Voriconazol AET 50 mg filmomhulde tabletten

Voriconazol AET contains the active substance voriconazole. Voriconazol AET is an antifungal medicine. It works by killing or stopping the growth of the fungi that cause infections.

It 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),

. candidaemia (another type of fungal infection due to Candida sp) in non-neutropenic patients (patients without abnormally low white blood cells count),

. 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).

Voriconazol AET is intended for patients with worsening, possibly life-threatening, fungal infections. This product should only be taken under the supervision of a doctor.

Do not take Voriconazol AET:

-If you are allergic to voriconazole or any of the other ingredients of this medicine (listed in section 6)

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.

The medicines in the following list must not be taken during your course of Voriconazol AET treatment:

• Terfenadine (used for allergy)
• Astemizole (used for allergy)
• Cisapride (used for stomach problems)
• Pimozide (used for treating mental illness)
• Quinidine (used for irregular heart beat)
• Rifampicin (used for treating tuberculosis)
• Carbamazepine (used to treat seizures)
• Phenobarbital (used for severe insomnia and seizures)
• Ergot alkaloids (e.g. ergotamine, dihydroergotamine; used for migraine)
• Sirolimus (used in transplant patients)
• Ritonavir (used for treating HIV) in doses of 400mg and more twice daily
• St John’s Wort (herbal supplement)
• Efavirenz (used for treating HI) in doses of 400 mg and above once daily

Warnings and precautions:

Talk to your doctor or pharmacist before taking Voriconazol AET if

. you have had an allergic reaction to other azoles.

. you are suffering from, or have ever suffered from liver disease. If you have liver disease, your doctor may prescribe a lower dose of Voriconazol AET. Your doctor should also monitor your liver function while you are being treated with Voriconazol AET by doing blood tests.

. you are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome’.

You should avoid sunlight and sun exposure while being treated. It is important to cover sun exposed areas of skin and use sunscreen, as an increased sensitivity of skin to the sun’s UV rays can occur.

While being treated with Voriconazol AET:

. tell your doctor immediately if you develop a severe skin rash or blisters or bone pain.

. your doctor should monitor the function of your liver and kidney by doing blood tests.

Children and adolescents

Voriconazol AET should not be given to children younger than 2 years of age.

Other medicines and Voriconazol AET:

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

Some medicines, when taken at the same time as Voriconazol AET, may affect the way Voriconazol AET works or Voriconazol AET may affect the way they work.

Tell your doctor if you are taking the following medicine, as treatment with Voriconazol AET at the same time should be avoided if possible:

• Ritonavir (used for treating HIV) in doses of 100 mg twice daily

Tell your doctor if you are taking either of the following medicines, as treatment with Voriconazol AET at the same time should be avoided if possible, and a dose adjustment of voriconazole may be required:

• Rifabutin (used for treating tuberculosis). If you are already being treated with rifabutin your blood counts and side effects to rifabutin will need to be monitored.
• Phenytoin (used to treat epilepsy). If you are already being treated with phenytoin your blood concentration of phenytoin will need to be monitored during your treatment with Voriconazol AET and your dose may be adjusted.

Tell your doctor if you are taking any of the following medicines, as a dose adjustment or monitoring may be required to check that the medicines and/or Voriconazol AET are still having the desired effect:

• Warfarin and other anticoagulants (e.g. phenprocoumon, acenocoumarol; used to slow down clotting of the blood)
• Ciclosporin (used in transplant patients)
• Tacrolimus (used in transplant patients)
• Sulphonylureas (e.g. tolbutamide, glipizide, and glyburide) (used for diabetes)
• Statins (e.g. atorvastatin, simvastatin) (used for lowering cholesterol)
• Benzodiazepines (e.g midazolam, triazolam) (used for severe insomnia and stress)
• Omeprazole (used for treating ulcers)
• Oral contraceptives (if you take Voriconazol AET whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders)
• Vinca alkaloids (e.g. vincristine and vinblastine) (used in treating cancer)
• Indinavir and other HIV protease inhibitors (used for treating HIV)
• Non-nucleoside reverse transcriptase inhibitors (e.g. efavirenz, delavirdine, nevirapine) (used for treating HIV) (some doses of efavirenz can NOT be taken at the same time as Voriconazol AET
• Methadone (used to treat heroin addiction)
• Alfentanil and fentanyl and other short acting opiates such as sufentanil (painkillers used for surgical procedures)
• Oxycodone and other long acting opiates such as hydrocodone (used for moderate to severe pain)
• Non-steroidal anti-inflammatory drugs (e.g. ibuprofen, diclofenac) (used for treating pain and inflammation)
• Fluconazole (used for fungal infections)
• Everolimus (used for treating advanced kidney cancer and in transplant patients)

Voriconazol AET with food and drink and alcohol:

Take your tablet at least one hour before or one hour after a meal. Swallow the tablet whole with some water.

Pregnancy, breast-feeding and fertility:

Voriconazol AET must not be taken during pregnancy, unless indicated by your doctor. Effective contraception must be used in women of childbearing potential. Contact your doctor immediately if you become pregnant while taking Voriconazol AET.

Voriconazol AET must not be taken during breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine whilst breast-feeding.

Driving and using machines:

Voriconazol AET may cause blurring of vision or uncomfortable sensitivity to light. While affected, do not drive or operate any tools or machines. Contact your doctor if you experience this.

Voriconazol AET contains lactose:

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Voriconazol AET.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will determine your dose depending on your weight and the type of infection you have.

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

	Tablets
	Patients 40 kg and above	Patients less than 40 kg
Dose for the first 24
hours	400 mg every 12 hours	200 mg every 12 hours
(Loading Dose)	for the first 24 hours	for the first 24 hours
Dose after the first 24
hours	200 mg twice a day	100 mg twice a day
(Maintenance Dose)

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.

Use in children and adolescents

The recommended dose for children and teenagers is as follows:

			Tablets
		Children aged 2 to less		Teenagers aged 12 to 14
		than 12 years and teenagers
			years weighing 50 kg or
		aged 12 to 14
			more; and all teenagers
		years weighing less than
			older than 14
		50 kg
	Dose for the first
	24 hours	Your treatment will be		400 mg every 12 hours for
	(Loading Dose)	started as an infusion		the first 24 hours
	Dose after the first
	24 hours	9 mg/kg twice a day		200 mg twice a day
	(Maintenance Dose)
	(a maximum dose of
		350 mg twice daily)

Depending on your response to treatment, your doctor may increase or decrease the daily dose. Tablets must only be given if the child is able to swallow tablets.

Voriconazol AET should not be given to children younger than 2 years of age.

Take your tablet at least one hour before, or one hour after a meal. Swallow the tablet whole with some water.

If you take more Voriconazol AET than you should:

If you take more tablets than prescribed (or if someone else takes your tablets) you must seek medical advice or go to the nearest hospital casualty department immediately. Take your box of Voriconazol AET tablets with you. You may experience abnormal intolerance to light as a result of taking more Voriconazol AET than you should.

If you forget to take Voriconazol AET:

It is important to take your Voriconazol AET tablets regularly at the same time each day. If you forget to take one dose, take your next dose when it is due. Do not take a double dose to make up for a forgotten dose.

If you stop taking Voriconazol AET:

It has been shown that taking all doses at the appropriate times may greatly increase the effectiveness of your medicine. Therefore unless your doctor instructs you to stop treatment, it is important to keep taking Voriconazol AET correctly, as described above.

Continue taking Voriconazol AET until your doctor tells you to stop. Do not stop treatment early because your infection may not be cured. Patients with a weakened immune system or those with difficult infections may require long term treatment to prevent the infection from returning.

When Voriconazol AET treatment is stopped by your doctor, you should not experience any effects. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any side effects occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

Serious side effects — Stop taking Voriconazol AET and see a doctor immediately

• Rash
• Jaundice; Changes in blood tests of liver function
• Pancreatitis

Other side effects

Very common side effects (may affect more than 1 in 10 people) are:

• Visual disturbances (change in vision)
• Fever
• Rash
• Nausea, vomiting, diarrhoea
• Headache
• Swelling of the extremities
• Stomach pains.

Common side effects (may affect up to 1 in 10 people) are:

• Flu-like symptoms, inflammation of the sinuses, chills, weakness
• Anaemia
• Low numbers of cells called platelets that help the blood to clot, low numbers of some types of white blood cells or of all types of blood cells, red or purple discoloration of the skin which may be caused by low platelet count , other blood cell changes
• Anxiety, depression, tingling, confusion, dizziness, agitation, trembling, hallucinations and

other nervous symptoms

• Low blood pressure, inflammation of a vein (which may be associated with the formation of a blood clot)
• Breathing difficulty, chest pain, fluid accumulation in the lungs
• Low blood sugar, low blood potassium
• Jaundice, redness of the skin
• Swelling of the lips or face
• Allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reaction following exposure to light or sun
• Itchiness
• Hair loss
• Back pain
• Kidney failure, blood in the urine, changes in blood tests of kidney function
• Changes in blood tests of liver function
• Inflammation of the gastrointestinal tract

Uncommon side effects (may affect up to 1 in 100 people) are:

• Enlarged lymph glands (sometimes painful)
• Increase in a type of white blood cell which may be associated with allergic reaction, disorder of blood clotting system
• Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting
• Depressed function of the adrenal gland
• Problem with coordination
• Swelling of the brain
• Double vision pain and inflammation of the eyes and eyelids, involuntary movement of the eye
• Decreased sensitivity to touch
• Constipation, inflammation of upper small intestine, dyspepsia,pancreatitis, peritonitis
• Gingivitis,
• Swelling and inflammation of the tongue
• Enlarged liver, hepatitis, liver failure, gallbladder disease, gallstones
• Joint pain
• Inflammation of the kidney, proteins in the urine
• Abnormal electrocardiogram (ECG)
• Blood chemistry changes
• Skin rash, which may lead to severe blistering and peeling of the skin
• Swelling or inflammation of the skin, hives, skin redness and irritation

Rare side effects (may affect up to 1 in 1000 people) are:

• Inability to sleep
• Hearing difficulties, ringing in the ears
• Abnormal sense of taste
• Increase in muscle tone, muscle weakness caused by an abnormal immune system response
• Abnormal brain function, Parkinson-like symptoms, convulsion, nerve injury resulting in numbness, pain, tingling or burning in the hands or feet.
• Severe, persistent or bloody diarrhoea associated with abdominal pain or fever
• Overactive or underactive thyroid gland
• Damage to the optic nerve resulting in vision impairment, eye bleeding, abnormal eye movement, clouding of the cornea
• Damage to the kidneys
• Heart rhythm problems including very fast heartbeat and very slow heartbeat
• Lymph infection, loss of consciousness due to liver failure

As Voriconazol AET has been known to affect the liver and the kidney, your doctor should monitor the function of your liver and kidney by doing blood tests. Please advise your doctor if you have any stomach pains or if your stools have a different consistency.

If any of these side effects persist or are troublesome, please tell your doctor.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or houshold waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Voriconazol AET contains

. The active substance is voriconazole. Each tablet contains either 50 mg voriconazole (for Voriconazol AET 50 mg film-coated tablets) or 200 mg voriconazole (for Voriconazol AET 200 mg film-coated tablets).

. The other ingredients are lactose monohydrate, pregelatinised starch, croscarmellose sodium, povidone and magnesium stearate which make up the tablet core and lactose monohydrate, hypromellose (E464), titanium dioxide (E171) and triacetin which make up the film-coat.

What Voriconazol AET looks like and contents of the pack

Voriconazol AET 50 mg filmomhulde tabletten are supplied as white to off-white, round film-coated tablets.

Voriconazol AET 200 mg filmomhulde tabletten are supplied as white to off-white, capsule-shaped film-coated tablets.

Voriconazol AET 50 mg filmomhulde tabletten and 200 mg filmomhulde tabletten are available as packs of 2, 10, 14, 20, 28, 30, 50, 56 and 100.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

ALFRED E. TIEFENBACHER (GmbH & Co. KG)

Van-der-Smissen-Straße 1

22767 Hamburg

Germany

Manufacturer

Aegis Ltd

17, Athinon Street, Ergates Industrial Area

2643 Nicosia

Cyprus

Pharmacare Premium Ltd

HHF 003

Hal Far Industrial Estate

Birzebbugia

Malta

In het register ingeschreven onder het nummer:

50 mg: RVG 111731

200 mg: RVG 111732

This medicinal product is authorised in the Member States of the EEA under the following names:

Deze bijsluiter is voor het laatst goedgekeurd in april 2013