Consumer medicine information

Di-Con One Capsules

Fluconazole

BRAND INFORMATION

Brand name

Di-Con One Capsules

Active ingredient

Fluconazole

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Di-Con One Capsules.

What is in this leaflet

This leaflet answers some common questions about DI-CON ONE. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor or pharmacist has weighed the risks of you taking DI-CON ONE against the benefits expected for you.

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

Keep this leaflet with your medicine.

You may need to read it again.

The information in this leaflet relates only to DI-CON ONE. It is not to be used in relation to any other product, which may contain the same active ingredient.

What DI-CON ONE is used for

DI-CON ONE is used to treat a fungal infection known as vaginal thrush.

The active ingredient in DI-CON ONE is fluconazole, which is classified with medicines known as azole antifungals. This group of antifungal medicines work by preventing the growth of the fungi causing your infection.

Ask your doctor or pharmacist if you have any questions about why DI-CON ONE has been recommended for you.

Your doctor or pharmacist may have recommended DI-CON ONE for another reason.

DI-CON ONE is not recommended for children under 18 years of age except under doctor supervision. There is no evidence that DI-CON ONE is addictive.

DI-CON ONE is a “Pharmacist Only Medicine”. It is available without a doctor’s prescription but your pharmacist’s advice is required.

What is vaginal thrush?

Vaginal candidiasis, an infection caused by a yeast-like fungus Candida, is commonly referred to as “vaginal thrush”.

Candida is one of the many organisms that live in the vagina and its growth is normally balanced by your body’s natural defence mechanism known as the ‘immune system’. However, when this natural balancing is upset, Candida can multiply in the vagina to cause the symptoms of thrush.

Common symptoms of vaginal thrush include:

  • itching, burning or soreness around the vagina
  • curdled- ‘cottage cheese’-like whitish discharge
  • swelling or irritation of the infected area

What you can do to avoid thrush in the future

  • avoid wearing synthetic clothing
  • wear loose-fitting cotton briefs, stockings
  • wash the area regularly, but do not wash and dry yourself harshly
  • avoid vaginal deodorants, perfumed soaps and bath additives

Ask your doctor or pharmacist for more information on things you can do to avoid thrush in the future.

Before you take DI-CON ONE

When you must not take it

Do not take DI-CON ONE if you have an allergy to:

  • medicines containing fluconazole
  • medicines related to fluconazole such as miconazole (eg Daktarin), ketoconazole (eg. Nizoral), clotrimazole (eg. Canestan, Clonea) or itraconazole (Sporanox)
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itching or hives, shortness of breath, swelling of the face, lips, or tongue which may cause difficulty in swallowing or breathing; wheezing or shortness of breath.

Do not take DI-CON ONE if you are taking cisapride (Prepulsid), a medicine used to treat stomach problems.

Combining DI-CON ONE with cisapride may cause serious side effects such as an abnormal heart rhythm.

Do not take DI-CON ONE if you are pregnant, suspect you may be pregnant or if you become pregnant during treatment.

DI-CON ONE should not be used during pregnancy because it may affect your developing baby.

Do not take DI-CON ONE if you are breast- feeding.

DI-CON ONE passes into breast milk and may affect your baby.

Do not take DI-CON ONE if the expiry date (EXP) printed on the packaging has passed.

Do not take DI-CON ONE if the packaging is torn or shows signs of tampering or the capsule does not look right.

If you are not sure whether you should start taking this medicine, talk to your doctor or pharmacist.

Before you start to take it

Tell your doctor or pharmacist if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor or pharmacist if you have any of the following medical conditions:

  • abnormal or irregular vaginal bleeding or blood stained discharge
  • vulvar or vaginal sores, ulcers or blisters
  • lower abdominal pain or burning when passing urine
  • any liver problems
  • any kidney problems
  • any heart problems.

Your doctor or pharmacist may want to take special care if you have any of these conditions.

Tell your doctor or pharmacist before using DI-CON ONE if you are taking warfarin (eg. MAREVAM, COUMADIN) as bleeding or bruising may occur.

If you have not told your doctor about any of the above, tell them before you start taking DI-CON ONE.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicine, including any you get without a prescription from a pharmacy, supermarket or health food shop.

If you are taking cisapride (Prepulsid), a medicine used to treat stomach problems, do not take DI-CON ONE.

Some medicines and DI-CON ONE may interfere with each other. These include:

  • some medicines used to treat diabetes
    - such as glipizide (Minidiab, Melizide), tolbutamide or glibenclamide (eg. Daonil, Glimel), glimepiride (eg. Amaryl), gliclazide (eg. Diamicron, Glyade)
    - pioglitazone (Actos), rosiglitazone (Avandia)
  • some antibiotics and antiviral drugs such as rifampicin (eg. Rifadin, Rimycin) or rifabutin (Mycobutin) or zidovudine
  • some drugs used in problems with the immune system, such as cyclosporin or tacrolimus
  • warfarin (used to stop blood clots)
  • phenytoin (used to treat epilepsy)
  • theophylline (used to treat asthma)
  • some benzodiazepines such as midazolam (eg. Hypnovel) and triazolam (Halcion)
  • hydrochlorothiazide (Dithaizide)-used for treating fluid problems and high blood pressure
  • the contraceptive pill (birth control pill)

Talk to your doctor or pharmacist about the need for an additional method of contraception while taking DI-CON ONE.

DI-CON ONE may decrease the effectiveness of some birth control pills.

Your doctor or pharmacist can tell you what to do when you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with a doctor or pharmacist.

These medicines may be affected by DI-CON ONE or may affect how well DI-CON ONEor these medicines work. You may need different amounts of your medicines, or you may need to take different medicines. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking DI-CON ONE.

How to take DI-CON ONE

Follow all directions given to you by your doctor and pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

Adults
For vaginal thrush in adults, only a single dose (1 capsule) of DI-CON ONE is needed.

DI-CON ONE is not recommended for children under 18 years of age except under doctor supervision.

How to take it

Swallow the whole capsule with a glass of water.

When to take it

DI-CON ONE can be taken any time before, with or after food.

If you take too much DI-CON ONE(Overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26 in Australia) or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much DI-CON ONE.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are taking DI-CON ONE

Things you must do

Before starting any new medicine, tell your doctor or pharmacist that you are taking or have taken DI-CON ONE.

  • Tell any other doctors, dentists and pharmacists who treat you that you are taking DI-CON ONE.
  • Use effective contraception to prevent pregnancy while taking DI-CON ONE.
  • Immediately tell your doctor if you do become pregnant while taking DI-CON ONE.
  • If the symptoms of your infection do not improve after 3 days, or if they become worse, tell your doctor or pharmacist.

Things you must not do

  • Do not use DI-CON ONE to treat any other medical complaints unless your doctor or pharmacist tells you to.
  • Do not give DI-CON ONE to anyone else, even if they have the same condition as you.

Things to be careful of:

  • Tell your doctor or pharmacist immediately if you develop a rash while taking DI-CON ONE.
  • People with AIDS or weak immune system may be more prone to serious side effects of the skin.

Side effects

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

DI-CON ONE helps most people with yeast infections, but it may have a few unwanted effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following list of side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

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

  • nausea or “feeling sick”, vomiting
  • stomach pain, indigestion
  • diarrhoea
  • headache

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

Tell your doctor or pharmacist as soon as possible if you notice any of the following:

  • unusual muscle stiffness causing poor control of movement
  • frequent infections such as fever, severe chills, sore throat or mouth ulcers
  • bleeding or bruising more easily than normal
  • passing more urine than normal, kidney pain (pain on the sides of the body)
  • Symptoms of liver disease such as yellowing of the skin or eyes- also called jaundice; dark urine, pale stools; loss of appetite; unusual tiredness
  • fast or irregular heart beat or palpitations.

These side effects are serious and need urgent medical attention.

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

  • Signs of an allergic reaction such as skin rash, itching or hives; swelling of the face, lips, or tongue which may cause difficulty in swallowing or breathing; wheezing or shortness of breath
  • Severe blisters and bleeding of the lips, eyes, mouth, nose and genitals
  • A severe rash with skin peeling, fever, chills and aching muscles.

These side effects are rare but very serious and need urgent medical attention or hospitalisation.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

This is not a complete list of all possible side effects. Others may also occur in some people and there may be some side effects not yet known.

After taking DI-CON ONE

Storage

Keep DI-CON ONE where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Keep your medicine in its original pack until it is time to take it.

If you take it out of the pack it may not keep well.

Keep DI-CON ONE capsules in a cool, dry place where the temperature stays below 30°C.

Do not store DI-CON ONE in the bathroom or near a sink.

Do not leave DI-CON ONE on a windowsill or in the car.

Heat and dampness can destroy some medicines.

Disposal

If your doctor or pharmacist tells you to stop taking this medicine, or it has passed its expiry date, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

DI-CON ONE is a hard gelatin capsule of size ‘1’ with sky blue opaque body and cap.

Each pack contains 1 capsule.

Ingredients

Each DI-CON ONE capsule contains 150 mg Fluconazole.

Each capsule also contains the following inactive ingredients:

  • lactose
  • maize starch
  • colloidal anhydrous silica
  • talc
  • sodium lauryl sulfate
  • gelatin
  • titanium dioxide
  • patent blue colour E131

Supplier

DI-CON ONE is supplied in Australia by:

AUST R 152 841

This leaflet was prepared in April 2017.

BRAND INFORMATION

Brand name

Di-Con One Capsules

Active ingredient

Fluconazole

Schedule

S3

 

Name of the medicine

Fluconazole.

Excipients.

Lactose, maize starch, colloidal anhydrous silica, talc and sodium lauryl sulfate, gelatin, titanium dioxide, patent blue colour E131 and black printing ink TEK-SW 9008 containing black iron oxide E 172.

Description

Fluconazole is a bis-triazole antifungal.
Chemical name: 2-(2,4-difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)-2-propanol. Molecular formula: C13H12F2N6O. Molecular weight: 306.3. CAS Number: 86386-73-4. Fluconazole is a white to off-white crystalline powder, which is sparingly soluble in water and saline.

Other ingredients.

Lactose, maize starch, colloidal anhydrous silica, talc and sodium lauryl sulfate, gelatin, titanium dioxide, patent blue colour E131 and black printing ink TEK-SW 9008 containing black iron oxide E 172.

Pharmacology

Pharmacodynamics.

Fluconazole is a member of the bis-triazole class of antifungal agents. Fluconazole is a highly selective inhibitor of fungal cytochrome P-450 sterol C-14 alpha demethylation. Mammalian cell demethylation is much less sensitive to fluconazole inhibition. The subsequent loss of normal sterols correlates with the accumulation of 14 alpha-methyl sterols in fungi and may be responsible for the fungistatic activity of fluconazole. Fluconazole 50 mg daily given up to 28 days has been shown not to affect corticosteroid levels or ACTH stimulated response in healthy female volunteers. Plasma oestradiol levels and urinary free cortisol levels were decreased with little effect on plasma testosterone levels. Interaction studies with antipyrine indicate that single or multiple doses of fluconazole 50 mg do not affect its metabolism.

Pharmacokinetics.

Adults.

The pharmacokinetic properties of fluconazole are similar following administration by the intravenous or oral routes. In normal volunteers, the bioavailability of orally administered fluconazole is over 90% compared with intravenous administration. In fasted normal volunteers, peak plasma concentrations occur between 1 and 2 hours post dose with a terminal plasma elimination half-life of approximately 30 hours (range 20-50 hours). Plasma concentrations are proportional to dose and steady-state levels are reached within 5-10 days with oral doses of 50-400 mg once daily. Steady-state levels are approximately 2.5 times the levels achieved with single doses. The apparent volume of distribution approximates to total body water. Plasma protein binding is low (11-12%). Fluconazole has been found to achieve good penetration into all tissues and body fluids studied. See Table 1.
The major route of excretion is renal, with approximately 80% of the administered dose appearing in the urine as unchanged drug. About 11% of the dose is excreted in the urine as metabolites. The pharmacokinetics of fluconazole is markedly affected by reduction in renal function. There is an inverse relationship between the elimination half-life and creatinine clearance. The long plasma elimination half-life provides the basis for single dose therapy for vaginal candidiasis, once daily and once weekly (if required).

Microbiology.

Fluconazole administered orally or intravenously was active in a variety of animal models of fungal infections using standard laboratory strains of fungi. Fluconazole exhibits in vitro activity against Candida spp. Activity has been demonstrated in vivo in normal and immunocompromised animals against infections with Candida spp, including systemic candidiasis. One case of cross-resistance of Candida to fluconazole in a patient (non-HIV) previously treated with ketoconazole has been reported. The efficacy of fluconazole in vivo is greater than would be apparent from in vitro testing against the above-mentioned fungi.

Indications

Di-Con One, given orally, is indicated for the treatment of vaginal candidiasis.

Contraindications

Di-Con One should not be used in patients with known sensitivity to fluconazole; to related azole compounds or to any of its excipients. Concomitant administration with cisapride is contraindicated (see Interactions with Other Medicines).

Precautions

Anaphylaxis has been reported in rare instances. Fluconazole has been associated with rare cases of serious hepatic toxicity including fatalities, primarily in patients with serious underlying medical conditions. In cases of fluconazole-associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex or age of patient has been observed.
Fluconazole should not be used again if clinical signs and symptoms consistent with liver disease develop that may be attributable to fluconazole (see Adverse Effects).
Patients have rarely developed exfoliative cutaneous reactions, such as Stevens-Johnson Syndrome and toxic epidermal necrolysis, during treatment with fluconazole. AIDS patients are more prone to the development of serious cutaneous reactions to many drugs. If rash which is attributable to fluconazole develops in a patient treated for a superficial fungal infection, fluconazole should not be used again. Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation and torsade de pointes in patients taking fluconazole. These reports included seriously ill patients with multiple confounding risk factors, such as structural heart disease, electrolyte abnormalities and concomitant medications that may have been contributory. Fluconazole should be administered with caution to patients with these potentially pro-arrhythmic conditions (see Adverse Effects).

Use in children.

Insufficient evidence is available to establish safety and efficacy of fluconazole in the above indications in children.

Use in pregnancy.

(Category D)
There are no adequate and well-controlled studies in pregnant women. There have been reports of multiple congenital abnormalities in infants whose mothers were being treated for 3 or more months with high dose (400-800 mg/day) fluconazole therapy for coccidiomycosis. The relationship between fluconazole use and these events is unclear. Adverse foetal effects have been seen in animals only at high dose levels associated with maternal toxicity. These findings are not considered relevant to Di-Con One used at therapeutic doses. Fluconazole should not be used in women who are pregnant or in women of childbearing potential, unless adequate contraception is employed.
Australian categorisation definition of Category D: Drugs, which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human foetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

Use in lactation.

Fluconazole has been found in human breast milk at concentrations similar to plasma, hence its use in nursing mothers is not recommended.

Carcinogenesis, mutagenesis and impairment of fertility.

Fluconazole showed no evidence of carcinogenic potential in mice and rats treated orally for 24 months at doses of 2.5, 5 or 10 mg/kg/day (approximately 2-7 x recommended human dose). Male rats treated with 5 and 10 mg/kg/day had an increased incidence of hepatocellular adenomas. Fluconazole, with or without metabolic activation, was negative in tests for mutagenicity in 4 strains of Salmonella typhimurium and in the mouse lymphoma system. Cytogenetic studies in vivo and in vitro showed no evidence of chromosomal mutations.
Fluconazole did not affect the fertility of male or female rats treated orally with daily doses of 5, 10 or 20 mg/kg or with parenteral doses of 5, 25 or 75 mg/kg, although the onset of parturition was slightly delayed at 20 mg/kg p.o. In an intravenous perinatal study in rats at 5, 20 and 40 mg/kg, dystocia and prolongation of parturition were observed in a few dams at 20 mg/kg and 40 mg/kg, but not at 5 mg/kg. The disturbances in parturition were reflected by a slight increase in the number of still born pups and decrease of neonatal survival at these dose levels. The effects on parturition in rats are consistent with the species specific oestrogen-lowering property produced by high doses of fluconazole. Such a hormone change has not been observed in women treated with fluconazole (see Pharmacodynamics).

Interactions

The relevance of the following drug interactions to single-dose fluconazole is unknown. Patients on other medications should be advised to consult their doctor or pharmacist before starting Di-Con One. Fluconazole is an inhibitor of the cytochrome P450 system, particularly the CYP 2C and to a lesser extent the CYP 3A isoforms. There are possibilities that other drugs may affect the metabolism of fluconazole and that fluconazole may affect the metabolism of other drugs. In vitro studies conducted in human hepatic microsomes demonstrate that the extent of inhibition of CYP 3A isoforms is lowest with fluconazole, when compared with ketoconazole and itraconazole.

Hydrochlorothiazide.

Concomitant oral administration of fluconazole 100 mg and hydrochlorothiazide 50 mg for 10 days in normal volunteers resulted in an increase of 41% in Cmax and an increase of 43% in area under the curve (AUC) of fluconazole, compared to fluconazole given alone. An effect of this magnitude should not necessitate a change in the fluconazole dose regimen in subjects receiving diuretics, although the prescriber should bear it in mind.

Rifampicin.

Administration of a single oral dose of fluconazole 200 mg after chronic rifampicin administration resulted in a 25% decrease in AUC and a 20% shorter half-life of fluconazole in normal volunteers. Depending on clinical circumstances, an increase of the dose of fluconazole should be considered when it is administered with rifampicin.

Cisapride.

Cardiac events including torsades de pointes have been reported in patients receiving fluconazole and cisapride concomitantly. A controlled study found that concomitant fluconazole 200 mg once daily and cisapride four times a day yielded a significant increase in cisapride plasma levels and prolongation of QTc interval. Coadministration of cisapride is contraindicated in patients receiving fluconazole (see Contraindications).

Cyclosporin.

A kinetic study in renal transplant patients found fluconazole 200 mg daily slowly increased cyclosporin concentrations. However, in another multiple dose study with 100 mg daily, fluconazole did not affect cyclosporin levels in patients with bone marrow transplants. Cyclosporin plasma concentration monitoring in patients, with or without impaired renal function, receiving fluconazole is recommended.

Oral contraceptives.

Fluconazole at a dose of 50 mg for 10 days decreased the AUC for ethinyloestradiol by 16%, but values for levonorgestrel were unchanged.

Oral hypoglycaemic agents.

The effects of fluconazole on the pharmacokinetics of the sulfonylurea oral hypoglycaemic agents tolbutamide, glipizide and glibenclamide were examined in three placebo-controlled, crossover studies in normal volunteers. All subjects received the sulfonylurea alone and following treatment with fluconazole 100 mg as a single daily oral dose for 7 days. Fluconazole administration resulted in significant increases in Cmax and AUC of the sulfonylurea. Several subjects in these three studies experienced symptoms consistent with hypoglycaemia. In the glibenclamide study, several volunteers required oral glucose treatment. As fluconazole is a potent inhibitor CYP 2C8 and CYP 2C9, it may also interact with other sulfonylureas (e.g. glimepiride and gliclazide) and the thiazolidinediones (e.g. pioglitazone and rosiglitazone), which are metabolised by these enzymes. When fluconazole and sulfonylureas or thiazolidinediones are co-administered, blood glucose concentrations should be monitored carefully. The possibility of a hypoglycaemic episode should be borne in mind.

Phenytoin.

Concomitant administration of oral fluconazole 200 mg with phenytoin at steady-state resulted in average increase of 75% of phenytoin AUC values in normal volunteers. Careful monitoring of phenytoin concentrations in patients receiving fluconazole and phenytoin is recommended.

Short acting benzodiazepines.

Studies in human subjects have reported changes in midazolam pharmacokinetics and clinical effects that are dependent on dosage and route of administration. Single doses of fluconazole 150 mg resulted in modest increases in midazolam concentrations and psychomotor effects following oral administration of 10 mg that may not be clinically significant. At doses used to treat systemic mycoses, fluconazole resulted in substantial increases in midazolam concentrations and psychomotor effects following oral administration of midazolam 7.5 mg, but only modest increases that are not likely to be clinically significant following intravenous infusion of midazolam 0.05 mg/kg. If concomitant benzodiazepine therapy is necessary in patients being treated with fluconazole, consideration should be given to decreasing the benzodiazepine dosage, and the patients should be appropriately monitored.

Rifabutin.

There have been reports that an interaction exists when fluconazole is administered concomitantly with rifabutin, leading to increased serum levels of rifabutin. There have been reports of uveitis in patients to whom fluconazole and rifabutin were co-administered. Patients receiving rifabutin and fluconazole concomitantly should be carefully monitored.

Tacrolimus.

There have been reports that an interaction exists when fluconazole is administered concomitantly with tacrolimus, leading to increased serum levels of tacrolimus. There have been reports of nephrotoxicity in patients to whom fluconazole and tacrolimus were co-administered. Patients receiving tacrolimus and fluconazole concomitantly should be carefully monitored.

Theophylline.

In a placebo controlled interaction study, the administration of fluconazole 200 mg for 14 days resulted in an 18% decrease in the mean plasma clearance of theophylline. Patients who are receiving high doses of theophylline or who are otherwise at increased risk of theophylline toxicity should be observed for signs of theophylline toxicity while receiving fluconazole and therapy modified appropriately if signs of toxicity develop.

Warfarin.

A single dose of warfarin 15 mg given to normal volunteers, following 14 days of orally administered fluconazole 200 mg resulted in a 12% increase in the prothrombin time response (area under the prothrombin time-time curve). One in 13 subjects experienced a two-fold increase in prothrombin time response. In post-marketing experience, as with other azole antifungals, bleeding events (bruising, epistaxis, gastrointestinal bleeding, haematuria and melaena) have been reported in association with increases in prothrombin time in patients receiving fluconazole concurrently with warfarin. Careful monitoring of prothrombin time in patients receiving fluconazole and coumarin-type anticoagulants is recommended.

Zidovudine.

The AUC of zidovudine significantly increased (74%) during co-administration with fluconazole. Patients receiving this combination should be monitored for the development of zidovudine-related adverse reactions.

Gastrointestinal drugs.

In fasted normal volunteers, absorption of orally administered fluconazole does not appear to be affected by agents that increase gastric pH. Single dose administration of fluconazole 100 mg with cimetidine 400 mg resulted in a 13% reduction in AUC and 21% reduction in Cmax of fluconazole. Administration of an antacid containing aluminium and magnesium hydroxides immediately prior to a single dose of fluconazole 100 mg had no effect on the absorption or elimination of fluconazole.

Other.

Physicians should be alert to the potential for drug-drug interactions, with other drugs for which pharmacokinetic drug-drug interaction studies have not been conducted.

Adverse Effects

Fluconazole is generally well tolerated.
Common adverse events (>1%) observed during vaginal candidiasis clinical trials and associated with fluconazole:

Nervous system.

Headache.

Gastrointestinal.

Nausea, abdominal pain, diarrhoea, dyspepsia.
Uncommon adverse events (>0.1% and <1%) observed during vaginal candidiasis clinical trials associated with fluconazole.

Dermatological.

Pruritus, genital pruritus, rash, erythematous rash, dry skin, abnormal skin odour, urticaria.

Nervous system.

Dizziness, flushing, dry mouth, vertigo, hyperkinesia, hypertonia, taste perversion.

Gastrointestinal.

Constipation, anorexia, flatulence, vomiting, loose stools.

Metabolic.

Thirst.

Psychiatric.

Insomnia, nervousness, female sexual dysfunction.

Reproductive.

Intermenstrual bleeding, dysmenorrhoea, leucorrhoea, menorrhagia, uterine spasm, vaginal disorder.

Respiratory.

Pharyngitis.

Special senses.

Abnormal vision, visual field defect.

Urinary.

Polyuria, renal pain.

General.

Fatigue, hot flushes, malaise, back pain, herpes simplex, pain, rigors.
The following adverse events have occurred during experience with overall fluconazole use:

Blood and lymphatic system.

Leukopenia including neutropenia and agranulocytosis, thrombocytopenia.

Cardiovascular.

QT prolongation, torsade de pointes (see Precautions).

Nervous system.

Seizures.

Immune system disorders.

Anaphylaxis (including face oedema, angioedema, urticaria and pruritus).

Metabolic.

Hypercholesterolaemia, hypertriglyceridaemia and hypokalaemia.

Hepatobiliary disorders.

Hepatic failure, hepatitis, hepatocellular necrosis, jaundice.

Skin and subcutaneous tissue disorders.

Alopecia, exfoliative skin disorders including Steven-Johnson syndrome and toxic epidermal necrolysis.

Dosage and Administration

Adults.

Di-Con One should be administered as a single oral dose.

Use in renal impairment.

Fluconazole is predominantly excreted in the urine as unchanged drug. No adjustments in single-dose therapy are necessary in patients with minor or moderate renal impairment.

Children.

Di-Con One is not recommended in children under 18 years of age.

Overdosage

There have been reports of overdosage with fluconazole, and in one case, a 42-year-old patient infected with human immunodeficiency virus developed hallucinations and exhibited paranoid behaviour after reportedly ingesting 8,200 mg of fluconazole. The patient was admitted to hospital and his condition resolved within 48 hours.
For further information, contact the Poisons Information Centre on 131 126.

Presentation

Di-Con One is a hard gelatin capsule of size ‘1’ with sky blue opaque body and cap.
Each pack contains 1 capsule.
AUST R 152 841

Storage

Store below 30°C. Keep dry and protect from light.

Poison Schedule

S3.