Vcide Film-Coated Tablets

    Vcide Film-Coated Tablets

    S4

    API: Voriconazole | Company: Abex

    1. What VCIDE is and what it is used for

    VCIDE is an antifungal medicine. It works by killing or stopping the growth of the fungi that cause infections.

    VCIDE is used for the treatment of patients (adults and children over the age of 2) with:

    • invasive aspergillosis (a serious type of fungal infection due to Aspergillus sp.),
    • serious invasive Candida sp. infections (including C. krusei),
    • serious fungal infections caused by Scedosporium sp. or Fusarium sp. (two different species of fungi).

    VCIDE may also be used for the prevention of fungal infections in high-risk patients, for example bone marrow transplant recipients, where another antifungal medicine cannot be used.

    VCIDE should only be used under the supervision of a doctor.

    2. What you need to know before you take VCIDE

    Do not take VCIDE:

    • if you are hypersensitive (allergic) to voriconazole or any ingredient in VCIDE (listed in section 6);
    • if you have prolonged QT-syndrome (a heart rhythm disorder);
    • if your liver function is severely affected;
    • if you are pregnant or breastfeeding.

    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. There are many medicines that must not be taken during your course of VCIDE treatment:

    • Terfenadine (used for allergy)
    • Astemizole (used for allergy)
    • Cisapride (used for stomach problems)
    • Pimozide (used for treating mental illness)
    • Quinidine (used for irregular heartbeat)
    • Rifampicin (used for treating tuberculosis)
    • Carbamazepine (used to treat seizures)
    • Phenobarbital (used for severe insomnia and seizures)
    • Ritonavir (used for treating HIV) in doses of 400 mg and more, twice daily
    • Ergot alkaloids (e.g., ergotamine, dihydroergotamine; used for migraine)
    • Sirolimus (used in transplant patients)
    • Rifabutin (used for treating tuberculosis)
    • St. John’s Wort (herbal supplement).

    Warnings and precautions

    Tell your doctor, pharmacist or healthcare provider before you take VCIDE, if you:

    • are allergic to other azole type medicines (these are antifungal medicines, for example, fluconazole or ketoconazole. Ask your doctor or pharmacist if you are unsure);
    • are suffering from liver disease or have ever suffered from it. If you have liver disease, your doctor may prescribe a lower dose of VCIDE. Your doctor should also monitor your liver function while you are being treated with VCIDE by doing blood tests;
    • you are known to have cardiomyopathy (diseased heart muscle), irregular heartbeat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome’ (see section 2 “Do not take VCIDE”);
    • have electrolyte disturbances such as low potassium, calcium or magnesium;
    • have a kidney disease. Your doctor should monitor your renal function while you are being treated with VCIDE by doing blood tests.

    You should also know that: 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.

    While being treated with VCIDE, tell your doctor immediately if you develop:

    • 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 VCIDE.

    VCIDE can cause problems with your eyes and vision, including blurred vision and light sensitivity. You should wear sunglasses to protect your eyes from bright light.

    If you had an organ transplant and receive VCIDE, you may have inflammation and pain in the bones. See your doctor as soon as possible. He/she will decide if you should continue treatment with VCIDE and will treat you as necessary.

    Effective contraception must be used in women of childbearing potential.

    Children

    VCIDE is not recommended for use in children below the age of 2 years because there is insufficient data on safety and effectiveness in this age group.

    3. How to take VCIDE

    Do not share medicines prescribed for you or your child with any other person. Always take VCIDE exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

    Your doctor will decide what dose you should receive for your condition and also for how long you need to receive it. The dose and duration of treatment will depend on how your body and the infection reacts on the treatment. Depending on your response to treatment, your doctor may increase or decrease your dose.

    Take your tablet at least one hour before, or one hour after a meal. Swallow the tablet whole with some water.

    Use in children and adolescents

    Tablets must only be given if the child is able to swallow tablets. Your child’s doctor will work out the dose for your child, based on his/her mass. He/she will tell you how long the treatment with VCIDE will last. Take your tablet at least one hour before, or one hour after a meal. Swallow the tablet whole with some water.

    Continue taking VCIDE 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.

    If you have the impression that the effect of VCIDE is too strong or too weak, tell your doctor or pharmacist.

    If you take more VCIDE than you should

    In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

    If you forget to take VCIDE

    Do not take a double dose to make up for forgotten individual doses.

    If you stop taking VCIDE

    It is important that you finish your treatment as prescribed by your doctor. Do not stop taking VCIDE just because you feel better. If you stop taking treatment before the course is completed, the fungus causing the disease may become resistant to VCIDE and your disease will get worse.

    4. Possible side effects

    VCIDE can have side effects. Not all side effects reported for VCIDE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VCIDE, please consult your doctor, pharmacist or other healthcare provider for advice.

    If any of the following happens, stop using VCIDE and tell your doctor immediately:

    • Serious allergic reactions, including a shock reaction. You may have swelling of the tongue and/or throat, difficulty in swallowing, difficulties in breathing, facial swelling, severe dizziness with very fast heartbeat and heavy sweating.
    • 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. These are all very serious side effects. If you have them, you may have had a serious reaction to VCIDE. You may need urgent medical attention or hospitalisation.

    Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

    • Jaundice (yellowing of the eyes or skin, dark urine, upper stomach pain), liver failure, gallbladder disease, gallstones.
    • Deterioration of brain function that is a serious complication of liver disease.
    • Inflammation of the pancreas (abdominal pain, fever, rapid pulse, nausea, shivering).
    • Severe diarrhoea and nausea with fever and weakness. This is a serious condition for which you may need urgent treatment.
    • Heart rhythm disturbances, including very fast heartbeat, very slow heartbeat, conduction problems (sometimes life threatening), fainting.

    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.

    Disorder of blood clotting system (clotting in the blood vessels).

    Guillain-Barre syndrome (the body’s immune system attacks part of the peripheral nervous system, with resulting muscle weakness, beginning in the feet and hands).

    Kidney failure, inflammation in the kidney, blood in the urine, problems urinating, changes in kidney function tests, proteins in the urine. These are all serious side effects. You may need urgent medical attention.

    Tell your doctor if you notice any of the following:

    Frequent side effects

    • Sinusitis (infection of the nasal passages).
    • 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.
    • You get more infections than usual. This could be because of a decrease in white blood cells. Your doctor will confirm this with a blood test.
    • Low blood sugar, low blood potassium or low sodium in the blood (you will only know for sure that you have these deficiencies if you go for blood tests). Tell your doctor if you have muscle cramps and feel weak.
    • Easy or excessive bruising, superficial bleeding into the skin, unexpected excessive bleeding, particularly if you also take or receive blood thinning medicines such as warfarin.
    • Depression, problems falling asleep, anxiety, hallucinations (false perceptions).
    • Sleepiness, feeling faint and/or dizzy.
    • Convulsions (fits or jerks), severe headache, loss of coordination.
    • Tingling or abnormal skin sensations, increase in muscle tone.
    • Bleeding in the eye.
    • Low blood pressure (you may feel faint or dizzy).
    • Inflammation of a vein (phlebitis, a condition where the veins close to the surface of the body become swollen, tender, and red and may develop blood clots).
    • Nausea (feeling sick), vomiting (being sick), diarrhoea (loose bowels), stomach pain, inflammation of the lips.
    • Constipation, indigestion.
    • Skin rashes, hair loss.
    • Back pain.
    • Feeling tired and generally weak.

    Less frequent side effects

    • Enlarged lymph glands (sometimes painful), failure of bone marrow, increased eosinophil.
    • Disorder of blood clotting system.
    • Overactive thyroid. If you have muscle weakness, have a rapid heartbeat and increased appetite, tell your doctor.
    • Underactive thyroid (some signs may be weight gain, fatigue and depression).
    • Abnormal sense of taste.
    • Decreased sensitivity to touch.
    • Abnormal brain function, Parkinson-like symptoms, nerve injury resulting in numbness, pain, tingling or burning in the hands or feet.
    • Sudden behaviour changes, problems with thinking or speech.
    • Problems with balance or coordination, swelling of the brain.
    • Eye-rolling disorder where the eyes fix upwards.
    • Ringing in the ears, dizziness, hearing loss.
    • Inflammation of certain internal organs – pancreas and duodenum, swelling and inflammation of the tongue.
    • Inflammation of the thin tissue that lines the inner wall of the abdomen and covers the abdominal organ.
    • Bullous photosensitivity.
    • Freckles and pigmented spots.
    • Joint and muscle pains in the legs and arms.
    • Flu-like illness.
    • Increased blood cholesterol.

    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.

    Some side effects such as temporary blood, cholesterol, kidney or liver problems can only be detected when your doctor orders blood or urine tests to check your progress. 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 you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

    5. How to store VCIDE

    Store all medicines out of reach of children. Store in the original pack at or below 25 °C. Do not use after the expiry date stated on the label and carton. Bottles: Use within 30 days after first opening. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

    Important Disclaimer

    The Vcide Film-Coated Tablets professional information leaflet below is the property of Abex and is provided on Somayeza exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Somayeza serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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