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• leaflet MAH GENERIC_PL 08828-0261
• leaflet MAH GENERIC_PL 17815-0064
• leaflet MAH GENERIC_PL 35533-0036
• leaflet MAH GENERIC_PL 41734-0006

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Package leaflet: Information for the user

VORICONAZOLE

Voriconazole

What is in this leaflet

1.    What Voriconazole 200 mg powder for solution for infusion is and what it is used for

2.    What you need to know before you use Voriconazole 200 mg powder for solution for infusion

3.    How to use Voriconazole 200 mg powder for solution for infusion

4.    Possible side effects

5.    How to store Voriconazole 200 mg powder for solution for infusion

6.    Content of the pack and other information

1.    What Voriconazole 200 mg powder for solution for infusion is and what it is used for

Voriconazole 200 mg powder for solution for infusion 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 200 mg powder for solution for infusion is intended for patients with worsening, possibly life-threatening, fungal infections.

•    Prevention of fungal infections in high risk bone marrow transplant recipients.

This product should only be used under the supervision of a doctor.

2.    What you need to know before you use Voriconazole 200 mg powder for solution for infusion Do not use Voriconazole 200 mg powder for solution for infusion

- 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, pharmacist or nurse if you are taking or have taken any other medicines, even those that are obtained without a prescription, or herbal medicines.

Do not take the following medicines during your course of treatment with Voriconazole 200 mg powder for solution for infusion:

•    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 400 mg and more twice daily

•    St. John's Wort (herbal supplement)

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Voriconazole 200 mg powder for solution for infusion if you:

•    have had an allergic reaction to other azoles.

•    are suffering from, or have ever suffered from liver disease. If you have liver disease, your doctor may prescribe a lower dose of Voriconazole 200 mg powder for solution for infusion. Your doctor should also monitor your liver function while you are being treated with Voriconazole 200 mg powder for solution for infusion 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 also applicable to children.

Tell your doctor immediately if you develop the following symptoms while being treated with Voriconazole 200 mg powder for solution for infusion:

•    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 200 mg powder for solution for infusion.

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

Children and adolescents

Voriconazole 200 mg powder for solution for infusion should not be given to children younger than 2 years of age.

Other medicines and Voriconazole 200 mg powder for solution for infusion

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

•    Some medicines, when taken at the same time as Voriconazole 200 mg powder for solution for infusion, may affect the way Voriconazole 200 mg powder for solution for infusion works or Voriconazole 200 mg powder for solution for infusion may affect the way they work.

Tell your doctor if you are taking the following medicine, as treatment with Voriconazole 200 mg powder for solution for infusion 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 200 mg powder for solution for infusion 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 200 mg powder for solution for infusion 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 200 mg powder for solution for infusion 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 200 mg powder for solution for infusion 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 200 mg powder for solution for infusion)

•    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 200 mg powder for solution for infusion 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 200 mg powder for solution for infusion.

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 using this medicine.

Driving and using machines

Voriconazole 200 mg powder for solution for infusion 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.

3. How to use Voriconazole 200 mg powder for solution for infusion

Always use 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.

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.

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

Voriconazole 200 mg 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 using Voriconazole 200 mg powder for solution for infusion for prevention of fungal infections, your doctor may stop giving Voriconazole 200 mg powder for solution for infusion if you or your child develop treatment related side effects.

If a dose of Voriconazole 200 mg powder for solution for infusion 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, pharmacist or nurse if you think that a dose has been forgotten.

If you stop using Voriconazole 200 mg powder for solution for infusion:

Voriconazole 200 mg powder for solution for infusion treatment will continue for as long as your doctor advises, however duration of treatment with Voriconazole 200 mg 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 200 mg powder for solution for infusion 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 200 mg powder for solution for infusion and see a doctor immediately

-    Rash

-    Jaundice; Changes in blood tests of liver function

-    Pancreatitis

Volume of Voriconazole 200 mg powder for solution for infusion Concentrate (10 mg/ml) required for:

9 mg/kg dose (number of vials)

9.0 ml (1)

13.5 ml (1)

E o CO

22.5 ml (2)

27.0 ml (2)

31.5 ml (2)

CN E o CD CO

40.5 ml (3)

45.0 ml (3)

49.5 ml (3)

54.0 ml (3)

58.5 ml (3)

■

■

■

■

■

■

■

8 mg/kg dose (number of vials)

E o CO

12.0 ml (1)

E o CD

20.0 ml (1)

24.0 ml (2)

28.0 ml (2)

S E o c\i CO

E o CD CO

40.0 ml (2)

44.0 ml (3)

CO E o 00

52.0 ml (3)

■

■

■

■

■

■

■

6 mg/kg dose (number of vials)

■

■

■

■

E o CO

21.0 ml (2)

24.0 ml (2)

27.0 ml (2)

CN E o o CO

CN E o CO CO

S E o CD CO

39.0 ml (2)

42.0 ml (3)

45.0 ml (3)

s E o 00

51.0 ml (3)

54.0 ml (3)

57.0 ml (3)

s E o o CO

4 mg/kg dose (number of vials)

4.0 ml (1)

E o CD

E o CO

10.0 ml (1)

12.0 ml (1)

14.0 ml (1)

E o CD

E o CO

20.0 ml (1)

22.0 ml (2)

24.0 ml (2)

26.0 ml (2)

28.0 ml (2)

CN E o o CO

S E o c\i CO

CN E o CO

E o CD CO

E o 00 CO

40.0 ml (2)

3 mg/kg dose (number of vials)

■

■

■

■

9.0 ml (1)

10.5 ml (1)

12.0 ml (1)

13.5 ml (1)

15.0 ml (1)

16.5 ml (1)

E o CO

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)

CN E o o CO

Body Weight (kg)

O

ID

20

25

30

35

40

45

50

55

09

65

70

75

80

85

06

95

100

Other side effects

Very common side effects (may affect more than 1 in 10 people) are:

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

-    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 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 bone 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 electric 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

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 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'

Side effects with frequency not known:

-    Freckles and pigmented spots

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 200 mg powder for solution for infusion (including flushing, fever, sweating, increased heart rate and shortness of breath). Your doctor may stop the infusion if this occurs.

As Voriconazole 200 mg powder for solution for infusion 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 200 mg powder for solution for infusion 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, 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:

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 200 mg powder for solution for infusion

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.

This medicinal product does not require any special storage conditions.

Once reconstituted, Voriconazole 200 mg powder for solution for infusion 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 200 mg powder for solution for infusion 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 200 mg powder for solution for infusion contains

-    The active substance is voriconazole.

-    The other ingredient is hydroxypropylbetadex (HPBCD).

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 200 mg powder for solution for infusion looks like and contents of the pack

Voriconazole 200 mg powder for solution for infusion is presented in one single use glass vial as a powder for solution for infusion.

Marketing Authorisation Holder

Xellia Pharmaceuticals ApS Dalslandsgade 11 2300 Copenhagen S Denmark

Manufacturer

Xellia Pharmaceuticals ApS Dalslandsgade 11 2300 Copenhagen S Denmark

Distributor

Panpharma UK Ltd,

Cotton Exchange,

Bixteth Street,

Liverpool, L3 9LQ UK

This leaflet was last revised in 07/2016. Version 03.