Patient leaflet - VORICONAZOLE TORRENT 50 MG FILM-COATED TABLETS
1. what voriconazole torrent is and what it is used for
Voriconazole Torrent film-coated tablets contain 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 Torrent 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.
2. what you need to know before you take voriconazole torrent
Do not take Voriconazole Torrent:
-
– 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 or pharmacist if you are taking or have taken any other medicines, even those that are obtained without a prescription, or herbal medicines.
- The medicines in the following list must not be taken during your course of Voriconazole Torrent treatment: 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 400mg and more twice daily
- St John’s Wort (herbal supplement) Warnings and precautions Talk to your doctor before taking Voriconazole Torrent if:
- you have had an allergic reaction to other azoles.
- you are suffering from, or have ever suffered from liver disease. If you have liver disease, your doctor may prescribe a lower dose of Voriconazole. Your doctor should also monitor your liver function while you are being treated with Voriconazole Torrent by doing blood tests.
- you 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.
While being treated with Voriconazole Torrent:
- tell your doctor immediately if you develop o Sunburn
o Severe skin rash or blisters
o 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.
Your doctor should monitor the function of your liver and kidney by doing blood tests.
If you develop signs of ‘adrenal insufficiency’ where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol which may lead to symptoms such as: chronic, or long lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain, please tell your doctor.
Children and adolescents
Voriconazole Torrent should not be given to children younger than 2 years of age.
Other medicines and Voriconazole Torrent
Please tell your doctor or pharmacist if you 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 Voriconazole Torrent, may affect the way Voriconazole works or Voriconazole Torrent may affect the way they work.
Tell your doctor if you are taking the following medicine, as treatment with Voriconazole Torrent 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 Torrent 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 Torrent 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 Torrent 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 take Voriconazole Torrent 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 Torrent)
- 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)
- Tolvaptan (used to treat hyponatremia (low levels of sodium in your blood) or to slow kidney function decline in patients with polycystic kidney disease)
- Letermovir (used for preventing cytomegalovirus (CMV) disease after bone marrow transplant)
- Naloxegol: used to treat constipation specifically caused by pain medicines, called opioids, (e.g., morphine, oxycodone, fentanyl, tramadol, codeine)
- Ivacaftor: used to treat cystic fibrosis
Pregnancy and breast-feeding Voriconazole Torrent must not be taken 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 taking Voriconazole Torrent.
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 taking this medicine.
Driving and using machines Voriconazole Torrent may cause blurring of vision or uncomfortable sensitivity to light. While affected, do not drive or operate any tools or machines. Contact your doctor if you experience this.
Voriconazole Torrent contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Information on sodium content
This medicine contains less than 1 mmol sodium (23 mg) per 50 mg tablet, that is to say essentially ‘sodium-free’
3. how to take voriconazole torrent
Always take this medicine exactly as your doctor 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.
The recommended dose for adults (including elderly patients) is as follows:
| Tablets | ||
| Patients 40 kg and above | Patients less than 40 kg | |
| Dose 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 a day | 100 mg twice a day |
Depending on your response to treatment, your doctor may increase the daily dose to 300 mg twice a day. The doctor may decide to decrease the dose if you have mild to moderate cirrhosis.
Use in children and adolescents
The recommended dose for children and teenagers is as follows:
| Tablets | ||
| Children aged 2 to less than 12 years and teenagers aged 12 to 14 years weighing less than 50 kg | Teenagers aged 12 to 14years weighing 50 kg or more; and all teenagers older than 14 | |
| Dose for the first 24 hours (Loading Dose) | Your 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 a day (a maximum dose of 350 mg twice daily) | 200 mg twice a day |
Depending on your response to treatment, your doctor may increase or decrease the daily dose.
- Tablets must only be given if the child is able to swallow tablets.
Take your tablet at least one hour before, or one hour after a meal. Swallow the tablet whole with some water.
If you or your child are taking Voriconazole Torrent for prevention of fungal infections, your doctor may stop giving Voriconazole Torrent if you or your child develop treatment related side effects.
If you take more Voriconazole Torrent than you should
If you take more tablets than prescribed (or if someone else takes your tablets) you must seek medical advice or go to the nearest hospital casualty department immediately. Take your box of Voriconazole Torrent tablets with you. You may experience abnormal intolerance to light as a result of taking more Voriconazole Torrent than you should.
If you forget to take Voriconazole Torrent
It is important to take your Voriconazole Torrent film-coated tablets regularly at the same time each day. If you forget to take one dose, take your next dose when it is due. Do not take a double dose to make up for a forgotten dose.
If you stop taking Voriconazole Torrent
It has been shown that taking all doses at the appropriate times may greatly increase the effectiveness of your medicine. Therefore unless your doctor instructs you to stop treatment, it is important to keep taking Voriconazole Torrent correctly, as described above. Continue taking Voriconazole Torrent 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.
When Voriconazole Torrent 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 taking Voriconazole Torrent 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 ofthe 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: 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 tissue the mouth, inflammation of 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
- 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
As Voriconazole 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store voriconazole torrent
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 carton and blister after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions.
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 Torrent contains
-
– The active substance is voriconazole.
-
– Voriconazole Torrent 50 mg film-coated tablets: Each tablet contains 50 mg voriconazole.
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– Voriconazole Torrent 200 mg film-coated tablets: Each tablet contains 200 mg voriconazole.
-
– The other ingrediens are lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, povidone K29/32, magnesium stearate, hypromellose 6cP, titanium dioxide (E171), macrogol 3350, triacetin.
What Voriconazole Torrent film-coated tablets look like and contents of the pack
Voriconazole Torrent 50 mg film-coated tablets are white 7 mm round tablets with VC50 debossed on one side.
Voriconazole Torrent 200 mg film-coated tablets are white 15.5× 7.9 mm oval tablets with VC200 debossed on one side.
Voriconazole Torrent 50 mg and 200 mg film-coated tablets are available as packs of 10, 14, 20, 28, 30, 50, 56, 98 and 100.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Torrent Pharma (UK) Ltd.
3rd Floor, Nexus Building, 4 Gatwick Road, Crawley, West Sussex, RH10 9BG, United Kingdom
Manufacturer
Actavis Ltd.
BLB 016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta
This leaflet was last revised in 03/2021.
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