond street

Dublin 2, D02FK02

Ireland

Manufacturer

Altan Pharmaceuticals S.A.

Polígono Industrial de Bernedo s/n

01118 Bernedo, Álava

Spain

Local Representative

Altan Pharmaceuticals S.A.

C/ Cólquide, nº 6, Portal 2, 1ª Planta, Oficina F, Edificio Prisma

28230 Las Rozas, Madrid

Spain

Date of the Last Revision of this Prospectus:05/2025

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

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This information is intended only for healthcare professionals:

Administration Instructions

? Transfer, in an aseptic manner, 16.7 ml of posaconazole to an intravenous infusion bag (or bottle) that contains a compatible mixing solvent (see below for the list of solvents) using a volume range of 150 ml to 283 ml, depending on the final concentration desired (not less than 1 mg/ml and not more than 2 mg/ml).

? Administer through a central venous line, which includes a central venous catheter or a peripherally inserted central catheter (PICC), via slow intravenous infusion over approximately 90 minutes. It should not be administered as a bolus.

? If a central venous catheter is not available, a single infusion can be administered through a peripheral venous catheter with the appropriate volume to achieve a dilution of approximately 2 mg/ml. In this case, the infusion should be administered over approximately 30 minutes.

Note: In clinical trials, multiple peripheral infusions performed through the same vein resulted in reactions at the infusion site (see section 4.8).

? This medicine is for single use.

The following medicines can be infused at the same time as Posaconazole Altan concentrated solution for infusion and through the same intravenous line (or cannula):

Do not administer any medicine that is not included in this table at the same time as this medicine through the same intravenous line (or cannula).

Before administration, the infusion solution should be visually inspected for the presence of particles. The solution ranges from colorless to slightly yellowish. Color variations within this range do not affect the quality of the medicine.

Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

Posaconazole Altan should not be diluted with:

Lactated Ringer's Solution

5% Dextrose with Lactated Ringer's Solution

4.2% Sodium Bicarbonate

This medicine should not be mixed with other medicines, except for those mentioned below:

5% Dextrose in water

0.9% Sodium Chloride

0.45% Sodium Chloride

5% Dextrose and 0.45% Sodium Chloride

5% Dextrose and 0.9% Sodium Chloride

5% Dextrose and 20 mEq of KCl