Package leaflet: Information for the user Voriconazole Glenmark 50 mg & 200 mg Film-coated Tablets

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 or pharmacist.

•    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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Voriconazole Glenmark is and what it is used for

2.    What you need to know before you take Voriconazole Glenmark

3.    How to take Voriconazole Glenmark

4.    Possible side effects

5.    How to store Voriconazole Glenmark

6.    Contents of the pack and other information

1. What Voriconazole Glenmark is and what it is used for

Voriconazole Glenmark contains the active substance voriconazole.Voriconazole Glenmark 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 Glenmark is intended for patients with worsening, possibly life threatening fungal infections.

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

2. What you need to know before you take Voriconazole Glenmark

Do not take Voriconazole Glenmark

•    If you are allergic to voriconazole or any of the other ingredients of this medicine (listed in section 6)

•    If you are taking certain other medicines - see “Other medicines and Voriconazole Glenmark”

Voriconazole Glenmark must not be taken if you are already taking any of the following medicines:

•    Terfenadine (used for allergy)

•    Astemizole (used for allergy)

•    Carbamazepine (used to treat seizures)

•    Cisapride (used for stomach problems)

•    Pimozide (used for treating mental illness)

•    Quinidine (used for irregular heart beat)

•    Rifampicin (used for treating tuberculosis)

•    Phenobarbital (used for severe insomnia and seizures)

•    Ergot alkaloids (e.g. ergotamine, dihydroergotamine; used for migraine)

•    Sirolimus (used in transplant patients)

•    Ritonavir (for treating HIV) in doses of 400 mg and more twice daily

•    St John’s Wort (herbal supplement)

•    Efavirenz (used for treating HIV) in doses of 400 mg and above once daily

Warnings and precautions

Talk to your doctor or pharmacist before taking Voriconazole Glenmark:

•    If you have ever had an allergic reaction to any similar medicines (e.g. ketoconazole, fluconazole).

•    If you are suffering from, or have ever suffered from liver disease. Your doctor may prescribe a lower dose and monitor your liver function by doing blood tests.

•    If you have any of the following heart problems: cardiomyopathy, irregular heartbeat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome’.

You should avoid sunlight and sun exposure while being treated. You should cover exposed areas of skin and use sunscreen, as this medicine can increase sensitivity of skin to the sun’s UV rays. These precautions are also applicable to children.

While being treated with Voriconazole Glenmark:

•    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 Glenmark.

While being treated with Voriconazole Glenmark your doctor will monitor the function of your liver and kidney by doing blood tests.

Children and adolescents

Voriconazole Glenmark should not be given to children younger than 2 years of age.

Other medicines and Voriconazole Glenmark

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 Glenmark, may affect the way Voriconazole Glenmark works or Voriconazole Glenmark may affect the way they work.

Tell your doctor if you are taking any of the following medicine, as treatment with Voriconazole Glenmark 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 Glenmark 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 Glenmark 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 Glenmark 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 (for treating ulcers)

•    Oral contraceptives (if you take Voriconazole Glenmark whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders)

•    Vinca alkaloids (e.g. vincristine and vinblastine) (used to treat 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 Glenmark)

•    Methadone (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) (for treating pain and inflammation)

•    Fluconazole (for fungal infections)

•    Everolimus (for treating advanced kidney cancer and in transplant patients)

Pregnancy, breast-feeding and fertility

Voriconazole Glenmark must not be taken during pregnancy, unless your doctor tells you to. Women of childbearing age should take effective contraception. Contact your doctor immediately if you become pregnant while taking these tablets.

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

Driving and using machines:

Voriconazole may cause blurred vision or uncomfortable sensitivity to light. If you are affected, do not drive or operate any tools or machines and contact your doctor.

Voriconazole Glenmark 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.

3. How to take Voriconazole Glenmark

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

Your doctor will determine your dose depending on your weight and the type of infection you have.

The doctor may decide to decrease the dose if you have mild to moderate liver disease.

Tablets must only be given if the child is able to swallow tablets.

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

If you forget to take Voriconazole Glenmark

It is important to take Voriconazole Glenmark tablets regularly at the same time of 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 Glenmark 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 Glenmark correctly, as described above Continue taking Voriconazole Glenmark until your doctor tells you to stop, Do not stop treatment 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 Glenmark 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.

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 Glenmark and see a doctor immediately if you have:

•    Jaundice (yellowing of the skin and whites of the eyes)

•    Pancreatitis (abdominal pain)

•    Rash

Other side effects:

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

•    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)

•    Flu-like symptoms, inflammation of the sinuses, 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

•    Sunburn or 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)

•    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

•    Abnormal sense of taste

•    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, increase in muscle tone

•    Inflammation of the kidney, proteins in the urine

•    Abnormal electrocardiogram (ECG)

•    Blood chemistry changes

•    Skin rashes, which may lead to severe blistering and peeling of the skin

•    Swelling or inflammation of the skin, hives, skin redness and irritation

•    Low sodium in the blood

Rare side effects (may affect up to 1 in 1,000 people)

•    Inability to sleep

•    Hearing difficulties, ringing in the ears

•    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

•    Lymph infection, loss of consciousness due to liver failure

As Voriconazole Glenmark 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 Yellow Card SchemeWebsite: www.mhra. gov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Voriconazole Glenmark

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 waste water 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 Glenmark contains

•    The active substance is voriconazole. Each tablet contains either 50 mg or 200 mg voriconazole

•    The other ingredients are Lactose monohydrate, Maize Starch, Croscarmellose sodium, Povidone, Talc and Magnesium stearate which make up the tablet core and Hypromellose, Titanium dioxide (E171), Lactose monohydrate and Triacetin which make up the film-coat.

What Voriconazole Glenmark looks like and contents of the pack

50 mg film-coated tablets: white to off white circular biconvex film-coated tablets, debossed with ‘73’ on one side and G on other side.

200 mg film-coated tablets: white to off white oval film-coated tablets, debossed with ‘573’ on one side and G on other side.

The tablets are available in PVC/PVdC hard tempered Aluminium blister pack in cartons of 1, 20, 28, 30, 50, 56 and 100.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Glenmark Pharmaceuticals Europe Limited Laxmi House, 2B Draycott Avenue,

Harrow, Middlesex United Kingdom

Manufacturer

Glenmark Pharmaceuticals s.r.o.

Fibichova 143,566 17 Vysoke Myto,

Czech Republic

Glenmark Pharmaceuticals Europe Limited Building 2, Croxley Green Business Park Croxley Green Hertfordshire, WD18 8YA United Kingdom

This leaflet was last revised in 07/2014.

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