Vorispore Film-Coated Tablets

Vorispore is an antifungal medicine. It works by killing or stopping the growth of the fungi that cause infections. Vorispore is used for the treatment of patients (adults and children over the age of 2) with: invasive aspergillosis (a type of fungal infection due to Aspergillus sp), serious invasive Candida sp. infections when the fungus is resistant to fluconazole (another antifungal medicine), serious fungal infections caused by Scedosporium sp. or Fusarium sp. (two different species of fungi). Vorispore may also be used for the prevention of fungal infections in high risk bone marrow transplant recipients. Vorispore should only be used under the supervision of a doctor.

Vorispore should not be administered to you:

• if you are hypersensitive (allergic) to voriconazole or any ingredient in Vorispore (listed in section 6);
• if you have prolonged QT-syndrome (a heart rhythm disorder);
• if your liver function is severely affected.

It is very important that you inform your doctor or pharmacist if you are taking or have taken any other medicines, even those that are obtained without a prescription, or herbal medicines. There are many medicines that must not be taken during your course of Vorispore treatment. (See comprehensive list below, under “Other medicines and Vorispore “ Vorispore must not be used if you are already taking any of the following list of medicines”)

Do not share medicines prescribed for you or your child with any other person. Always take Vorispore exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide what dose you should receive for your condition and also for how long you need to receive it. The dose and duration of treatment will depend on how your body and the infection reacts on the treatment.

The usual dose for adults (including elderly patients) is as follows:

Body weight 40 kg and more

Dose for the first 24 hours (Loading dose) 400 mg every 12 hours for the first 24 hours

Body weight below 40 kg

Dose for the first 24 hours (Loading dose) 200 mg every 12 hours for the first 24 hours

Dose after the first 24 hours (Maintenance dose) 200 mg twice a day 100 mg twice a day

Depending on your response to treatment, your doctor may increase the daily dose to 300 mg twice a day. The doctor may decide to decrease the dose if you have mild to moderate cirrhosis. Take your tablet at least one hour before, or one hour after a meal. Swallow the tablet whole with some water.

Use in children and adolescents Tablets must only be given if the child is able to swallow tablets. Your child’s doctor will work out the dose for your child, based on his/her mass. He/she will tell you how long the treatment with Vorispore will last. Take your tablet at least one hour before, or one hour after a meal. Swallow the tablet whole with some water. The usual dose for children and teenagers is as follows: Children aged 2 - 12 years Dose for the first 24 hours (Loading dose) 6 mg/kg every 12 hours. Your treatment will be started as an infusion Dose after the first 24 hours (Maintenance dose) 4 mg/kg every 12 hours. If you have the impression that the effect of Vorispore is too strong or too weak, tell your doctor or pharmacist.

Vorispore can have side effects. Not all side effects reported for Vorispore are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving Vorispore, please consult your healthcare provider for advice.

If any of the following happens, stop using Vorispore and tell your doctor immediately:

• Serious allergic reactions, including a shock reaction. You may have swelling of the tongue and/or throat, difficulty in swallowing, difficulties in breathing, facial swelling, severe dizziness with very fast heartbeat and heavy sweating.
• Allergic skin reactions (sometimes severe), including rapid swelling (oedema) of the dermis, subcutaneous tissue, mucosa and submucosal tissues, itchy or sore patches of thick, red skin with silvery scales of skin, irritation of the skin and mucous membranes, life threatening skin condition that causes large portions of the epidermis, the skin's outermost layer, to detach from the layers of skin below.
• Jaundice (yellowing of the eyes or skin, dark urine, upper stomach pain), liver failure, gallbladder disease, gallstones.
• Deterioration of brain function that is a serious complication of liver disease.
• Inflammation of the pancreas (abdominal pain, fever, rapid pulse, nausea, shivering).
• Severe diarrhoea and nausea with fever and weakness. This is a serious condition for which you may need urgent treatment.
• Heart rhythm disturbances, including very fast heartbeat, very slow heartbeat, conduction problems (sometimes life threatening), fainting.
• Double vision, serious conditions of the eye including pain and inflammation of the eyes and eyelids, abnormal eye movement, damage to the optic nerve resulting in vision impairment, optic disc swelling.
• Disorder of blood clotting system (clotting in the blood vessels).
• Guillain-Barré syndrome (the body’s immune system attacks part of the peripheral nervous system, with resulting muscle weakness, beginning in the feet and hands).
• Kidney failure, inflammation in the kidney, blood in the urine, problems urinating, changes in kidney function tests, proteins in the urine. These are all very serious side effects. If you have them, you may have had a serious reaction to Vorispore. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following: Also tell your doctor if you notice any of the following: Frequent side effects

• Sinusitis (infection of the nasal passages)
• Low numbers of some types, including severe, of red (sometimes immune-related) and/or white blood cells (sometimes with fever), low numbers of cells called platelets that help the blood to clot
• You get more infections than usual. This could be because of a decrease in white blood cells Your doctor will confirm this with a blood test
• Low blood sugar, low blood potassium or low sodium in the blood (you will only know for sure that you have these deficiencies if you go for blood tests) Tell your doctor if you have muscle cramps and feel weak
• Easy or excessive bruising, superficial bleeding into the skin, unexpected excessive bleeding, particularly if you also take or receive blood thinning medicines such as warfarin
• Depression, problems falling asleep, anxiety, hallucinations (false perceptions)
• Sleepiness, feeling faint and/or dizzy
• Convulsions (fits or jerks), severe headache, loss of coordination
• Tingling or abnormal skin sensations, increase in muscle tone
• Bleeding in the eye
• Low blood pressure (you may feel faint or dizzy)
• Inflammation of a vein (phlebitis, a condition where the veins close to the surface of the body become swollen, tender, and red and may develop blood clots)
• Nausea (feeling sick), vomiting (being sick), diarrhoea (loose bowels), stomach pain, inflammation of the lips
• Constipation, indigestion
• Skin rashes, hair loss
• Back pain
• Feeling tired and generally weak.

Less frequent side effects

• Enlarged lymph glands (sometimes painful), failure of bone marrow, increased eosinophil
• Disorder of blood clotting system
• Overactive thyroid. If you have muscle weakness, have a rapid heartbeat and increased appetite, tell your doctor
• Underactive thyroid (some signs may be weight gain, fatigue and depression).
• Abnormal sense of taste
• Decreased sensitivity to touch
• Abnormal brain function, Parkinson-like symptoms, nerve injury resulting in numbness, pain, tingling or burning in the hands or feet
• Sudden behaviour changes, problems with thinking or speech
• Problems with balance or coordination, swelling of the brain
• Eye-rolling disorder where the eyes fix upwards
• Ringing in the ears, dizziness, hearing loss
• Inflammation of certain internal organs – pancreas and duodenum, swelling and inflammation of the tongue
• Inflammation of the thin tissue that lines the inner wall of the abdomen and covers the abdominal organ
• Bullous photosensitivity
• Freckles and pigmented spots
• Joint and muscle pains in the legs and arm.
• Flu-like illness
• Increased blood cholesterol.

Other significant side effects whose frequency is not known, but should be reported to your doctor immediately:

• Skin cancer
• Inflammation of the tissue surrounding the bone
• Red, scaly patches or ring-shaped skin lesions that may be a symptom of an autoimmune disease called cutaneous lupus erythematosus.

Some side effects such as temporary blood, cholesterol, kidney or liver problems can only be detected when your doctor orders blood or urine tests to check your progress. Children Sunburn or severe skin reaction following exposure to light or sun was experienced more frequently in children. If you or your child develops skin disorders, your doctor may refer you to a dermatologist, who after consultation may decide that it is important for you or your child to be seen on a regular basis. Elevated liver enzymes were also observed more frequently in children.

Store all medicines out of reach of children. Store in the original pack at or below 25 °C. Do not use after the expiry date stated on the label and carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).