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VORICONAZOLE TORRENT 200 MG FILM-COATED TABLETS

Active substance(s): VORICONAZOLE

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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.
- Keep this leaflet. You may need to
read it again.
- If you have any further questions,
ask your doctor or pharmacist.
- 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 or pharmacist. 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
Voriconazole 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 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 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 cardiomy
opathy, 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
o Sunburn
o Severe skin rash or blisters
o 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,
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:
• Ritonavir (used for treating HIV) in
doses of 100 mg twice daily

(used for treating pain and
inflammation)
• Fluconazole (used for fungal
infections)
• Everolimus (used for treating
• Warfarin and other anticoagulants
advanced kidney cancer and in
(e.g. phenprocoumon,
transplant patients)
acenocoumarol; used to slow down
Pregnancy and breast-feeding
clotting of the blood)
Voriconazole must not be taken
• Ciclosporin (used in transplant
during pregnancy, unless indicated
patients)
by your doctor. Effective contracep• Tacrolimus (used in transplant
tion must be used in women of
patients)
childbearing potential. Contact your
• Sulphonylureas (e.g. tolbutamide,
doctor immediately if you become
glipizide, and glyburide) (used for
pregnant while taking Voriconazole.
diabetes)
If you are pregnant or breast-feeding,
• Statins (e.g. atorvastatin,
think you may be pregnant or are
simvastatin) (used for lowering
planning to have a baby, ask your
cholesterol)
doctor or pharmacist for advice
• Benzodiazepines (e.g midazolam,
before taking this medicine.
triazolam) (used for severe
insomnia and stress)
Driving and using machines
• Omeprazole (used for treating
Voriconazole may cause blurring of
ulcers)
vision or uncomfortable sensitivity to
• Oral contraceptives (if you take
light. While affected, do not drive or
Voriconazole whilst using oral
operate any tools or machines.
contraceptives, you may get side
Contact your doctor if you experieffects such as nausea and
ence this.
menstrual disorders)
• Vinca alkaloids (e.g. vincristine and Voriconazole contains lactose
If you have been told by your doctor
vinblastine) (used in treating
Tell your doctor if you are taking
that you have an intolerance to some
cancer)
either of the following medicines, as
sugars, contact your doctor before

Indinavir
and
other
HIV
protease
treatment with Voriconazole at the
taking this medicinal product.
inhibitors
(used
for
treating
HIV)
same time should be avoided if

Non-nucleoside
reverse
3. How to take Voriconazole
possible, and a dose adjustment of
transcriptase inhibitors (e.g.
Always take this medicine exactly as
voriconazole may be required:
efavirenz, delavirdine, nevirapine)
your doctor has told you. Check with
• Rifabutin (used for treating
(used for treating HIV) (some doses your doctor or pharmacist if you are
tuberculosis). If you are already
of efavirenz can NOT be taken at
not sure.
being treated with rifabutin your
the same time as Voriconazole)
blood counts and side effects to
Your doctor will determine your dose
rifabutin will need to be monitored. • Methadone (used to treat heroin
depending on your weight and the
addiction)
• Phenytoin (used to treat epilepsy).
type of infection you have.

Alfentanil
and
fentanyl
and
other
If you are already being treated
The recommended dose for adults
short acting opiates such as
with phenytoin your blood
(including elderly patients) is as
sufentanil
(painkillers
used
for
concentration of phenytoin will
follows:
surgical procedures)
need to be monitored during your
• Oxycodone and other long acting
Tablets
treatment with Voriconazole and
opiates such as hydrocodone (used
your dose may be adjusted.
Patients Patients
for moderate to severe pain)
40 kg and less than
Tell your doctor if you are taking any • Non-steroidal anti-inflammatory
above
40 kg
of the following medicines, as a dose
drugs (e.g. ibuprofen, diclofenac)
adjustment or monitoring may be
required to check that the medicines
and/ or Voriconazole are still having
the desired effect:

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

400 mg
every 12
hours for
the first
24 hours
200 mg
twice a
day

200 mg
every 12
hours for
the first
24 hours
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 Teenagers
aged 2
aged 12
to less
to 14
than 12
years
years and weighing
teenagers 50 kg or
aged 12 to more;
14 years and all
weighing teenagers
less than older than
50 kg
14
Dose for the Your
400 mg
first 24 hours treatment every 12
(Loading
will be
hours for
Dose)
started as the first
an infusion 24 hours
Dose after
9 mg/kg 200 mg
the first
twice a
twice a
24 hours
day (a
day
(Maintenance maximum
Dose)
dose of
350 mg
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
• 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 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 side effects (may affect
up to 1 in 100 people) are:
• Inflammation of the gastrointestinal
tract causing antibiotic associated
diarrhea, 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,
Parkison-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
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 or pharmacist. This

includes any possible side effects not
listed in this leaflet. You can also
report side effects directly via Yellow
Card Scheme Website:
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 and blister 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.
6. Contents of the pack and other
information
What Voriconazole contains
- The active substance is
voriconazole.
- Voriconazole 50 mg film-coated
tablets: Each tablet contains 50 mg
voriconazole.
Voriconazole 200 mg film-coated
tablets: Each tablet contains 200
mg voriconazole.
- The other ingrediens are lactose
monohydrate, cellulose
microcrystalline, croscarmellose
sodium, povidone K29/32,
magnesium stearate, hypromellose
6cP , titanium dioxide (E171),
macrogol 3350, triacetin.
What Voriconazole tablets look
like and contents of the pack
Voriconazole 50 mg film-coated
tablets are white 7 mm round tablets
with VC50 debossed on one side.

Voriconazole 200 mg film-coated
tablets are white 15.5x 7.9 mm oval
tablets with VC200 debossed on one
side.
Voriconazole 50 mg and 200 mg
film-coated tablets are available as
packs of 10, 14, 20, 28, 30, 50, 56, 98
and 100.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court,
County Oak Way,
Crawley,
West Sussex.
RH11 7XA
United Kingdom
Manufacturer
Actavis Ltd.
BLB 016 Bulebel Industrial Estate,
Zejtun ZTN 3000,
Malta
This leaflet was last revised in
07/2015.

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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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