Full description:
Voricona-Denk 200 mg contains the active substance voriconazole. Voricona-Denk 200 mg 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).
Voricona-Denk 200 mg 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 taken under the supervision of a doctor.
What Voricona-Denk 200 mg contains:
- The active substance is voriconazole. Each tablet contains 200 mg voriconazole.
- The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone K29/32, magnesium stearate [vegetable], hypromellose 6cP, titanium dioxide, macrogol 3350, triacetin.
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 Voricona-Denk 200 mg 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
- 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 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 eosinophils
- 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 1,000 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”
Not known: frequency cannot be estimated from the available data
- 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 As Voricona-Denk 200 mg has been known to affect the liver and the kidneys, your doctor should monitor the function of your liver and kidneys 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 Voricona-Denk 200 mg 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.
How to take:
Take your tablet at least one hour before, or one hour after a meal. Swallow the tablet whole with some water.
