Consumer medicine information

Halcion Tablets

Triazolam

BRAND INFORMATION

Brand name

Halcion Tablets

Active ingredient

Triazolam

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Halcion Tablets.

What is in this leaflet

This leaflet answers some common questions about Halcion.

It does not contain all of 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 Halcion against the benefits they expect it will have for you.

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

Keep this leaflet with the medicine.

You may need to read it again.

What Halcion is used for

Halcion is used to treat sleeping problems, also called insomnia. It should be used for short-term treatment only, usually 7 - 10 days.

Continuous long-term use is not recommended unless advised by your doctor. The use of Halcion may lead to dependence on the medicine.

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

Halcion belongs to a group of medicines called benzodiazepines. They are thought to work by their action on brain chemicals.

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

Before you take Halcion

When you must not take it

Do not take Halcion if you have an allergy to triazolam, any other benzodiazepine, or any of the ingredients listed under "Ingredients" at the end of this leaflet.

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

Do not take Halcion if you have the following medical conditions:

  • depression
  • severe and chronic lung disease
  • myasthenia gravis, a disease that causes severe muscle weakness.

Do not take Halcion if are taking the following medicines:

  • nefazodone, a medicine used to treat depression
  • ketoconazole and itraconazole, medicines used to treat fungal infections
  • ritonavir and indinavir, medicines to treat HIV infections.

Do not take Halcion if you are pregnant or plan to become pregnant. Do not use in future episodes of insomnia unless you are sure you are not pregnant.

Do not take Halcion if you are breastfeeding or plan to breast-feed.

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

Do not take Halcion after the expiry date (EXP) printed on the pack.

Halcion is not recommended for use in children. Do not give this medicine to children unless advised by the child's doctor.

The safety and effectiveness of Halcion has not been established in children.

Before you start to take it

You must tell your doctor if you:

  1. have any allergies to:
  • Halcion, any other benzodiazepine or any of the ingredients listed at the end of this leaflet
  • any other medicines
  • any other substances, such as foods, preservatives or dyes.
  1. have or have had any other medical conditions including:
  • liver, kidney, heart or lung disease
  • sleep apnoea (when breathing either slows or stops for short periods while sleeping)
  • fits or convulsions
  • high or low blood pressure
  • glaucoma (high pressure in the eye)
  • depression, psychosis or schizophrenia.
  1. have an addiction to any drug including alcohol.
    Alcohol may increase the effects of Halcion.
  2. have experienced an episode of driving, preparing and eating food, making phone calls or other behaviours while not fully awake after having previously taken Halcion or another sleeping pill.
  3. are pregnant or intend to become pregnant.
  4. are breast-feeding or planning to breast-feed.

If you have not told your doctor about any of the above, tell them before you take any Halcion.

Taking other medicines and foods

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

Do not have any grapefruit juice if you are taking Halcion tablets as grapefruit juice may interfere with Halcion.

Some medicines may interfere with Halcion. These include:

  • other sleeping tablets, sedatives or tranquillisers
  • medicines for depression, anxiety or mood disorders
  • medicines for allergies, for example antihistamines, or cold tablets
  • muscle relaxants
  • medicines to control fits
  • pain relievers
  • antibiotics (e.g., erythromycin, clarithromycin and troleandomycin)
  • medicines used to treat reflux and ulcers (e.g., cimetidine)
  • medicines used for various heart conditions (e.g., verapamil and diltiazem)
  • medicines used to control alcohol problems (e.g., disulfiram)
  • medicines used to treat fungal infection (e.g., ketoconazole, itraconazole)
  • medicines used to treat HIV infection (e.g., ritonavir and indinavir).

These medicines may increase the effects of Halcion. You may need to take different amounts of your medicine or you may need to take different medicines. Your doctor will advise you.

Your doctor or pharmacist may have more information on medicines to be careful with or avoid while taking Halcion.

How to take Halcion

How much to take

The usual adult dose is 0.25 mg (2 tablets) before going to sleep. Sometimes your doctor will recommend you take less than this, rarely they might recommend you take more. Follow all your instructions from your doctor or pharmacist about how much Halcion to take.

When to take it

Halcion should be taken immediately before going to bed.

How long to take it

Do not take Halcion for longer than your doctor says.

Halcion should be used for short periods only (usually 7 - 10 days). Continuous long-term use is not recommended unless advised by your doctor. The use of benzodiazepines may lead to dependence on the medicine.

If you forget to take it

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

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

If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.

If you take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Halcion. Do this even if there are no signs of discomfort or poisoning.

You should also report any other medicine or alcohol which has been taken. You may need urgent medical attention. Keep telephone numbers for these places handy.

While you are taking Halcion

Things you must do

Take Halcion exactly as your doctor has prescribed.

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

Tell all doctors, dentists and pharmacists who are treating you that you are taking Halcion.

If you become pregnant while you are taking Halcion, tell your doctor immediately.

Visit your doctor regularly.

Your doctor needs to check your progress and see whether you need to keep taking Halcion.

Always discuss with your doctor any problems or difficulties during or after taking Halcion.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.

Otherwise your doctor may think that it was not effective and change your treatment unnecessarily.

Keep enough Halcion to last weekends and holidays.

Things you must not do

Do not drive or operate machinery until you know how Halcion affects you.

Halcion may cause drowsiness or dizziness in some people and therefore may affect alertness.

Even if you take Halcion at night, you may still be drowsy or dizzy the next day. Caution should be taken when a full night's sleep is not possible. Patients should also take care as pedestrians.

Do not take Halcion for a longer time than your doctor has prescribed.

Halcion should be taken for short periods only (usually 7 to 10 days), unless advised otherwise by your doctor.

Do not change your dose without first checking with your doctor.

Do not stop taking Halcion, without first checking with your doctor.

Stopping this medicine suddenly may cause some unwanted effects. You and your doctor will slowly reduce your dose of Halcion before you can stop taking it completely.

Do not take Halcion to treat any other complaints unless your doctor tells you to.

Do not give Halcion to anyone else, even if their symptoms seem similar to yours.

You must not take more than 4 Halcion tablets (0.5 mg) in a 24 hour period.

Things to be careful of

Be careful when drinking alcohol while taking Halcion.

Combining Halcion and alcohol can make you more sleepy, dizzy or lightheaded.

Alcohol can increase the risk of sleep-walking or other behaviours such as driving or eating food while asleep. Sometimes these behaviours are not remembered by the person taking Halcion. The risk of these behaviours occurring is also increased if you take more than the recommended dose.

Your doctor may suggest that you avoid alcohol or reduce the amount of alcohol you drink while you are taking Halcion.

Be careful if you are elderly, unwell or taking other medicines.

Some people may experience side effects such as drowsiness, confusion, dizziness and unsteadiness, which may increase the risk of a fall.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Halcion, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Like other medicines, Halcion can cause some side effects. If they occur, most are likely to be minor or temporary. However, some may be serious and need medical attention.

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

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

  • drowsiness or sleepiness during the day
  • tiredness
  • light headedness and dizziness
  • difficulty concentrating
  • headache.

These side effects are usually mild.

Tell your doctor immediately if you or anyone has noticed any of the following:

  • confusion, hallucinations
  • difficulty with coordination
  • feeling depressed
  • nervousness, excitation with possible outbursts of anger
  • pains or cramps
  • altered mood
  • anxiety
  • fainting
  • nausea, vomiting
  • transient amnesia or memory impairment
  • rebound insomnia
  • sleep-walking or other behaviours while you are asleep
  • swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
  • hives.

Other side effects not listed above may occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell when you are taking Halcion, or soon after you have finished taking, Halcion.

Ask your doctor or pharmacist if you don't understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking Halcion

Storage

Keep your tablets in their bottle until it is time to take them.

If you take the tablets out of the packaging they may not keep well.

Keep Halcion in a cool dry place where the temperature stays below 30°C.

Do not store it, or any other medicines, in a bathroom or near a sink. Do not leave it in the car or on window sills.

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 taking Halcion or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets left over.

Product description

What it looks like

Halcion tablets are available in strengths of 0.125 mg in bottles of 50 tablets.

Halcion tablets are violet in colour marked with "Upjohn 10".

Halcion tablets can be identified by the Australian Registration Number on the box, AUST R 12304.

Ingredients

The active ingredient in Halcion tablets is triazolam.

Halcion tablets also contain lactose, sodium benzoate, microcrystalline cellulose, colloidal anhydrous silica, maize starch, magnesium stearate, docusate sodium and colouring agents; indigo carmine and erythrosine.

Supplier

Halcion tablets are supplied in Australia by:
Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114
Toll Free Number: 1800 675 229.

This leaflet was revised on December 2013.

© Pfizer Australia Pty Ltd 2013.

®Registered trademark of Pfizer Inc.

BRAND INFORMATION

Brand name

Halcion Tablets

Active ingredient

Triazolam

Schedule

S4