What is in this leaflet

This leaflet answers some common questions about Ortrex. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor as weighed the risks of you taking Ortrex against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Read this leaflet carefully before taking Ortrex® and keep this leaflet. You may need to read it again.

What Ortrex is used for

Ortrex is used to treat fungal and yeast infections such as:

• Invasive aspergillosis (as-pur-jilosis), a fungal infection caused by a fungus called Aspergillus (as-pur-jilus), which usually begins in the respiratory tract (in the nose, sinuses or lungs). Aspergillus is harmless in most healthy people; however, in people with poor immune systems (such as people who have had organ transplants and people with cancer or HIV/AIDS) invasive aspergillosis can be serious and spread to other tissues and organs.
• Serious Candida (can-did-da) infections, including Candida infections of the oesophagus (food pipe or gullet) and those that have spread into the blood stream or to other parts of the body.
• Serious fungal infections caused by Scedosporium (ski-doe-sporerium) species and Fusarium (fewsaa-rium) species.
• Other serious fungal infections in patients who do not respond to, or cannot tolerate, other antifungal medicines.

Ortrex is also used to prevent invasive fungal infections in patients who are at risk of developing such infections.

This medicine belongs to a group of medicines called triazole antifungals.

This medicine works by preventing the growth of fungal and yeast organisms causing your infection.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor's prescription.

Before you start to use it

When you must not use it

Do not take Ortrex if you have ever had an allergy to:

• any medicine containing voriconazole.
• any of the ingredients listed at the end of this leaflet.
• any other similar medicines. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling

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

• pimozide, a medicine used to treat mental illness.
• quinidine, a medicine used to treat irregular heartbeat.
• rifampicin, a medicine used to treat tuberculosis and other infections.
• carbamazepine, a medicine used to treat seizures.
• long-acting barbiturates such as phenobarbitone, medicines used to treat severe insomnia and seizures.
• rifabutin an antibiotic.
• ergotamine or dihydroergotamine (e.g. Dihydergot), medicines used to treat migraine.
• sirolimus, a medicine used in transplant patients.
• efavirenz (a medicine used to treat HIV infection) in doses of 400 mg or more once a day.
• ritonavir (a medicine used to treat HIV infection) in doses of 400 mg or more twice a day.
• St John's Wort (a herbal medicine).

Ortrex should not be given to a child under the age of 2 years.
Safety and effectiveness in children younger than 2 years has not been established.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor first.

Before you start to take it

Tell your doctor if you have allergies to any foods, preservatives or dyes or any other medicines, especially antifungal medicines such as itraconazole (Sporanox), fluconazole (Diflucan), posaconazole (Noxafil) or ketoconazole (Nizoral) (not all brands given).

Tell your doctor if you have or have had any of the following medical conditions:

• heart problems.
• any problems affecting your kidneys.
• any problems affecting your liver. If you have liver disease your doctor may prescribe a lower dose.
• recent chemotherapy or stem cell transplant.

Tell your doctor if you are pregnant or plan to become pregnant.
Ortrex should not be taken during pregnancy, unless indicated by your doctor. Effective contraception should be used in women of childbearing potential. Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you are breast feeding.
Ortrex should not be taken whilst breastfeeding, unless indicated by your doctor. It is not known if the active ingredient voriconazole passes into breast milk. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell your doctor before you start taking Ortrex.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you get without a prescription from a pharmacy, supermarket or health food shop.

Some medicines should not be taken with Ortrex. These include (not all brands given):

• pimozide, a medicine used to treat mental illness.
• quinidine, a medicine for irregular heartbeat.
• rifampicin, a medicine used to treat tuberculosis and other infections.
• carbamazepine, a medicine used to treat seizures.
• long-acting barbiturates such as phenobarbitone, medicines used to treat severe insomnia and seizures.
• rifabutin an antibiotic.
• ergotamine or dihydroergotamine (e.g. Dihydergot), medicines used to treat migraine.
• sirolimus a medicine used in transplant patients.
• efavirenz (a medicine used to treat HIV infection) in doses of 400 mg or more once a day.
• ritonavir (a medicine used to treat HIV infection) in doses of 400 mg or more twice a day.
• St John's Wort, (a herbal medicine).

Some medicines and Ortrex may interfere with each other. These include (not all brands given):

• efavirenz (a medicine used to treat HIV infection) in doses below 400 mg once a day.
• ritonavir (a medicine used to treat HIV infection) in doses of 100 mg twice a day.
• warfarin, a medicine used to stop blood clots.
• everolimus, a medicine used to treat cancer.
• fluconazole, a medicine used to treat fungal infections.
• phenytoin, a medicine used to treat epilepsy.
• cyclosporin, a medicine used to prevent organ transplant rejection or to treat certain problems with the immune system.
• sulphonylureas, medicines used to treat diabetes such as glibenclamide, gliclazide and glipizide.
• some antihistamines, medicines used to treat hayfever, allergic skin reactions, itching.
• theophylline, a medicine used to treat asthma.
• benzodiazepines, medicines used to treat insomnia or anxiety.
• statins, medicines used for lowering cholesterol.
• tacrolimus, a medicine used in patients who have had a liver or kidney transplant.
• indinavir and some other medicines used to treat HIV infection.
• omeprazole, a medicine used to treat indigestion, reflux and stomach or duodenal ulcers.
• methadone (used to treat heroin addiction).
• oral contraceptives (the Pill).
• vincristine, vinblastine or vinorelbine, medicines used in treating cancer.
• strong pain killers such as alfentanil, fentanyl and oxycodone.
• non-steroidal anti-inflammatory drugs, medicines used to treat pain and inflammation such as ibuprofen and diclofenac.

How to take ORTREX

Follow all directions given to you by your doctor or pharmacist carefully.

How much to take

Your doctor will tell you how much to take depending on your weight.

Adults

Treatment of invasive fungal infections

The usual dose of ORTREX Tablets in adults weighing 40 kg and greater is 400 mg (two 200 mg tablets twice a day) for the first day and then 200 mg to 300 mg twice a day thereafter.

The usual dose of ORTREX Oral Suspension in adults weighing 40 kg and greater is 10 ml twice a day for the first day and then 5 ml twice a day.

In adults weighing less than 40 kg the dose of ORTREX Tablets and Oral Suspension is halved.

The usual dose of ORTREX IV is 6 mg/kg every 12 hours for the first day. The dose is then adjusted to 3 mg/kg or 4 mg/kg every 12 hours, depending on the type of infection you have.

Prevention of invasive fungal infections.

The usual dose is 6 mg/kg every 12 hours for the first day, given by injection. The dose is then adjusted to 4 mg/kg every 12 hours by injection or, in adults weighing 40 kg and greater, one 200 mg tablet twice a day or 5 ml oral suspension twice a day.

In adults weighing less than 40 kg the dose of ORTREX Tablets and Oral Suspension is halved.

Children

ORTREX should not be given to a child under the age of 2 years.

Your doctor will determine the dose of ORTREX required for your child.

Depending on how serious the infection is and how your child reacts to the medicine, your doctor may increase or decrease the dose.

Adolescents (12-16 years of age)

Adolescents aged 12-16 years of age are usually given the same dose as adults.

How to take it

ORTREX needs to be taken regularly to be effective.

Tablets

Take ORTREX tablets at least one hour before or one hour after a meal.

Swallow the tablets whole with a full glass of water. Oral Suspension

Take ORTREX Oral Suspension at least one hour before or one hour after a meal.

Your pharmacist should advise you how to measure ORTREX Oral Suspension using the multi-dosing syringe provided in the pack.

ORTREX Oral Suspension should not be mixed with any other medication.

Please see instructions below before using ORTREX Oral Suspension.

Injection

ORTREX IV is given as an injection by a doctor or trained nurse.

ORTREX IV is a powder which is mixed with Water for Injections and then diluted by your pharmacist or doctor. It is then given by injection into a vein.