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VORICONAZOLE MILPHARM 200 MG FILM-COATED TABLETS

Active substance(s): VORICONAZOLE

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Voriconazole
film-coated tablets
P15XXXXX
Package leaflet: Information for the user

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 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 lifethreatening, fungal infections.
Prevention of fungal infections in high risk bone marrow transplant
recipients in adults.
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 (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 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:
• Tell your doctor immediately if you develop
o sunburn
o severe skin rash or blisters
o 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.

Voriconazole
film-coated tablets
P15XXXXX

Pharmacode position may change as per Supplier's m/c requirement & additional
small pharma code may appear on the front / back panel

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)
• 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 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)
Pregnancy and breast-feeding
Voriconazole 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.
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 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 contains lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking
medicinal product.
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:

Dose for the first
24 hours (Loading Dose)
Dose after the first 24 hours
(Maintenance Dose)

Tablets
Patients 40 kg and above

Patients less than 40 kg

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
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 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

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

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.

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

Take your tablet at least one hour before, or one hour after a meal. Swallow
the tablet whole with some water.

Other medicines and Voriconazole
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.

If you are taking Voriconazole for prevention of fungal infections, your
doctor may stop giving Voriconazole if you develop treatment related side
effects.

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

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.

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

Black

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 have any further questions on the use of this medicine, ask your
doctor or pharmacist.

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 fibers 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’

4. Possible side effects

Side effects with frequency not known:
- Freckles and pigmented spots

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.

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 taking Voriconazole and see a doctor
immediately
- Rash
- Jaundice; Changes in blood tests of liver function
- Pancreatitis
Other side effects
Very common: may affect more than 1 in 10 people
- Visual impairment (change in vision including blurred vision, visual color
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
- Rash
- Nausea, vomiting, diarrhoea
- Headache
- Swelling of the extremities
- Stomach pains
- Breathing difficulties
- Elevated liver enzymes
Common:may affect up to 1 in 10 people
- Inflammation of the sinuses, inflammation of the gums, chills, weakness
- Low numbers of some types, including severe, 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 eyes), fluid accumulation in the lungs
- Constipation, indigestion, inflammation of the lips
- Jaundice, inflammation of the liver, and liver injury
- 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: may affect up to 1 in 100 people
- Flu-like symptoms, irritation and inflammation of the gastrointestinal
tract, Inflammation of the gastrointestinal tract causing antibiotic
associated diarrhea, 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 eosinophil
- 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, 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 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, 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 discoloration of the skin which may
be caused by low platelet count, eczema
- Infusion site reaction

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
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. Elevated liver enzymes were also observed more
frequently in children.
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
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,
bottle and 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 contains
- The active substance is voriconazole.
Each film-coated tablet contains 50 mg voriconazole.
Each film-coated tablet contains 200 mg voriconazole.
- The other ingredients are
Tablet Core: Lactose monohydrate, pregelatinized, starch (Maize
starch), maize starch, croscarmellose sodium, povidone (K - 30) , silica,
colloidal anhydrous, magnesium stearate.
Tablet coating: Hypromellose 2910, lactose monohydrate, titanium
dioxide (E 171), triacetin.
What Voriconazole looks like and contents of the pack
Film-coated tablet.
Voriconazole 50 mg film-coated tablets
White, round, biconvex, film coated tablets debossed with 'CC' on one side
and '52' on the other side.
Voriconazole 200 mg film-coated tablets
White, oval shaped, biconvex, film coated tablets debossed with 'CC' and
'56' separated by a break line on one side and plain on the other side.
The tablet can be divided into equal doses.
Voriconazole film-coated tablets are available in Clear PVC - Aluminium foil
blister pack and HDPE container packs.
Packsizes:
Blister packs: 10, 14, 28, 30, 56, 90 and 100 film-coated tablets.
HDPE packs: 100 and 250 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 02/2016.

P15XXXXX

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.

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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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