Voriconazol Sandoz 50 mg, filmomhulde tabletten

ATC-Code
J02AC03
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Sandoz

Stof Verdovend Psychotrope
Voriconazol Nee Nee
Farmacologische groep Antimycotica voor systemisch gebruik

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Sandoz

Waarvoor wordt dit middel gebruikt?

Voriconazol Sandoz contains the active substance voriconazole. Voriconazol Sandoz 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).

Voriconazol Sandoz is intended for patients with worsening, possibly life-threatening, fungal infections.

This product should only be taken under the supervision of a doctor.

Advertentie

Wanneer mag u dit middel niet gebruiken of moet u er extra voorzichtig mee zijn?

Do not take Voriconazol Sandoz

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, have recently taken or might take 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 Voriconazol Sandoz 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 400 mg and more twice daily
  • St John’s Wort (herbal supplement)

Warnings and precautions

Talk to your doctor before taking Voriconazol Sandoz 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 Voriconazol Sandoz. Your doctor should also monitor your liver function while you are being treated with Voriconazol Sandoz by doing blood tests.
  • you are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome’.

You should avoid sunlight and sun exposure while being treated. It is important to cover sun exposed areas of skin and use sunscreen, as an increased sensitivity of skin to the sun’s UV rays can occur.

While being treated with Voriconazol Sandoz:

  • tell your doctor immediately if you develop a severe skin rash or blisters or bone pain.
  • your doctor should monitor the function of your liver and kidney by doing blood tests.

Children and adolescents

Voriconazol Sandoz should not be given to children younger than 2 years of age.

Other medicines and Voriconazol Sandoz

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 Voriconazol Sandoz, may affect the way Voriconazol Sandoz works or Voriconazol Sandoz may affect the way they work.

Tell your doctor if you are taking the following medicine, as treatment with Voriconazol Sandoz 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 Voriconazol Sandoz 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 Voriconazol Sandoz 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 Voriconazol Sandoz 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 Voriconazol Sandoz 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 Voriconazol Sandoz)
  • 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

Voriconazol Sandoz 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 Voriconazol Sandoz.

Voriconazol Sandoz must not be taken during breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine whilst breast-feeding.

Driving and using machines

Voriconazol Sandoz 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.

Voriconazol Sandoz contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Voriconazol Sandoz.

Hoe gebruikt u dit middel?

Always take this medicine exactly as your doctor or pharmacist 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 400 mg every 12 hours   200 mg every 12 hours
(Loading Dose) for the first 24 hours   for the first 24 hours
Dose after the first 24 hours 200 mg twice a day   100 mg twice a day
(Maintenance Dose)  

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 Teenagers aged 12 to 14
  than 12 years and years weighing 50 kg or
  teenagers aged 12 to 14 more; and all teenagers
  years weighing less than older than 14
  50 kg  
Dose for the first 24 hours Your treatment will be 400 mg every 12 hours
(Loading Dose) started as an infusion for the first 24 hours
Dose after the first 24 hours 9 mg/kg twice a day  
(Maintenance Dose) (a maximum dose of 200 mg twice a day
  350 mg twice daily)  

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 take more Voriconazol Sandoz 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 Voriconazol Sandoz tablets with you. You may experience abnormal intolerance to light as a result of taking more Voriconazol Sandoz than you should.

If you forget to take Voriconazol Sandoz

It is important to take your Voriconazol Sandoz 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 Voriconazol Sandoz

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 Voriconazol Sandoz correctly, as described above.

Continue taking Voriconazol Sandoz 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 Voriconazol Sandoz 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 or pharmacist.

Mogelijke bijwerkingen?

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 Voriconazol Sandoz and see a doctor immediately

  • Rash
  • Jaundice; Changes in blood tests of liver function
  • Pancreatitis

Other possible side effects

Very common side effects (may affect more than 1 in 10 people) are:

  • Visual disturbances (change in vision)
  • Fever
  • Rash
  • Nausea, vomiting, diarrhoea
  • Headache
  • Swelling of the extremities
  • Stomach pains.

Common side effects (may affect up to 1 in 10 people) are:

  • Flu-like symptoms, sinusitis, chills, weakness
  • Anaemia
  • Low numbers of cells called platelets that help the blood to clot, low numbers of some types of white blood cells or of all types of blood cells, red or purple discoloration of the skin which may be caused by low platelet count, other blood cell changes
  • Anxiety, depression, tingling, confusion, dizziness, agitation, trembling, hallucinations and other nervous symptoms
  • Low blood pressure, inflammation of a vein (which may be associated with the formation of a blood clot)
  • Breathing difficulty, chest pain, fluid accumulation in the lungs
  • Low blood sugar, low blood potassium
  • Jaundice, redness of the skin
  • Swelling of the lips or face
  • Allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reaction following exposure to light or sun
  • Itchiness
  • Hair loss
  • Back pain
  • Kidney failure, blood in the urine, changes in blood tests of kidney function
  • Changes in blood tests of liver function
  • Inflammation of the gastrointestinal tract

Uncommon side effects (may affect up to 1 in 100 people) are:

  • Enlarged lymph glands (sometimes painful)
  • Increase in a type of white blood cell which may be associated with allergic reaction, disorder of blood clotting system
  • Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting
  • Depressed function of the adrenal gland
  • Problem with coordination
  • Swelling of the brain
  • Double vision pain and inflammation of the eyes and eyelids, involuntary movement of the eye
  • Decreased sensitivity to touch
  • Constipation, inflammation of upper small intestine, dyspepsia, pancreatitis, peritonitis
  • Gingivitis
  • Swelling and inflammation of the tongue
  • Enlarged liver, hepatitis, liver failure, gallbladder disease, gallstones
  • Joint pain
  • Inflammation of the kidney, proteins in the urine
  • Abnormal electrocardiogram (ECG)
  • Blood chemistry changes
  • Skin rash, which may lead to severe blistering and peeling of the skin
  • Swelling or inflammation of the skin, hives, skin redness and irritation

Rare side effects (may affect up to 1 in 1000 people) are:

  • Inability to sleep
  • Hearing difficulties, ringing in the ears
  • Abnormal sense of taste
  • Increase in muscle tone, muscle weakness caused by an abnormal immune system response
  • Abnormal brain function, Parkinson-like symptoms, convulsion, nerve injury resulting in numbness, pain, tingling or burning in the hands or feet.
  • Severe, persistent or bloody diarrhoea associated with abdominal pain or fever
  • Overactive or underactive thyroid gland
  • Damage to the optic nerve resulting in vision impairment, eye bleeding, abnormal eye movement, clouding of the cornea
  • Damage to the kidneys
  • Heart rhythm problems including very fast heartbeat and very slow heartbeat
  • Lymph infection, loss of consciousness due to liver failure

As Voriconazol Sandoz 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.

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 the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

Hoe bewaart u dit middel?

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 blister, carton and bottle after EXP. The expiry date refers to the last day of the month.

This medicinal product 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 to protect the environment.

Anvullende Informatie

What Voriconazol Sandoz contains

  • The active substance is voriconazole. Each tablet contains either 50 mg voriconazole (for Voriconazol Sandoz 50 mg film-coated tablets) or 200 mg voriconazole (for Voriconazol Sandoz 200 mg film-coated tablets).
  • The other ingredients are Lactose Monohydrate, Pregelatinised Maize Starch, Croscarmellose sodium, Povidone (, Magnesium stearate (which make up the tablet core) andhypromellulose (E464), Lactose Monohydrate, Titanium Dioxide (E171) and Triacetin (which makes up the film-coat).

What Voriconazol Sandoz looks like and contents of the pack

[Voriconazol Sandoz 50 mg]:

White to off-white, round, biconvex, film coated tablets with ‘50’ debossed on one side and plain on other side

[Voriconazol Sandoz 200 mg]:

White to off-white, biconvex, capsule shaped film coated tablets with ‘200’ debossed on one side and plain on other side

PVC/PVDC/Al blister

Pack sizes (blister): 2, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 500, or 1000 film-coated tablets

HDPE bottle with a child-resistant screw cap

Pack sizes (bottle): 30, 50, 56 or 100 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

Nederland

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Duitsland

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana Slovenië

LEK S.A.

ul. Domaniewska 50 C 02-672 Warschau Polen

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A

RO-540472 Targu-Mures

Roemenië

In het Register ingeschreven onder:

RVG 111735

RVG 111736

<This medicinal product is authorised in the Member States of the EEA under the following names:>

Nederland Voriconazol Sandoz 50 mg,
  filmomhulde tabletten
  Voriconazol Sandoz 200 mg,
  filmomhulde tabletten
Oostenrijk Voriconazol Sandoz 50 mg –
  Filmtabletten
  Voriconazol Sandoz 200 mg –
  Filmtabletten
België Voriconazol Sandoz 50 mg filmomhulde
  tabletten
  Voriconazol Sandoz 200 mg
  filmomhulde tabletten
Tsjechië Vorikonazol Sandoz 200 mg
Denemarken Voriconazole Sandoz
Estland Voriconazole Sandoz
Finland Voriconazole Sandoz
Frankrijk Voriconazole Sandoz 50 mg, comprimé
  pelliculé
  Voriconazole Sandoz 200 mg,
  comprimé pelliculé
Ierland Voriconazole Rowex 50 mg Film-
  Coated Tablets
  Voriconazole Rowex 200 mg Film-
  Coated Tablets
Italië Voriconazolo Sandoz
Luxemburg Voriconazol Sandoz 50 mg comprimés
  pelliculés
  Voriconazol Sandoz 200 mg
  comprimés pelliculés
Noorwegen Voriconazole Sandoz
Polen Voriconazole Sandoz
Portugal Voriconazol Sandoz
Roemenië Voriconazol Sandoz 50 mg
  comprimate filmate
  Voriconazol Sandoz 200 mg
  comprimate filmate
Slowakijke Vorikonazol Sandoz 50 mg
  filmomobalené tablety
  Vorikonazol Sandoz 200 mg filmom
  obalené tablety
Spanje Voriconazol Sandoz 50 mg
  comprimidos recubiertos con película
  EFG
  Voriconazol Sandoz 200 mg
  comprimidos recubiertos con película
Zweden Voriconazole Sandoz

Deze bijsluiter is voor het laatst goedgekeurd in juni 2013

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