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VORICONAZOLE PFIZER 40 MG/ML POWDER FOR ORAL SUSPENSION

Active substance(s): VORICONAZOLE

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Package Leaflet: Information for the user
Voriconazole Pfizer 40 mg/ml powder for oral suspension.
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 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.
What is in this leaflet:
1.
What Voriconazole Pfizer is and what it is used for
2.
What you need to know before you take Voriconazole Pfizer
3.
How to take Voriconazole Pfizer
4.
Possible side effects
5.
How to store Voriconazole Pfizer
6
Content of the pack and other information
1. What Voriconazole Pfizer is and what it is used for
Voriconazole Pfizer contains the active substance voriconazole. Voriconazole Pfizer 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 Pfizer 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 Pfizer
Do not take Voriconazole Pfizer
If you are allergic to voriconazole or any of the other ingredients of Voriconazole Pfizer (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 Pfizer treatment:



Terfenadine (used for allergy)
Astemizole (used for allergy)

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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 before taking Voriconazole Pfizer 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 Pfizer. Your doctor should also monitor your
liver function while you are being treated with Voriconazole Pfizer 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 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 Pfizer:

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 Pfizer.
Your doctor should monitor the function of your liver and kidney by doing blood tests.
Children and adolescents
Voriconazole Pfizer should not be given to children younger than 2 years of age.
Other medicines and Voriconazole Pfizer
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those that are obtained without a prescription.
Some medicines, when taken at the same time as Voriconazole Pfizer, may affect the way Voriconazole
Pfizer works or Voriconazole Pfizer may affect the way they work.
Tell your doctor if you are taking the following medicine, as treatment with Voriconazole Pfizer at the same
time should be avoided if possible:


Ritonavir (used for treating HIV) in doses of 100 mg twice daily

Tell your doctor if you are taking either of the following medicines, as treatment with Voriconazole Pfizer at
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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 Pfizer
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 Pfizer 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 Pfizer 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 Pfizer)
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 Pfizer 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 Pfizer.
Voriconazole Pfizer 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 Pfizer 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 Pfizer contains sucrose
Voriconazole Pfizer suspension contains 0.54g sucrose per ml of suspension. If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor before taking Voriconazole Pfizer.
3.
How to take Voriconazole Pfizer
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.
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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:
Oral suspension
Patients 40 kg and above Patients less than 40 kg
Dose for the first 24
hours
(Loading Dose)

400 mg (10 ml) every 12
hours for the first 24
hours

Dose after the first 24
hours (Maintenance Dose)

200 mg (5 ml) twice a
day

200 mg (5 ml) every 12
hours for the first 24 hours
100 mg (2.5 ml) 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:
Oral suspension
Children aged 2 to less
Teenagers aged 12 to 14
than 12 years and
years weighing 50 kg or
teenagers aged 12 to 14
more; and all teenagers
years weighing less than
older than 14
50 kg
Dose for the first 24
hours
Your treatment will be
400 mg every 12 hours for
(Loading Dose)
started as an infusion
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.
Take your suspension at least one hour before, or two hours after a meal.
Voriconazole Pfizer suspension should not be mixed with any other medicine. The suspension should not
be further diluted with water or any other liquids.
Instructions to constitute the suspension:
It is recommended that your pharmacist constitutes Voriconazole Pfizer suspension before giving it to you.
Voriconazole Pfizer suspension is constituted if it is in a liquid form. If it appears to be a dry powder you
should constitute the oral suspension by following the instructions below.
1.
2.
3.

Tap the bottle to release the powder.
Remove the cap.
Measure 23 ml of water by filling the measuring cup (included in the carton) to the top of the
marked line then pour the water into the bottle. Using the cup measure another 23 ml of water and
add this to the bottle. You should always add a total of 46 ml (2 x 23 ml) of water irrespective of the

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4.
5.
6.

dose you are taking.
Replace the cap and shake the bottle vigorously for about 1 minute.
Remove the cap. Press the bottle adaptor into the neck of the bottle (as shown on figure below). The
adaptor is provided so that you can fill the oral syringe with medicine from the bottle. Replace the
cap on the bottle.
Write the date of expiry of the constituted suspension on the bottle label (the shelf-life of the
constituted suspension is 14 days). Any unused suspension should be discarded after this date.

Instructions for use:
Your pharmacist should advise you how to measure the medicine using the multi-dosing oral syringe
provided in the pack. Please see instructions below before using Voriconazole Pfizer suspension.
1.
2.
3.
4.
5.
6.

7.

Shake the closed bottle of constituted suspension for approximately 10 seconds before use. Remove
the cap.
While the bottle is upright, on a flat surface, insert the tip of the oral syringe into the adaptor.
Turn the bottle upside down while holding the oral syringe in place. Slowly pull back the plunger of
the oral syringe to the graduation mark that marks the dose for you. To measure the dose accurately,
the top edge of the black ring should be lined up with the graduated mark on the oral syringe.
If large bubbles can be seen, slowly push the plunger back into the syringe. This will force the
medicine back into the bottle. Repeat step 3 again.
Turn the bottle back upright with the oral syringe still in place. Remove the oral syringe from the
bottle.
Put the tip of the oral syringe into the mouth. Point the tip of the oral syringe towards the inside of
the cheek. SLOWLY push down the plunger of the oral syringe. Do not squirt the medicine out
quickly. If the medicine is to be given to a child, make sure the child is sitting, or is held, upright
before giving the medicine.
Replace the cap on the bottle, leaving the bottle adaptor in place. Wash the oral syringe as instructed
below.

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1

2

3/4

5

6

Cleaning and storing the syringe:
1.
The syringe should be washed after each dose. Pull the plunger out of the syringe and wash both
parts in warm soapy water. Then rinse with water.
2.
Dry the two parts. Push the plunger back in to the syringe. Keep it in a clean safe place with the
medicine.
If you take more Voriconazole Pfizer than you should:
If you take more suspension than prescribed (or if someone else takes your suspension) you must seek
medical advice or go to the nearest hospital casualty department immediately. Take your bottle of
Voriconazole Pfizer suspension with you. You may experience abnormal intolerance to light as a result of
taking more Voriconazole Pfizer than you should.
If you forget to take Voriconazole Pfizer:
It is important to take your Voriconazole Pfizer suspension 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 the
forgotten dose.
If you stop taking Voriconazole Pfizer:
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 Pfizer correctly, as described above.
Continue taking Voriconazole Pfizer 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 Pfizer 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 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 Pfizer 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 disturbances (change in vision)
Fever
Rash
Nausea, vomiting, diarrhoea
Headache
Swelling of the extremities

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-

Stomach pains

Common side effects (may affect up to 1 in 10 people) are:
-

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
Low blood sugar, low blood potassium
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)
Breathing difficulty, chest pain, fluid accumulation in the lungs
Jaundice, redness of the skin
Swelling of the lips or face
Allergic reactions (sometimes severe), including widespread blistering rash and skin peeling
Sunburn or severe skin reaction following exposure to light or sun
Itchiness
Hair loss
Back pain
Kidney failure, 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) are:
-

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
Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting
Depressed function of the adrenal gland
Problem with coordination
Swelling of the brain
Double vision pain and inflammation of the eyes and eyelids, involuntary movement of the eye
Decreased sensitivity to touch
Abnormal sense of taste
Constipation, inflammation of upper small intestine, dyspepsia, pancreatitis, peritonitis
Gingivitis,
Swelling and inflammation of the tongue
Enlarged liver, hepatitis, liver failure, gallbladder disease, gallstones
Joint pain, increase in muscle tone
Inflammation of the kidney, proteins in the urine
Abnormal electrocardiogram (ECG)
Blood chemistry changes
Eczema
Skin rashes, which may lead to severe blistering and peeling of the skin
Swelling or inflammation of the skin, hives, skin redness and irritation
Low sodium in the blood
Rare side effects (may affect up to 1 in 1000 people) are:
-

Inability to sleep
Hearing difficulties, ringing in the ears

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-

Muscle weakness caused by an abnormal immune system response
Abnormal brain function, Parkinson-like symptoms, convulsion, 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
Damage to the optic nerve resulting in vision impairment, eye bleeding, abnormal eye movement,
clouding of the cornea
Damage to the kidneys
Lymph infection, loss of consciousness due to liver failure

As Voriconazole Pfizer 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 Pfizer for long periods of time.
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.
5. How to store Voriconazole Pfizer
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 and on the carton. The expiry date
refers to the last day of that month.
Powder for oral suspension: store at 2°C - 8°C (in a refrigerator) before constitution.
For the constituted suspension:
Do not store above 30°C.
Do not refrigerate or freeze.
Store in the original container
Keep the container tightly closed.
Any remaining suspension should be discarded 14 days after constitution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
What Voriconazole Pfizer contains:
- The active substance is voriconazole. Each bottle contains 45 g of powder providing 70 ml of suspension
when constituted with water as recommended. One ml of the constituted suspension contains 40 mg
voriconazole. (See section 3 ‘How to take Voriconazole Pfizer’).
- The other ingredients are sucrose; silica colloidal; titanium dioxide; xanthan gum; sodium citrate;
sodium benzoate; citric acid; natural orange flavour.
What Voriconazole Pfizer looks like and contents of the pack
Voriconazole Pfizer is supplied as a white to off-white powder for oral suspension providing a white to offwhite, orange flavoured suspension when constituted with water. One pack contains one 100 ml high-density
polyethylene (HDPE) bottle (with a polypropylene child resistant closure), a measuring cup (graduated to
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indicate 23 ml), one 5 ml oral syringe and a press-in bottle adaptor.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer
Fareva Amboise, Zone Industrielle, 29 Route des Industries, 37530 Pocé-sur-Cisse, France.

This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria
Belgium
France
Denmark
Greece
Germany
Italy
Ireland
Spain
Sweden
Netherlands
Luxembourg
Portugal
United
Kingdom

Voriconazol Pfizer 40 mg/ml Pulver zur Herstellung
einer Suspension zum Einnehmen
Voriconazole Pfizer 40 mg/ml powder for oral
suspension
Voriconazole Pfizer 40 mg/ml poudre pour suspension
buvable
Voriconazol Pfizer
Voriconazole/Pfizer
Voriconazol Pfizer 40 mg/ml Pulver zur Herstellung
einer Suspension zum Einnehmen
Voriconazolo Pfizer
Voriconazole Pfizer 40 mg/ml powder for oral
suspension
Voriconazol Pfizer 40 mg/ml polvo para suspensión
oral
Voriconazole Pfizer 40 mg/ml pulver till oral
suspension
Voriconazol Pfizer 40 mg/ml powder for oral
suspension
Voriconazole Pfizer 40 mg/ml powder for oral
suspension
Voriconazole Pfizer
Voriconazole Pfizer 40 mg/ml powder for oral
suspension

This leaflet was last approved in 10/2014.

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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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