FLUCONAZOLE APOTEX

FLUCONAZOLE APOTEX

Active ingredient(s): Fluconazole

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Consumer Medicine Information (CMI)

This leaflet provides important information about using FLUCONAZOLE APOTEX. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using FLUCONAZOLE APOTEX.

Where to find information in this leaflet:

1. Why am I using FLUCONAZOLE APOTEX?
2. What should I know before I use FLUCONAZOLE APOTEX?
3. What if I am taking other medicines?
4. How do I use FLUCONAZOLE APOTEX?
5. What should I know while using FLUCONAZOLE APOTEX?
6. Are there any side effects?
7. Product details

1. Why am I using FLUCONAZOLE APOTEX?

FLUCONAZOLE APOTEX is used to treat certain fungal and yeast infections.

FLUCONAZOLE APOTEX belongs to a group of medicines called azole antibiotics. It works by preventing the growth of the fungal and yeast organisms causing your infections.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed this medicine for another reason.

This medicine is available only with a doctor’s prescription.

This medicine is not addictive.

This medicine is not suitable for children weighing less than 35 kg.

2. What should I know before I use FLUCONAZOLE APOTEX?

Warnings

Do not use FLUCONAZOLE APOTEX if:

• you are allergic to fluconazole, or any of the ingredients listed at the end of this leaflet, or related to any medicines such as miconazole, ketoconazole or clotrimazole.
• Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat, or other parts of the body; muscle pain or tenderness or joint pain or rash, itching or hives on the skin.

Do not use FLUCONAZOLE APOTEX if you are taking any of the following medicines:

• terfenadine or astemizole (a medicine used to treat allergies).
• cisapride (a medicine used to treat stomach problems)
• erythromycin (a medicine used to treat infections)
• primozide (a medicine used to treat mental illness)
• quinidine (a medicine used to treat irregular heartbeat).

Check with your doctor if:

• have allergies to any other substances, such as foods, preservatives, or dyes.
• are taking medicines for any other conditions
• have other medical conditions
• have liver problems
• have heart problems
• have kidney problems

Your doctor may need to monitor the function of the liver using blood tests. Be sure to follow the doctor’s advice if regular checks on your liver are recommended.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

FLUCONAZOLE APOTEX use should be avoided during pregnancy except on doctor’s advice for severe or life-threatening infections. Effective contraception should be used in women of childbearing potential and should continue throughout the treatment period and for approximately 1 week after the final dose. Your doctor can discuss with you the risks and benefits involved.

Talk to your doctor about the need for an additional method of contraception while being given FLUCONAZOLE APOTEX.

FLUCONAZOLE APOTEX may decrease the effectiveness of some birth control pills.

FLUCONAZOLE APOTEX is not recommended for use whilst breastfeeding however your doctor can discuss with you the risks and benefits involved.

3. What if I am taking other medicines?

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

Some medicines may interfere with FLUCONAZOLE APOTEX and affect how it works.

These are listed under Section 2.

What should I know before treatment with FLUCONAZOLE APOTEX.

Some medicines and FLUCONAZOLE APOTEX may interfere with each other. These medicines and some others may be affected by FLUCONAZOLE APOTEX or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines. These include:

• some medicines for diabetes such as glipizide, tolbutamide or glibenclamide
• some antibiotics, antiviral and antifungal drugs such as rifampicin, rifabutin, zidovudine, amphotericin B, azithromycin, saquinavir or voriconazole
• some medicines used for heart problems, such as verapamil
• some drugs which affect the immune system, such as ciclosporin, tacrolimus, sirolimus, or tofacitinib
• some medicine use to lower cholesterol such as atorvastatin, simvastatin or Fluvastatin
• cyclophosphamide, vincristine, vinblastine, Olaparib or ibrutinib (use to treat certain types of cancer)
• tolvaptan (used to treat low levels of sodium in your blood or for kidney problems
• halofantrine (used to treat malaria)
• warfarin and other medicines used to prevent blood clots
• phenytoin, used to treat epilepsy
• prednisone (used to treat inflammation or supress the immune system)
• theophylline, used to treat asthma
• some benzodiazepines such as midazolam
• lemborexant (used to treat insomnia or sleeping difficulties)
• ivacaftor (used to manage cystic fibrosis)
• lurasidone (used to manage schizophrenia)
• hydrochlorothiazide (used for treating fluid problems)
• the contraceptive pill (birth control pill)
• carbamazepine, used to treat epilepsy and conditions such as bipolar disorder
• NSAIDS such as naproxen, diclofenac and celecoxib
• opioid pain killers such as alfentanil, fentanyl and methadone
• losartan (used for treating high blood pressure)
• antidepressants such as amitriptyline and nortriptyline.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect FLUCONAZOLE APOTEX.

4. How do I use FLUCONAZOLE APOTEX?

How much to take

• Your doctor will tell you how much of this medicine you should take. This will depend on whether you are taking any other medicines.
• For children, the dose is also dependent on the weight of the child.

When to take FLUCONAZOLE APOTEX

Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.

It does not matter if you take it before, with or after food.

How to take it

Swallow the capsules whole with water.

How long to take it

Continue taking FLUCONAZOLE APOTEX until you finish the pack or until your doctor recommends.

The length of time you take FLUCONAZOLE APOTEX will depend on the sort of infection you have.

Patients with a weakened immune system or those with difficult infections may need long-term treatment to prevent the infection from returning.

Do not stop taking your FLUCONAZOLE APOTEX because you are feeling better. If you do not complete the full course prescribed by your doctor, the infection may not clear completely or your symptoms may return.

If you forget to take FLUCONAZOLE APOTEX

If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time.

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

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

If you use too much FLUCONAZOLE APOTEX

If you think that you have used too much FLUCONAZOLE APOTEX, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using FLUCONAZOLE APOTEX?

Things you should do

• If you are a woman of child-bearing age, you should avoid becoming pregnant while taking FLUCONAZOLE APOTEX. Talk to your doctor about the need for an additional method of contraception while being given FLUCONAZOLE APOTEX.
  If you do become pregnant while taking FLUCONAZOLE APOTEX, tell your doctor immediately.
• If you suffer from HIV or have a weakened immune system and develop a rash while taking FLUCONAZOLE APOTEX, tell your doctor immediately.
  If this rash worsens, FLUCONAZOLE APOTEX may need to be stopped.
• Be sure to follow your doctor’s advice if regular checks on your liver are recommended. In rare cases, FLUCONAZOLE APOTEX may affect the liver and may need to be stopped.
• If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.
• Remind any doctor, dentist, or pharmacist you visit that you are using FLUCONAZOLE APOTEX.

Things you should not do

• Do not start treatment if you have ever had an allergic reaction to any medicine containing fluconazole, any of the ingredients listed at the end of this CMI
• Do not stop taking FLUCONAZOLE APOTEX or lower the dosage without checking with your doctor.
  If you do not complete the full course prescribed by your doctor, all the organisms causing your infection may not be killed. These organisms may continue to grow and multiply so that your infection may not clear completely or may return.
• Do not give your medicine to anyone else, even if they have the same condition as you.
• Do not use FLUCONAZOLE APOTEX to treat any other medical complaints unless your doctor tells you to.

Driving or using machines

Be careful before you drive operate machinery as occasional dizziness or seizures may occur.

Drinking alcohol

No information available.

Looking after your medicine

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

If you take it out of the pack it may not keep well. Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink,
• in the car or on window sills.

Store FLUCONAZOLE APOTEX below 25°C.

Do not use this medicine after the expiry date.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
nausea or feeling sick, vomiting headache stomach pain, indigestion, diarrhoea acne blurred or abnormal vision hot flushes constipation low blood potassium which can result in fatigue, muscle cramps and abnormal heart rhythms* changes in liver function* * These side effects may show up when you have a blood test.	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

Allergy or reaction related: swelling of the face, lips or tongue difficulty in swallowing or breathing asthma, wheezing, shortness of breath Skin Changes: yellowing of the skin or eyes, also called jaundice sudden or sever itching, skin rash, or hives bleeding or bruising more easily than normal reddish or purplish blotches under the skin flaking of the skin Changes to urine: dark urine and light coloured bowel movements (cholestasis) Signs of frequent or worrying infections such as: fever, severe chills, sore throat or mouth ulcers Other: fainting, seizures or fits fast or irregular heartbeat increased sweating

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What FLUCONAZOLE APOTEX contains

Active ingredient (main ingredient)	Fluconazole
Other ingredients (inactive ingredients)	lactose monohydrate maize starch colloidal anhydrous silica magnesium stearate sodium lauryl sulfate The capsule shells contain: Patent blue V titanium dioxide gelatin erythrosine purified water
Potential allergens	Sugars as lactose May contain traces of sulfites and phenylalanine

Do not take this medicine if you are allergic to any of these ingredients.

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

What FLUCONAZOLE APOTEX looks like

200 mg capsules – Purple/ white hard gelatin self-locked capsules of size ‘0’ containing white to off white powder.

AUST R – 293315

Available in blister packs of 28 capsules.

Who distributes FLUCONAZOLE APOTEX

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113

This leaflet was prepared in February 2023