Document: Fluconazol Pharmathen solution for infusion, Marknadsförs ej för närvarande, ENG PL change

• Fluconazol Pharmathen solution for infusion, maräknadsförs ej för närvaradne, PL
• Fluconazol Pharmathen solution for infusion, Marknadsförs ej för närvarande, ENG PL

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Package leaflet: Information for the user

Fluconazol Pharmathen 2 mg/ml Solution for Infusion

Fluconazole

Read all of this leaflet carefully before you start using 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 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 ilness are the same as yours.

What is in this leaflet

1. What Fluconazol Pharmathen is and what it is used for

2. What you need to know before you take Fluconazol Pharmathen

3. How to take Fluconazol Pharmathen

4. Possible side effects

5. How to store Fluconazol Pharmathen

6. Contents of the pack and other information

Fluconazol Pharmathen is one of a group of medicines called “antifungals”. The active substance is fluconazole.

Fluconazol Pharmathen isused to treat infections caused by fungi and may also be used to stop you from getting candidal infection. The most common cause of fungal infection is a yeast called Candida.

Adults

You might be given this medicine by your doctor to treat the following types of fungal infections:

• Cryptococcal meningitis – a fungal infection in the brain

• Coccidioidomycosis – a disease of the bronchopulmonary system

• Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs) or urinary tract

• Mucosal thrush – infection affecting the lining of the mouth, throat and denture sore mouth

You might also be given Fluconazol Pharmathen to:

• stop cryptococcal meningitis from coming back

• stop mucosal thrush from coming back

• stop you from getting an infection caused by Candida (if your immune system is weak and not working properly)

Childrens and adolescents (0 to 17 years old)

You might be given this medicine by your doctor to treat the following types of fungal infections:

• Mucosal thrush – infection affecting the lining of the mouth, throat

• Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs) or urinary tract

• Cryptococcal meningitis – a fungal infection in the brain

You might also be given Fluconazol Pharmathen to:

• stop you from getting an infection caused by Candida (if your immune system is weak and not working properly)

• stop cryptococcal meningitis from coming back

Do not take Fluconazol Pharmathen:

• if you are allergic to fluconazole or other medicines you have taken to treat fungal infections or to any of the other ingredients of this medicine (listed in section 6). The symptoms may include itching, reddening of the skin or difficulty in breathing

• if you are taking astemizole, terfernadine (antihistamine medicines for allergies)

• if you are taking cisapride (used for stomach upsets)

• if you are taking pimozide (used for treating mental illness)

• if you are taking quinidine (used to control problems with your heart arrhythmia)

• if you are taking erythromycin (an antibiotic for treating infections)

Warnings and precautions

Talk to your doctor or nurse before taking Fluconazol Pharmathen:

• if you have liver or kidney problems

• if you suffer from heart disease, including heart rhythm problems

• if you have abnormal levels of potassium, calcium or magnesium in your blood

• if you develop severe skin reactions (itching, reddening of the skin or difficulty in breathing)

• if you develop signs of ‘adrenal insufficiency’ where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic, or long lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).

Other medicines and Fluconazol Pharmathen

Tell your doctor immediatelyif you are taking astemizole, terfenadine (an antihistamine for treating allergies) or cisapride (used for stomach upsets) or pimozide (used for treating mental illness) or quinidine (used for treating heart arrhythmia) or amiodarone or erythromycin (an antibiotic for treating infections) as these should not be taken with Fluconazol Pharmathen (see section: “Do not take Fluconazol Pharmathen if you”).

There are some medicines that may interact with Fluconazol Pharmathen. Make sure your doctor knows if you are taking any of the following medicines:

• alfentanil, fentanyl (used as anaesthetic)

• amitriptyline or nortriptyline (used as an anti-depressant)

• amphotericin B, voriconazole (anti-fungal)

• medicines that thin the blood to prevent blood clots (warfarin, indanedione or similar medicines)

• benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety

• carbamazepine , phenytoin (used for treating fits)

• if you are taking amiodarone (used for treating uneven heartbeats)

• hydrochlorothiazide (used as a diuretic)

• nifedipine, isradipine, amlodipine, felodipine and losartan (for hypertension - high blood pressure)

• ciclosporin, everolimus, sirolimus or tacrolimus (to prevent transplant rejection)

• halofantrine (used for treating malaria)

• statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used for reducing high cholesterol levels

• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs (NSAID))

• oral contraceptives

• prednisone (steroid)

• zidovudine, also known as AZT; saquinavir (used in HIV-infected patients)

• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide

• theophylline (used to control asthma)

• Vitamin A (nutritional supplement)

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

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.

Driving and using machines

When driving vehicles or using machines it should be taken into account that occasionally dizziness or fits may occur.

Important information about some of the ingredients of Fluconazol Pharmathen

Fluconazol Pharmathen contains 0.154 mmol sodium per ml. To be taken into consideration by patients on a controlled sodium diet.

3. How to take Fluconazol Pharmathen

This medicine will be given by your doctor or nurse as a slow injection (infusion) into your vein. Fluconazol Pharmathen is supplied as a solution. It will not be diluted further.

The usual doses of this medicine for different indications are below. Check with your doctor or nurse if you are not sure why you are being given Fluconazol Pharmathen.

Adults:

Condition	Dose
To treat cryptococcal meningitis	400 mg on the first day then 200 mg to 400 mg once daily for 6 to8 weeks or longer if needed. Sometimes doses are increased up to 800 mg.
To stop cryptococcal meningitis from coming back	200 mg once daily until you are told to stop.
To treat coccidioidomycosis	200 mg to 400 mg once daily from 11 months for up to 24 months or longer if needed. Sometimes doses are increased up to 800 mg.
To treat internal fungal infections caused by Candida	800 mg on the first day then 400 mg once daily until you are told to stop
To treat mucosal infections affecting the lining of mouth, throat and denture sore mouth	200 mg to 400 mg on the first day then 100 mg to 200 mg until you are told to stop.
To treat mucosal thrush – dose depends on where the infection is located	50 mg to 400 mg once daily for 7 to 30 days until you are told to stop.
To stop mucosal infections affecting the lining of mouth, throat	100 mg to 200 mg once daily, or 200 mg 3 times a week, while you are at risk of getting an infection.
To stop you from getting an infection caused by Candida (if your immune system is weak and not working properly	200 mg to 400 mg once daily while you are at risk of getting an infection.

Adolescents from 12 to 17 years old

Follow the dose prescribedby your doctor (either adults or children posology).

Children to 11 years old

The maximum dose for children is 400 mg daily.

The dose will be based on the child’s weight in kilograms.

Condition	Dose
Mucosal thrush and throat infections caused by Candida – dose and duration depends on the severity of the infection and on where the infection is located	3 mg per kg of body weight (6 mg per kg of body weight might be given on the first day).
Cryptococcal meningitis or internal fungal infections caused by Candida	6 mg to 12 mg per kg of body weight.
To stop children from getting an infection caused by Candida (if their immune system is not working properly)	3 mg to 12 mg per kg of body weight.

Use in children 0 to 4 weeks of age

Use in children of 3 to 4 weeks of age:

Use in children less than 2 weeks old:

Doctors sometimes prescribe different doses to these. Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Elderly

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

Patients with kidney problems

Your doctor may change your dose, depending on your kidney function.

If you take more Fluconazol Pharmathen than you should

If you are concerned that you may have been given too much Fluconazol Pharmathen, tell your doctor or nurse immediately. The symptoms of a possible overdose may include hearing, seeing, feeling and thinking things are not real (hallucination and paranoid behaviour).

If you forget to take Fluconazol Pharmathen

As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed. However tell your doctor or pharmacist if you think that a dose has been forgotten.

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.

A few people developallergic reactions although serious allergic reactions are rare. If you get any of the following symptoms,tell your doctor immediately:

• sudden wheezing, difficulty in breathing or tightness in the chest

• swelling of eyelids, face or lips

• itching all over the body reddening of the skin or itchy red spots

• skin rash

• severe skin reactions such as a rash that causes blistering (this can affect the mouth and tongue).

Fluconazol Pharmathen may affect your liver. The signs of liver problems include:

• tiredness

• loss of appetite

• vomiting

• yellowing of your skin or the whites of your eyes (jaundice)

If any of these happen, stop taking Fluconazol Pharmathen and tell your doctor immediately.

Other side effects:

Additionally, if any of the followingside effects gets serious, or if you notice anyside effects not listed in this leaflet, please tell your doctor or pharmacist.

Commonside effects may affect up to 1 in 10 people

• headache

• stomach discomfort, diarrhoea, feeling sick, vomiting

• increases in blood tests of liver function

• rash

Uncommonside effects may affect up to 1 in 100 people

• reduction in red blood cells which can make skin pale and cause weakness or breathlessness

• decreased appetite

• inability to sleep, feeling drowsy

• fit, dizziness, sensation of spinning, tingling, prickling or numbness, changes in sense of taste

• constipation, difficult digestion, wind, dry mouth

• muscle pain

• liver damage and yellowing of the skin and eyes (jaundice)

• wheals, blistering (hives), itching, increased sweating

• tiredness, general feeling of being unwell, fever

Rareside effects may affect up to 1 in 1,000 people

• lower than normal white blood cells that help defend against infections and blood cells that help to stop bleeding

• red or purple discoloration of the skin which may be caused by low platelet count, other blood cell changes

• blood chemistry changes (high blood levels of cholesterol, fats)

• shaking

• low blood potassium

• abnormal electrocardiogram (ECG), change in heart rate or rhythm

• liver failure

• allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of the lips or face

• hair loss

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. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fluconazol Pharmathen

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 expiry date refers to the last day of the month.

Do not throw away any medicines via wastewater or household waste. Ask the doctor or nurse 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 Fluconazol Pharmathen solution for infusion contains

The active substance is fluconazole.

Each ml of solution for injection contains 2 mg of fluconazole. Equivalent to 50 mg per 25 ml, 100 mg per 50 ml, 200 mg per 100 ml and 400 mg per 200 ml.

The other ingredients are: sodium hydroxide, sodium chloride, hydrochloric acid and water for injection.

What Fluconazol Pharmathen solution for infusion looks like and contents of the pack

Fluconazol Pharmathen is a clear, colourless solution with no visible particles.

It comes in glass vials with a rubber stopper and an aluminium cap, containing 25 ml, 50 ml, 100 ml or 200 ml of solution for infusion.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Pharmathen S.A.

6 Dervenakion str.,

15351 Pallini, Attica,

Greece

Manufacturer:

Pharmathen S.A.

Dervenakion 6

Pallini 15351

Greece

This leaflet was last revised in 2016-03-22