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VORICONAZOLE ZENTIVA 200 MG FILM-COATED TABLETS

Active substance(s): VORICONAZOL

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GENERAL INFORMATION

PRODUCT NAME: LEAFLET
-

Package leaflet: Information for the patient

Voriconazole 50 mg film-coated tablets
Voriconazole 200 mg film-coated tablets
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 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
The name of your medicine is Voriconazole 50mg and
200mg film-coated tablets (called voriconazole throughout
this leaflet). It 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 spp.),
• candidaemia (another type of fungal infection due to
Candida spp.) in non-neutropenic patients (patients without
abnormally low white blood cells count),
• serious invasive Candida spp. infections when the fungus
is resistant to fluconazole (another antifungal medicine),

• serious fungal infections caused by Scedosporium spp. or
Fusarium spp. (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 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 400mg and
more 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.
• 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 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:
• 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
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.
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, contact your doctor before
taking voriconazole.
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:

Dose for the first
24 hours
(Loading Dose)

Dose after the first
24 hours
(Maintenance Dose)

Tablets
Patients less
Patients 40 kg
and above
than 40 kg
400 mg every
200 mg every
12 hours for the 12 hours for the
first 24 hours
first 24 hours
200 mg twice
a day

100 mg twice
a day

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:

Dose for the first
24 hours
(Loading Dose)
Dose after the first
24 hours
(Maintenance Dose)

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

200 mg twice
a day

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.

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
• 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

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 blood 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 discoloration of the skin which may be caused by
low platelet count, eczema
• Injection site reaction
• 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

This medicine does not require any special storage conditions.

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.

What Voriconazole 50mg and 200mg film-coated tablets
contain
The active substance is voriconazole.
Each tablet contains 50 mg or 200mg voriconazole.
The other ingredients are lactose monohydrate,
pregelatinized maize starch, crosscarmellose sodium,
povidone K-30 and magnesium stearate which make up the
tablet core and hypromellose 6 mPa.s, titanium dioxide
(E171), lactose monohydrate and triacetin which make up
the film-coat.

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

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 50mg and 200mg film-coated tablets
look like and contents of the pack
Voriconazole 50 mg film-coated tablets are white to offwhite, round film-coated tablets.
Voriconazole 200 mg film-coated tablets are white to offwhite, oval film-coated tablets.
Pack size : 2, 10, 14, 20, 28, 30, 50, 56 and 100 film-coated
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Manufacturer
S.C.Zentiva S.A.
50 Theodor Pallady Blvd., District 3, Bucharest, 032266
Romania
This leaflet was last revised in December 2014.

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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 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

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

4. Possible side effects

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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