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VORICONAZOLE 50 MG FILM-COATED TABLETS

Active substance(s): VORICONAZOLE

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Package leaflet: Information for the patient

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 contains 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
aged 2 years and above) 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. 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, mephobarbital (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 or pharmacist 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 or had before cardiomyopathy
(particularly when heart failure), irregular heart beat, slow
heart rate or an abnormality of electrocardiogram (ECG)
called ‘long QT syndrome’.
You should avoid 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
** sunburn
** severe skin rash or blisters
** bone pain.

Tell your doctor if you are taking either of the following
medicines, as treatment with Voriconazole 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, 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 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)
•• Sulfonylureas (e.g. tolbutamide, glipizide, and glyburide)
(used for diabetes) (if you take Voriconazole whilst using oral
contraceptives, you doctor may monitor you blood sugar
levels).
•• Statins (e.g. atorvastatin, simvastatin, lovastatin) (used for
lowering cholesterol)
•• Benzodiazepines (e.g. midazolam, triazolam, alprazolam)
(used for severe insomnia and stress)
•• Omeprazole (used for treating ulcers)
•• Oral contraceptives (e.g. norethisterone/ethinylestradiol)
(if you take Voriconazole 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)
•• 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)
•• 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 must not be taken during pregnancy, unless
indicated by your doctor. Effctive contraception must be
used in women of childbearing potential. Contact your
doctor immediately if you become pregnant while taking
Voriconazole.
Voriconazole must not be taken during breast-feeding.
Ask your doctor or pharmacist for advice before taking any
medicine whilst breast-feeding.
Driving and using machines
Voriconazole may cause blurring of vision, altered visual
perception or uncomfortable sensitivity to light. While
affected, do not drive or operate any tools or machines.
Contact your doctor if you experience this.
Voriconazole contains lactose monohydrate.
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicine.
3. How to take Voriconazole
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 Patients less
above
than 40 kg
Dose for the first 400 mg every 12
200 mg every
24 hours
hours for the first 12 hours for the
(Loading Dose)
24 hours
first 24 hours
Dose after the first
24 hours
200 mg twice a day 100 mg twice a day
(Maintenance
Dose)
Patients 40 kg and above: Depending on your response to
treatment, your doctor may increase the daily dose to 300 mg
twice a day.
Patients less than 40 kg: Depending on your response to
treatment, your doctor may increase the daily dose to 150 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

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, kidney
and pancreas 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 it 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

Children aged 2 to
less than 12 years
and teenagers
aged 12 to 14
years weighing
less than 50 kg

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

Dose for the first
24 hours
(Loading Dose)

Your treatment
will be started as
an infusion

400 mg every
12 hours for the
first 24 hours

Dose after the
first 24 hours
(Maintenance
Dose)

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

200 mg 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. An oral suspension is more appropriate for infants
and children under the age of 12 years.
Voriconazole is not available as an oral suspension. If an
oral solution is needed, your doctor will prescribe an oral
suspension from another company.

Date: 23 Jun 2014
Description Voriconazole 50/250 mg 28
Component Type Leaflet

Pharma Code N/A

Affiliate Item Code 432126

SAP No. N/A

Superceded Affiliate Item Code 10004579

Vendor Job No. 230585

TrackWise PR No. 432126

Proof No. 1

MA No. TBC

Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code TBC

Barcode Info N/A

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Take your tablet at least one hour before, or one hour after a
meal. Swallow the tablet whole with some water.
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 or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If any of the following happen, stop taking Voriconazole and
tell your doctor immediately or go to the nearest hospital
emergency department
Common side effects (may affect up to 1 in 10 people)
•• A condition where the red blood cells, white blood cells
and platelets are all reduced in number with the following
symptoms; tiredness, being short of breath and looking pale
(pancytopenia)
•• Breathing difficulty, fluid accumulation in the lungs
•• Yellowing of the skin or whites of the eyes (jaundice)
•• Kidney failure.
Uncommon side effects (may affect up to 1 in 100 people)
•• An allergic reaction. Such reactions may appear in the form
of anaphylaxis (a severe form of allergic reaction) with
symptoms such as:
** rash
** swelling of the face, lips, mouth, tongue or throat
(angioedema)
•• A widespread rash with blisters and peeling skin, particularly
around the mouth, nose, eyes and genitals (Stevens-Johnson
Syndrome).
•• Severe low numbers of some types of white blood cells
causing more infections (agranulocytosis)
•• Severe skin reaction following exposure to light or sun
•• Liver failure or liver disease with the following symptoms;
nausea, vomiting, loss of appetite, feeling generally unwell,
fever, itching, yellowing of the skin and eyes, light coloured
bowel motions, dark coloured urine (hepatitis)
•• Heart rhythm problems
•• Inflammation of the pancreas which causes severe pain in
the abdomen and back (pancreatitis)
•• Fits (convulsion)
•• Depressed function of the adrenal gland
•• Swelling of the brain
•• Swelling of nerves at the back of the eye
Rare side effects (may affect up to 1 in 1,000 people)
•• Loss of consciousness due to liver failure
•• Heart rhythm problems including very fast heartbeat
•• Severe, persistent or bloody diarrhoea associated with
abdominal pain or fever
•• A widespread rash with blisters and skin peeling on much of
the body surface (toxic epidermal necrolysis)
•• Abnormal brain function
•• Damage to the kidneys
•• Damage to the optic nerve resulting in vision impairment.
Not known (frequency cannot be estimated from the
available data)
•• Muscle pain (periostitis).
There have been reports of skin cancer in patients treated with
Voriconazole for long periods of time.
Other side effects
Very common side effects (may affect more than 1 in
10 people)
-- Visual disturbances (change in vision)
-- Fever
-- Rash
-- Nausea, vomiting, diarrhoea
-- Headache
-- Swelling of the extremities
-- Stomach pains.
Common side effects (may affect up to 1 in 10 people)
-- Flu-like symptoms, inflammation of the sinuses, chills,
weakness
-- Anaemia
-- Low numbers of cells called platelets that help the blood
to clot, low numbers of some types of white blood cells
or of all types of blood cells, red or purple discoloration of
the skin which may be caused by low platelet count, other
blood cell changes
-- Anxiety, depression, tingling, confusion, dizziness, agitation,
trembling, hallucinations and other nervous symptoms
-- Low blood pressure, inflammation of a vein (which may be
associated with the formation of a blood clot)
-- Chest pain
-- Low blood sugar, low blood potassium
-- Redness of the skin
-- Sunburn or severe skin reaction following exposure to light
or sun
-- Itchiness
-- Hair loss
-- Back pain
-- Blood in the urine, changes in blood tests of kidney
function
-- Changes in blood tests of liver function
-- Inflammation of the gastrointestinal tract.
Uncommon side effects (may affect up to 1 in 100 people)
-- Enlarged lymph glands (sometimes painful)
-- Increase in a type of white blood cell which may be
associated with allergic reaction, disorder of blood clotting
system

-- Very fast heartbeat, very slow heartbeat, fainting
-- Problem with coordination
-- Double vision, pain and inflammation of the eyes and
eyelids, involuntary movement of the eye
-- Decreased sensitivity to touch
-- Constipation, inflammation of upper small intestine,
dyspepsia, peritonitis
-- Gingivitis
-- Swelling and inflammation of the tongue
-- Enlarged liver, gallbladder disease, gallstones
-- Joint pain
-- Inflammation of the kidney, proteins in the urine
-- Abnormal electrocardiogram (ECG)
-- Blood chemistry changes
-- Skin rash, which may lead to severe blistering and peeling,
burning or soreness of the skin
-- Swelling or inflammation of the skin, hives, skin redness and
irritation.
Rare side effects (may affect up to 1 in 1,000 people)
-- Inability to sleep
-- Hearing difficulties, ringing in the ears
-- Abnormal sense of taste
-- Increase in muscle tone, muscle weakness caused by an
abnormal immune system response
-- Red, scaly patches on the face and scalp
-- Parkinson-like symptoms, nerve injury resulting in
numbness, pain, tingling or burning in the hands or feet
-- Severe, persistent or bloody diarrhoea associated with
abdominal pain or fever
-- Overactive or underactive thyroid gland
-- Eye bleeding, abnormal eye movement, clouding of the
cornea
-- Heart rhythm problems including very fast heartbeat and
very slow heartbeat
-- Lymph infection
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.
If any of these side effects persist or are troublesome, please
tell your doctor.
If you get any side effects, talk to your doctor or pharmacist.
This includes any specific side effects not listed in this leaflet.
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 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.
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. Each tablet contains
either 50 mg or 200 mg voriconazole.
The other ingredients are:
Tablet core: Lactose monohydrate (see section 2 “Voriconazole
contains lactose monohydrate”), croscarmellose sodium,
pregelatinised maize starch, povidone and magnesium
stearate.
Film-coating: Lactose monohydrate, hypromellose, titanium
dioxide (E171) and triacetin.
What Voriconazole looks like and contents of the pack
Voriconazole 50 mg film-coated tablets: a white to off-white
film-coated, oval, biconvex tablet debossed with “V26” on one
side of the tablet and blank on the other side.
Voriconazole 200 mg film-coated tablets: a white to off-white
film-coated, capsule shaped, biconvex tablet debossed with
“M164” on one side of the tablet and blank on the other side.
Voriconazole is available in blister packs of:
20, 28, 30, 90, 100, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1, 100 x 1 filmcoated tablets for Voriconazole 50 mg film-coated tablets.
14, 20, 28, 30, 90, 100, 14 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1,
100 x 1 for Voriconazole 200 mg film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturers
Generics (UK) Limited, Station Close, Potters Bar, Herts EN6 1TL,
United Kingdom.
GE Pharmaceuticals Ltd., Industrial Zone, Chekanitza-South
area, 2140 Botevgrad, Bulgaria.
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13, Ireland.
Mylan Hungary Kft., H-2900 Komárom, Mylan utca 1, Hungary.

Date: 23 Jun 2014
Description Voriconazole 50/250 mg 28
Component Type Leaflet

Pharma Code N/A

Affiliate Item Code 432126

SAP No. N/A

Superceded Affiliate Item Code 10004579

Vendor Job No. 230585

TrackWise PR No. 432126

Proof No. 1

MA No. TBC

Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code TBC

Barcode Info N/A

Sign-offs

432126

This leaflet was last revised in June 2014.

No. of colours
Colours

1

Time: 14:08
Page Count

Black

2/2

PMS
xxx

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 196 x 490mm

Body Text Size 9 pt

Expand view ⇕

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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