Patient Leaflet Updated 20-Dec-2021 | Aspire Pharma Ltd
Voriconazole 50mg and 200mg film-coated tablets
Package leaflet: Information for the user
Voriconazole 50mg film-coated tablets
Voriconazole 200mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1.What Voriconazole is and what it is used for
2.What you need to know before you take Voriconazole
3.How to take Voriconazole
4.Possible side effects
5.How to store Voriconazole
6.Contents of the pack and other information
1. What Voriconazole is and what it is used for
This medicine contains 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:
Voriconazole 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
Do not take Voriconazole:
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 treatment:
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Voriconazole if:
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, tell your doctor immediately if you develop:
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.
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.
Your doctor should monitor the function of your liver and kidneys by doing blood tests.
Children and adolescents
Voriconazole should not be given to children younger than 2 years of age.
Other medicines and Voriconazole
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines, when taken at the same time as Voriconazole, may affect the way Voriconazole works or Voriconazole may affect the way they work.
Tell your doctor if you are taking the following medicine, as treatment with Voriconazole at the same time should be avoided, if possible:
Tell your doctor if you are taking either of the following medicines, as treatment with Voriconazole at the same time should be avoided, if possible, and a dose adjustment of voriconazole may be required:
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 are still having the desired effect:
Pregnancy and breast-feeding
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.
Voriconazole must not be taken during pregnancy, unless indicated by your doctor. Effective contraception must be used in women of child-bearing potential. Contact your doctor immediately if you become pregnant while taking Voriconazole.
Driving and using machines
Voriconazole 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 contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Information on sodium content
This medicine contains less than 1mmol sodium (23mg) per film-coated tablet, that is to say essentially ‘sodium-free’.
3. How to take Voriconazole
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:
Patient 40kg and above:
Patients less than 40kg:
Depending on your response to treatment, your doctor may increase the daily dose to 300mg 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 adolescents is as follows:
Children aged 2 to less than 12 years and adolescents aged 12 to 14 years weighing less than 50kg:
Adolescents aged 12 to 14 years weighing 50kg or more; and all adolescents older than 14:
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 for prevention of fungal infections, your doctor may stop giving Voriconazole if you or your child develop treatment-related side effects.
If you take more Voriconazole 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 tablets with you. You may experience abnormal intolerance to light as a result of taking more Voriconazole than you should.
If you forget to take Voriconazole
It is important to take your Voriconazole 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
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 correctly, as described above.
Continue taking Voriconazole 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 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 and see a doctor immediately if you experience:
Other side effects
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Side effects with frequency not known (cannot be estimated from the available data):
Other significant side effects whose frequency is not known, but should be reported to your doctor immediately:
As voriconazole has been known to affect the liver and the kidney, 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 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard 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
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, the blister and the bottle after ‘EXP’. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Bottles: Use within 30 days after first opening.
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 contains
What Voriconazole looks like and contents of the pack
Voriconazole 50mg film-coated tablets are supplied as white to off-white, round, biconvex film-coated tablets with “V50” marked on one side, 7.1 ± 0.2 mm in diameter.
Voriconazole 200mg film-coated tablets are supplied as white to off-white, oval, biconvex film-coated tablets with “V200”marked on one side, 15.7 ± 0.2 mm in length and 7.9 ± 0.2 mm in width.
Voriconazole 50mg film-coated tablets are supplied in PVC transparent/Aluminium foil blister available in packs of 28, 30, 50, 56 or 100 film-coated tablets or in white opaque HDPE bottle with a polypropylene child-resistant screw cap and induction seal liner, containing 30 film-coated tablets.
Voriconazole 200mg film-coated tablets are supplied in PVC transparent/Aluminium foil blister available in packs of 14, 28, 30, 50, 56 or 100 film-coated tablets or in white opaque HDPE bottle with a polypropylene child-resistant screw cap, and induction seal liner, containing 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
This leaflet was last revised in July 2021
4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
+44 (0)1730 231148
+44 (0)1730 231148
+44 (0)1730 231148