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VORICONAZOLE TEVA 200MG FILM-COATED TABLETS

Active substance(s): VORICONAZOLE

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TEVA UK Ref:

231-30-30206-C LEA VORICONAZOLE 50mg & 200mg FC TAB TUK Dimensions:

Length:
Width:

Colours Used:

500 mm
155 mm

Depth:

-

Foil Width:

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.
What is in this leaflet:

1. What Voriconazole Film-coated Tablets are and
what they are used for
2. What you need to know before you take
Voriconazole Film-coated Tablets
3. How to take Voriconazole Film-coated Tablets
4. Possible side effects
5. How to store Voriconazole Film-coated Tablets
6. Contents of the pack and other information

What Voriconazole Film-coated Tablets
are and what they are used for

Voriconazole Film-coated 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 Film-coated 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 Film-coated Tablets

Do not take Voriconazole Film-coated Tablets
• if you are allergic to voriconazole or any of the
other ingredients of this medicine (listed in
section 6).

07 April 2016

PANTONE® GREEN C
BLACK

-

Shelf Ready Pack:

Package leaflet:
Information for the user

2

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Perforated:

VORICONAZOLE 50 mg AND 200 mg
FILM-COATED TABLETS

1

Version:

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Tell your doctor if you are taking the following
medicine, as treatment with Voriconazole
Film-coated Tablets at the same time should be
avoided if possible:
• 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
Film-coated 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 Film-coated 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 Film-coated 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)
• Statins (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
Film-coated 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
Film-coated 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)
• 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 Film-coated Tablets must not be taken
during pregnancy, unless indicated by your doctor.
Effective contraception must be used in women of
The medicines in the following list must not be taken childbearing potential. Contact your doctor
immediately if you become pregnant while taking
during your course of treatment with Voriconazole
Voriconazole Film-coated Tablets.
Film-coated Tablets:
It is very important that you inform your doctor,
pharmacist or nurse if you are taking or have taken
any other medicines, even those that are obtained
without a prescription, or herbal medicines.















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
400 mg and more twice daily
St John’s Wort (herbal supplement).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Voriconazole Film-coated 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 Film-coated Tablets. Your doctor
should also monitor your liver function while you
are being treated with Voriconazole Film-coated
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 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 Film-coated
Tablets 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.

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 Film-coated 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 Film-coated Tablets contains lactose
If you have been told by your doctor that you have
an intolerance to some sugars, tell your doctor
before taking Voriconazole Film-coated Tablets.

3

How to take Voriconazole Film-coated
Tablets

Always take this medicine exactly as your doctor or
pharmacist 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 40 kg
and above

Dose for the first 400 mg every
200 mg every
24 hours
12 hours for the 12 hours for the
(Loading Dose) first 24 hours
first 24 hours
Dose after the
first 24 hours
(Maintenance
Dose)

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

Children and adolescents
Voriconazole Film-coated Tablets should not be
given to children younger than 2 years of age.

Some medicines, when taken at the same time as
Voriconazole Film-coated Tablets, may affect the
way Voriconazole Film-coated Tablets work or
Voriconazole Film-coated Tablets may affect the
way they work.

200 mg twice a 100 mg twice a
day
day

Depending on your response to treatment, your
doctor may increase the daily dose to 300 mg twice
a day.

Your doctor should monitor the function of your liver
and kidney by doing blood tests.

Other medicines and Voriconazole Film-coated
Tablets
Tell your doctor or pharmacist if you are
taking/using, have recently taken/used or might
take/use any other medicines.

Patients less
than 40 kg

Dose for the first Your treatment 400 mg every
will be started 12 hours for the
24 hours
(Loading Dose) as an infusion first 24 hours
Dose after the
first 24 hours
(Maintenance
Dose)

9 mg/kg twice a 200 mg twice a
day (a maximum day
dose of 350 mg
twice daily)

TEVA UK Ref:

231-30-30206-C LEA VORICONAZOLE 50mg & 200mg FC TAB TUK Dimensions:

Length:
Width:

Depth:

Version:

Colours Used:

500 mm
155 mm
-

Foil Width:

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
Film-coated Tablets for prevention of fungal
infections, your doctor may stop giving Voriconazole
Film-coated Tablets if you or your child develop
treatment related side effects.
If you take more Voriconazole Film-coated 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 Film-coated Tablets with you. You may
experience abnormal intolerance to light as a result
of taking more Voriconazole Film-coated Tablets
than you should.
If you forget to take Voriconazole Film-coated Tablets
It is important to take your Voriconazole Film-coated
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.

PANTONE® GREEN C
BLACK

-

Shelf Ready Pack:

• Tablets must only be given if the child is able to
swallow tablets.

07 April 2016

-

Perforated:

Depending on your response to treatment, your
doctor may increase or decrease the daily dose.

2

Template

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• 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 discolouration of the
skin which may be caused by low platelet count,
eczema
• 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
If you stop taking Voriconazole Film-coated Tablets • damage to the optic nerve resulting in vision
impairment, clouding of the cornea
It has been shown that taking all doses at the
• bullous photosensitivity
appropriate times may greatly increase the
• a disorder in which the body’s immune system
effectiveness of your medicine. Therefore unless
attacks part of the peripheral nervous system
your doctor instructs you to stop treatment, it is
• severe heart rhythm problems that may be life
important to keep taking Voriconazole Film-coated
threatening.
Tablets correctly, as described above.
Other significant side effects whose frequency is
Continue taking Voriconazole Film-coated Tablets
not known, but should be reported to your doctor
until your doctor tells you to stop. Do not stop
treatment early because your infection may not be immediately:
cured. Patients with a weakened immune system or • skin cancer
those with difficult infections may require long term • inflammation of the tissue surrounding the bone
• red, scaly patches or ring-shaped skin lesions
treatment to prevent the infection from returning.
that may be a symptom of an autoimmune disease
When Voriconazole Film-coated Tablets treatment is
called cutaneous lupus erythematosus.
stopped by your doctor you should not experience
As
Voriconazole Film-coated Tablets have been
any effects.
known to affect the liver and the kidney, your doctor
If you have any further questions on the use of this
should monitor the function of your liver and kidney
medicine, ask your doctor, pharmacist or nurse.
by doing blood tests. Please advise your doctor if
you have any stomach pains or if your stools have a
Possible
side
effects
4
different consistency.
Like all medicines, this medicine can cause side
There have been reports of skin cancer in patients
effects, although not everybody gets them.
treated with voriconazole for long periods of time.
If any side effects occur, most are likely to be minor Sunburn or severe skin reaction following exposure
and temporary. However, some may be serious and to light or sun was experienced more frequently in
need medical attention.
children. If you or your child develops skin disorders,
your doctor may refer you to a dermatologist, who
Serious side effects – Stop taking Voriconazole
Film-coated Tablets and see a doctor immediately after consultation may decide that it is important for
you or your child to be seen on a regular basis.
• rash
• jaundice; Changes in blood tests of liver function If any of these side effects persist or are
• pancreatitis.
troublesome, please tell your doctor.
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.

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 at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

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 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.

Keep this medicine out of the sight and reach of
children.

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 painful),
disorder of blood clotting system, failure of bone
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, 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, 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

5

How to store Voriconazole Film-coated
Tablets

Do not use this medicine after the expiry date which
is stated on the blister or carton 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 Film-coated Tablets contains
• The active substance is voriconazole. Each tablet
contains 50 mg voriconazole (Voriconazole 50 mg
Film-coated Tablets) or 200 mg voriconazole
(Voriconazole 200 mg Film-coated Tablets).
• The other ingredients are lactose monohydrate
(see section 2 “Voriconazole Film-coated Tablets
contains lactose”), croscarmellose-sodium,
povidone K25, pregelatinised maize starch,
magnesium stearate, hypromellose 5 mPa·s,
glycerol 85%, titanium dioxide (E 171).
What Voriconazole Film-coated Tablets looks like
and contents of the pack
Voriconazole 50 mg is supplied as white, round,
biconvex film-coated tablets (diameter: approx.
7.2 mm) with imprint “V” on one and “50” on the
other side.
Voriconazole 200 mg is supplied as white, oblong
film-coated tablets (dimensions: approx. 17.2 mm x
7.2 mm) with imprint “V” on one and “200” on the
other side.
Voriconazole 50 mg Film-coated Tablets are
available as packs of 2, 10, 14, 20, 28, 30, 50, 56, 98
and 100 in PVC/Alu-blisters as multipack and unit
pack.
Voriconazole 200 mg Film-coated Tablets are
available as packs of 2, 10, 14, 20, 28, 30, 50, 56, 98
and 100 in PVC/Alu-blisters as multipack and unit
pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz
baruna Filipovića 25, 10000 Zagreb, Croatia
This leaflet was last revised in 04/2016
PL 00289/1783-4

30206-C

155 x 500

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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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