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VORICONAZOLE 50MG FILM-COATED TABLETS

Active substance(s): VORICONAZOLE

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Package Leaflet: Information for the user

Tell your doctor if you are taking either of the following
medicines, as treatment with Voriconazole at the same
Voriconazole 50mg film-coated tablets
time should be avoided if possible, and a dose
adjustment of voriconazole may be required:
Voriconazole 200mg film-coated tablets

Rifabutin (used for treating tuberculosis). If you are
Voriconazole
already being treated with rifabutin your blood
counts and side effects to rifabutin will need to be
Read all of this leaflet carefully before you start
monitored.
taking this medicine because it contains important
• Phenytoin (used to treat epilepsy). If you are already
information for you.
being treated with phenytoin your blood
• Keep this leaflet. You may need to read it again.
concentration of phenytoin will need to be
monitored during your treatment with Voriconazole
• If you have any further questions, ask your doctor
and your dose may be adjusted.
or pharmacist.
Tell your doctor if you are taking any of the following
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if medicines, as a dose adjustment or monitoring may be
required to check that the medicines and/ or
their signs of illness are the same as yours.
Voriconazole are still having the desired effect:
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
• Warfarin and other anticoagulants (e.g.
not listed in this leaflet. See section 4.
phenprocoumon, acenocoumarol; used to slow
down clotting of the blood)
What is in this leaflet
• Ciclosporin (used in transplant patients)
1. What Voriconazole is and what it is used for
• Tacrolimus (used in transplant patients)
2. What you need to know before you take Voriconazole
• Sulphonylureas (e.g. tolbutamide, glipizide, and
3. How to take Voriconazole
glyburide) (used for diabetes)
4. Possible side effects
• Statins (e.g. atorvastatin, simvastatin)
5. How to store Voriconazole
(used for lowering cholesterol)
6. Contents of the pack and other information
• Benzodiazepines (e.g midazolam, triazolam)
(used for severe insomnia and stress)
1. What Voriconazole is and what it is used for
• Omeprazole (used for treating ulcers)
Voriconazole contains the active substance
• Oral contraceptives (if you take Voriconazole whilst
voriconazole. Voriconazole is an antifungal medicine.
using oral contraceptives, you may get side effects
It works by killing or stopping the growth of the fungi
such as nausea and menstrual disorders)
that cause infections.
• Vinca alkaloids (e.g. vincristine and vinblastine)
It is used for the treatment of patients (adults and
(used in treating cancer)
children over the age of 2) with:
• Indinavir and other HIV protease inhibitors
(used for treating HIV)
• invasive aspergillosis (a type of fungal infection due
to Aspergillus sp.),
• Non-nucleoside reverse transcriptase inhibitors (e.g.
efavirenz, delavirdine, nevirapine) (used for treating
• candidaemia (another type of fungal infection due to
HIV) (some doses of efavirenz can not be taken at the
Candida sp.) in non-neutropenic patients (patients
same time as Voriconazole)
without abnormally low white blood cells count),
• Methadone (used to treat heroin addiction)
• serious invasive Candida sp. infections when the
fungus is resistant to fluconazole (another antifungal • Alfentanil and fentanyl and other short acting opiates
medicine),
such as sufentanil (painkillers used for surgical
procedures)
• serious fungal infections caused by Scedosporium sp.
or Fusarium sp. (two different species of fungi).
• Oxycodone and other long acting opiates such as
hydrocodone (used for moderate to severe pain)
Voriconazole is intended for patients with worsening,
possibly life-threatening, fungal infections.
• Non-steroidal anti-inflammatory drugs (e.g.
ibuprofen, diclofenac) (used for treating pain and
Prevention of fungal infections in high risk bone
inflammation)
marrow transplant recipients.

Fluconazole (used for fungal infections)
This product should only be taken under the
• Everolimus (used for treating advanced kidney
supervision of a doctor.
cancer and in transplant patients)

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

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:
Tablets
Patients 40kg
and above
Dose for the 400mg
first 24 hours every 12 hours
(Loading Dose) for the first
24 hours
Dose after the 200mg
first 24 hours twice a day
(Maintenance
Dose)

Patients less than
40kg
200mg
every 12 hours
for the first
24 hours
100mg
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:
Tablets
Children aged Teenagers aged
2 to less than
12 to 14 years
12 years and
weighing 50kg or
teenagers aged more; and all
12 to 14 years teenagers
weighing less
older than 14
than 50kg
Dose for the Your treatment 400mg every
first 24 hours will be started 12 hours for the
(Loading Dose) as an infusion
first 24 hours
Dose after the 9mg/kg twice a 200mg
first 24 hours day (a maximum twice a day
(Maintenance dose of 350mg
Dose)
twice daily
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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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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