VFEND 50 mg film-coated tablets

VFEND belongs to a group of medicines called triazole antifungal agents. These medicines are used to treat a wide variety of fungal infections. VFEND works by killing or stopping the growth of the fungi that cause infections.

What fungal infections are treated with VFEND?
VFEND is used to treat serious fungal infections caused by Aspergillus, Scedosporium, Fusarium, fluconazole-resistant Candida, and candidaemia in patients with normal white blood cell counts. This product should only be taken under the supervision of a doctor.

VFEND is mainly for use in seriously ill patients.

Do not take VFEND:
-If you are allergic to voriconazole or any of the other ingredients of VFEND

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. Some medicines affect the way VFEND works, or VFEND may affect the way they work.

A list of the medicines that may affect VFEND is shown in the section ?Taking other medicines with VFEND?. However, the medicines in the following list must not be taken during your course of VFEND 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)

Take special care with VFEND:

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

Taking other medicines with VFEND:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those that are obtained without a prescription.

Some medicines, when taken at the same time as VFEND, may affect the way VFEND works or VFEND may affect the way they work. Tell your doctor if you are taking any of the following medicines, as VFEND must not be taken if you are already taking any of these medicines (See also Section 2 above ?Do not take VFEND?):

• Terfenadine (used for allergy)
• Astemizole (used for allergy)
• Carbamazepine (used to treat seizures)
• Cisapride (used for stomach problems)
• Pimozide (used for treating mental illness)
• Quinidine (used for irregular heart beat)
• Rifampicin (used for treating tuberculosis)
• 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)

Tell your doctor if you are taking the following medicine, as treatment with VFEND 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 VFEND at the same time should be avoided if possible, and a dose adjustment of voriconazole may be required:
• Rifabutin (used for treating tuberculosis)
• Phenytoin (used to treat epilepsy)

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 VFEND 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 VFEND 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)
• Methadone (used to treat heroin addiction)
• Efavirenz (used for treating HIV) (some doses of efavirenz can NOT be taken at the same time as VFEND)
• Alfentanil and fentanyland 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)

Before being treated with VFEND, tell your doctor 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 VFEND. Your doctor should also monitor your liver function while you are being treated with VFEND by doing blood tests.
• you are already being treated with phenytoin (used to treat epilepsy). Your blood concentration of phenytoin will need to be monitored during your treatment with VFEND and your dose may be adjusted.
• you are already being treated with rifabutin (used for treating tuberculosis). Your blood counts and side effects to rifabutin will need to be monitored.

While being treated with VFEND:

• tell your doctor immediately if you develop a severe skin rash or blisters.
• avoid sunlight and sun exposure while being treated with VFEND. Cover sun exposed areas of skin and use sunscreen, as an increased sensitivity of skin to the sun?s UV rays can occur.
• your doctor should monitor the function of your liver and kidney by doing blood tests.

Taking VFEND with food and drink:
VFEND tablets must be taken at least one hour before or one hour after a meal.

Pregnancy and breast-feeding:
VFEND 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 VFEND.

VFEND 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:
VFEND 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.

Important information about some of the ingredients of VFEND:
VFEND tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking VFEND.

Always take VFEND exactly as your doctor has told you. You should 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 usual 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 Loading Dose 400 mg every 12 hours for the first 24 hours 200 mg every 12 hours for the first 24 hours 200 mg twice a day 100 mg twice a day Dose after the first 24 hours 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.

• The usual dose for children aged 2 to less than 12 years is 200 mg twice daily.
• Tablets must only be given if the child is able to swallow tablets.

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

Teenagers (aged 12 to 16 years) should be dosed as for adults.

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

Continue taking VFEND 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.

If you take more VFEND 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 VFEND tablets with you.

If you forget to take VFEND:
It is important to take your VFEND 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 VFEND:
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 VFEND correctly, as described above.

When VFEND treatment is stopped by your doctor you should not experience any effects. However if you were taking medicines containing ciclosporin or tacrolimus you must mention this to your doctor, as the dose will need to be adjusted.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, VFEND 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.

Very common side effects (occurring in at least 1 in 10 patients) are:

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

Common side effects (occurring in at least 1 in 100 patients) are:

• Flu-like symptoms, sinusitis, 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

Uncommon side effects (occurring in at least 1 in 1,000 patients) 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

Rare side effects (occurring in at least 1 in 10,000 patients) 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.

As VFEND 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

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

There are no special storage instructions.

Medicines should not be disposed of via wastewater or houshold waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What VFEND contains

• The active substance is voriconazole. Each tablet contains either 50 mg voriconazole (for VFEND 50 mg film-coated tablets) or 200 mg voriconazole (for VFEND 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 hypromellose, titanium dioxide (E171), lactose monohydrate and glycerol triacetate which make up the film-coat.

What VFEND looks like and contents of the pack
VFEND 50 mg film-coated tablets is supplied as white to off-white round film-coated tablets with Pfizer marked on one side and VOR50 on the reverse.

VFEND 200 mg film-coated tablets is supplied as white to off-white capsule shaped film-coated tablets with Pfizer marked on one side and VOR200 on the reverse.

VFEND 50 mg film-coated tablets and 200 mg film-coated tablets are available as packs of 2, 10, 14, 20, 28, 30, 50, 56 and 100.

Not all pack sizes may be marketed. The information in this leaflet is about VFEND 50 mg tablets and VFEND 200 mg tablets only. For further information on VFEND 200 mg powder for solution for infusion or VFEND 40 mg/ml powder for oral suspension, please see the User Package Leaflets for these products.

Marketing Authorisation Holder
Pfizer Limited, Ramsgate Rd, Sandwich, Kent, CT13 9NJ, United Kingdom.

Manufacturer
Pfizer Manufacturing Deutschland GmbH
Heinrich-Mack-Str. 35
D-89257 Illertissen
Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België BelgiqueBelgien Pfizer S.A.N.V. TélTel 32 02 554 62 11 LuxembourgLuxemburg Pfizer S.A. Tél 32 02 554 62 11

, . 359 2 970 4333 Magyarország Pfizer Kft. Tel. 36 1 488 37 00

eská republika Pfizer s.r.o. Tel 420-283-004-111 Malta V.J. Salomone Pharma Ltd. Tel 356 21 22 01 74

Danmark Pfizer ApS Tlf 45 44 20 11 00 Nederland Pfizer bv Tel 31 010 406 43 01

Deutschland Pfizer Pharma GmbH Tel 49 030 550055 51000 Norge Pfizer AS Tlf 47 67 52 61 00

Eesti Pfizer Luxembourg SARL Eesti filiaal Tel 372 6 405 328 Österreich Pfizer Corporation Austria Ges.m.b.H. Tel 43 01 521 15-0

Pfizer Hellas A.E. 30 210 6785 800 Polska Pfizer Polska Sp. z o.o., Tel. 48 22 335 61 00

España Pfizer S.A. Tel 34 91 490 99 00 Portugal Laboratórios Pfizer, Lda. Tel 351 214 235 500

France Pfizer Tél 33 01 58 07 34 40 România Pfizer România S.R.L Tel 40 021 207 28 00

Ireland Slovenija

Pfizer Healthcare Ireland Tel 1800 633 363 toll free 44 01304 616161 Pfizer Luxembourg SARL Pfizer, podrunica za svetovanje s podroja farmacevtske dejavnosti, Ljubljana Tel 386 0152 11 400

Ísland Icepharma hf., Sími 354 540 8000 Slovenská republika Pfizer Luxembourg SARL, organizaná zloka Tel 421-2-3355 5500

Italia Pfizer Italia S.r.l. Tel 39 06 33 18 21 SuomiFinland Pfizer Oy PuhTel 35809 43 00 40

GEO. PAVLIDES ARAOUZOS LTD, 35722818087 Sverige Pfizer AB Tel 46 08 5505 2000

United Kingdom Pfizer Limited Tel 44 01304 616161 Latvija Pfizer Luxembourg SARL Filile Latvij Tel 371 670 35 775

Lietuva
Pfizer Luxembourg SARL
Filialas Lietuvoje
Tel. +3705 2514000

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