50 mg and 200 mg film-coated tablets
voriconazole
What Voriconazole Accord is and what it is used for
Voriconazole Accord contains the active substance voriconazole. Voriconazole Accord is a medicine against fungal infections. It works by killing or stopping the growth of the fungi that cause the infection.
Voriconazole Accord is used to treat patients (adults and children from 2 years of age) with:
- invasive aspergillosis (a type of fungal infection caused by Aspergillus sp. )
- candidemia (another type of fungal infection caused by Candida sp.) in non-neutropenic patients (patients without an abnormally low white blood cell count )
- severe invasive Candida sp. infection when the fungus is resistant to fluconazole (another antifungal medicine)
- severe fungal infections caused by Scedosporium sp. or Fusarium sp . (two different mushroom species).
Voriconazole Accord is intended for patients with worsening and possibly life-threatening fungal infections.
Preventive treatment in stem cell transplant patients who are at high risk of developing a fungal infection.
This product should only be used under medical supervision.
What you need to know before you use Voriconazole Accord
Do not use Voriconazole Accord
if you are allergic to voriconazole or any of the other ingredients of this medicine (listed in section 6).
You must tell your doctor or pharmacist if you are taking or have taken any other medicines, even those without a prescription, or herbal remedies.
The following medicines must not be taken during your treatment with Voriconazole Accord:
- terfenadine (used for allergies)
- astemizole (used for allergy )
- cisapride (used for stomach upset)
- pimozide (used to treat mental illness)
- quinidine (used for irregular heartbeat)
- ivabradine (used for symptoms of chronic heart failure )
- rifampicin (used in the treatment of tuberculosis )
- efavirenz (used in the treatment of HIV ) at a dose of 400 mg or more once daily
- carbamazepine (used to treat seizures)
- phenobarbital (used for severe sleep disorders and convulsions)
- ergot alkaloids (eg, ergotamine, dihydroergotamine; used for migraine )
- sirolimus (used in transplant patients)
- ritonavir (used in the treatment of HIV ) at a dose of 400 mg or more twice daily
- St. John’s wort (natural medicine)
- naloxegol (used to treat constipation specifically caused by painkillers called opioids (eg morphine, oxycodone, fentanyl, tramadol, codeine ))
- tolvaptan (used to treat hyponatremia (low levels of sodium in the blood) or to slow the deterioration of kidney function in patients with polycystic kidney disease)
- lurasidone (used to treat depression)
- venetoclax (used in the treatment of patients with chronic lymphocytic leukemia – CLL ).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Voriconazole Accord if:
- you have previously had an allergic reaction to other azoles
- you have or have previously had liver disease. If you have liver disease, the doctor may prescribe a lower dose of Voriconazole Accord. The doctor must also check your liver function through blood tests during the time you are treated with Voriconazole Accord
- you have a known disease of the heart muscle, irregular heartbeats, slow heartbeats, or an ECG change called “long QTc syndrome”.
Avoid all sunlight and exposure to the sun while you are being treated with Voriconazole Accord. It is important to cover exposed areas of the skin and to use sunscreen with a high sun protection factor (SPF), as the skin can become more sensitive to the sun’s UV rays. These precautions also apply to children.
While you are being treated with Voriconazole Accord should
- you immediately tell the doctor if you get
- sun damage
- skin rash or blisters
- bone pain
If you develop the above skin problems, your doctor may refer you to a dermatologist who, after a consultation, may decide that it is important for you to be examined regularly. There is a small risk of developing skin cancer during long-term use of Voriconazole Accord.
Tell your doctor if you develop signs of ‘adrenal insufficiency. This means that the adrenal glands do not produce enough of certain steroid hormones such as cortisol, which can lead to symptoms such as chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, and abdominal pain.
Talk to your doctor if you develop signs of Cushing’s syndrome. This means that the body produces too much of the hormone cortisol, which can lead to symptoms such as weight gain, lumps of fat between the shoulder blades, a round face, darker skin on the stomach, thighs, breasts, and arms, thin skin, bruising more easily, high blood sugar, excessive hair growth, excessive sweating.
Your doctor checks liver and kidney function by taking certain blood samples.
Children and young people
Voriconazole Accord should not be given to children under 2 years of age.
Other medicines and Voriconazole Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription.
Some medicines can affect or be affected by the simultaneous use of the Voriconazole Accord.
Tell your doctor if you are taking the following medicines as Voriconazole Accord should not be taken at the same time if it can be avoided:
- Ritonavir (for the treatment of HIV ) in a dose of 100 mg twice daily
- Glasdegib (for cancer treatment) – if you need to be treated with both medicines, your doctor will do frequent checks on your heart rhythm.
Tell your doctor if you are taking any of the following medicines as concomitant treatment with Voriconazole Accord should be avoided if possible, and dose adjustment of voriconazole may be necessary:
- Rifabutin (for the treatment of tuberculosis ). If you are already being treated with rifabutin, your blood values and side effects from rifabutin must be monitored.
- Phenytoin (for the treatment of epilepsy ). If you are already being treated with phenytoin, the concentration of phenytoin in the blood must be monitored during treatment with Voriconazole Accord and the dose may need to be adjusted.
Tell your doctor if you are taking any of the following medicines as a dose adjustment or control may be needed to ensure that these medicines and Voriconazole Accord are still having the desired effect:
- warfarin and other anticoagulants (eg phenprocoumon, acenocoumarol; used to inhibit the blood’s ability to clot)
- ciclosporin (used in transplant patients)
- tacrolimus (used in transplant patients)
- sulfonylureas (tolbutamide, glipizide and glyburide) (used for diabetes )
- statins (atorvastatin, simvastatin ) (cholesterol-lowering drugs)
- benzodiazepines (midazolam, triazolam) (used for severe sleep disorders and stress)
- omeprazole (used in the treatment of stomach ulcers )
- Oral contraceptives (if you take Voriconazole Accord at the same time as using oral contraceptives, you may experience side effects such as nausea and menstrual disturbances)
- vinca alkaloids (vincristine and vinblastine) (used in the treatment of cancer)
- tyrosine kinase inhibitors (eg axitinib, bosutinib, cabozantinib, ceritinib, cobimetinib, dabrafenib, dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib) (used to treat cancer)
- tretinoin (used in the treatment of leukemia )
- indinavir and other HIV protease inhibitors (used in the treatment of HIV )
- non-nucleoside reverse transcriptase inhibitors (efavirenz, delavirdine, nevirapine) (used in the treatment of HIV ) (some doses of efavirenz must NOT be used at the same time as Voriconazole Accord)
- methadone (used to treat heroin addiction)
- alfentanil and fentanyl and other short-acting opiates such as sufentanil (painkillers used in surgery)
- oxycodone and other long-acting opiates such as hydrocodone (used for moderate to severe pain)
- non-steroidal anti-inflammatory drugs (eg ibuprofen, diclofenac ) (used to treat pain and inflammation )
- fluconazole (used for fungal infections)
- everolimus (used in the treatment of advanced kidney cancer and transplant patients)
- letermovir (used to prevent cytomegalovirus ( CMV ) disease after bone marrow transplantation)
- ivacaftor (used in the treatment of cystic fibrosis ).
Pregnancy and breastfeeding
Voriconazole Accord must not be taken during pregnancy unless prescribed by your doctor. Effective contraception must be used by women of childbearing age. Contact your doctor immediately if you become pregnant while taking Voriconazole Accord.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving ability and use of machinery
Voriconazole Accord may cause blurred vision or unpleasant sensitivity to light. While you are experiencing something like this, do not drive, or use tools or machines. Contact your doctor if you experience this.
Voriconazole Accord contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking Voriconazole Accord.
Voriconazole Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 50 mg tablet, i.e. it is almost “sodium-free”.
This medicine contains less than 1 mmol (23 mg) of sodium per 200 mg tablet, i.e. it is almost “sodium-free”.
How to use Voriconazole Accord
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Your doctor will decide 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 with 40 kg or more | Patients under 40 kg | |
| Dose one for the first 24 hours (Loading Dose) | 400 mg every 12 hours for the first 24 hours | 200 mg every 12 hours for the first 24 hours |
| Dose after the first 24 hours (Maintenance dose) | 200 mg twice daily | 100 mg twice daily |
Depending on how the treatment works, the doctor may prescribe an increase in dose from one to 300 mg twice daily.
The doctor may prescribe a reduction in dose if you have mild to moderate liver dysfunction.
Use for children and adolescents
The recommended dose for children and adolescents is:
| Tablets | ||
| Children from 2 years and up to 12 years and young people 12-14 years weighing less than 50 kg | Young people aged 12-14 years who weigh more than 50 kg, as well as young people older than 14 years | |
| Dose one for the first 24 hours (Loading Dose) | 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 daily (maximum dose is 350 mg twice daily) | 200 mg twice daily |
Depending on how the treatment works, the doctor may increase or decrease the daily dose.
- Tablets may only be given to children who can swallow tablets.
Take your tablet at least one hour before, or one hour after, a meal. Swallow the tablet whole with water.
If you or your child are taking Voriconazole Accord to prevent fungal infections, the doctor may stop giving Voriconazole Accord if you or your child develop side effects caused by the treatment
If you have taken too much Voriconazole Accord
If you take more Voriconazole Accord than prescribed (or if someone else takes your tablets), you must consult a doctor or go immediately to the emergency department of the nearest hospital. Bring your pack of Voriconazole Accord tablets. You may experience an abnormal sensitivity to light if you take too much Voriconazole Accord.
If you forget to take Voriconazole Accord
You must take your Voriconazole Accord tablets regularly at the same time every day. If you forget to take a dose, take the next dose as planned. Do not take a double dose to make up for a missed dose.
If you stop taking Voriconazole Accord
It has been shown that the effect of your medicine can be significantly increased if all doses are taken at the right time. Therefore, unless your doctor tells you to stop treatment, it is important to continue taking Voriconazole Accord as described above.
Keep taking Voriconazole Accord until your doctor tells you to stop. Do not stop treatment prematurely as your infection may not clear up. Patients with weakened immune systems or those with severe infections may need long-term treatment to prevent infection from returning.
When treatment with Voriconazole Accord is stopped by your doctor, you should not notice any effect from this.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
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 or temporary. However, some can be serious and require medical attention.
Serious side effects – Stop taking Voriconazole Accord and see a doctor immediately
- rash
- jaundice; changes in blood tests that test liver function
- inflammation of the pancreas
Other side effects are
Very common (may affect more than 1 in 10 people):
- visual impairment (visual changes, including blurred vision, altered color vision, abnormal hypersensitivity to light, color blindness, eye disorders, the experience of halo phenomenon, night blindness, oscillating visual experience, flashes in the visual field, visual aura, decreased visual acuity, enhanced visual experience of light, loss of parts of the normal field of vision et, spots in front of the eyes [fly vision])
- fever
- rash
- nausea, vomiting, diarrhea
- headache
- swollen arms and legs
- stomach pains
- breathing difficulties
- elevated liver enzyme levels
Common (may affect up to 1 in 10 people):
- sinusitis, inflammation of the gums, chills, weakness
- reduced number, even severe, of certain types of red (sometimes immune-related) and/or white blood cells (sometimes with fever), reduced number of thrombocytes ( platelets ) – cells that help blood clot
- low blood sugar, low level of potassium in the blood, low level of sodium in the blood
- anxiety, depression, confusion, restlessness, difficulty sleeping, hallucinations
- seizures, tremors or uncontrolled muscle movements, tingling or abnormal skin sensations, increased muscle tension, sleepiness, dizziness
- bleeding in the eye
- heart rhythm disorders, including very fast heartbeats, very slow heartbeats, fainting low blood pressure, inflammation of a blood vessel (which can cause blood clots)
- acute breathing problems, chest pain, swelling of the face (mouth, lips, and around the eyes), water in the lungs
- constipation, indigestion, inflammation of the lips
- jaundice, inflammation of the liver, and liver damage
- skin rash that can lead to severe blistering and scaling of the skin characterized by a flat, red area of skin covered in small confluent bumps, redness of the skin
- itching
- hair loss
- back pain
- kidney failure, blood in the urine, altered kidney function values
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 membrane that covers the inside of the abdominal wall and the abdominal organs
- enlarged lymph nodes (sometimes painful), bone marrow failure, increased level of eosinophils
- impaired adrenal function, underactive thyroid gland
- abnormal brain function, Parkinson-like symptoms, nerve damage that causes numbness, pain, tingling, or burning in the hands or feet
- impaired balance and coordination skills
- brain swelling
- double vision, serious eye conditions, including pain and inflammation of the eye and eyelid, abnormal eye movements, damage to the optic nerve leading to visual impairment, swelling of the optic nerve papilla
- impaired sense of touch
- altered sense of taste
- hearing difficulties, ringing in the ears, vertigo
- inflammation of specific internal organs – the pancreas and duodenum, swelling of and inflammation of the tongue
- liver enlargement, liver failure, gallstones, gallstones
- joint inflammation, inflammation of veins under the skin (which may be associated with blood clot formation)
- nephritis, protein in the urine, kidney damage
- very fast pulse or skipped heartbeats, sometimes with irregular electrical impulses
- abnormal EKG
- increased level of cholesterol in the blood, increased level of urea in the blood
- allergic skin reactions (sometimes serious), including life-threatening skin diseases that cause painful blisters and sores on the skin and mucous membranes, especially in the mouth, inflammation of the skin, hives, sunburn, or severe skin reactions after exposure to light or sun, skin redness and skin irritation, red or purple discoloration of the skin which may be due to a reduced number of platelets, eczema
- infusion site reaction
- allergic reactions or excessive immune response
Rare (may affect up to 1 in 1,000 people):
- overactive thyroid
- impaired brain function which is a serious complication of liver disease
- loss of most of the fibers in optic nerve one, clouding of the cornea, involuntary eye movements
- bullous photosensitivity
- a disorder in which the body’s immune system attacks parts of the peripheral nervous system
- disturbances of the heart rhythm or conduction in the heart (sometimes life-threatening)
- life-threatening allergic reaction
- changes in the blood’s ability to clot
- allergic skin reactions (sometimes severe) including rapid swelling (edema) of the “leathery skin” ( dermis ), subcutaneous tissue, mucous membranes and submucosal tissue, itchy or sore patches of thick, red skin with silvery scales, irritation of the skin and mucous membranes, a life-threatening skin disease which causes large parts of the skin’s outermost layer ( epidermis ) to detach from the underlying skin layer
- small patches of dry and scaly skin, sometimes thickened with corn
Adverse effects with no known frequency:
- freckles and pigment spots
Other important side effects whose frequency is not known but which should be reported to the doctor immediately:
- skin cancer
- inflammation of the tissue surrounding the bone
- red, scaly patches or ring-shaped skin changes that may be symptoms of an autoimmune disease called cutaneous lupus erythematosus
As Voriconazole Accord can affect the liver and kidneys, your doctor should check your liver and kidney function by taking blood tests. Tell your doctor if you have a stomach ache or if your stool has a different consistency.
Skin cancer has been reported in patients treated with Voriconazole Accord during long-term treatment.
Sun damage or severe skin reaction after exposure to light or sun was more common in children. If you or your child develop skin changes, the doctor may refer you or your child to a dermatologist who, after consultation, may decide that it is important for you or your child to have regular check-ups. Elevated liver enzyme levels were also seen more often in children.
If any of these side effects do not go away or are bothersome, tell your doctor.
How to store Voriconazole Accord
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is voriconazole. Each tablet contains 50 mg voriconazole (for Voriconazole Accord 50 mg film-coated tablets) or 200 mg voriconazole (for Voriconazole Accord 200 mg film-coated tablets).
- Other ingredients are lactose monohydrate, pregelatinized starch, croscarmellose sodium, povidone, and magnesium stearate which make up the tablet core, and hypromellose, titanium dioxide (E171), lactose monohydrate, and triacetin which make up the film coating (see section 2, Voriconazole Accord 50 mg film-coated tablets or Voriconazole Accord 200 mg film-coated tablets contain lactose and sodium ).
Appearance and package sizes of the medicine
Voriconazole Accord 50 mg film-coated tablets are supplied as white to off-white round film-coated tablets, approximately 7 mm in diameter, marked with “V50” on one side and unmarked on the other side.
Voriconazole Accord 200 mg film-coated tablets are supplied as white to off-white oval film-coated tablets, approximately 15.5 mm long and 7.8 mm wide, marked with “V200” on one side and unmarked on the other side.
Voriconazole Accord 50 mg film-coated tablets and 200 mg film-coated tablets are available in pack sizes of 2, 10, 14, 20, 28, 30, 50, 56, and 100 tablets or single-dose blister packs (PVC/aluminum) containing 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1 and 100 x 1 film-coated tablet.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare SLU
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Paradox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000
Malta
Accord Healthcare Polska Sp.z oo,
ul. Lutomirska 50,95-200 Pabianice, Poland
Accord Healthcare BV,
Winthontlaan 200,
3526 VK Utrecht,
Netherlands