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VORICONAZOLE PFIZER 50 MG FILM-COATED TABLETS

Active substance(s): VORICONAZOLE

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Other medicines and Voriconazole
Please 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 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:
p 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:
p 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.
p 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:
p Warfarin and other anticoagulants (e.g., phenprocoumon,
acenocoumarol; used to slow down clotting of the blood)
p Ciclosporin (used in transplant patients)
p Tacrolimus (used in transplant patients)
p Sulfonylureas (e.g., tolbutamide, glipizide, and glyburide) (used
for diabetes)
p Statins (e.g., atorvastatin, simvastatin) (used for lowering
cholesterol)
p Benzodiazepines (e.g., midazolam, triazolam) (used for severe
insomnia and stress)
p Omeprazole (used for treating ulcers)
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p Oral contraceptives (if you take Voriconazole whilst using oral
contraceptives, you may get side effects such as nausea and
menstrual disorders)
p Vinca alkaloids (e.g., vincristine and vinblastine) (used in treating
cancer)
p Indinavir and other HIV protease inhibitors (used for treating HIV)
p 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)
p Methadone (used to treat heroin addiction)
p Alfentanil and fentanyl and other short-acting opiates such as
sufentanil (painkillers used for surgical procedures)
p Oxycodone and other long-acting opiates such as
hydrocodone(used for moderate to severe pain)
p Non-steroidal anti-inflammatory drugs (e.g., ibuprofen, diclofenac)
(used for treating pain and inflammation)
p Fluconazole (used for fungal infections)
p 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. Effective contraception must be used in women of
childbearing potential. Contact your doctor immediately if you become
pregnant while taking Voriconazole.
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 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 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.
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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:
Tablets
Patients 40 kg and
above
Dose for the
first 24 hours
(Loading Dose)
Dose after the
first 24 hours
(Maintenance Dose)

Patients less than
40 kg

400 mg every 12 hours 200 mg every 12 hours
for the first 24 hours
for the 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 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:
Tablets
Children aged 2 to
less than 12 years and
teenagers aged 12 to
14 years weighing less
than 50 kg
Dose for the
first 24 hours
(Loading Dose)
Dose after the
first 24 hours
(Maintenance Dose)

Teenagers aged 12 to
14 years weighing
50 kg or more;
and all teenagers
older than 14

Your treatment will be 400 mg every 12 hours
started as an infusion
for the first 24 hours
9 mg/kg twice a day
(a maximum dose of
350 mg twice daily)

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200 mg twice a day

Depending on your response to treatment, your doctor may increase
or decrease the daily dose.
p 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
p Rash
p Jaundice; Changes in blood tests of liver function
p Pancreatitis
Other side effects
Very common: may affect more than 1 in 10 people
p Visual impairment (change in vision including blurred vision, visual
colour alterations, abnormal intolerance to visual perception of light,
colour blindness, eye disorder, halo vision, night blindness, swinging
vision, seeing sparks, visual aura, visual acuity reduced, visual
brightness, loss of part of the usual field of vision, spots before the
eyes)
p Fever
p Rash
p Nausea, vomiting, diarrhoea
p Headache
p Swelling of the extremities
p Stomach pains
p Breathing difficulties
p Elevated liver enzymes
Common: may affect up to 1 in 10 people
p Inflammation of the sinuses, inflammation of the gums, chills,
weakness
p Low numbers of some types, including severe of red (sometimes
immune-related) and/or white blood cells (sometimes with fever),
low numbers of cells called platelets that help the blood to clot
p Allergic reaction or exaggerated immune response
p Low blood sugar, low blood potassium, low sodium in the blood
p Anxiety, depression, confusion, agitation, inability to sleep,
hallucinations

p Seizures, tremors or uncontrolled muscle movements, tingling or
abnormal skin sensations, increase in muscle tone, sleepiness,
dizziness
p Bleeding in the eye
p Heart rhythm problems including very fast heartbeat, very slow
heartbeat, fainting
p Low blood pressure, inflammation of a vein (which may be
associated with the formation of a blood clot)
p Acute breathing difficulty, chest pain, swelling of the face
(mouth, lips and around eyes), fluid accumulation in the lungs
p Constipation, indigestion, inflammation of the lips
p Jaundice, inflammation of the liver and liver injury
p 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, redness of the skin
p Itchiness
p Hair loss
p Back pain
p Kidney failure, blood in the urine, changes in kidney function tests
Uncommon: may affect up to 1 in 100 people
p Flu-like symptoms, irritation and inflammation of the gastrointestinal
tract, inflammation of the gastrointestinal tract causing antibiotic
associated diarrhoea, inflammation of the lymphatic vessels
p Inflammation of the thin tissue that lines the inner wall of the
abdomen and covers the abdominal organ
p Enlarged lymph glands (sometimes painful), failure of blood marrow,
increased eosinophils
p Depressed function of the adrenal gland, underactive thyroid gland
p Abnormal brain function, Parkinson-like symptoms, nerve injury
resulting in numbness, pain, tingling or burning in the hands or feet
p Problems with balance or coordination
p Swelling of the brain
p Double vision, serious conditions of the eye including: pain and
inflammation of the eyes and eyelids, abnormal eye movement,
damage to the optic nerve resulting in vision impairment, optic disc
swelling
p Decreased sensitivity to touch
p Abnormal sense of taste

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p Hearing difficulties, ringing in the ears, vertigo
p Inflammation of certain internal organs- pancreas and duodenum,
swelling and inflammation of the tongue
p Enlarged liver, liver failure, gallbladder disease, gallstones
p Joint inflammation, inflammation of the veins under the skin
(which may be associated with the formation of a blood clot)
p Inflammation of the kidney, proteins in the urine, damage to the kidney
p Very fast heart rate or skipped heartbeats, sometimes with erratic
electrical impulses
p Abnormal electrocardiogram (ECG)
p Blood cholesterol increased, blood urea increased
p Allergic skin reactions (sometimes severe), including life-threatening
skin condition that causes painful blisters and sores of the skin and
mucous membranes, especially in the mouth, inflammation of the
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
p Infusion site reaction
Rare: may affect up to 1 in 1000 people
p Overactive thyroid gland
p Deterioration of brain function that is a serious complication of liver
disease
p Loss of most fibers in the optic nerve, clouding of the cornea,
involuntary movement of the eye
p Bullous photosensitivity
p A disorder in which the body’s immune system attacks part of the
peripheral nervous system
p Heart rhythm or conduction problems (sometimes life threatening)
p Life threatening allergic reaction
p Disorder of blood clotting system
p Allergic skin reactions (sometimes severe), including 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, irritation of the skin and mucous membranes,
life-threatening skin condition that causes large portions of the
epidermis, the skin’s outermost layer, to detach from the layers of
skin below
p Small dry scaly skin patches, sometimes thick with spikes or ‘horns’

Side effects with frequency not known:
p Freckles and pigmented spots
Other significant side effects whose frequency is not known,
but should be reported to your doctor immediately:
p Skin cancer
p Inflammation of the tissue surrounding the bone
p 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. Elevated liver enzymes were also observed
more frequently in children.
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.

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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
label and on the carton. 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
p The active substance is voriconazole. Each tablet contains either
50 mg voriconazole (for Voriconazole 50 mg film-coated tablets) or
200 mg voriconazole (for Voriconazole 200 mg film-coated tablets).
p 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 Voriconazole looks like and contents of the pack
Voriconazole 50 mg film-coated tablets are supplied as white to
off-white round film-coated tablets with marked on one side and
VOR50 on the reverse.
Voriconazole 200 mg film-coated tablets are supplied as white to
off-white capsule shaped film-coated tablets with marked on one side
and VOR200 on the reverse.
Voriconazole 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 presented in either a bottle or blister pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
This leaflet was last revised in 03/2016.
Ref: dVF 8_0
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Manufacturer
R-Pharm Germany GmbH
Heinrich-Mack-Str. 35
89257 Illertissen
Germany

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.
p Keep this leaflet. You may need to read it again.
p If you have any further questions, ask your doctor, pharmacist or
nurse.
p 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.
p 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. Content 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.
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It is used for the treatment of patients (adults and children over the
age of 2) with:
p invasive aspergillosis (a type of fungal infection due to
Aspergillus sp),
p candidaemia (another type of fungal infection due to Candida sp)
in non-neutropenic patients (patients without abnormally low white
blood cells count),
p serious invasive Candida sp. infections when the fungus is resistant
to fluconazole (another antifungal medicine),
p serious fungal infections caused by Scedosporium sp. or
Fusarium sp. (two different species of fungi).
Voriconazole is intended for patients with worsening, possibly lifethreatening, 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:
p Terfenadine (used for allergy)
p Astemizole (used for allergy)
p Cisapride (used for stomach problems)
p Pimozide (used for treating mental illness)
p Quinidine (used for irregular heart beat)
p Rifampicin (used for treating tuberculosis)
p Efavirenz (used for treating HIV) in doses of 400 mg and above once
daily
p Carbamazepine (used to treat seizures)
p Phenobarbital (used for severe insomnia and seizures)
p Ergot alkaloids (e.g., ergotamine, dihydroergotamine; used for
migraine)
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p Sirolimus (used in transplant patients)
p Ritonavir (used for treating HIV) in doses of 400mg and more twice
daily
p St. John’s Wort (herbal supplement)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Voriconazole if:
p you have had an allergic reaction to other azoles.
p 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.
p 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:
p tell your doctor immediately if you develop
P sunburn
P severe skin rash or blisters
P 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.

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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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