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Package Leaflet: Information for the user

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

Voriconazole is intended for patients with worsening, possibly life-threatening, fungal infections.

Prevention of fungal infections in high risk bone marrow transplant recipients.

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 400mg and above once daily

•    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 than twice daily

•    St John's Wort (herbal supplement)

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Voriconazole:

•    if you have had an allergic reaction to other azoles;

•    if 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;

•    if you are known to have cardiomyopathy, irregular heartbeat, slow heart rate or an abnormality of electrocardiogram (ECG) called 'long QTc syndrome'.

You should avoid any 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 and kidney by doing blood tests.

Children and adolescents

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

Other medicines and Voriconazole

Please 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 Voriconazole, may affect the way Voriconazole 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)

•    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 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)

•    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 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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Voriconazole 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 Voriconazole.

Voriconazole must not be used 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 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

If you have been told by your doctor that you have an intolerance to some sugars, tell your doctor before taking this medicinal product.

3. How to take Voriconazole

Always take this medicine exactly as your doctor 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:

Depending on your response to treatment, your doctor may increase the daily dose to 300mg 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.

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

If you or your child are taking Voriconazole for prevention of fungal infections, your doctor may stop giving Voriconazole if you or your child develop treatment related side effects.

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, pharmacist or nurse.

4. Possible side effects

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 Voriconazole and see a doctor immediately if you experience:

-    Rash

-    Jaundice or changes in blood tests of liver function

-    Pancreatitis

Other side effects

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

-    Visual impairment (change in vision)

-    Fever

-    Rash

-    Nausea, vomiting, diarrhoea

-    Headache

-    Swelling of the extremities

-    Stomach pains

-    Breathing difficulties

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

-    Flu-like symptoms, irritation and inflammation in the gastrointestinal tract, inflammation of the sinuses, inflammation of the gums, chills, weakness

-    Low numbers of some types of red or white blood cells, low numbers of cells called platelets that help the blood to clot

-    Allergic reaction or exaggerated immune response

-    Anxiety, depression, confusion, agitation, inability to sleep, hallucinations

-    Seizures, tremors or uncontrolled muscle movements, tingling or abnormal skin sensations, increase in muscle tone, sleepiness, dizziness

-    Bleeding in the eye

-    Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting

-    Low blood pressure, inflammation of a vein (which may be associated with the formation of a blood clot)

-    Breathing difficulty, chest pain, swelling of the face, fluid accumulation in the lungs

-    Constipation, indigestion, inflammation of the lips

-    Low blood sugar, low blood potassium, low sodium in the blood

-    Jaundice, inflammation of the liver, redness of the skin

-    Skin rashes which may lead to severe blistering and peeling of the skin characterized by a flat, red area on the skin that is covered with small confluent bumps

-    Itchiness

-    Hair loss

-    Back pain

-    Kidney failure, blood in the urine, changes in kidney function tests

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

-    Inflammation of the gastrointestinal tract causing antibiotic associated diarrhoea, inflammation of the lymphatic vessels

-    Inflammation of the thin tissue that lines the inner wall of the abdomen and covers the abdominal organ

-    Enlarged lymph glands (sometimes painful), disorder of blood clotting system, failure of blood marrow, other blood cell changes (increased eosinophil and low white blood cells in blood)

-    Abnormal brain function, Parkinson-like symptoms, nerve injury resulting in numbness, pain, tingling or burning in the hands or feet

-    Depressed function of the adrenal gland, underactive thyroid gland

-    Problems with balance or coordination

-    Swelling of the brain

-    Double vision serious conditions of the eye including: pain and inflammation of the eyes and eyelids, involuntary movement of the eye, abnormal eye movement, damage to the optic nerve resulting in vision impairment, optic disc swelling

-    Decreased sensitivity to touch

-    Abnormal sense of taste

-    Hearing difficulties, ringing in the ears, vertigo

-    Inflammation of certain internal organs- pancreas and duodenum, swelling and inflammation of the tongue

-    Enlarged liver, liver failure, gallbladder disease, gallstones

-    Joint inflammation, inflammation of the veins under the skin (which may be associated with the formation of a blood clot)

-    Inflammation of the kidney, proteins in the urine

-    Very fast heart rate or skipped heartbeats

-    Abnormal electrocardiogram (ECG)

-    Blood cholesterol increased, blood urea increased

-    Allergic skin reactions (sometimes severe), including widespread blistering rash and skin peeling, inflammation of the skin, the 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, hives, sunburn or severe reaction following exposure to light or sun, skin redness and irritation, red or purple discolouration of the skin which may be caused by low platelet count, eczema

-    Injection site reaction

-    Life threatening allergic reaction

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

-    Overactive thyroid gland

-    Deterioration of brain function that is a serious complication of liver disease

-    Damage of the optic nerve resulting in vision impairment, clouding of the cornea

-    Bullous photosensitivity

-    A disorder in which the body's immune system attacks part of the peripheral nervous system

-    Severe heart rhythm problems that may be life threatening

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

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.

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

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

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

This medicine does not require any special storage conditions.

Bottles: Use within 30 days after first opening 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 50mg voriconazole (for Voriconazole 50mg film-coated tablets) or 200mg voriconazole (for Voriconazole 200mg film-coated tablets).

•    The other ingredients are lactose monohydrate, pregelatinised starch (maize starch), croscarmellose sodium, povidone K30, silica colloidal anhydrous, magnesium stearate and opadry II white OY-LS 28908.

The opadry II white OY-LS 28908 coating contains: HPMC/Hypromellose (3cP, 15cP and 50 cP) (E464), titanium dioxide (E171), lactose monohydrate and macrogol 4000/PEG (E1521).

What Voriconazole looks like and contents of the pack

Voriconazole 50mg film-coated tablets are supplied as white to off-white round biconvex tablets with "V50" marked on one side, 7.1 ± 0.2 mm in diameter. Voriconazole 200mg film-coated tablets are supplied as white to off-white oval biconvex tablets with "V200"marked on one side, 15.7 ± 0.2 mm in length and 7.9 ± 0.2 mm in width.

Voriconazole 50mg film-coated tablets are supplied in PVC/Aluminum blister available in packs of 28, 30, 56 or 100 tablets or in white opaque HDPE bottle with a polypropylene child resistant screw cap, containing 30 tablets.

Voriconazole 200mg film-coated tablets are supplied in PVC/Aluminum blister available in packs of 14, 28, 30,

56 or 100 tablets or in white opaque HDPE bottle with a polypropylene child resistant screw cap, containing 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Marketing Authorisation Holder

Aspire Pharma Ltd,

Bellamy House,

Winton Road,

Petersfield,

Hampshire,

GU32 3HA United Kingdom Manufacturer Pharmathen S.A.

6, Dervenakion str.,

15351, Pallini, Attiki,

Greece

or

Pharmathen International S.A.

Sapes Industrial Park Block 5,

69300 Rodopi,

Greece.

This leaflet was last revised in May 2015

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