TEVA UK Ref: 231-30-30206-C LEA VORICONAZOLE 50mg & 200mg FC TAB TUK <ZAG

Version: 2    07 April 2016

TEVA UK Ref: 231-30-30206-C LEA VORICONAZOLE 50mg & 200mg FC TAB TUK <ZAG

Version: 2    07 April 2016

Dimensions:

Length:

Width:

Depth:

Colours Used:

500 mm 155 mm

Foil Width: Perforated:

Shelf Ready Pack:

PANTONE® GREEN C BLACK

Template

™

UK

Eastbourne

Artwork

Origination

Dimensions:

Length:

Width:

Depth:

500 mm 155 mm

Foil Width: Perforated:

Shelf Ready Pack:

Colours Used:

PANTONE® GREEN C BLACK

Template

VORICONAZOLE 50 mg AND 200 mg FILM-COATED TABLETS

Package leaflet: Information for the user

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, pharmacist or nurse.

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

What is in this leaflet:

1.    What Voriconazole Film-coated Tablets are and what they are used for

2.    What you need to know before you take Voriconazole Film-coated Tablets

3.    How to take Voriconazole Film-coated Tablets

4.    Possible side effects

5.    How to store Voriconazole Film-coated Tablets

6.    Contents of the pack and other information

OH What Voriconazole Film-coated Tablets are and what they are used for

Voriconazole Film-coated Tablets contain 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 Film-coated Tablets are 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.

What you need to know before you take Voriconazole Film-coated Tablets

Do not take Voriconazole Film-coated Tablets

• 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, pharmacist or nurse 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 treatment with Voriconazole Film-coated Tablets:

• 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 (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 400 mg and more twice daily • St John’s Wort (herbal supplement).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Voriconazole Film-coated Tablets 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 Film-coated Tablets. Your doctor should also monitor your liver function while you are being treated with Voriconazole Film-coated Tablets by doing blood tests • you are known to have cardiomyopathy, irregular heart beat, 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 Film-coated Tablets 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 Film-coated Tablets should not be given to children younger than 2 years of age.

Other medicines and Voriconazole Film-coated Tablets

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

Some medicines, when taken at the same time as Voriconazole Film-coated Tablets, may affect the way Voriconazole Film-coated Tablets work or Voriconazole Film-coated Tablets may affect the way they work.

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

•    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 Film-coated Tablets 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 Film-coated Tablets.

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.

Driving and using machines

Voriconazole Film-coated Tablets 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 Film-coated Tablets contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, tell your doctor before taking Voriconazole Film-coated Tablets.

©H How to take Voriconazole Film-coated Tablets

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:

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:

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 Film-coated Tablets for prevention of fungal infections, your doctor may stop giving Voriconazole Film-coated Tablets if you or your child develop treatment related side effects.

If you take more Voriconazole Film-coated Tablets 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 Film-coated Tablets with you. You may experience abnormal intolerance to light as a result of taking more Voriconazole Film-coated Tablets than you should.

If you forget to take Voriconazole Film-coated Tablets

It is important to take your Voriconazole Film-coated 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 Film-coated Tablets

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 Film-coated Tablets correctly, as described above.

Continue taking Voriconazole Film-coated Tablets 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 Film-coated Tablets 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.

^ 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 Film-coated Tablets 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 impairment (change in vision)

fever

rash

nausea, vomiting, diarrhoea headache

swelling of the extremities stomach pains breathing difficulties.

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

flu-like symptoms, irritation and inflammation of 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

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

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 jaundice, inflammation of the liver, redness of the skin

skin rashes which may lead to severe blistering

and peeling of the skin characterised 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 side effects (may affect up to 1 in 100

people) are:

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 bone marrow, other blood cell changes (increased eosinophil and low white blood cells in blood) depressed function of the adrenal gland, underactive thyroid gland abnormal brain function, Parkinson-like symptoms, nerve injury resulting in numbness, pain, tingling or burning in the hands or feet 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 (edema) 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 skin 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

life threatening allergic reaction.

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

overactive thyroid gland

deterioration of brain function that is a serious

complication of liver disease

damage to 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 Film-coated Tablets have 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 the 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.

How to store Voriconazole Film-coated Tablets

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 blister or carton 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.

©H Contents of the pack and other information

What Voriconazole Film-coated Tablets contains

The active substance is voriconazole. Each tablet contains 50 mg voriconazole (Voriconazole 50 mg Film-coated Tablets) or 200 mg voriconazole (Voriconazole 200 mg Film-coated Tablets).

The other ingredients are lactose monohydrate (see section 2 "Voriconazole Film-coated Tablets contains lactose"), croscarmellose-sodium, povidone K25, pregelatinised maize starch, magnesium stearate, hypromellose 5 mPas, glycerol 85%, titanium dioxide (E 171).

What Voriconazole Film-coated Tablets looks like and contents of the pack

Voriconazole 50 mg is supplied as white, round, biconvex film-coated tablets (diameter: approx.

7.2 mm) with imprint "V" on one and "50" on the other side.

Voriconazole 200 mg is supplied as white, oblong film-coated tablets (dimensions: approx. 17.2 mm x 7.2 mm) with imprint "V" on one and "200" on the other side.

Voriconazole 50 mg Film-coated Tablets are available as packs of 2, 10, 14, 20, 28, 30, 50, 56, 98 and 100 in PVC/Alu-blisters as multipack and unit pack.

Voriconazole 200 mg Film-coated Tablets are available as packs of 2, 10, 14, 20, 28, 30, 50, 56, 98 and 100 in PVC/Alu-blisters as multipack and unit pack.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne, BN22 9AG, UK

Manufacturer

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovica 25, 10000 Zagreb, Croatia

This leaflet was last revised in 04/2016

PL 00289/1783-4

TEUZD

TEVA UK LIMITED

30206-C 155x500