AZOCAN 50 MG CAPSULES, FLUCONAZOLE 50 MG CAPSULES - patient leaflet, side effects, dosage

1. what fluconazole is and what it is used for

Fluconazole, the active ingredient, belongs to a group of medicines called anti-fungal agents and it is used to treat infections caused by fungi and may also be used to stop you from getting a candidal infection. The most common cause of fungal infections is 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

• – Genital thrush – infection of the vagina or penis

• – Skin infections – e.g. athlete's foot, ringworm, jock itch, nail infection

You might also be given Fluconazole to:

• – stop cryptococcal meningitis from coming back

• – stop mucosal thrush from coming back

• – reduce recurrence of vaginal thrush

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

2. what you need to know before you take fluconazole

Do not take Fluconazole if:

l You have ever had an allergic reaction to fluconazole, to 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.

l You are taking terfenadine or astemizole (antihistamine medicines for allergies), cisapride (used for stomach upsets), pimozide (used for treating mental illness), quinidine (used for treating heart arrhythmia) or erythromycin (an antibiotic for treating infections).

Warnings and precautions

Talk to your doctor or pharmacist before taking Fluconazole

l if you have any disease or illness affecting your liver or kidneys

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

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

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

l 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 Fluconazole

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

Tell your doctor immediately if 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 erythromycin (an antibiotic for treating infections) as these should not be taken with Fluconazole (see section: “Do not take Fluconazole if you”). There are some medicines that may interact with Fluconazole. Make sure your doctor knows if you are taking any of the following medicines:

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

l rifampicin, rifabutine (antibiotics for infections)

l medicines that thin the blood to prevent blood clots (Warfarin or similar medicines)

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

l olaparib (used for treating ovarian cancer)

l chlorpropamide, glibenclamide, glipizide or tolbutamide (used to control diabetes)

l phenytoin, carbamazepine (used for treating fits)

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

l theophylline (used to control asthma)

l tofacitinib (used for treating rheumatoid arthritis)

l zidovudine, also known as AZT, or saquinavir (used in HIV infected patients)

l prednisone (steroid)

l oral contraceptives

l alfentanil, fentanyl (used as anaesthesia)

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

l amitriptyline and nortriptyline (used as anti-depressant)

l amphotericin B, voriconazole (anti-fungal)

l cyclophosphamide and vinca alkaloids (vincristine, vinblastine or similar medicines) used for treating cancer

l halofantrine (used for treating malaria)

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

l vitamin A (nutritional supplement)

l methadone (used for pain)

l ivacaftor (used for treating cystic fibrosis)

l amiodarone (used for treating uneven heartbeats ‚arrhythmias‘)

l hydrochlorothiazide (a diuretic)

Fluconazole with food and drink

You may take the capsule with or without a meal.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not take Fluconazole while you are pregnant unless your doctor has told you to.

You can continue breast-feeding after taking a single dose of Fluconazole up to 150 mg. You should not breast-feed if you are taking a repeated dose of Fluconazole.

Driving and using machines

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

Fluconazole contains lactose (milk sugar) and sodium (salt)

This medicine contains a small amount of lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, such as lactose, please contact your doctor before taking this medicine.

Fluconazole capsules contain less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’

3. how to take fluconazole

Always take Fluconazole exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the capsule whole with a glass of water. It is best to take your capsules at the same time each day.

The recommended doses of this medicine for treatment of the different infections are as below:

Adults:

Condition	Dose
To treat cryptococcal meningitis	400 mg on the first day then 200 mg to 400 mg once daily for 6 to 8 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

Adolescents from 12 to 17 years old

Follow the dose prescribed by 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	Daily 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 once daily

Use in children 0 to 4 weeks of age

Use in children of 3 to 4 weeks of age:

The same dose as above but given once every 2 days. The maximum dose is 12 mg per kg of body weight every 48 hours.

Use in children less than 2 weeks old:

The same dose as above but given once every 3 days. The maximum dose is 12 mg per kg of body weight every 72 hours.

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 take more Fluconazole than you should

Taking too many capsules at once may make you unwell. Contact your doctor or your nearest hospital casualty department at once. The symptoms of a possible overdose may include hearing, seeing, feeling and thinking things that are not real (hallucination and paranoid behaviour). Symptomatic treatment (with supportive measures and gastric lavage if necessary) may be adequate.

If you forget to take Fluconazole

Do not take a double dose to make up for a forgotten dose. If you forgot to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the dose that you missed.

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

• 4. POSSIBLE SIDE-EFFECTS

Like all medicines Fluconazole may sometimes cause side-effects, although not everybody gets them.

A few people develop allergic reactions although serious allergic reactions are rare. if you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. If you get any of the following symptoms, tell your doctor immediately.

• 1 sudden wheeziness, difficulty breathing or tightness in the chest l swelling of the eyelids, face or lips

5. how to store fluconazole

l Keep out of the sight and reach of children.

l Do not store above 25o C.

l Do not use your medicine after the expiry date shown on the carton after EXP. The expiry date refers to the last day of the month.

Medicines should not be disposed of via 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 contains

Fluconazole 50mg Capsules contain 50mg fluconazole as the active ingredient.

Fluconazole 200mg Capsules contain 200mg fluconazole as the active ingredient.

The capsules also contain lactose, pregelatinised maize starch, sodium laurilsulfate, colloidal anhydrous silica, magnesium stearate and purified talc. The capsule shells also contain gelatin, sodium laurilsulfate, water and the colours brilliant blue (E133), titanium dioxide (E171) and erythrosine (E127).

What FLUCONAZOLE looks like and contents of pack

The 50mg capsules are blue and white and the 200mg capsules are violet and white.

Both the 50mg and 200mg capsules are supplied in packs containing 7 capsules.

Marketing Authorisation Holder and Manufacturer

FDC International Ltd, Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham, o

Hampshire, PO15 7FE

Hard to see or read the leaflet? Call+ 44(0) 1489 565222 f­or help.

This leaflet was last revised in February 2020.

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