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VORICONAZOLE ARISTO 200MG FILM-COATED TABLETS

Active substance(s): VORICONAZOLE / VORICONAZOLE / VORICONAZOLE

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ARTWORK DETAILS

Package leaflet: Information for the patient

Voriconazole Aristo 50 mg
film-coated tablets

Voriconazole Aristo 200 mg
film-coated tablets

Customer

Aristo Pharma GmbH

Product Name

Voriconazole - PIL - Combi

Market

United Kingdom (UK)

Language/s

English

Client Job No.:

N/A

Item Code

N/A

Manufacturer Code

N/A

Our Ref

Voriconazole_combi_PIL_-v01 —
(** to follow final proof)

Issue

03

Date

13 March 2017

Voriconazole

SPECIFICATION DETAILS

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 Aristo is and what it
is used for
2. What you need to know before you
take Voriconazole Aristo
3. How to take Voriconazole Aristo
4. Possible side effects
5. How to store Voriconazole Aristo
6. Contents of the pack and other
information

1. What Voriconazole Aristo is
and what it is used for
Voriconazole Aristo contains the active
substance voriconazole. Voriconazole
Aristo 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 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 Aristo is intended for
• patients with worsening, possibly lifethreatening, 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
Aristo
Do not take Voriconazole Aristo
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 Aristo 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 (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 Aristo 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 Aristo.
Your doctor should also monitor your
liver function while you are being
treated with Voriconazole Aristo 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
Aristo:
• 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 Aristo.
Your doctor should monitor the function
of your liver and kidneys by doing blood
tests.
Children and adolescents
Voriconazole Aristo should not be given to
children younger than 2 years of age.
Other medicines and Voriconazole
Aristo
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines, including those that
are obtained without prescription.
Some medicines, when taken at the same
time as Voriconazole Aristo, may affect
the way Voriconazole Aristo works or
Voriconazole Aristo may affect the way
they work.
Tell your doctor if you are taking the
following medicine, as treatment with
Voriconazole Aristo at the same time
should be avoided if possible:
• Ritonavir (used for treating HIV) in doses
of 100 mg twice daily

Origination

13 March 2017 — (as Issue 01)

Dimensions

150 x 650 mm

Border

10 mm

Pharmacode No.

n/a

Font details

Main title: Frutiger LT Std - 75 Black
- 21pt
Sub-titles: Frutiger LT Std - 75 Black
— 11pt
Body copy: Frutiger LT Std - 55
Roman —
9 pt

Colours

Black - K

Tell your doctor if you are taking either
of the following medicines, as treatment
with Voriconazole Aristo 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 Aristo 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 Aristo 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 Aristo 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 Aristo)
• 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 Aristo 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 Aristo.
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 Aristo may cause blurring of
vision or uncomfortable sensitivity to light.
If affected, do not drive or operate any
tools or machines. Contact your doctor if
you experience these symptoms.
Voriconazole Aristo contains lactose
If you have been told by your doctor
that you have an intolerance to some
sugars, contact your doctor before taking
Voriconazole Aristo.

3. How to take Voriconazole
Aristo
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 Patients less
and above
than 40 kg
Dose for
the first
24 hours
(Loading
dose)
Dose after
the first
24 hours
(Maintenance
dose)

400 mg every
12 hours for
the first
24 hours
200 mg twice
a day

200 mg
every
12 hours for
the first
24 hours
100 mg
twice a day

Depending on your response to treatment,
your doctor may increase the dose to 300 mg
twice a day.
Your doctor may decide to decrease your
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 Teenagers
2 to less than
aged 12 to
12 years and
14 years
teenagers aged weighing
12 to 14 years 50 kg or
weighing less
more; and
than 50 kg
all teenagers
older than 14
Dose for the Your treatment 400 mg
first 24 hours will be started every 12
(Loading dose) as an infusion hours for
the first 24
hours
Dose after
9 mg/kg
200 mg
the first
twice a day
twice a day
24 hours
(a maximum
(Maintenance dose of 350 mg
dose)
twice daily)

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

Falz

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 Aristo for prevention of
fungal infections, your doctor may stop
giving Voriconazole Aristo if you or your
child develop treatment-related side
effects.
Voriconazole Aristo 200 mg film-coated
tablets can be divided into equal doses.
If you take more Voriconazole Aristo
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 tablets
with you. You may experience abnormal
intolerance to light as a result of taking
more tablets than you should.
If you forget to take Voriconazole
Aristo
It is important to take your 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 Aristo
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 Aristo correctly, as
described above.
Continue taking Voriconazole Aristo
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 Aristo 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.

• Enlarged liver, liver failure, gall bladder
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, 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 a 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
discoloration of the skin which may be
caused by low platelet count, eczema
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
• 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, lifethreatening skin condition that causes
large portions of the epidermis, the
skin's outermost layer, to detach from
the layers of skin below
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

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 Aristo and see a doctor
immediately
• Rash
• Jaundice; Changes in blood tests of liver
function
• Pancreatitis

As Voriconazole Aristo has been known
to affect the liver and the kidneys, your
doctor should monitor the function of
your liver and kidneys by doing blood
tests. Please advise your doctor if you have
any stomach pains or if your stools have a
different consistency.

Very common side effects (may affect
more than 1 in 10 people) are:
• Visual impairment (change in vision
including blurred vision, visual colour
alterations, abnormal intolerance
to visual perception of light, colour
blindness, eye disorder, halo vision, night
blindness, swinging vision, seeing sparks,
visual aura, visual acuity reduced, visual
brightness, loss of part of the usual field
of vision, spots before the eyes)
• Fever
• Nausea, vomiting, diarrhoea
• Headache
• Swelling of the extremities
• Stomach pains
• Breathing difficulties
• Elevated liver enzymes

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.
Elevated liver enzymes were also observed
more frequently in children.

Common side effects (may affect up
to 1 in 10 people) are:
• Inflammation of the sinuses,
inflammation of the gums, chills,
weakness
• Low numbers, including severe, of
some types of red (sometimes immune
related) and/or white blood cells
(sometimes with fever), 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)
• Acute breathing difficulty, chest pain,
swelling of the face (mouth, lips and
around the eyes), fluid accumulation in
the lungs
• Constipation, indigestion, inflammation
of the lips
• 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, redness of the skin
• 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:
• Flu-like symptoms, irritation and
inflammation of the gastrointestinal
tract, 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), failure of blood marrow,
increased eosinophils
• Depressed function of the adrenal
gland, underactive thyroid gland
• Abnormal brain function, Parkinsonlike 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, 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
GI541000-01/UK/0216

There have been reports of skin cancer
in patients treated with voriconazole for
long periods of time.

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
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
Aristo
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, bottle
or blister after “EXP:”. The expiry date
refers to the last day of that month.
This medicine does not require any special
storage conditions
Tablets packed in HDPE bottles:
Shelf-life after first opening: 28 days, not
exceeding the expiry date.
Do not throw away any medicines via
wastewater. 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 Aristo contains
• The active substance is voriconazole
Each tablet contains 50 mg or 200 mg
voriconazole.
• The other ingredients are: lactose
monohydrate, partially pregelatinized
starch, maize starch, croscarmellose
sodium, povidone, silica, colloidal
anhydrous, magnesium stearate,
hypromellose, titanium dioxide, triacetin
What Voriconazole Aristo looks like
and contents of the pack
Voriconazol Aristo 50 mg film-coated
tablets are white to almost white, round
film-coated tablets.
Voriconazol Aristo 200 mg film-coated
tablets are white to almost white, oblong
film-coated tablets with one-sided
breaking notch. The tablet can be divided
into equal doses.
Voriconazole Aristo is available in blister
packs and HDPE bottles containing 2, 10,
14, 20, 28, 30, 50, 56 and 100 film-coated
tablets.
Not all pack sizes may be marketed.
Marketing
Authorisation Holder
and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany
This leaflet was last revised in March
2017.

40128287/1

Expand Transcript

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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