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Fluconazole 50 Mg Capsules

Document: leaflet MAH GENERIC_PL 00289-0399 change

TEVA UK Ref: 231-30-62020-Z LEA FLUCONAZOLE CAPS A/S TUK Version: 3 28 April 2016

UK

Dimensions:

Length: 323 mm Width: 320 mm folded to 160 mm

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^ BLACK [

Origination

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•    tiredness, general feeling of being unwell, fever.

Rare: 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)

•    low blood potassium

•    shaking

•    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, 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.

r5 How to store Fluconazole


Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised in April 2016

PL 00289/0399 and 0402


Keep this medicine out of the sight and reach of children.


Do not store above 30°C. Do not transfer the capsules to another container.

Do not use Fluconazole after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.


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 protect the environment.

©Contents of the pack and other information


What Fluconazole capsules contain:

•    The active ingredient is fluconazole 50 mg or 200 mg.

•    The other ingredients are lactose monohydrate, maize starch, colloidal anhydrous silica, sodium laurilsulfate and magnesium stearate. The capsule shell contains gelatin and the following colours:

•    50 mg capsules: titanium dioxide (E171) and brilliant blue (E133)

•    200 mg capsules: titanium dioxide (E171), azorubine (E122) and brilliant blue (E133).

What Fluconazole capsules look like and contents of the pack:

•    Fluconazole 50 mg are hard gelatin capsules filled with white to yellowish white homogeneous powder, with a light blue opaque cap and white opaque body.

•    Fluconazole 200 mg are hard gelatin capsules filled with white to yellowish white homogeneous powder, with a purple opaque cap and white opaque body.

•    The 50 and 200 mg capsules are available in pack sizes of 7, 10, 20, 30, 50, and 100 capsules.

Not all pack sizes may be marketed.


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TEVA UK LIMITED    320 x 323


Fluconazole 50 mg and 200 mg capsules


Package leaflet: Information for the user


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


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.


©


What you need to know before you take Fluconazole


What is in this leaflet


1.    What Fluconazole is and what it is used for

2.    What you need to know before you take Fluconazole

3.    How to take Fluconazole

4.    Possible side effects

5.    How to store Fluconazole

6.    Contents of the pack and other information

OWhat Fluconazole is and what it is used for

Fluconazole is one of a group of medicines called "antifungals" The active substance is fluconazole.

Fluconazole 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 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

• 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.


Do not take Fluconazole:

•    if you are allergic to Fluconazole or any of the other ingredients of this medicine (listed in section 6)..

•    if you are allergic to any other medicines you have taken to treat fungal infections.

•    if you are taking astemizole, terfenadine (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 for treating heart arrhythmia)

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

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

Warnings and precautions

Talk to your doctor or pharmacist before

taking Fluconazole

•    if you have kidney or liver 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 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) amiodarone (used for treating uneven heartbeats 'arrhythmias') as these should not be taken with Fluconazole (see "Do not take Fluconazole").

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

•    rifampicin or rifabutin (antibiotics for infections)

•    alfentanil, fentanyl (used as anaesthetic)

•    amitriptyline, nortriptyline (used as anti-depressant)

•    amphotericin B, voriconazole (anti-fungal)

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

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

•    carbamazepine, phenytoin (used for treating fits)

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

Peel HereTo Open


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TEVA UK Ref: 231-30-62020-Z LEA FLUCONAZOLE CAPS A/S TUK Version: 3 28 April 2016

UK

Dimensions:

Length: 323 mm Width: 320 mm folded to 160 mm

Colours Used: ^mntone©greenC^

^ BLACK [

Originttton

1—Templ^—1

PAGE 2: LEFT HAND INSIDE FACE AFTER FOLDING AND TACKING

LINE. PAGE 3: RIGHT HAND INSIDE FACE AFTER FOLDING AND TACKING

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

•    cyclosphosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for treating cancer

•    halofantrine (used for treating malaria)

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

•    methadone (used for pain)

•    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)

•    hydrochlorothiazide (a 'water pill').

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Fluconazole with food and drink

You can take your medicine with or without a meal.

Pregnancy and breast-feeding and fertility

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.

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

Ask your doctor or pharmacist for advice before taking any medicines.

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 and E122 (Azorubine)

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

•    The 200 mg capsules also contain E122 (Azorubine), which can cause an allergic-type reaction, including asthma. This reaction is more common in those people who are allergic to aspirin.

T3 How to take Fluconazole

Always take this medicine exactly as your doctor has told you. 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 different infections are 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

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 and denture sore mouth

100 mg to 200 mg once daily, or 200 mg 3 times a week, while you are at risk of getting an infection

To treat genital thrush

150 mg as a single dose

To reduce recurrence of vaginal thrush

150 mg every third day for a total of 3 doses (day 1, 4 and 7) and then once a week for 6 months while you are at risk of getting an infection

To treat fungal skin and nail infections

Depending on the site of the infection 50 mg once daily, 150 mg once weekly, 300 to 400 mg once weekly for 1 to 4 weeks (Athlete's foot may be up to 6 weeks, for nail infection treatment until infected nail is replaced)

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


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 the 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 and adolescents

Adolescents from 12 to 17 years old

Follow the dose prescribed by your doctor (either adults or children dosage).

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.

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.

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.

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 recommended adult dose should be taken unless you have kidney problems.

Patients with kidney problems

Your doctor may change 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 forget 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 stop taking Fluconazole

Do not stop treatment early, even if you start to feel better, because the original infection may still be present and recur if treatment is stopped. Take the full course.

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

^ Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

A few people develop allergic reactions although serious allergic reactions are rareIf you get any of the following symptoms,

tell your doctor immediately.

•    The symptoms may include itching, reddening of the skin, itchy red spots or difficulty in breathing.

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

•    swelling of eyelids, face or lips

•    skin rash

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

Fluconazole 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).

Fluconazole may affect your adrenal glands and the levels of steroid hormones produced.

The signs of adrenal problems include:

•    tiredness

•    muscle weakness

•    loss of appetite

•    weight loss

•    abdominal pain

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

Other side effects:

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

Common: may affect up to 1 in 10 people

•    headache

•    stomach discomfort, diarrhoea, feeling sick, vomiting

•    increase in blood tests of liver function

•    rash.

Uncommon: 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, pricking 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