FLUCONAZOLE 50 MG / 5ML POWDER FOR ORAL SUSPENSION - patient leaflet, side effects, dosage

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. this includes any possible side effects not listed in this leaflet. see section 4. -

What is in this leaflet

• 1. What Fluconazole 50mg/5ml Suspension is and what it is used for

• 2. What you need to know before you take Fluconazole 50mg/5ml Suspension

• 3. How to take Fluconazole 50mg/5ml Suspension

• 4. Possible side-effects

• 5. How to store Fluconazole 50mg/5ml Suspension

• 6. Contents of the pack and other information

1. what fluconazole 50mg/5ml suspension is and what it is used for

The name of this product is Fluconazole 50mg/5ml Powder for Oral Suspension.

It will be referred to as Fluconazole 50mg/5ml Suspension in this leaflet.

The active ingredient in Fluconazole 50mg/5ml Suspension is fluconazole.

Fluconazole belongs to a group of medicinal products called “antifungals”. Fluconazole is used to treat infections caused by fungi and may also be used to stop you from getting a candida 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

• 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
• Cryptococcal meningitis – a fungal infection in the brain
• Coccidioidomycosis – a disease of the bronchopulmona­ry system
• 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 (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:

• Infections caused by Candida (candidiasis) 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
• 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 50mg/5ml suspension

Do not take Fluconazole 50mg/5ml Suspension:

• if you are allergic (hypersensitive) to fluconazole, to other medicines you have taken to treat fungal infections or to any of the components of Fluconazole 50mg/5ml Suspension (listed in section 6). The symptoms may include itching, reddening of the skin or difficulty breathing
• if you are taking cisapride (used for stomach upsets)
• if you are taking astemizole, terfenadine (antihistamine medicines for allergies)
• if you are taking pimozide (used for treating mental illness)
• if you are taking quinidine (used to treat heart arrhythmia)
• if you are taking erythromycin (an antibiotic for treating infections)

Warnings and precautions

• 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 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)
• if you develop severe skin reactions (itching, reddening of the skin or difficulty in breathing)
• if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking fluconazole
• if you have an intolerance to sugars, as this product contains 2.88g of sucrose per 5ml
• if the fungal infection does not improve, as alternative antifungal therapy may be needed.

Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with fluconazole treatment. Stop taking this medicine and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Children and adolescents

• This medicine contains 14.8mg sodium benzoate in each 5ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

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 50mg/5ml Suspension:”)

There are some medicines that may interact with Fluconazole 50mg/5ml

Suspension. 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, lorazepamor similar medicines) used to help you sleep or for anxiety
• carbamazepine, phenytoin (used for treating fits)
• nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (for hypertension-high blood pressure)
• hydrochlorothiazide (a diuretic drug, i.e. it increases the amount of urine produced by the kidneys, used to treat hypertension).
• 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 (NonSteroidal 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)
• ivacaftor (used for treating cystic fibrosis)
• amiodarone (used for treating uneven heartbeats ‚arrhythmias‘).
• olaparib (used for treating ovarian cancer)
• tofacitinib (used for treating rheumatoid arthritis)

Fluconazole 50mg/5ml Suspension with food and drink

Fluconazole 50mg/5ml Suspension can be taken with or without food.

Pregnancy, 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.

Pregnancy

You should not take this medicine if you are pregnant, think you may be pregnant, are trying to become pregnant or breast-feeding, unless your doctor has told you so.

Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken at low doses during the first trimester may slightly increase the risk of a baby being born with birth defects affecting the bones and/or muscles.Breast-feeding

You can continue breast-feeding after taking a single dose of 150mg Fluconazole. 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.

Important information about some of the ingredients of Fluconazole 50mg/5ml Suspension

• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product
• This drug contains 2.88g/5ml of sucrose. This should be taken into account in patients with diabetes mellitus
• May be harmful to teeth if used for a period longer than 2 weeks
• This medicine contains less than 1mmol sodium (23mg) per 5ml, that is to say essentially ‘sodium-free’.

3. how to take fluconazole 50mg/5ml suspension

Always take Fluconazole 50mg/5ml Suspension exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.

It is best to take medicine at the same time each day.

The recommended doses of this medicine for different infections are below.

Adults

To treat genital thrush : a single dose of 150mg.

To treat mucosal infections affecting the lining of the mouth, throat and denture sore mouth, the dose is 200mg to 400mg on the first day then 100mg to 200mg once daily until you are told to stop.

To treat mucosal thrush (dose dependent on infection location), the dosage is 50mg to 400mg once daily for 7 to 30 days until you are told to stop.

To treat fungal skin and nail infections (depending on the site of infection): 50mg once daily, 150mg once weekly, 300 to 400mg 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 treat internal fungal infections caused by Candida: 800mg the first day followed by 400mg daily until you are told to stop.

To treat cryptococcal meningitis: 400mg on the first day then 200mg to 400mg once daily for 6 to 8 weeks or longer if needed (sometimes doses are increased up to 800mg).

To treat coccidioidomycosis: 200mg to 400mg once daily from 11 months for up to 24 months or longer if needed. Sometimes doses are increased up to 800mg

To stop cryptococcal meningitis from coming back: 200mg once daily until you are told to stop. To stop mucosal infections affecting the lining of the mouth and throat from coming back: 100mg to 200mg once daily, or 200mg 3 times a week, while you are at risk of getting an infection.

To reduce recurrence of vaginal thrush: 150mg 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 stop you from getting an infection caused by Candida (if your immune system is weak and not working properly): 200mg to 400mg once daily while you are at risk of getting an infection.

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 400mg daily.

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

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: 3mg per kg of body weight once daily. 6mg per kg of body weight may be given on the first day.

Cryptococcal meningitis or internal fungal infections caused by Candida : 6mg to 12mg per kg of body weight once daily..

To stop children from getting an infection caused by Candida (if their immune system is not working properly): 3mg to 12mg per kg of body weight once daily.

To stop cryptococcal meningitis from coming back: 6mg per kg of body weight once daily

Use in children (from 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 12mg 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 12mg per kg of body weight every 72 hours.

Elderly

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

In patients with kidney problems

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

Instructions for the correct administration of the preparation

Turn the bottle upside down and tap it gently until all the powder moves freely. Add 23ml of water and shake vigorously. Shake again before use. A whitish suspension is obtained after its reconstitution with water. Dilution is not appropriate.

Every 5ml of reconstituted suspension will contain 50mg of fluconazole.

If you take more Fluconazole 50mg/5ml Suspension than prescribed

If you take more fluconazole than you have been told to, seek medical advice immediately. Symptoms of a possible overdose may include hallucinations and paranoid behaviour. Symptomatic treatment (with supportive measures and gastric lavage if necessary) may be adequate.

If you forget to take Fluconazole 50mg/5ml Suspension

If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose. In that case, skip the missed dose and take the next dose as normal. Do not take a double dose.

If you stop taking Fluconazole 50mg/5ml Suspension

Do not stop treatment early because your symptoms have improved. Your condition may not have been resolved and may reoccur if you do not finish your course of treatment.

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

4. POSSIBLE SIDE-EFFECTS

Like all medicines, fluconazole can 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.

Stop taking this medicine and seek medical attention immediately if you notice any of the following symptoms:

• 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 may affect the mouth and tongue).
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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).

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 side effects (may affect up to 1 in 10 people) are:

• headache
• stomach discomfort, diarrhoea, feeling sick, vomiting
• increases in blood tests of liver function.
• rash

Uncommon side effects (may affect up to 1 in 100 people) are:

• reduction in red blood cells (anaemia) 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
• tiredness, general feeling of being unwell, fever.

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

• 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
• abnormal electrocardiogram (ECG), change in heart rate or rhythm
• liver failure.
• shaking/tremors
• 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 or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.

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

5. how to store fluconazole 50mg/5ml suspension

Keep out of the sight and reach of children.

Do not use Fluconazole 50mg/5ml Suspension after the expiry date which is stated on the bottle and carton. The expiry date refers to the last day of that month. The unopened medicinal product does not require any special storage conditions. The suspension, once reconstituted, can be maintained at room temperature for a maximum period of 14 days, after which it must be disposed of. Do not store the reconstituted solution above 30°C. Do not freeze the reconstituted solution.

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 50mg/5ml Suspension contains

The active ingredient is fluconazole. Every 5ml of suspension contains 50mg of fluconazole. The excipients are: sucrose, citric acid monohydrate, sodium citrate anhydrous, sodium benzoate (E-211), xanthan gum, colloidal silica, titanium dioxide (E-171) and orange flavour (containing maltodextrin and arabic gum).

What Fluconazole 50mg/5ml Suspension looks like and contents of the pack

POM

PL 06831/0220 Fluconazole 50mg/5ml Powder for Oral Suspension

Marketing Authorisation Holder:

Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.

Manufacturer:

Laboratorios Lesvi, S.L.,

Avda. Barcelona 69, 08970 Sant Juan Desp^ Barcelona, Spain.

This leaflet was last revised in February 2021.