Posaconazole 300 mg Solution

POSACONAZOLE contains a medicine called posaconazole. This 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.

POSACONAZOLE can be used to treat the following types of fungal infections in patients 18 years of age or older:

• Infections caused by fungi of the Aspergillus family that have not improved during treatment with the antifungal medicine’s amphotericin B, itraconazole or voriconazole, or when these medicines had to be stopped.
• Infections of the mouth or throat area caused by fungi of the Candida family that have not improved during treatment with the antifungal medicine’s amphotericin B, itraconazole or voriconazole, or when these medicines had to be stopped.
• Infections caused by fungi of the Fusarium family that have not improved during treatment of amphotericin B or other therapy, or when such therapy had to be stopped.
• Infections caused by fungi that cause the conditions known as zygomycosis, cryptococcosis, chromoblastomycosis and mycetoma, that have not improved during treatment with itraconazole, or other therapy, or when such therapy had to be stopped.
• Infections caused by the condition known as coccidioidomycosis.
• POSACONAZOLE can be used to prevent fungal infections in patients whose immune systems may be weakened due to other medicines or diseases.

POSACONAZOLE should not be administered to you if:

• If you are hypersensitive (allergic) to posaconazole or to any of the other ingredients of POSACONAZOLE
• If you are taking medicines that contain ergot alkaloids (used to treat migraines). POSACONAZOLE can increase the blood levels of these medicines, which can lead to severe reductions in blood flow to some parts of the body and damage tissues
• If you are taking any of the following medicines. POSACONAZOLE can increase the blood levels of these medicines, which can lead to very serious disturbances in heart rhythm
• terfenadine (used to treat allergies)
• astemizole (used to treat allergies)
• cisapride (used to treat stomach problems)
• pimozide (used to treat symptoms of Tourette’s disorder)
• quinidine (used to treat abnormal heart rhythms)
• If you are taking simvastatin, lovastatin, atorvastatin and some similar medicines (called HMG-CoA reductase inhibitors or statins) that are used to treat high cholesterol levels in the blood
• If you are pregnant or breastfeeding.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before being given POSACONAZOLE if you:

• have had an allergic reaction to another antifungal medicine such as ketoconazole, fluconazole, itraconazole or voriconazole
• have or have ever had liver problems. You may need to have blood tests while you are taking this medicine
• have an abnormal heart rhythm tracing (ECG) that shows a problem called long QTc interval
• have a weakness of the heart muscle or heart failure
• have a very slow heartbeat
• have heart rhythm disturbance
• have any problem with potassium, magnesium or calcium levels in your blood
• are taking vincristine, vinblastine and other “vinca alkaloids” (medicines used to treat cancer)
• are taking venetoclax (a medicine used to treat cancer).

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before being given POSACONAZOLE.

If you develop severe diarrhoea or vomiting (being sick) while taking POSACONAZOLE, talk to your doctor, pharmacist or nurse straight away, as this may stop it from working properly. See Section 4 for more information.

Children

It is not recommended for children under the age of 18 years to take POSACONAZOLE.

Do not share medicines prescribed for you with any other person.

You will not be expected to give yourself POSACONAZOLE. It will be administered by a person qualified to do so.

If you take more POSACONAZOLE than you should

Since a healthcare provider will administer POSACONAZOLE he/ she will control the dosage. However, in the event of overdosage your doctor will manage the situation.

If a dose of POSACONAZOLE is missed

Since a healthcare provider will administer POSACONAZOLE, it is unlikely that a dose would be missed. However, tell your doctor or pharmacist if you think that a dose has been forgotten.

Not all side effects reported for POSACONAZOLE are included in this leaflet. Should your general health worsen of if you experience any untoward effects while taking POSACONAZOLE, please consult your healthcare provider for advice.

Tell your doctor, pharmacist or nurse straight away if you notice any of the following serious side effects-you may need urgent medical treatment:

• signs of liver problems, these include yellowing of your skin or whites of the eyes, unusually dark urine or pale faeces, feeling sick for no reason
• an increase in liver enzymes -shown up in blood tests
• low magnesium levels – shown up in blood tests
• water retention (oedema)
• a change in the salt level in your blood shown in blood tests signs include feeling confused or weak
• heart rhythm problems

Common (> 1/100, < 1/10) side effects:

• rash
• headache
• high blood pressure
• loss of appetite, stomach pain or upset stomach, passing wind, dry mouth, changes in your taste
• pain or an uncomfortable feeling in the upper middle part of your stomach area.
• Fever with low white blood cell count (febrile neutropenia)
• feeling weak, dizzy, tired, or sleepy
• itching
• constipation
• rectal discomfort
• nausea or vomit (feeling or being sick), diarrhoea
• shivering
• swelling, redness, and tenderness along the vein in which POSACONAZOLE was given
• low potassium levels – shown up in blood tests
• abnormal skin sensations, such as numbness, tingling, itching, creeping, pricking, or burning
• low phosphate levels – shown up in blood tests
• chest discomfort
• redness and sores of the lining of the mouth, lips, throat, stomach, and genitals
• swelling of the lungs or the major air passages of the lungs due to fungal infection
• acute renal failure: A condition when one or both of the kidneys suddenly stop working which can cause a build-up of waste that may require medical treatment or dialysis

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side- effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of POSACONAZOLE 300 mg concentrate for solution for infusion.

Store in a refrigerator at 2°C-8°C.

From a microbiological point of view, once admixed, the product should be used immediately.

If not used immediately, the solution can be stored up to 24 hours refrigerated 2°C-8°C. This medicinal product is for single use only.

Store all medicines out of the reach of children.