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VORICONAZOLE ACTAVIS 50MG FILM-COATED TABLETS

Active substance(s): VORICONAZOLE

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Package leaflet:
Information for the user

Voriconazole 50mg and 200mg
Film-coated Tablets

T00075-01 Malta Zejtun 190x380 PIL

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

• candidaemia (another type of fungal
infection due to Candida sp) in nonneutropenic 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 Tablets are intended for
patients with worsening, possibly lifethreatening, fungal infections.
Prevention of fungal infections in high risk
bone marrow transplant recipients.

Warnings and precautions
Talk to your doctor before taking
Voriconazole Tablets 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 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’.

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
2. What you need to know before you take protection factor (SPF), as an increased
Voriconazole Tablets
sensitivity of skin to the sun’s UV rays
can occur. These precautions are also
Do not take Voriconazole Tablets:
applicable to children.
• if you are allergic to voriconazole or any
of the other ingredients of this medicine
While being treated with Voriconazole
(listed in section 6).
Tablets:
What is in this leaflet
• tell your doctor immediately if you
It
is
very
important
that
you
inform
your
1. What Voriconazole Tablets are and what
develop
doctor
or
pharmacist
if
you
are
taking
they are used for
- sunburn
or
have
taken
any
other
medicines,
2. What you need to know before you take
- severe skin rash or blisters
even those that are obtained without a
Voriconazole Tablets
- bone pain.
prescription,
or
herbal
medicines.
3. How to take Voriconazole Tablets
If you develop skin disorders as described
4. Possible side effects
The medicines in the following list must
above, your doctor may refer you to a
5. How to store Voriconazole Tablets
not be taken during your course of
dermatologist, who after consultation may
6. Contents of the pack and other
Voriconazole Tablets treatment:
decide that it is important for you to be
information
• Terfenadine (used for allergy)
seen on a regular basis. There is a small
• Astemizole (used for allergy)
chance that skin cancer could develop with
1. What Voriconazole Tablets are and what • Cisapride (used for stomach problems)
• Pimozide (used for treating mental illness) long-term use of Voriconazole Tablets.
they are used for
• Quinidine (used for irregular heart beat)
Your doctor should monitor the function of
Voriconazole Tablets contains the active
• Rifampicin (used for treating tuberculosis) your liver and kidney by doing blood tests.
substance voriconazole. Voriconazole
• Efavirenz (used for treating HIV) in doses
Tablets are an antifungal medicine. It works
of 400mg and above once daily
Children and adolescents
by killing or stopping the growth of the
• Carbamazepine (used to treat seizures)
Voriconazole Tablets should not be given to
fungi that cause infections.
•P
 henobarbital (used for severe insomnia
children younger than 2 years of age.
and seizures)
It is used for the treatment of patients
Other
medicines and Voriconazole Tablets
(adults and children over the age of 2) with: • Ergot alkaloids (e.g. ergotamine,
Tell your doctor or pharmacist if you are
dihydroergotamine;
used
for
migraine)
• invasive aspergillosis (a type of fungal
taking, have recently taken or might take
• Sirolimus (used in transplant patients)
infection due to Aspergillus sp)
any other medicines, including those that
• Ritonavir (used for treating HIV) in doses
are obtained without a prescription.
of 400mg and more twice daily
• St John’s Wort (herbal supplement).
This product should only be taken under
the supervision of a doctor.

Voriconazole 50mg & 200mg Tablets PIL - UK
item no: AAAI5746

dimensions: 190 x 380

print proof no: 1

pharmacode:

origination date: 04.12.15

min pt size: 9

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date:

Technical Approval

revised by:

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.

Some medicines, when taken at the same
time as Voriconazole Tablets, may affect
the way Voriconazole Tablets work or
Voriconazole Tablets may affect the way
they work.
Tell your doctor if you are taking the
following medicine, as treatment with
Voriconazole Tablets at the same time
should be avoided if possible:
• Ritonavir (used for treating HIV) in doses
of 100mg twice daily.
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:
• 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)
• S tatins (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 Tablets 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 Tablets)
• 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)
•N
 on-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.
Driving and using machines
Voriconazole Tablets 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 Tablets contains lactose
If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicinal product.
3. How to take Voriconazole Tablets
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 every
first 24 hours
12 hours for
(Loading Dose) the first 24
hours
Dose after the 200mg twice
first 24 hours
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
2 to less than
12 years and
teenagers
aged 12 to
14 years
weighing less
than 50kg
Dose for the
Your
first 24 hours treatment will
(Loading Dose) be started as
an infusion
Dose after the 9mg/kg twice
first 24 hours a day
(Maintenance (a maximum
Dose)
dose of
350mg twice
daily)

Teenagers
aged 12 to
14 years
weighing
50kg or
more; and
all teenagers
older than 14
400mg every
12 hours for
the first 24
hours
200mg 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
Tablets for prevention of fungal infections,
your doctor may stop giving Voriconazole
Tablets if you or your child develop
treatment related side effects.
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.

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 Tablets and see a doctor
immediately
• Rash
• Jaundice; Changes in blood tests of liver
function
• Pancreatitis.
Other side effects

• 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
characterised 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.

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
If you stop taking Voriconazole Tablets
painful), disorder of blood clotting system,
It has been shown that taking all doses
failure of blood marrow, other blood cell
Common side effects (may affect up to 1 in
at the appropriate times may greatly
changes (increased eosinophil and low
10 people) are:
increase the effectiveness of your medicine. • Flu-like symptoms, irritation and
white blood cells in blood)
Therefore unless your doctor instructs you
inflammation of the gastrointestinal tract, • Depressed function of the adrenal gland,
to stop treatment, it is important to keep
underactive thyroid gland
inflammation of the sinuses, inflammation
taking Voriconazole Tablets correctly, as
• Abnormal brain function, Parkinson
of the gums, chills, weakness
described above.
like symptoms, nerve injury resulting in
• Low numbers of some types of red or
numbness, pain, tingling or burning in the
white
blood
cells,
low
numbers
of
cells
Continue taking Voriconazole Tablets until
hands or feet
called
platelets
that
help
the
blood
to
clot
your doctor tells you to stop. Do not stop
• Problems with balance or coordination

A

llergic
reaction
or
exaggerated
immune
treatment early because your infection may
• Swelling of the brain
response
not be cured. Patients with a weakened
• Double vision, serious conditions of the

L

ow
blood
sugar,
low
blood
potassium,
immune system or those with difficult
eye including: pain and inflammation
low
sodium
in
the
blood
infections may require long term treatment
of the eyes and eyelids, involuntary

A

nxiety,
depression,
confusion,
agitation,
to prevent the infection from returning.
movement of the eye, abnormal eye
inability to sleep, hallucinations
movement, damage to the optic nerve
When Voriconazole Tablet treatment is
• Seizures, tremors or uncontrolled muscle
resulting in vision impairment, optic disc
stopped by your doctor you should not
movements, tingling or abnormal skin
swelling
experience any effects.
sensations, increase in muscle tone,
• Decreased sensitivity to touch
sleepiness, dizziness
If you have any further questions on the
• Abnormal sense of taste
• Bleeding in the eye
use of this medicine, ask your doctor,
• Heart rhythm problems including very fast • Hearing difficulties, ringing in the ears,
pharmacist or nurse.
vertigo
heartbeat, very slow heartbeat, fainting
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

4. Possible side effects

Voriconazole 50mg & 200mg Tablets PIL - UK
item no: AAAI5746

dimensions: 190 x 380

print proof no: 1

pharmacode:

origination date: 04.12.15

min pt size: 9

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date:

Technical Approval

revised by:

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.

• 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
discolouration of the skin which may be
caused by low platelet count, eczema
• Injection site reaction
• Life threatening allergic reaction.

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.

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.

By reporting side effects you can help
provide more information on the safety of
this medicine.

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.

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. 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 the Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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.

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
December 2015

Actavis, Barnstaple, EX32 8NS, UK
AAAI5746

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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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