Document: leaflet MAH GENERIC_PL 20395-0012 change

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• leaflet MAH GENERIC_PL 15413-0026
• leaflet MAH GENERIC_PL 20395-0012

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Read all ofthis leaflet carefully before you start taking this medicine because it contains important information foryou.

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

•    If you have any further questions, ask your doctor or 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Fluconazole Infusion is and what it is used for

2.    What you need to know before you use Fluconazole Infusion

3.    How to use Fluconazole Infusion

4.    Possible side effects

5.    How to store Fluconazole Infusion

6.    Contents of the pack and other information

1.    What Fluconazole Infusion is and what it is used for

Fluconazole Infusion is one of a group of medicines called anti-fungal agents. Fluconazole Infusion is used to treat infections caused by fungi/yeasts. It may also be used to stop you from getting a fungal infection. The most common cause offungal infections is yeast called Candida.

You may be given Fluconazole Infusion by your doctor to treat fungal infections such as:

-    Thrush of the mouth or throat (mucosal infections). Thrush is commonly caused by Candida.

-    Skin infections - e.g. athlete's foot, ring worm where local treatment has not worked.

-    Internal (systemic) fungal infections caused by Candida, e.g. infections ofthe blood stream, urinary tract or other body organs.

-    Internal (systemic) fungal infections caused by Cryptococcus, e.g.

Cryptococcal meningitis and infections of other sites such as the lungs and skin.

-    Genital Candida infections, e.g. vaginal thrush or candidal balanitis (inflammation of the end of the penis and/or foreskin).

You may also be given Fluconazole Infusion to:

-    Stop you from getting a fungal infection (if your immune system is not working properly).

-    Stop an infection caused by Cryptococcus from coming back (in AIDS patients).

2.    What you need to know before you use Fluconazole Infusion

Do not use Fluconazole Infusion:

•    If you have ever had an allergic reaction to any of the ingredients of Fluconazole Infusion (listed in section 6) or other medicines which you may have taken to treat a fungal infection.

•    If you are taking either terfenadine (an antihistamine), cisapride (used for stomach upsets) or pimozide (used in psychosis), Astemizole, quinidine or amiodarone or erythromycin (an antibiotic for treating infections).

Warnings and precautions

Talk to your doctor or pharmacist before taking these tablets:

•    If you have any liver problems as you may need to be monitored more closely.

•    If you have kidney problems as the dose may need to be adjusted.

•    If you have AIDS, as rarely, you can develop severe skin reactions.

•    If you have an unusual heartbeat or other heart problems.

•    If you are taking astemizole used to control your heartbeat or other medicines to control the heart beat.

•    If you have low potassium or magnesium in the blood.

Other medicines and Fluconazole Infusion

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular:

•    Terfenadine (antihistamines).

•    Cisapride (used for stomach upsets).

•    Astemizole (antiarrhythmic drug).

•    Hydrochlorothiazide (used to treat high blood pressure and fluid retention).

•    Rifampicin or rifabutin (antibiotics).

•    Warfarin or coumarin drugs (to prevent blood clots).

•    Phenytoin or carbamazepine (used to control epilepsy).

•    Benzodiazepines (used as tranquillizers).

•    Fluvastatin and atorvastatin (used to treat high cholesterol).

•    Nifedipine and amlodipine (calcium channel blockers), ACE inhibitors such as ramipril and angiotensin, blockers such as losartan (all ofwhich may be used to treat high blood pressure).

•    Oral sulphonylureas such as chlorpropamide, glibenclamide, glipizide or tolbutamide (to control diabetes).

•    Celecoxib (used to treat arthritis).

•    Didanosine, trimetrexate and (chemotherapy agents).

•    Ciclosporin, tacrolimus and prednisone (immunosuppressants).

•    The oral contraceptive.

•    Amitriptyline and nortriptyline (antidepressants).

•    Theophylline (used to control asthma).

•    Amphotericin B (used to treat serious fungal infections).

•    Pimozide.

•    Erythromycin (an antibiotic used for treating infection).

•    Alfentanil, fentanyl or methadone (for treating pain).

•    Azythromycin.

•    Saquinavir or zidovudine, also known as AZT (used in HIV-infected patients).

•    Halofantrine (to treat malaria).

•    Non-steroidal anti-inflammatory drugs (such as aspirin and ibuprofen) that are used to treat pain and fever.

•    Sirolimus and everolimus used to treat certain types of cancer.

•    Vitamin A (as a trans-retinoid acid used to treat acne).

•    Cyclophosphamide, prednisoneorvinca alkaloids (for treating some forms of leukaemia).

•    Quinidine used to treat abnormal heart rythmns

•    Voriconazole used to treat fungal infections.

Pregnancy and Breast-feeding:

Tell your doctor if you are, you think you might be or are planning to become pregnant.

Do not use Fluconazole Infusion if you are pregnant or if you are breast-feeding.

Driving and using machines:

Treatmentwith Fluconazole Infusion has occasionally lead to dizziness or seizures to occur and could affect your ability to drive or use machinery.

3. How to use Fluconazole Infusion

Always use Fluconazole Infusion exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

This medicine is given by your doctor or nurse as an intravenous infusion over approximately 30 minutes.

Fluconazole Infusion is supplied as a solution. It is unnecessary to dilute it further. This medicine should not be mixed with any other drug before infusion.

Duration of treatment will depend on the type and severity of infection being treated and how well you respond to the treatment.

If you are not sure why you are being given Fluconazole Infusion, ask your doctor or the nurse.

The usual doses of Fluconazole Infusion for different infections are given below:

Adult

•    Thrush infections of mouth and throat:

The usual dose is 50 mg (25ml) once daily for 7-14 days.

•    Vaginal thrush infections: Asingledose of150 mg (75ml).

•    Mucosal thrush (dose depends on where the infection is located): 50mg once daily for 7-14 days or 14-30 days. Sometimes doses are increased to 100 mg.

•    Candidaemia(lnternalthrush): A single dose of400 mg (200ml) on the first day followed by a daily dose of 200 mg (100ml).

•    To prevent thrush infections in patients with a poor immune system due to low numbers ofwhite blood cells (neutropenic patients): 50-400 mg (25200ml) once daily depending on your risk ofinfection.

•    To treat crytococcal meningitis in patients with a poor immune system: A

single dose 400 mg (200ml) on the first day followed by a daily of 200-400 mg (100-200ml) for6-8 weeks. To prevent repeat infection a daily dose of 100-200 mg (50-100 ml) is recommended.

•    Fungal skin infections: 50mg (25 ml) once daily for 2-4 weeks. Athlete's foot may need up to 6 weeks treatment.

Children

Use of Fluconazole for treating genital Candida infections in children under 16 years old is not recommended.

4 weeks to 15years old

The maximum daily dose for children is 400 mg. For children over 4 weeks old, the dose is based on their body weight.

•    For infections of the body surfaces 3mg for every kg of body weight daily. The first dose may sometimes be 6 mg per kg.

•    For treatment of infections that have invaded the body and for cryptococcal meningitis, a dose of6-12 mg per kg of body weight daily.

•    For prevention of infection in children with a poor immune system, due to low numbers ofwhite blood cells (neutropenic patients): a dose of3-12 mg per kg daily, depending on the severity of the neutropenia.

2- 4 weeks old

The maximum daily dose for infants 2 - 4 weeks is12mg per kg of body weight every 2 days. The dosage is the same as for children but to be given once every 2 days.

Less than 2 weeks old

The maximum daily dose for infants 2 - 4 weeks is12mg per kg of body weight every 3 days. The dosage is the same as for children but to be given once every 3 days.

Elderly

The usual adult dose should be given unless you have kidney problems.

Patients with kidney problems

Your doctor may modify your dose, depending on your kidney function. If you are on dialysis the recommended doses detailed above can be given after dialysis. If you have poor kidney function but are not on dialysis then the dose will be halved if appropriate.

If you are unsure about the dose being given ask your doctor or nurse to explain.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If any of the following symptoms occur soon after receiving the infusion, tell your nurse or doctor immediately. This kind of reaction is rare and may mean you are suffering from an allergic reaction to the infusion:

•    Swelling of the face, lips tongue or throat, or difficulty breathing or swallowing.

•    Severe skin reactions such as large fluid filled blisters, ulceration in the mouth and throat, around the anus and genital region. These symptoms are usually accompanied by sickness, headache and fever.

•    If you are an AIDS patient you are more likely to get severe skin reactions to drugs including Fluconazole infusion.

Common (between 1in10 and 1 in 100):

•    Nausea

•    Stomach pain

•    Diarrhoea

•    Headache

•    Skin rashes

•    Vomiting

Uncommon (between 1 in 100 and 1 in 1000):

•    Insomnia (difficulty in sleeping)

•    Somnolence (feeling sleepy)

•    Seizures

•    Dizziness

•    Parathesia (sensation oftingling, burning)

•    Altered sense of taste

•    Vertigo

•    Stomach upset

•    Flatulence

•    Dry mouth

•    Changes in the number of red blood cells (anaemia)

•    Decreased appetite

•    Constipation

•    Yellowing of skin and eyes (Jaundice)

•    Myalgia (muscle pain)

•    Decreased potassium levels in blood

•    Fever

•    Fatigue.

Rare (less than 1 in 1000 patients):

•    Decrease in the number of white blood cells and decrease in the number of platelets which may make you more prone to infections.

•    Anaphylaxis.

•    High blood levels offats and cholesterol.

•    Change in heart rate or rhythm.

•    Liver damage.

•    Tremors.

•    Alopecia.

Reporting of side effects

If you get any side effects, talk to your doctor or 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 at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Fluconazole Infusion

Keep out of the sight and reach of children.

Do not use after the expiry date stated on the label.

The expiry date refers to the last day of that month.

Medicines should not be disposed ofvia wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Contents of the pack and other information

What Fluconazole Infusion contains

The active substance is fluconazole. Fluconazole 2mg/ml Intravenous Infusion contains 2mg per ml of solution for infusion. The other ingredients are sodium chloride and waterfor injection.

What Fluconazole Infusion looks like and contents ofthe pack

Fluconazole Infusion is packed in glass vials of 50, 100 and 200ml with a rubber stopper and aluminium overseal.

The 50ml bottle contains 100mg of Fluconazole, the 100ml bottle contains 200mg Fluconazole and the 200 ml bottle contains 400 mg of Fluconazole.

Marketing Authorisation Holder

Relonchem Limited,

27 Old Gloucester Street, London WC1 3XX. Manufacturer

Slovakofarm a.s., Mediprodukt Lipany, Slovak Republic.

This leaflet was last revised in October 2015.

PL 20395/0012