APO-MODAFINIL

APO-MODAFINIL

Active ingredient(s): [modafinil]

---

Consumer Medicine Information (CMI)

This leaflet provides important information about using APO-MODAFINIL. 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 APO-MODAFINIL.

Where to find information in this leaflet:

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

1. Why am I using APO-MODAFINIL?

APO-MODAFINIL contains the active ingredient modafinil.

APO-MODAFINIL is used to improve wakefulness in people with excessive daytime sleepiness associated with the medical condition known as narcolepsy or with Obstructive Sleep Apnoea/Hypopnoea Syndrome (OSAHS), or Shift Work Sleep disorder (SWSD).

In narcolepsy, there is a sudden and irresistible tendency to fall asleep during normal waking hours. This happens at unpredictable times, even when it is inappropriate or may be unsafe to do so. APO-MODAFINIL decreases this unwanted excessive daytime sleepiness.

With OSAHS, daytime sleepiness may occur due to an interrupted nighttime sleep. APO-MODAFINIL only treats the symptom of sleepiness and does not treat the cause of OSAHS. Whilst taking APO-MODAFINIL you should continue with treatments intended to help manage your underlying medical condition, such as Continuous Positive Airway Pressure, unless your doctor tells you otherwise.

If you have been diagnosed with moderate to severe chronic Shift Work Sleep Disorder (SWSD) and non-drug therapies have been unsuitable or unsuccessful, APO-MODAFINIL may be prescribed to keep you awake during your work shift.

Precisely how APO-MODAFINIL works is not known, but it is known that it acts on the central nervous system (the brain). It differs from other stimulant medicines that promote wakefulness. APO-MODAFINIL increases wakefulness. Unlike other stimulants it does not overstimulate or produce a “high” feeling.

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

2. What should I know before I use APO-MODAFINIL?

Warnings

Do not use APO-MODAFINIL if:

• you are allergic to modafinil, or any of the ingredients listed at the end of this leaflet.

Always check the ingredients to make sure you can use this medicine.

• are pregnant currently, planning to become pregnant or likely to become pregnant or are breastfeeding.

Check with your doctor if you:

• are under 18 or over 65 years old
• have a history of mental health problems
• have heart problems, including, for example, angina (chest pain), previous heart attack, enlarged heart
• have an abnormal/irregular heart rhythm
• have high blood pressure or your high blood pressure is controlled by medication
• have kidney or liver problems
• are taking hormonal contraceptives
• are currently receiving treatment for anxiety.

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

If you could become pregnant, you should confirm by a pregnancy test that you are not pregnant within a week prior to starting treatment.

Modafinil is suspected to cause birth defects if taken during pregnancy.

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 APO-MODAFINIL and affect how it works. These include:

• brain stimulants, such as methylphenidate
• any medicines to treat depression, including those called monoamine oxidase inhibitors (MAOIs)
• medicines to treat epilepsy or fits, such as phenytoin, carbamazepine and phenobarbitone
• medicines to treat fungal infections, such as ketoconazole and itraconazole
• medicines to help you sleep (sedatives)
• rifampicin, an antibiotic used to treat tuberculosis
• cyclosporin, a medicine used to stop organ transplant rejection
• propranolol, a medicine used to treat high blood pressure, heart problems or migraine
• warfarin, a medicine used to prevent unwanted blood clotting
• theophylline, a medicine used in asthma and lung problems

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

4. How do I use APO-MODAFINIL?

How much to take / use

The usual daily dose of modafinil depends on individual response

• For sleepiness associated with narcolepsy or OSAHS, the dose ranges from 200 mg to 400 mg. Each day you can take either
  – two APO-MODAFINIL tablets; OR
  – up to four APO-MODAFINIL tablets
• For SWSD, a dose of 200 mg is recommended.

Follow the instructions provided and use APO-MODAFINIL until your doctor tells you to stop.

Do not exceed the recommended daily dose unless directed to do so by your doctor.

When to take / use APO-MODAFINIL

For sleepiness associated with narcolepsy or OSAHS, you should take your APO-MODAFINIL tablets either:

• as two separate doses, one in the morning and one at midday,
• as one dose, in the morning.

For narcolepsy or OSAHS, do not take your APO-MODAFINIL tablets later than midday, or you may have trouble sleeping at night.

For SWSD, you should take your APO-MODAFINIL tablets as a single dose 1 hour prior to commencing your shift work.

How to take APO-MODAFINIL

• swallow tablet whole with a little water

NOTE: Your doctor may start your treatment with less than two tablets a day

If you need more than two tablets per day, your doctor should increase the dose stepwise, one additional tablet at a time, depending on how you respond to the treatment. The highest dose is four tablets per day.

If you are currently on another treatment for narcolepsy, your doctor will advise you how best to withdraw from that treatment and begin taking APO-MODAFINIL. Other stimulants used for narcolepsy may cause a “high” feeling. Be aware therefore that you may feel different as you withdraw from other stimulants.

APO-MODAFINIL only treats the symptom of sleepiness. Other treatments intended to help manage your underlying medical condition should still be used regularly, unless your doctor tells you otherwise. You should commence or continue disease-modifying interventions (for example, Continuous Positive Airway Pressure).

REMEMBER: This medicine is only for you. Only a doctor can prescribe it for you. Never give it to anyone else. It may harm them, even if their symptoms appear to be the same as yours.

If you forget to use APO-MODAFINIL

APO-MODAFINIL should be used regularly at the same time each day.

If you miss your dose, just take the next dose at your usual time.

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

If you use too much APO-MODAFINIL

If you think that you have used too much APO-MODAFINIL, 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 APO-MODAFINIL?

Things you should do

If you could become pregnant, you should confirm by a pregnancy test that you are not pregnant within a week prior to starting treatment.

Tell your doctor if you are planning to become pregnant.

If you become pregnant while you are taking APO-MODAFINIL, stop taking it and tell your doctor immediately.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking APO-MODAFINIL.

Tell your doctor if you believe that APO-MODAFINIL is not helping your condition. Your doctor may need to change the dose.

Call your doctor straight away if you:

• Have any serious side effects listed in Section 6

Remind any doctor, dentist or pharmacist you visit that you are using APO-MODAFINIL.

Things you should not do

• Do not stop using this medicine suddenly.
• Do not give APO-MODAFINIL to anyone else, even if they have the same symptoms as you.

Things to be careful of

APO-MODAFINIL may reduce the effectiveness of hormonal contraceptives (including the contraceptive pill, implants, injectables and some intrauterine devices (IUDs)).

If you are using these forms of contraceptives, you should either use an alternative non-hormonal birth control method together with your current contraceptive while taking APO-MODAFINIL and for 2 months after you stop treatment with APO-MODAFINIL.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how APO-MODAFINIL affects you.

APO-MODAFINIL may cause dizziness in some people.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

• Store APO-MODAFINIL tablets below 25°C

Follow the instructions in the carton on how to take care of your medicine properly.

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, or
• in the car or on window sills.

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.

Do not use this medicine after the expiry date.

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
Body as a whole: headache runny nose sore throat back pain Digestive system: nausea diarrhoea dry mouth poor appetite upset stomach Nervous system nervous feeling dizziness feeling anxious trouble sleeping	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

Other serious side effects: mental (psychiatric) symptoms. including depression, anxiety, aggression, agitation, irritability, hallucinations, mania, thoughts of suicide or other mental problems. chest pain or abnormal heart beats fits or convulsions APO-MODAFINIL may cause a serious rash: skin rash, hives, sores in your mouth, or your skin blisters and peels, swelling of your face, eyes, lips, tongue or throat, trouble swallowing or breathing fever, shortness of breath, swelling of the legs, yellowing of the skin or white of the eyes or dark urine.

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 APO-MODAFINIL contains

Active ingredient (main ingredient)	Modafinil 100 mg
Other ingredients (inactive ingredients)	Lactose monohydrate Microcrystalline cellulose Mannitol Crospovidone Povidone Magnesium stearate
Potential allergens	Sugars as lactose

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

What APO-MODAFINIL looks like

APO-MODAFINIL tablets are white to off-white, capsule shape, biconvex, uncoated tablets with ‘L233’ debossed on one side and plain on the other side (Aust R 395230).

APO-MODAFINIL 100 mg tablets are available in packs of 30 and 60 tablets.

Not all presentations are available.

Who distributes APO-MODAFINIL

Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street
Cremorne VIC 3121

This leaflet was prepared in June 2023.