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VORICONAZOLE TEVA 200MG FILM-COATED TABLETS

Active substance(s): VORICONAZOLE / VORICONAZOLE / VORICONAZOLE

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TEVA UK Ref:

231-30-30206-E LEA VORICONAZOLE 50mg & 200mg FC TAB TUK Dimensions Changed:
No
Length:
500 mm
Width:
155 mm
Depth:
Foil Width:
-

VORICONAZOLE 50 mg AND 200 mg
FILM-COATED TABLETS
Package leaflet:
Information for the user

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

1

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).
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.
The medicines in the following list must not be taken
during your course of treatment with Voriconazole
Film-coated Tablets:
• 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.
Your doctor should monitor the function of your liver
and kidney by doing blood tests.
Children and adolescents
Voriconazole Film-coated Tablets should not be
given to children younger than 2 years of age.
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.
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.
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.

REG0101243

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
childbearing potential. Contact your doctor
immediately if you become pregnant while taking
Voriconazole Film-coated 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 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

Patients less
than 40 kg

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

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.
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 weighing
years and
teenagers aged 50 kg or more;
12 to 14 years and all
weighing less teenagers
older than 14
than 50 kg
Dose for the first Your treatment 400 mg every
24 hours
will be started 12 hours for the
(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)

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.

Colours Used:

Version:

5

05 Spetember 2016

BLACK
PANTONE® GREEN C
Template

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.
If you stop taking Voriconazole Film-coated 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 Film-coated
Tablets correctly, as described above.
Continue taking Voriconazole Film-coated 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 Film-coated Tablets 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.

• 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.
Rare: 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 fibres 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 conduction 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,
subcutaneous 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
4 Possible side effects
not known, but should be reported to your doctor
Like all medicines, this medicine can cause side
immediately:
effects, although not everybody gets them.
• skin cancer
If any side effects occur, most are likely to be minor • inflammation of the tissue surrounding the bone
and temporary. However, some may be serious and • red, scaly patches or ring-shaped skin lesions
need medical attention.
that may be a symptom of an autoimmune disease
called cutaneous lupus erythematosus.
Serious side effects – Stop taking Voriconazole
Film-coated Tablets and see a doctor immediately As Voriconazole Film-coated Tablets have been
• rash
known to affect the liver and the kidney, your doctor
• jaundice; Changes in blood tests of liver function should monitor the function of your liver and kidney
• pancreatitis.
by doing blood tests. Please advise your doctor if
you have any stomach pains or if your stools have a
Other side effects
different consistency.
Very common: may affect more than 1 in 10 people
• visual impairment (change in vision including
There have been reports of skin cancer in patients
blurred vision, visual colour alterations, abnormal treated with voriconazole for long periods of time.
intolerance to visual perception of light, colour
Sunburn or severe skin reaction following exposure
blindness, eye disorder, halo vision, night
blindness, swinging vision, seeing sparks, visual to light or sun was experienced more frequently in
children.
If you or your child develops skin disorders,
aura, visual acuity reduced, visual brightness,
your doctor may refer you to a dermatologist, who
loss of part of the usual field of vision, spots
after
consultation
may decide that it is important for
before the eyes)
you or your child to be seen on a regular basis.
• fever
Elevated liver enzymes were also observed more
• rash
frequently in children.
• nausea, vomiting, diarrhoea
If any of these side effects persist or are
• headache
troublesome, please tell your doctor.
• swelling of the extremities
• stomach pains
Reporting of side effects
• breathing difficulties
If you get any side effects, talk to your doctor,
• elevated liver enzymes.
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
Common: may affect up to 1 in 10 people
side effects directly via the Yellow Card Scheme at:
• inflammation of the sinuses, inflammation of the
www.mhra.gov.uk/yellowcard
gums, chills, weakness
• low numbers of some types, including severe, of By reporting side effects you can help provide more
information on the safety of this medicine.
red (sometimes immune-related) and/or white
blood cells (sometimes with fever), low numbers
to store Voriconazole Film-coated
5 How
of cells called platelets that help the blood to clot
Tablets
• low blood sugar, low blood potassium, low sodium
Keep this medicine out of the sight and reach of
in the blood
• anxiety, depression, confusion, agitation, inability children.
to sleep, hallucinations
Do not use this medicine after the expiry date which
• seizures, tremors or uncontrolled muscle
is stated on the blister or carton after EXP. The
movements, tingling or abnormal skin sensations, expiry date refers to the last day of that month.
increase in muscle tone, sleepiness, dizziness
This medicine does not require any special storage
• bleeding in the eye
conditions.
• heart rhythm problems including very fast
Do not throw away any medicines via wastewater
heartbeat, very slow heartbeat, fainting
• low blood pressure, inflammation of a vein (which or household waste. Ask your pharmacist how to
may be associated with the formation of a blood throw away medicines you no longer use. These
measures will help protect the environment.
clot)
• acute breathing difficulty, chest pain, swelling of
of the pack and other
the face (mouth, lips and around eyes), fluid
6 Contents
information
accumulation in the lungs
• constipation, indigestion, inflammation of the lips What Voriconazole Film-coated Tablets contains
• jaundice, inflammation of the liver and liver injury • The active substance is voriconazole. Each tablet
• skin rashes which may lead to severe blistering
contains 50 mg voriconazole (Voriconazole 50 mg
and peeling of the skin characterised by a flat, red
Film-coated Tablets) or 200 mg voriconazole
area on the skin that is covered with small
(Voriconazole 200 mg Film-coated Tablets).
confluent bumps, redness of the skin
• The other ingredients are lactose monohydrate
• itchiness
(see section 2 “Voriconazole Film-coated Tablets
• hair loss
contains lactose”), croscarmellose-sodium,
• back pain
povidone K25, pregelatinised maize starch,
• kidney failure, blood in the urine, changes in
magnesium stearate, hypromellose 5 mPa·s,
kidney function tests.
glycerol 85%, titanium dioxide (E 171).
Uncommon: may affect up to 1 in 100 people
What Voriconazole Film-coated Tablets looks like
• flu-like symptoms, irritation and inflammation of
and contents of the pack
the gastrointestinal tract, inflammation of the
Voriconazole 50 mg is supplied as white, round,
gastrointestinal tract causing antibiotic
biconvex film-coated tablets (diameter: approx.
associated diarrhoea, inflammation of the
7.2 mm) with imprint “V” on one and “50” on the
lymphatic vessels
• inflammation of the thin tissue that lines the inner other side.
Voriconazole 200 mg is supplied as white, oblong
wall of the abdomen and covers the abdominal
film-coated tablets (dimensions: approx. 17.2 mm x
organ
• enlarged lymph glands (sometimes painful), failure 7.2 mm) with imprint “V” on one and “200” on the
other side.
of bone marrow, increased eosinophil
• allergic reaction or exaggerated immune
Voriconazole 50 mg Film-coated Tablets are
response
available as packs of 2, 10, 14, 20, 28, 30, 50, 56, 98
• depressed function of the adrenal gland,
and 100 in PVC/Alu-blisters as multipack and unit
underactive thyroid gland
pack.
• abnormal brain function, Parkinson-like
Voriconazole 200 mg Film-coated Tablets are
symptoms, nerve injury resulting in numbness,
available as packs of 2, 10, 14, 20, 28, 30, 50, 56, 98
pain, tingling or burning in the hands or feet
and 100 in PVC/Alu-blisters as multipack and unit
• problems with balance or coordination
pack.
• swelling of the brain
Not all pack sizes may be marketed.
• double vision, serious conditions of the eye
including: pain and inflammation of the eyes and Marketing Authorisation Holder
eyelids, abnormal eye movement, damage to the TEVA UK Limited, Eastbourne, BN22 9AG, UK
optic nerve resulting in vision impairment, optic
Manufacturer
disc swelling
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.),
• decreased sensitivity to touch
Prilaz baruna Filipovića 25, 10000 Zagreb, Croatia
• abnormal sense of taste
This leaflet was last revised in 09/2016
• hearing difficulties, ringing in the ears, vertigo
• inflammation of certain internal organs PL 00289/1783-4
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
30206-E
formation of a blood clot)

155 x 500

Version 5.0

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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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