Consumer medicine information

Fungilin Lozenges

Amphotericin B (amphotericin)

BRAND INFORMATION

Brand name

Fungilin

Active ingredient

Amphotericin B (amphotericin)

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Fungilin Lozenges.

What is in this leaflet

Read this leaflet carefully before taking Fungilin Lozenges. This leaflet answers some common questions about Fungilin.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Fungilin against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Always follow the instructions that your doctor or pharmacist gives you about Fungilin Lozenges.

Keep this leaflet with the medicine. You may need to read it again.

What Fungilin is used for

Fungilin is a trade name for the antifungal medicine, Amphotericin B. Fungilin Lozenges are used to treat infections in or around the mouth, throat or tongue caused by yeast-like fungi called Candida. This condition is known as oral candidiasis or thrush. Candida albicans is the most common cause of thrush.

C. albicans is present in the gut of both men and women, and often in women’s vaginas without causing problems. When conditions are suitable for its growth, C. albicans will multiply and cause infection.

A number of different conditions provide favourable growth conditions for Candida, such as Acquired Immune Deficiency Syndrome (AIDS), diabetes, treatment with some antibiotic or cortisone medicines, or treatment for cancer.

Fungilin is not expected to affect your ability to drive a car or operate machinery. Fungilin Lozenges are tolerated well by all age groups.

Your doctor may have prescribed Fungilin for another reason. Ask your doctor if you have any questions about why Fungilin has been prescribed for you.

Before you take Fungilin

It is important that you check the information below before you take Fungilin Lozenges.

When you must not take them

Do not take Fungilin if you have an allergy to it or to any ingredients in the formulation listed at the end of this leaflet.

Do not take it after the expiry date printed on the back of the pack. If this medicine is used after the expiry date has passed, it may not work as well.

Do not take Fungilin Lozenges if the packaging is torn or shows signs of tampering.

Before you start taking it

Tell your pharmacist if:

  1. you have allergies to:
  • Amphotericin B or to any ingredients in the formulation listed at the end of this leaflet;
  • any other medicines; substances such as foods, preservatives or dyes.
Symptoms of an allergic reaction may include:
- swelling of the face, tongue, mouth, lips, throat and difficulty breathing
- severe and sudden onset of hives or a skin rash.
  1. you are pregnant or intend to become pregnant. Fungilin is not recommended for use during pregnancy unless the benefits of treatment outweigh the risks to the unborn baby.
  2. you are breast feeding or planning to breast-feed. It is not known whether Fungilin passes into breast milk.
  3. you have or have had any medical conditions. If you have diabetes, consult with your doctor first before taking Fungilin Lozenges.

If you have not told your pharmacist about any of the above, tell them before you start to take Fungilin Lozenges.

Taking other medicines

Tell your pharmacist if you are taking other medicines, including vitamin and herbal supplements or any medicines you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may affect the way others work. Your doctor or pharmacist may have more information on medicines to be careful with or to avoid while using Fungilin.

How to take Fungilin

Use Fungilin only as directed by your doctor or pharmacist. It is important that you always follow your doctor’s or pharmacist’s instructions as they may differ from the information in this leaflet.

How much to take

The recommended daily dose of Fungilin Lozenges is one lozenge, taken four times daily.

How to take it

Suck the lozenge and allow it to dissolve slowly in the mouth.

If you wear dentures, take them out while sucking the lozenge. This allows the medicine to reach where the dentures normally fit. Before replacing your dentures, clean them thoroughly.

If you do not understand the instructions on how to take Fungilin Lozenges, ask your pharmacist for help.

When to take it

Take Fungilin at about the same time each day, after meals and at bedtime. Taking Fungilin Lozenges at the same time each day will have the best effect and may help you remember when to take the Lozenges.

How long to take it

Continue taking Fungilin Lozenges for 10-15 days.

If your symptoms do not improve after several days of treatment or they return soon after completing you course of treatment, tell your doctor. This may be a sign that your infection is caused by an organism which is resistant to Fungilin Lozenges or, you may have another underlying condition of which you are not aware.

Therefore, it is very important that you advise your doctor if the condition persists after following the recommended course of treatment. Your doctor may request that you have additional tests to further diagnose and treat your condition.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to. Otherwise, take it as soon as you remember and then go back to taking it as you would normally.

Do not take a double dose to make up for the missed dose.

If you are not sure what to do, ask your pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Taking too many Fungilin Lozenges is unlikely to cause problems. Immediately call your doctor, or the Poisons Information Centre on 13 11 26 or go to the Accident and Emergency Centre at your nearest hospital if you or anyone else accidentally takes too much Fungilin. Do this even if there are no signs of discomfort or poisoning.

While you are taking Fungilin

Things you must do

If you are about to start taking any new medicines, tell all doctors and pharmacists who are treating you that you are taking Fungilin Lozenges.

If you become pregnant while using Fungilin Lozenges, tell your doctor immediately.

If you plan to have surgery, tell your doctor or dentist that you are taking Fungilin Lozenges.

If your symptoms do not improve while you are taking Fungilin or they become worse, tell your doctor.

Things you must not do

Do not give Fungilin Lozenges to anyone else, even if they have the same condition as you.

Fungilin Lozenges are intended for mouth infections only, caused by Candida yeast infections. Do not take Fungilin Lozenges to treat any other complaints unless your doctor or pharmacist tells you to.

Unless you experience a bad side effect or allergic reaction to Fungilin Lozenges, do not stop using Fungilin Lozenges until the infection is cured.

Things that may help your condition

To avoid the possibility of re-infection or infection of other household members, you must observe strict personal hygiene. Hands must be washed thoroughly before and after taking the lozenges.

Wash used kitchen utensils by boiling for 20 minutes. Wash your used utensils separately and keep them away from utensils used by other household members. This may help prevent spread of the infection.

If you have yellowing of the teeth while using Fungilin, this can be removed by brushing your teeth.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Fungilin Lozenges. Fungilin Lozenges helps most people with Candida infections, but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your pharmacist to answer any questions you may have.

Tell your doctor immediately, or go to the Accident and Emergency Centre at your nearest hospital if you notice any of the following:

  • hives,
  • swelling of the face, mouth, lips, tongue or throat and have difficulty breathing

These are very serious side effects. If you have them, you may have had an allergic reaction to Fungilin Lozenges. You may need urgent medical attention. All of these side effects are very rare.

Tell your doctor if you notice any of the following and they worry you:

  • diarrhoea
  • indigestion or upset stomach
  • nausea
  • vomiting
  • yellowing of the teeth (which can be removed by brushing the teeth).

These are the more common side effects of Fungilin Lozenges. Mostly these are mild and short-lived.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell. Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using Fungilin

Storage

Keep your Fungilin Lozenges in the pack until it is time to take them. If you take them out of bottle they may not keep as well.

Store Fungilin Lozenges in a cool dry place where the temperature stays below 25°C.

Do not store Fungilin Lozenges or any other medicine in the bathroom or near the kitchen sink. Do not leave it in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using Fungilin Lozenges, or the lozenges have passed their expiry date, ask your pharmacist what to do with any that is left over.

Product description

What it looks like

Fungilin Lozenges are round, yellow-coloured, fruit-flavoured lozenge.

Ingredients

Each lozenge contains:

Active ingredients:
Amphotericin B (amphotericin)

Other ingredients:
mannitol, acacia, stearic acid, sodium cyclamate, sodium saccharin, polyvinyl alcohol, talc purified, blood orange flavour 51226 T (PI 272), curacao 50397 AP0500 (PI 1834), and orange flavour 1AA01144.

Fungilin Lozenges do not contain lactose, gluten, tartrazine or any other azo dyes.

Presentation

Fungilin Lozenges 10mg Amphotericin B (amphotericin) lozenge are available in bottles containing 20 lozenges.

AUST R 19295.

Sponsor/Supplier

Aspen Pharma Pty Ltd
34-36 Chandos St
St Leonards
2065 NSW

This information in no way replaces the advice of your doctor or pharmacist.

This leaflet was revised in April 2021

Published by MIMS July 2021

BRAND INFORMATION

Brand name

Fungilin

Active ingredient

Amphotericin B (amphotericin)

Schedule

S4

 

1 Name of Medicine

Amphotericin B (amphotericin).

2 Qualitative and Quantitative Composition

Fungilin oral lozenges contains 10 milligrams of amphotericin B (amphotericin). Amphotericin is a mixture of macrolide - antifungal polyenes produced by the growth of certain strains of Streptomyces nodosus. It consists largely of amphotericin B (amphotericin).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Fungilin 10 mg oral lozenges are yellow, flat-faced, bevel-edged, disc-shaped lozenge.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of candidal infections of the oral and perioral areas including oral thrush, angular cheilitis, denture stomatitis and in other conditions of the mouth, throat and tongue complicated by the overgrowth of Candida albicans.

4.2 Dose and Method of Administration

One (1) lozenge should be sucked and allowed to dissolve slowly in the mouth four times a day for a duration of 7 to 14 days. The lozenges should be taken after meals and at bedtime. Patients wearing dentures should be especially careful to cleanse them thoroughly and to remove them while sucking the lozenge to allow the active material to reach all tissues.

4.3 Contraindications

Fungilin is contraindicated in patients with a history of hypersensitivity to amphotericin B (amphotericin) or any other component of the Fungilin formulation.

4.4 Special Warnings and Precautions for Use

Orally administered amphotericin B (amphotericin) is not to be used for the treatment of systemic fungal infections.

Hypersensitivity.

Hypersensitivity reactions to the Fungilin amphotericin B (amphotericin) lozenge are rare, but should sensitivity develop, treatment should be discontinued. Treatment with Fungilin lozenges should not be attempted in those individuals who have shown hypersensitivity to any of its components.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B3)
There are no adequate and well-controlled studies in pregnant women. Oral forms of amphotericin B (amphotericin) should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
It is not known whether amphotericin B (amphotericin) is excreted in human milk. Though gastrointestinal absorption is insignificant, caution should be exercised when amphotericin B (amphotericin) is prescribed for a nursing woman.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Amphotericin is not appreciably absorbed when taken orally, even at high dosage. No systemic adverse effects have followed oral administration of up to at least 3 g daily.

Gastrointestinal disorders.

Common: mild gastrointestinal distress; nausea; vomiting; diarrhoea.

Skin and subcutaneous tissue disorders.

Rare: urticaria, angioedema, Stevens-Johnson syndrome and toxic epidermal necrolysis.

Post marketing surveillance.

Skin exfoliation has been reported.
Transient yellowing of the teeth may occur with the use of the lozenge formulations, which can easily be removed by brushing.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

There is little information available regarding overdose with oral dosage forms of amphotericin B (amphotericin). Since absorption of amphotericin B (amphotericin) from the gastrointestinal tract is negligible, even in high doses, overdose should not normally result in systemic toxicity. In case of overdose, usual measures to remove drug substance from the gastrointestinal tract should be considered.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Amphotericin B (amphotericin) appears to act mainly by interfering with the permeability of the cell membrane of sensitive fungi by binding to sterols, chiefly ergosterol. It is reported to be fungistatic at concentrations achieved clinically.
This medicine is active against a wide range of yeasts and yeast like including Candida albicans. Candida albicans is generally quite susceptible to the medicine, but other Candida species may be less susceptible. Oral amphotericin B (amphotericin) has demonstrated antifungal activity towards many fungal species including candidal infections of the oral and perioral areas (see Section 4.1 Therapeutic Indications).
Amphotericin B (amphotericin) is inactive against bacteria (including Rickettsia) and viruses.

Resistance.

Fungal species with decreased susceptibility to amphotericin B (amphotericin) have been isolated after serial passage in culture media containing the drug, and from some patients receiving prolonged therapy.
Some resistant strains of Candida have been isolated from immunocompromised patients receiving prolonged treatment with amphotericin B (amphotericin).
However, strains of Candida albicans resistant to both amphotericin B (amphotericin) and fluconazole have emerged in a few patients who have received repeated or prolonged courses of fluconazole.
Reports of amphotericin B (amphotericin) resistant fungi are infrequent.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

There is little or no absorption of amphotericin B (amphotericin) from the gastrointestinal tract.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each lozenge of Fungilin contains amphotericin B (amphotericin), mannitol, acacia, stearic acid, sodium cyclamate, saccharin sodium, polyvinyl alcohol, talc-purified, blood orange flavour 51226 T (PI 272), orange flavour 1AA01144 and curacao 50397 AP0500 (PI 1834).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Fungilin lozenges are available in glass bottles of 20's.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

C47H73NO17.
Molecular weight: 924.

CAS number.

1397-89-3.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes