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VORICONAZOLE ACTAVIS 200MG FILM-COATED TABLETS

Active substance(s): VORICONAZOLE

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Package leaflet:
Information for the user

Voriconazole 50mg and 200mg
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.
• The full name of this medicine is Voriconazole
50mg and 200mg Film-coated Tablets but
within the leaflet it will be referred to as
Voriconazole Tablets.

T00075-01 Malta Zejtun 190x380 PIL

What is in this leaflet
1. What Voriconazole Tablets are and what they
are used for
2. What you need to know before you take
Voriconazole Tablets
3. How to take Voriconazole Tablets
4. Possible side effects
5. How to store Voriconazole Tablets
6. C
 ontents of the pack and other information
1. What Voriconazole Tablets are and what
they are used for
Voriconazole Tablets contains the active
substance voriconazole. Voriconazole Tablets
are 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)
• c andidaemia (another type of fungal infection
due to Candida sp) in non-neutropenic patients
(patients without abnormally low white blood
cells count)

• s erious invasive Candida sp. infections when
the fungus is resistant to fluconazole (another
antifungal medicine)
• s erious fungal infections caused by
Scedosporium sp. or Fusarium sp. (two different
species of fungi).
Voriconazole Tablets are 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 Tablets
Do not take Voriconazole Tablets:
• 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 Tablets
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 twice daily
• St John’s Wort (herbal supplement).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Voriconazole Tablets if:
• you have had an allergic reaction to other
azoles

Voriconazole 50mg & 200mg 28 Tablets PIL - UK
item no: AAAI7841

dimensions: 190 x 380

print proof no: 4

pharmacode:

origination date: 19.02.16

min pt size: 9

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 Tablets:
• tell your doctor immediately if you develop
- sunburn
- severe skin rash or blisters
- bone pain.

revision date: 29.02.16

Technical Approval

revised by: S.Anson

date sent: N/A

supplier: Malta Zejtun

approved: N/A

Tell your doctor if you are taking either of
the following medicines, as treatment with
Voriconazole Tablets 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 Tablets 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 Tablets are still
having the desired effect:

• 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
Voriconazole Tablets 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 Tablets.
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.

Tablets
Patients 40kg Patients less
and above
than 40kg
Dose for the 400mg every
first 24 hours 12 hours for
(Loading Dose) the first 24
hours
Dose after
the first 24
hours
(Maintenance
Dose)

200mg
every 12
hours for
the first 24
hours
200mg twice 100mg
a day
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
Driving and using machines
The recommended dose for children and
Voriconazole Tablets may cause blurring of
• Warfarin and other anticoagulants (e.g.
teenagers is as follows:
phenprocoumon, acenocoumarol; used to slow vision or uncomfortable sensitivity to light. While
Tablets
affected,
do
not
drive
or
operate
any
tools
or
down clotting of the blood)
Children aged Teenagers
machines. Contact your doctor if you experience
• Ciclosporin (used in transplant patients)
If you develop skin disorders as described above, • Tacrolimus (used in transplant patients)
2 to less
aged 12 to
this.
your doctor may refer you to a dermatologist,
than 12 years 14 years
• Sulphonylureas (e.g. tolbutamide, glipizide, and
who after consultation may decide that it is
and teenagers weighing
Voriconazole Tablets contains lactose
glyburide) (used for diabetes)
important for you to be seen on a regular basis.
aged 12 to 14 50kg or
• Statins (e.g. atorvastatin, simvastatin) (used for If you have been told by your doctor that you
There is a small chance that skin cancer could
years weighing more;
have an intolerance to some sugars, contact
lowering cholesterol)
develop with long-term use of Voriconazole
less than 50kg and all
your doctor before taking this medicinal
• Benzodiazepines (e.g midazolam, triazolam)
Tablets.
teenagers
product.
(used for severe insomnia and stress)
older than
Your doctor should monitor the function of your • Omeprazole (used for treating ulcers)
14
• Oral contraceptives (if you take Voriconazole
liver and kidney by doing blood tests.
3. How to take Voriconazole Tablets
Tablets whilst using oral contraceptives, you
Dose
for
the
Your
treatment
400mg
Children and adolescents
may get side effects such as nausea and
first 24 hours will be started every 12
Always take this medicine exactly as your
Voriconazole Tablets should not be given to
menstrual disorders)
(Loading Dose) as an infusion hours for
doctor has told you. Check with your doctor or
children younger than 2 years of age.
• Vinca alkaloids (e.g. vincristine and vinblastine) pharmacist if you are not sure.
the first 24
(used in treating cancer)
Other medicines and Voriconazole Tablets
hours
• Indinavir and other HIV protease inhibitors
Tell your doctor or pharmacist if you are taking,
Your doctor will determine your dose depending Dose after the 9mg/kg twice 200mg
(used for treating HIV)
have recently taken or might take any other
on your weight and the type of infection
first 24 hours a day
twice a day
• Non-nucleoside reverse transcriptase inhibitors you have. The recommended dose for adults
medicines.
(Maintenance (a maximum
(e.g. efavirenz, delavirdine, nevirapine) (used
(including elderly patients) is as follows:
Dose)
dose of
Some medicines, when taken at the same
for treating HIV) (some doses of efavirenz can
350mg twice
time as Voriconazole Tablets, may affect the
NOT be taken at the same time as Voriconazole
daily)
way Voriconazole Tablets work or Voriconazole
Tablets)
Tablets may affect the way they work.
• Methadone (used to treat heroin addiction)
Depending on your response to treatment, your
• Alfentanil and fentanyl and other short acting
doctor may increase or decrease the daily dose.
Tell your doctor if you are taking the following
opiates such as sufentanil (painkillers used for
• Tablets must only be given if the child is able to
medicine, as treatment with Voriconazole
surgical procedures)
swallow tablets.
Tablets at the same time should be avoided if
• Oxycodone and other long acting opiates such
possible:
as hydrocodone (used for moderate to severe
• Ritonavir (used for treating HIV) in doses of
pain)
100mg twice daily.

colours/plates:
1. Black
2.
3.
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originated by: S.Anson
approved for print/date

• 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 Tablets. Your doctor should also
monitor your liver function while you are being
treated with Voriconazole Tablets 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’.

Non Printing Colours
1.
2.
3.

*P
 lease note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

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

If any side effects occur, most are likely to be
minor and temporary. However, some may be
serious and need medical attention.

If you or your child are taking Voriconazole
Tablets for prevention of fungal infections, your
doctor may stop giving Voriconazole Tablets if
you or your child develop treatment related side
effects.

Serious side effects – Stop taking
Voriconazole Tablets and see a doctor
immediately
• Rash
• Jaundice; Changes in blood tests of liver
function
• Pancreatitis.

If you take more Voriconazole Tablets 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 Tablets than
you should.
If you forget to take Voriconazole Tablets
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.

T00075-01 Malta Zejtun 190x380 PIL

If you stop taking Voriconazole Tablets
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 Tablets
correctly, as described above.
Continue taking Voriconazole Tablets 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 Tablet 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.

Other side effects
Very common side effects (may affect more
than 1 in 10 people):
• 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)
• Fever
• Rash
• Nausea, vomiting, diarrhoea
• Headache
• Swelling of the extremities
• Stomach pains
• Breathing difficulties
• Elevated liver enzymes
Common side effects (may affect up to 1 in 10
people):
• Inflammation of the sinuses, inflammation of
the gums, chills, weakness
• 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
• 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

Voriconazole 50mg & 200mg 28 Tablets PIL - UK
item no: AAAI7841

dimensions: 190 x 380

print proof no: 4

pharmacode:

origination date: 19.02.16

min pt size: 9

Uncommon side effects (may affect up to 1 in
100 people):
• Flu-like symptoms, irritation and inflammation
of the gastrointestinal tract, 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),
failure of blood marrow, increased eosinophil)
• 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, 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

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3.
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5.
6.

originated by: S.Anson
approved for print/date

• 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)
• Acute breathing difficulty, chest pain, swelling
of the face (mouth, lips and around eyes), fluid
accumulation in the lungs
• Constipation, indigestion, inflammation of the
lips
• Jaundice, inflammation of the liver and liver
injury
• Skin rashes which may lead to severe blistering
and peeling of the skin characterised by a flat
red area on the skin that is covered with small
confluent bumps, redness of the skin
• Itchiness
• Hair loss
• Back pain
• Kidney failure, blood in the urine, changes in
kidney function tests.

revision date: 29.02.16

Technical Approval

revised by: S.Anson

date sent: N/A

supplier: Malta Zejtun

approved: N/A

Non Printing Colours
1.
2.
3.

*P
 lease note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

• 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, damage to the kidney
• Very fast heart rate or skipped heartbeats,
sometimes with erratic electrical impulses
• Abnormal electrocardiogram (ECG)
• Blood cholesterol increased, blood urea
increased
• 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
discolouration of the skin which may be caused
by low platelet count, eczema
• Injection site reaction
Rare side effects (may affect up to 1 in 1000
people):
• Overactive thyroid gland
• Deterioration of brain function that is a serious
complication of liver disease
• Loss of most fibers in the optic nerve, clouding
of the cornea, involuntary movement of the
eye
• Bullous photosensitivity
• A disorder in which the body’s immune system
attacks part of the peripheral nervous system
• Heart rhythm or condution problems
(sometimes life threatening)
• Life threatening allergic reaction
• Disorder of blood clotting system
• Allergic skin reactions (sometimes severe),
including rapid swelling (oedema) of the
dermis, subcutanous 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
• Small dry scaly skin patches, sometimes thick
with spikes or ‘horns’
Side effects with frequency not known:
• Freckles and pigmented spots
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 Tablets have 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 Tablets 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,
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
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 Tablets
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 Tablets contain
• The active substance is voriconazole. Each
tablet contains 50mg voriconazole.
• The active substance is voriconazole. Each
tablet contains 200mg voriconazole.
• The other ingredients 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 50mg film-coated tablets are white
7mm round tablets with VC50 debossed on one
side.
Voriconazole 200mg film-coated tablets are
white 15.5x 7.9mm oval tablets with VC200
debossed on one side.
Voriconazole 50mg and 200mg film-coated
tablets are available as packs of 28.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Actavis Ltd.
BLB016
Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

If you would like a
leaflet with larger text,
please contact
01271 385257.
This leaflet was last revised in February 2016

Actavis, Barnstaple, EX32 8NS, UK
AAAI7841

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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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