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«Package Leaflet: Information for the user VFEND 40 mg/ml powder for oral suspension Voriconazole Read all of this leaflet carefully before you ...»

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Package Leaflet: Information for the user

VFEND 40 mg/ml powder for oral suspension

Voriconazole

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible • side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What VFEND is and what it is used for

2. What you need to know before you take VFEND

3. How to take VFEND

4. Possible side effects

5. How to store VFEND 6 Content of the pack and other information

1. What VFEND is and what it is used for VFEND contains the active substance voriconazole. VFEND 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).

VFEND 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 VFEND

Do not take VFEND:

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 VFEND treatment:

Page 1 of 10 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, pharmacist or nurse before taking VFEND 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 VFEND. Your doctor should also monitor your liver function while you are being treated with VFEND 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.

–  –  –

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 VFEND.

Your doctor should monitor the function of your liver and kidney by doing blood tests.

Children and adolescents VFEND should not be given to children younger than 2 years of age.

Other medicines and VFEND 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 VFEND, may affect the way VFEND works or VFEND may affect the way they work.

Tell your doctor if you are taking the following medicine, as treatment with VFEND at the same time

should be avoided if possible:

–  –  –

Tell your doctor if you are taking either of the following medicines, as treatment with VFEND 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 VFEND 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 VFEND 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) • Sulfonylureas (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 VFEND 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 VFEND) 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) • Pregnancy and breast-feeding VFEND 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 VFEND.

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 VFEND 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.

VFEND contains sucrose

–  –  –

3. How to take VFEND 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:

–  –  –

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.

–  –  –

Depending on your response to treatment, your doctor may increase or decrease the daily dose.

Take your suspension at least one hour before, or two hours after a meal.

If you or your child are taking VFEND for prevention of fungal infections, your doctor may stop giving VFEND if you or your child develop treatment related side effects.

–  –  –

Instructions to constitute the suspension:

It is recommended that your pharmacist constitutes VFEND suspension before giving it to you.

VFEND suspension is constituted if it is in a liquid form. If it appears to be a dry powder you should constitute the oral suspension by following the instructions below.

1. Tap the bottle to release the powder.

2. Remove the cap.

3. Add 2 measuring cups (measure cup included in the carton) of water (total of 46 ml) to the bottle. Fill the measuring cup to the top of the marked line then pour the water into the bottle.

You should always add a total of 46 ml of water irrespective of the dose you are taking.

4. Replace the cap and shake the bottle vigorously for about 1 minute. Following constitution, the total volume of the suspension must be 75 ml.

5. Remove the cap. Press the bottle adaptor into the neck of the bottle (as shown on figure below). The adaptor is provided so that you can fill the oral syringe with medicine from the bottle. Replace the cap on the bottle.

6. Write the date of expiry of the constituted suspension on the bottle label (the shelf-life of the constituted suspension is 14 days). Any unused suspension should be discarded after this date.

Instructions for use:

Your pharmacist should advise you how to measure the medicine using the multi-dosing oral syringe provided in the pack. Please see instructions below before using VFEND suspension.

1. Shake the closed bottle of constituted suspension for approximately 10 seconds before use.

Remove the cap.

2. While the bottle is upright, on a flat surface, insert the tip of the oral syringe into the adaptor.

3. Turn the bottle upside down while holding the oral syringe in place. Slowly pull back the plunger of the oral syringe to the graduation mark that marks the dose for you. To measure the dose accurately, the top edge of the black ring should be lined up with the graduated mark on the oral syringe.

4. If large bubbles can be seen, slowly push the plunger back into the syringe. This will force the medicine back into the bottle. Repeat step 3 again.

5. Turn the bottle back upright with the oral syringe still in place. Remove the oral syringe from the bottle.

Page 5 of 10 6. Put the tip of the oral syringe into the mouth. Point the tip of the oral syringe towards the inside of the cheek. SLOWLY push down the plunger of the oral syringe. Do not squirt the medicine out quickly. If the medicine is to be given to a child, make sure the child is sitting, or is held, upright before giving the medicine.

7. Replace the cap on the bottle, leaving the bottle adaptor in place. Wash the oral syringe as instructed below.

1 2 3/4 5 6

Cleaning and storing the syringe:

1. The syringe should be washed after each dose. Pull the plunger out of the syringe and wash both parts in warm soapy water. Then rinse with water.

2. Dry the two parts. Push the plunger back in to the syringe. Keep it in a clean safe place with the medicine.

If you take more VFEND than you should If you take more suspension than prescribed (or if someone else takes your suspension) you must seek medical advice or go to the nearest hospital casualty department immediately. Take your bottle of VFEND suspension with you. You may experience abnormal intolerance to light as a result of taking more VFEND than you should.

If you forget to take VFEND It is important to take your VFEND suspension 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 the forgotten dose.

If you stop taking VFEND 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 VFEND correctly, as described above.

Continue taking VFEND 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 VFEND 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

–  –  –

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 VFEND 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

–  –  –

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



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