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• leaflet MAH GENERIC_PL 08553-0500
• leaflet MAH GENERIC_PL 43801-0036

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Package leaflet: Information for the patient

Voriconazole 50 mg film-coated tablets Voriconazole 200 mg film-coated tablets

voriconazole

Read all of this leaflet carefully before you

start taking 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 or pharmacist.

•    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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Voriconazole is and what it is used for

2.    What you need to know before you take Voriconazole

3.    How to take Voriconazole

4.    Possible side effects

5.    How to store Voriconazole

6.    Contents of the pack and other information

1.    WHAT voriconazole Is AND WHAT IT Is usED FoR

Voriconazole contains the active substance voriconazole. Voriconazole 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 aged 2 years and above) 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).

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

2.    What You need To KNoW BEFoRE You Take voriconazole

Do not take Voriconazole:

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 Voriconazole 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)

•    Efavirenz (used for treating HIV) in doses of 400 mg and above once daily

•    Carbamazepine (used to treat seizures)

•    Phenobarbital, mephobarbital (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)

Warnings and precautions

Talk to your doctor or pharmacist before taking Voriconazole 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 Voriconazole. Your doctor should also monitor your liver function while you are being treated with Voriconazole by doing blood tests.

•    you are known to have or had before cardiomyopathy (particularly when heart failure), 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 with high sun protection factor (SPF), as an increased sensitivity of skin to the sun's UV rays can occur. These precautions are also applicable to children.

While being treated with Voriconazole:

•    tell your doctor immediately if you develop

*    sunburn

*    severe skin rash or blisters

*    bone pain.

If you develop skin disorders as described above, your doctor may refer you to a dermatologist, who after consultation may decide that it is important for you to be seen on a regular basis. There is a small chance that skin cancer could develop with long term use of Voriconazole.

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

children and adolescents

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

other medicines and Voriconazole

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those that are obtained without a prescription.

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

Tell your doctor if you are taking the following medicine, as treatment with Voriconazole 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 Voriconazole 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 Voriconazole, 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 Voriconazole 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)

•    Sulfonylureas (e.g. tolbutamide, glipizide, and glyburide) (used for diabetes) (if you take Voriconazole whilst using oral contraceptives, you doctor may monitor you blood sugar levels).

•    Statins (e.g. atorvastatin, simvastatin, lovastatin) (used for lowering cholesterol)

•    Benzodiazepines (e.g. midazolam, triazolam, alprazolam) (used for severe insomnia and stress)

•    Omeprazole (used for treating ulcers)

•    Oral contraceptives (e.g. norethisterone/ethinylestradiol)

(if you take Voriconazole 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)

•    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 Voriconazole)

•    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)

Pregnancy and breast-feeding

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

Voriconazole 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

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

Voriconazole contains lactose monohydrate.

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

3. how to take voriconazole

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.

Patients 40 kg and above: Depending on your response to treatment, your doctor may increase the daily dose to 300 mg twice a day.

Patients less than 40 kg: Depending on your response to treatment, your doctor may increase the daily dose to 150 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:

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. An oral suspension is more appropriate for infants and children under the age of 12 years.

Voriconazole is not available as an oral suspension. If an oral solution is needed, your doctor will prescribe an oral suspension from another company.

Date: 23 JUN 2014

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 Voriconazole 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 Voriconazole tablets with you. You may experience abnormal intolerance to light as a result of taking more Voriconazole than you should.

If you forget to take Voriconazole

It is important to take your Voriconazole 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 Voriconazole

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 Voriconazole correctly, as described above.

Continue taking Voriconazole 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 Voriconazole 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.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happen, stop taking Voriconazole and tell your doctor immediately or go to the nearest hospital emergency department

common side effects (may affect up to 1 in 10 people)

•    A condition where the red blood cells, white blood cells and platelets are all reduced in number with the following symptoms; tiredness, being short of breath and looking pale (pancytopenia)

•    Breathing difficulty, fluid accumulation in the lungs

•    Yellowing of the skin or whites of the eyes (jaundice)

•    Kidney failure.

uncommon side effects (may affect up to 1 in 100 people)

•    An allergic reaction. Such reactions may appear in the form of anaphylaxis (a severe form of allergic reaction) with symptoms such as:

*    rash

*    swelling of the face, lips, mouth, tongue or throat (angioedema)

•    A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson Syndrome).

•    Severe low numbers of some types of white blood cells causing more infections (agranulocytosis)

•    Severe skin reaction following exposure to light or sun

•    Liver failure or liver disease with the following symptoms; nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine (hepatitis)

•    Heart rhythm problems

•    Inflammation of the pancreas which causes severe pain in the abdomen and back (pancreatitis)

•    Fits (convulsion)

•    Depressed function of the adrenal gland

•    Swelling of the brain

•    Swelling of nerves at the back of the eye

Rare side effects (may affect up to 1 in 1,000 people)

•    Loss of consciousness due to liver failure

•    Heart rhythm problems including very fast heartbeat

•    Severe, persistent or bloody diarrhoea associated with abdominal pain or fever

•    A widespread rash with blisters and skin peeling on much of the body surface (toxic epidermal necrolysis)

•    Abnormal brain function

•    Damage to the kidneys

•    Damage to the optic nerve resulting in vision impairment.

Not known (frequency cannot be estimated from the available data)

•    Muscle pain (periostitis).

There have been reports of skin cancer in patients treated with Voriconazole for long periods of time.

other side effects

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

-    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)

-    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)

-    Chest pain

-    Low blood sugar, low blood potassium

-    Redness of the skin

-    Sunburn or severe skin reaction following exposure to light or sun

-    Itchiness

-    Hair loss

-    Back pain

-    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)

-    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

-    Very fast heartbeat, very slow heartbeat, fainting

-    Problem with coordination

-    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, peritonitis

-    Gingivitis

-    Swelling and inflammation of the tongue

-    Enlarged liver, 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, burning or soreness of the skin

-    Swelling or inflammation of the skin, hives, skin redness and irritation.

Rare side effects (may affect up to 1 in 1,000 people)

-    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

-    Red, scaly patches on the face and scalp

-    Parkinson-like symptoms, 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

-    Eye bleeding, abnormal eye movement, clouding of the cornea

-    Heart rhythm problems including very fast heartbeat and very slow heartbeat

-    Lymph infection

As Voriconazole 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 specific side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    how to store voriconazole

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 carton and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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

6.    contents of the pack and other information

What Voriconazole contains

The active substance is voriconazole. Each tablet contains either 50 mg or 200 mg voriconazole.

The other ingredients are:

Tablet core: Lactose monohydrate (see section 2 "Voriconazole contains lactose monohydrate"), croscarmellose sodium, pregelatinised maize starch, povidone and magnesium stearate.

Film-coating: Lactose monohydrate, hypromellose, titanium dioxide (E171) and triacetin.

What Voriconazole looks like and contents of the pack

Voriconazole 50 mg film-coated tablets: a white to off-white film-coated, oval, biconvex tablet debossed with "V26" on one side of the tablet and blank on the other side.

Voriconazole 200 mg film-coated tablets: a white to off-white film-coated, capsule shaped, biconvex tablet debossed with "M164" on one side of the tablet and blank on the other side.

Voriconazole is available in blister packs of:

20, 28, 30, 90, 100, 28 x 1,30 x 1,50 x 1,56 x 1,60 x 1, 100 x 1 film-coated tablets for Voriconazole 50 mg film-coated tablets.

14, 20, 28, 30, 90, 100, 14 x 1,28 x 1,30 x 1,50 x 1,56 x 1,60 x 1, 100 x 1 for Voriconazole 200 mg film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. Manufacturers

Generics (UK) Limited, Station Close, Potters Bar, Herts EN6 1TL, United Kingdom.

GE Pharmaceuticals Ltd., Industrial Zone, Chekanitza-South area, 2140 Botevgrad, Bulgaria.

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Mylan Hungary Kft., H-2900 Komarom, Mylan utca 1, Hungary.

This leaflet was last revised in June 2014.    432126

Date: 23 JUN 2014