Voratex tablets 50mg are white to off-white, round, biconvex, with code V50 on one side.
Voratex tablets 200mg are white to off-white, oval, biconvex, with code V200 on one side.
Each tablet contains either 50 mg voriconazole (for Voratex tablets 50mg) or 200 mg voriconazole (for Voratex tablets 200mg).
Excipients/Inactive Ingredients: The other ingredients are Starch maize pregelatinized, Lactose monohydrate, Povidone K30, Croscarmellose sodium, Silica colloidal anhydrous, Magnesium stearate and Opadry II White OY-LS-28908 (titanium dioxide, lactose monohydrate, hypromellose, macrogol).
Voratex tablets 50mg and 200mg contain lactose and sodium.
Voratex contains the active substance voriconazole. Voratex is an antifungal medicine. It works by killing or stopping the growth of the fungi that cause infections.
Voratex is used for the treatment of patients (adults and children over the age of 2) with: invasive aspergillosis; candidaemia in non-neutropenic patients; serious invasive Candida sp infections when the fungus is resistant to fluconazole; serious fungal infections caused by Scedosporium sp or Fusarium sp.
Voratex is intended for patients with worsening, possibly life-threatening, fungal infections.
Voratex is used for the prevention of fungal infections in high risk bone marrow transplant recipients.
This product should only be taken under doctor's supervision.
This medicine should always be taken exactly as prescribed.
The dose will be determined depending on the weight and the type of infection.
The recommended dose for adults (including elderly patients) is as follows: See Table 1.
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Depending on the response to treatment, the daily dose may be increased to 300 mg twice a day.
The dose may be decreased in case of mild to moderate cirrhosis.
Use in children and adolescents: It is recommended to use the oral suspension formulation of other brands in children aged 2 to <12.
The recommended dose for children and teenagers is as follows: See Table 2.
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Depending on the response to treatment, the daily dose may be increased or decreased.
Tablets must only be given if the child is able to swallow tablets.
The tablet should be taken at least one hour before, or one hour after a meal. The tablet should be swallowed whole with some water.
In patients taking Voratex for prevention of fungal infections, treatment with Voratex may be discontinued if treatment-related side effects develop.
Forgotten intake of Voratex: It is important to take Voratex tablets regularly at the same time each day. If intake of one dose is forgotten, the next dose should be taken when it is due. A double dose should not be taken to make up for a forgotten dose.
Stopping intake of Voratex: It has been shown that taking all doses at the appropriate times may greatly increase the effectiveness of the medicine. Therefore, unless it has been instructed to stop treatment, it is important to keep taking Voratex correctly, as previously described.
Voratex intake should be continued until instructed to stop. Treatment should not be stopped early because the 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 Voratex treatment is stopped, patients should not experience any effects.
If patients take more tablets than prescribed (or if someone else takes the tablets), they must seek medical advice or go to the nearest hospital casualty department immediately. Patients should take their box of Voratex tablets with them. Patients may experience abnormal intolerance to light as a result of taking more Voratex than they should.
Voratex should not be taken by patients who are allergic to voriconazole or any of the other ingredients of this medicine (listed in Description).
The following medicines must not be taken during the course of Voratex treatment: Terfenadine; Astemizole; Cisapride; Pimozide; Quinidine; Ivabradine; Rifampicin; Efavirenz in doses of 400 mg and above once daily; Carbamazepine; Phenobarbital; Ergot alkaloids (e.g., ergotamine, dihydroergotamine); Sirolimus; Ritonavir in doses of 400 mg and more twice daily; St. John's Wort; Naloxegol; Tolvaptan; Lurasidone; Venetoclax.
Patients should exercise caution before taking Voratex if they: have had an allergic reaction to other azoles; are suffering from, or have ever suffered from liver disease; are known to have cardiomyopathy, irregular heartbeat, slow heart rate or long QTc syndrome.
A lower dose of Voratex may be prescribed in patients who have liver disease. Liver function should also be monitored while patients are being treated with Voratex.
Patients 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 Voratex, patients should exercise caution if they develop: sunburn; severe skin rash or blisters; bone pain. If patients develop skin disorders as previously described, they may be referred to a dermatologist. There is a small chance that skin cancer could develop with long-term use of Voratex.
Patients should exercise caution if they develop: signs of adrenal insufficiency (symptoms such as chronic or long-lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain); signs of Cushing's syndrome (symptoms such as weight gain, fatty hump between the shoulders, a rounded face, darkening of the skin on the stomach, thighs, breasts, and arms, thinning skin, bruising easily, high blood sugar, excessive hair growth, excessive sweating).
Liver and kidney functions should be monitored.
Voratex contains lactose: Presence of intolerance to some sugars should be confirmed before taking Voratex.
Voratex contains sodium: This medicine contains less than 1 mmol sodium (23 mg) per 50 mg tablet, that is to say essentially 'sodium-free'.
This medicine contains less than 1 mmol sodium (23 mg) per 200 mg tablet, that is to say essentially 'sodium-free'.
Driving and using machines: Voratex may cause blurring of vision or uncomfortable sensitivity to light. While affected, patients should not drive or operate any tools or machines.
Use in Children: Voriconazole should not be given to children younger than 2 years of age.
Voratex must not be taken during pregnancy, unless indicated by the doctor.
Effective contraception must be used in women of childbearing potential. Patients should contact their doctor immediately if they become pregnant while taking Voratex.
Patients should be advised before taking this medicine if they are pregnant or breast-feeding, think they may be pregnant or are planning to have a baby.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are likely to be minor and temporary. However, some may be serious and need medical attention.
Serious side effects: Voratex intake should be stopped and immediate medical attention is necessary in case of: 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 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; 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 platelets; Low blood sugar, low blood potassium, low blood sodium; 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 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 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; Allergic reaction or exaggerated immune response.
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 fibres in the optic nerve, clouding of the cornea, involuntary movement of the eye; Bullous photosensitivity; 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 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 immediately: Skin cancer; Inflammation of the tissue surrounding the bone; Red, scaly patches or ring-shaped skin lesions that may be a symptom of cutaneous lupus erythematosus.
As Voratex has been known to affect the liver and the kidney, liver and kidney function should be monitored. Any stomach pains or stools with different consistency should be reported.
There have been reports of skin cancer in patients treated with Voratex for long periods of time.
Sunburn or severe skin reaction following exposure to light or sun was experienced more frequently in children. If skin disorders develop, patients may be referred to a dermatologist. Elevated liver enzymes were also observed more frequently in children.
Reporting of side effects: Side effects should be reported. This includes any possible side effects not previously listed.
Patients should inform their doctor or pharmacist if they are taking, have recently taken or might take any other medicines, including those that are obtained without a prescription.
Some medicines, when taken at the same time as Voratex, may affect the way Voratex works or Voratex may affect the way they work.
Treatment with Voratex at the same time should be avoided if possible: Ritonavir in doses of 100 mg twice daily; Glasdegib (if both drugs need to be used, heart rhythm will be monitored frequently).
Treatment with Voratex at the same time should be avoided if possible, and a dose adjustment of voriconazole may be required: Rifabutin (if already being treated with rifabutin, blood counts and side effects to rifabutin will need to be monitored); Phenytoin (if already being treated with phenytoin, blood concentration of phenytoin will need to be monitored during treatment with Voratex and dose may be adjusted).
Dose adjustment or monitoring may be required to check that the medicines and/or Voratex are still having the desired effect: Warfarin and other anticoagulants (e.g., phenprocoumon, acenocoumarol); Ciclosporin; Tacrolimus; Sulfonylureas (e.g., tolbutamide, glipizide, and glyburide); Statins (e.g., atorvastatin, simvastatin); Benzodiazepines (e.g., midazolam, triazolam); Omeprazole; Oral contraceptives (if Voratex is taken whilst using oral contraceptives, side effects such as nausea and menstrual disorders may be experienced); Vinca alkaloids (e.g., vincristine and vinblastine); Tyrosine kinase inhibitors (e.g., axitinib, bosutinib, cabozantinib, ceritinib, cobimetinib, dabrafenib, dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib); Tretinoin; Indinavir and other HIV protease inhibitors; Non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, delavirdine, nevirapine) (some doses of efavirenz cannot be taken at the same time as Voratex); Methadone; Alfentanil and fentanyl and other short-acting opiates such as sufentanil; Oxycodone and other long-acting opiates such as hydrocodone; Non-steroidal anti-inflammatory drugs (e.g., ibuprofen, diclofenac); Fluconazole; Everolimus; Letermovir; Ivacaftor.
J02AC03 - voriconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.
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