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VORICONAZOLE 200MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): VORICONAZOLE

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Some medicines, when taken at the same time as
voriconazole, may affect the way voriconazole works
or voriconazole may affect the way they work.

Voriconazole 200 mg
powder for solution for infusion

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

Read all of this leaflet carefully before you start
using 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).

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.

What is in this leaflet
1. What Voriconazole is and what it is used for
2. What you need to know before you use
Voriconazole
3. How to use Voriconazole
4. Possible side effects
5. How to store Voriconazole
6. Content of the pack and other information

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)
• 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 use 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)
• 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)
• 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)

Package leaflet: Information for the user

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 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 is intended for patients with worsening,
possibly life-threatening, fungal infections. Prevention
of fungal infections in high risk bone marrow
transplant recipients.
This medicine should only be used under the
supervision of a doctor.

2. What you need to know before you use
Voriconazole

Pregnancy and breast-feeding
Voriconazole must not be used 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 being treated with Voriconazole.

Do not use Voriconazole
- If you are allergic to the active ingredient
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.

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.

Do not take the following medicines during your
course of treatment with Voriconazole:














Voriconazole must not be used during breast-feeding.
Driving and using machines
Voriconazole may cause blurring of vision or
uncomfortable sensitivity to light. While affected, do
not drive or operate any tools or machines. Tell your
doctor if you experience this.

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

Voriconazole contains sodium
This medical product contains 1.54 mmol (35.38 mg)
sodium per vial. This should be taken into consideration
if you are on a strictly controlled sodium diet.

3. How to use 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. Your
doctor may change your dose depending on your
condition.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using
Voriconazole if you:
• have had an allergic reaction to other azoles (a
kind of antifungical drugs).
• 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.
• 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 in particular applicable to children.
Tell your doctor immediately if you develop the
following symptoms while being treated with
voriconazole:
• 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
risk 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 should not be given to children younger
than 2 years of age.
Other medicines and Voriconazole
Please tell your doctor or pharmacist if you are
taking/using, have recently taken/used or might
take/use any other medicines.

The recommended dose for adults (including elderly
patients) is as follows:
Intravenous
Dose for the
6 mg/kg every 12 hours for the
first 24 hours
first 24 hours
(Loading Dose)
Dose after the
4 mg/kg twice a day
first 24 hours
(Maintenance
Dose)
Depending on your response to treatment, your
doctor may decrease the dose to 3 mg/kg twice daily.
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:
Intravenous
Children aged
Teenagers aged
2 to less than
12 to 14 years
12 years and
weighing 50 kg
teenagers aged or more; and all
12 to 14 years
teenagers older
weighing less
than 14
than 50 kg
Dose for
9 mg/kg every
6 mg/kg every
the first
12 hours for the 12 hours for the
24 hours
first 24 hours
first 24 hours
(Loading
Dose)
Dose after
8 mg/kg twice
4 mg/kg twice
the first
a day
a day
24 hours
(Maintenance
Dose)
Depending on your response to treatment, your
doctor may increase or decrease the daily dose.

The following information is intended for healthcare professionals only:
The following information is intended for medical or healthcare professionals only:
Reconstitution and Dilution information
• Voriconazole powder for solution for infusion needs to first be reconstituted with either 19 ml of Water for
Injections or 19 ml of 9 mg/ml (0.9%) Sodium Chloride for Infusion to obtain an extractable volume of
20 ml of clear concentrate containing 10 mg/ml voriconazole.
• Discard the Voriconazole vial if the vacuum does not pull the diluent into the vial.
• It is recommended that a standard 20 ml (non-automated) syringe be used to ensure that the exact
amount (19.0 ml) of Water for Injections or of 9 mg/ml (0.9%) Sodium Chloride for Infusion is dispensed.
• The required volume of the reconstituted concentrate is then added to a recommended compatible infusion
solution listed below to obtain a final Voriconazole solution containing 0.5 to 5 mg/ml of voriconazole.
• This medicinal product is for single use only and any unused solution should be discarded and only clear
solutions without particles should be used.
• Not for administration as a bolus injection. Administration as an infusion, at a maximum rate of 3 mg/kg
per hour.
• For storage information, please refer to Section 5 ‘How to store Voriconazole’.
Required Volumes of 10 mg/ml Voriconazole Concentrate
Volume of Voriconazole Concentrate (10 mg/ml) required for:
Body
3 mg/kg dose
4 mg/kg dose
6 mg/kg dose
8 mg/kg dose
9 mg/kg dose
Weight (number of
(number of
(number of
(number of
(number of
(kg)
vials)
vials)
vials)
vials)
vials)
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
90
95
100

9.0 ml (1)
10.5 ml (1)
12.0 ml (1)
13.5 ml (1)
15.0 ml (1)
16.5 ml (1)
18.0 ml (1)
19.5 ml (1)
21.0 ml (2)
22.5 ml (2)
24.0 ml (2)
25.5 ml (2)
27.0 ml (2)
28.5 ml (2)
30.0 ml (2)

4.0 ml (1)
6.0 ml (1)
8.0 ml (1)
10.0 ml (1)
12.0 ml (1)
14.0 ml (1)
16.0 ml (1)
18.0 ml (1)
20.0 ml (1)
22.0 ml (2)
24.0 ml (2)
26.0 ml (2)
28.0 ml (2)
30.0 ml (2)
32.0 ml (2)
34.0 ml (2)
36.0 ml (2)
38.0 ml (2)
40.0 ml (2)

18.0 ml (1)
21.0 ml (2)
24.0 ml (2)
27.0 ml (2)
30.0 ml (2)
33.0 ml (2)
36.0 ml (2)
39.0 ml (2)
42.0 ml (3)
45.0 ml (3)
48.0 ml (3)
51.0 ml (3)
54.0 ml (3)
57.0 ml (3)
60.0 ml (3)

8.0 ml (1)
12.0 ml (1)
16.0 ml (1)
20.0 ml (1)
24.0 ml (2)
28.0 ml (2)
32.0 ml (2)
36.0 ml (2)
40.0 ml (2)
44.0 ml (3)
48.0 ml (3)
52.0 ml (3)
-

9.0 ml (1)
13.5 ml (1)
18.0 ml (1)
22.5 ml (2)
27.0 ml (2)
31.5 ml (2)
36.0 ml (2)
40.5 ml (3)
45.0 ml (3)
49.5 ml (3)
54.0 ml (3)
58.5 ml (3)
-

Voriconazole powder for solution for infusion will be
reconstituted and diluted to the correct concentration
by your hospital pharmacist or nurse. (Please refer to
section 5 and the end of this leaflet for further
information)
This will be given to you by intravenous infusion (into
a vein) at a maximum rate of 3 mg/kg per hour over 1
to 3 hours.
If you or your child are taking Voriconazole for
prevention of fungal infections, your doctor may stop
giving Voriconazole if you or your child develops
treatment related side effects.
If a dose of Voriconazole has been forgotten:
As you will be given this medicine under close
medical supervision, it is unlikely that a dose would
be missed. However tell your doctor or pharmacist if
you think that a dose has been forgotten.
If you stop taking Voriconazole:
Voriconazole treatment will continue for as long as
your doctor advises, however duration of treatment
with Voriconazole powder for solution for infusion
should be no more than 6 months.
Patients with a weakened immune system or those
with difficult infections may require long-term
treatment to prevent the infection from returning. You
may be switched from the intravenous infusion to
tablets once your condition improves.
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, pharmacist or nurse.

4. Possible side effects
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 using Voriconazole
and see a doctor immediately
- Rash
- Jaundice; Changes in blood tests of liver function
- Pancreatitis
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
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 characterized 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
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
- Hearing difficulties, ringing in the ears, vertigo
- Inflammation of certain internal organspancreas 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 (oedema) 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 discoloration
of the skin which may be caused by low platelet
count, eczema
- Injection site reaction
- 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
- 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
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
Reactions during the infusion have occurred
uncommonly with voriconazole (including flushing,
fever, sweating, increased heart rate and shortness of
breath). Your doctor may stop the infusion if this
occurs.
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.
There have been reports of skin cancer in patients
treated with voriconazole 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 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
Store this medicine below 25 ºC.
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 label or carton after EXP. The expiry
date refers to the last day of that month.
Once reconstituted, Voriconazole should be used
immediately, but if necessary may be stored for up to
24 hours at 2°C - 8°C (in a refrigerator).
Reconstituted Voriconazole needs to be diluted with a
compatible infusion solution first before it is infused.
(Please refer to the end of this leaflet for further
information).
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.
− The other ingredients are hidroxypropylbetadex
and sodium chloride.
Each vial contains 200 mg voriconazole, equivalent to
a 10 mg/ml solution when reconstituted as directed
by your hospital pharmacist or nurse (see the
information at the end of this leaflet).
What Voriconazole looks like and contents of the
pack
Voriconazole is presented in single use glass vials as
a powder for solution for infusion.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer:
LABORATORIOS NORMON L, S.A.
Ronda de Valdecarrizo, 6 – 28760
Tres Cantos – Madrid
(SPAIN)
This leaflet was last revised in 02/2016.

Voriconazole is a single dose unpreserved sterile lyophile. Therefore, from a microbiological point of view, the
reconstituted solution must be used immediately. If not used immediately, in-use storage times and conditions
prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless
reconstitution has taken place in controlled and validated aseptic conditions.
Compatible Infusion Solutions:
The reconstituted solution can be diluted with:
Sodium Chloride 9 mg/ml (0.9%) Solution for Injection
Compound Sodium Lactate Intravenous Infusion
5% Glucose and Lactated Ringer’s Intravenous Infusion
5% Glucose and 0.45% Sodium Chloride Intravenous Infusion
5% Glucose Intravenous Infusion
5% Glucose in 20 mEq Potassium Chloride Intravenous Infusion
0.45% Sodium Chloride Intravenous Infusion
5% Glucose and 0.9% Sodium Chloride Intravenous Infusion
The compatibility of Voriconazole with diluents other than listed above (or listed below under ‘Incompatibilities’)
is unknown.
Incompatibilities:
Voriconazole must not be infused into the same line or cannula concomitantly with other drug infusions,
including parenteral nutrition (e.g., Aminofusin 10% Plus).
Infusions of blood products must not occur simultaneously with Voriconazole.
Infusion of total parenteral nutrition can occur simultaneously with Voriconazole but not in the same line or
cannula.
Voriconazole must not be diluted with 4.2% Sodium Bicarbonate Infusion.

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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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