Consumer medicine information

APOHEALTH Sleep Assist Tablets

Doxylamine succinate

BRAND INFORMATION

Brand name

APOHealth Sleep Assist

Active ingredient

Doxylamine succinate

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APOHEALTH Sleep Assist Tablets.

What is in this leaflet?

Read this leaflet carefully before taking your medicine.

This leaflet answers some common questions about APOHEALTH Sleep Assist tablets. It does not contain all the available information.

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

The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.

Ask your doctor or pharmacist:

  • if there is anything you do not understand in this leaflet,
  • if you are worried about taking your medicine, or
  • to obtain the most up-to-date information.

You can also download the most up to date leaflet from www.apotex.com.au.

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

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

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

What this medicine is used for

APOHEALTH Sleep Assist tablets helps relieve insomnia. It is intended for short term use to re-establish regular sleep patterns. Do not use it for more than ten days consecutively.

What is insomnia?

Insomnia is having trouble getting to sleep or staying asleep. It may also be the feeling that you are not getting enough sleep.

What causes insomnia?

Insomnia may be caused by some or all of the following:

  • stress
  • noise
  • late night eating
  • late night exercise
  • inactive lifestyle
  • drinking too much tea, coffee or cola
  • taking medicines containing stimulants such as cold or flu medicines

How it works

APOHEALTH Sleep Assist tablets belongs to a group of medicines called antihistamines. They block the action of histamine and other substances produced by the body to provide relief from allergic symptoms. Some antihistamines, including doxylamine cause the central nervous system to slow down at the same time and this provides relief for insomnia.

There is no evidence that this medicine is addictive.

Establishing Regular Sleep Patterns
In addition to taking APOHEALTH Sleep Assist, the following good sleep habits must be established and maintained:

  • go to bed and rise at the same time daily
  • engage in relaxing activities before bedtime
  • exercise regularly but not late in the evening
  • avoid eating meals or large snacks just before bedtime
  • eliminate day time naps
  • avoid caffeine containing drinks after midday
  • avoid alcohol or the use of nicotine late in the evening
  • minimise external disruption (e.g. light and noise)
  • if you are unable to sleep, do not become anxious; leave the bedroom and participate in relaxing activities such as reading or listening to music until you are tired.

Before you take this medicine

When you must not take it

Do not take this medicine if you have, or have had any of the following medical conditions:

  • asthma
  • chronic bronchitis
  • severe liver or kidney disease
  • closed-angle glaucoma
  • prostate problems
  • difficulty passing urine
  • a narrowing or blockage between the stomach and small intestine which causes vomiting of undigested food
  • epilepsy
  • You are pregnant or intend to become pregnant.
    Like most antihistamine medicines APOHEALTH Sleep Assist tablets is not recommended for use during pregnancy. APOHEALTH Sleep Assist tablets is not known to cause birth defects but studies to prove it is safe for the developing baby have not been done.
  • You are breastfeeding or plan to breastfeed.
    Small amounts of APOHEALTH Sleep Assist tablets pass into breast milk. There is a possibility that the breastfed baby may become unusually excited or irritable. It is also possible that breast milk supply will be affected.
  • You are hypersensitive to, or have had an allergic reaction to, APOHEALTH Sleep Assist, Dimetapp night time capsules, Dramamine or similar medicines or any of the ingredients listed at the end of this leaflet.
    Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.
    If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
  • The expiry date (EXP) printed on the pack has passed.
  • The packaging is torn, shows signs of tampering or it does not look quite right.

Some medicines may interact with APOHEALTH Sleep Assist These include:

  • antidepressant medicines known as monoamine oxidase inhibitors (MAOI's). These include moclobemide (Arima, Aurorix), phenelzine (Nardil) and tranylcypromine (Parnate)
  • tricyclic antidepressant medicines such as amitriptyline (Tryptanol), imipramine (Melipramine), nortriptyline (Allegron) and doxepin (Deptran)
  • strong pain killers such as codeine and morphine.
  • other medicines used to help you sleep including temazepam (Temaze, Normison) triazolam (Halcion) or nitrazepam (Mogadon)
  • medicines used to treat anxiety such as oxazepam (Serapax) or diazepam (Valium)
  • antibiotics known as aminoglycosides such as tobramycin.

Do not give APOHEALTH Sleep Assist tablet to a child under 12 years of age.

How to take this medicine

Follow carefully all directions given to you by your doctor or pharmacist. Their instructions may be different to the information in this leaflet.

APOHEALTH Sleep Assist tablets will cause drowsiness and should be used only at bedtime.

How much to take

Adults:
Take one or two tablets 20 minutes before bed. Swallow APOHEALTH Sleep Assist tablets with a glass of water.

How long to take it for

Do not take APOHEALTH Sleep Assist tablets for more than ten days. If sleeplessness persists continuously for longer than this tell your doctor. Insomnia might be a sign of another medical problem.

While you are taking this medicine

Things you must do

Tell your doctor that you are taking this medicine if:

  • you are about to be started on any new medicine
  • you are pregnant or are planning to become pregnant
  • you are breastfeeding or are planning to breast-feed
  • you are about to have any blood tests
  • you are going to have surgery or an anaesthetic or are going into hospital.

Things you must not do

Do not:

  • Give this medicine to anyone else, even if their symptoms seem similar to yours.
  • Take your medicine to treat any other condition unless your doctor or pharmacist tells you to.
  • Change the recommended dosage without first checking with your doctor or pharmacist.

Things to be careful of

Drowsiness on the following day may occur.

Use extreme care while doing anything that involves complete alertness such as driving a car, operating machinery, or piloting an aircraft.

Be careful drinking alcohol while taking this medicine. The effects of alcohol can be increased by some antihistamine medicines including APOHEALTH Sleep Assist tablets.

Possible side Effects

Tell your doctor as soon as possible if you do not feel well while you are taking APOHEALTH Sleep Assist tablets or if you have any questions or concerns.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

If you are over 65 years of age you may have an increased chance of experiencing side effects.

These are the more common side effects of APOHEALTH Sleep Assist tablets. Mostly these are mild and short lived.

Tell your doctor if you notice any of the following:

  • drowsiness on the day following use
  • dizziness
  • incoordination
  • dry mouth, nose and/or throat
  • headache
  • muscle weakness
  • thicker nasal discharge

Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Serious side effects are rare.

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

These may be serious side effects and you may need medical attention:

  • fast, pounding or irregular heartbeats
  • difficulty passing urine
  • constipation
  • tremors
  • nervousness
  • restlessness
  • excitation
  • faintness
  • blurred vision
  • increased gastric reflux

If you take too much (overdose)

If you think that you or anyone else may have taken too much APOHEALTH Sleep Assist Tablets, immediately contact your doctor, pharmacist or the Poisons Information Centre (telephone 13 11 26). Do this even if there are no signs of discomfort or poisoning.

If you have taken too much of this medicine, you may suffer:

  • severe drowsiness
  • severe dryness of the mouth, nose and throat
  • flushing or redness in the face
  • fast, pounding or irregular heartbeats
  • shortness of breath
  • hallucinations
  • seizures
  • convulsions
  • insomnia
  • dilated pupils
  • delirium

Storage and disposal

Storage

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

If you take your medicine out of its original packaging it may not keep well.

Keep your medicine in a cool dry place where the temperature will stay below 25°C.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it on the window sill or in the car. Heat and dampness can destroy some medicines.

Keep this medicine 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 or pharmacist tells you to stop taking this medicine, ask your pharmacist what to do with any tablets that are left over.

Product Description

APOHEALTH Sleep Assist tablets are white to off white circular biconvex uncoated tablets, breakline on one side and plain on the other and in packs of 20.

Ingredients:

Each tablet contains 25 mg of Doxylamine succinate as the active ingredient.

It also contains the following inactive ingredients:

  • lactose monohydrate
  • maize starch
  • microcrystalline cellulose
  • magnesium stearate
  • purified water

This medicine is gluten-free.

This medicine contains sugars as lactose.

Australian Registration Number

APOHEALTH Sleep Assist doxylamine succinate 25 mg tablet (Blister pack): 254173

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113

This leaflet was last updated in November 2021.

Published by MIMS December 2021

BRAND INFORMATION

Brand name

APOHealth Sleep Assist

Active ingredient

Doxylamine succinate

Schedule

S3

 

1 Name of Medicine

Doxylamine succinate.

2 Qualitative and Quantitative Composition

This medicine contains 25 mg doxylamine succinate as the active ingredient. It also contains lactose monohydrate, maize starch, microcrystalline cellulose and magnesium stearate, purified water.

3 Pharmaceutical Form

25 mg Tablets.

White to off white, circular, biconvex, uncoated tablets with a breakline on one side and plain on the other.

4 Clinical Particulars

4.1 Therapeutic Indications

For the temporary relief of sleeplessness.

4.2 Dose and Method of Administration

One or two tablets twenty minutes before bed.
This medicine should not be used for more than ten days consecutively.

Children.

Do not give to children under 12 years of age.

4.3 Contraindications

Hypersensitivity to doxylamine, other antihistamines in the ethanolamine class, lactose or any other component.
Doxylamine should not to be given to premature or newborn infants due to their heightened susceptibility to antimuscarinic effects.

4.4 Special Warnings and Precautions for Use

Avoid concurrent use with alcohol and medications which suppress the CNS as the effects of both may be enhanced.
A risk/ benefit approach should be adopted for patients with glaucoma. Increased ocular pressure could precipitate an attack of angle closure glaucoma. Use in caution in patients with asthma, bladder neck obstruction, urinary retention, chronic bronchitis, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy and epilepsy.

Use in hepatic impairment.

Use in caution. Dosage reduction may be necessary.

Use in renal impairment.

Use with caution. Dosage reduction may be necessary.

Use in the elderly.

Use with caution as studies indicate a longer duration of action, especially for elderly men. This, and enhanced susceptibility to antimuscarinic side effects, suggest dosage reduction may be necessary.

Paediatric use.

Do not give to children under 12 years of age due to heightened sensitivity towards paradoxical stimulation.

Effects on laboratory tests.

Antihistamines may inhibit the cutaneous histamine response. Discontinue at least 72 hours before skin testing begins.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Doxylamine has additive antimuscarinic effects with atropine-like drugs, tricyclic antidepressants and MAOIs. Concurrent use with other drugs and substances which suppress the CNS should be avoided. These include alcohol, sedatives (such as benzodiazepines and barbiturates), tranquillizers (e.g. antipsychotics) and opioid analgesics. Use with ototoxic medications, e.g. aminoglycoside antibiotics, may mask the symptoms of ototoxicity such as tinnitus, dizziness or vertigo.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Do not use during pregnancy.
 Do not use if breastfeeding. Doxylamine may be excreted into breast milk in small amounts and cause unusual excitement or irritability in infants. Anticholinergic effects may inhibit lactation.

4.7 Effects on Ability to Drive and Use Machines

Drowsiness and hangover effects may affect ability to drive or operate machinery the day following use.

4.8 Adverse Effects (Undesirable Effects)

More common reactions.

Drowsiness, dizziness, lassitude, disturbed coordination, headache, psychomotor impairment and muscular weakness. Antimuscarinic effects include dry mouth, nose and throat and thickened respiratory tract secretions.

Less common reactions.

Paradoxical stimulation of the CNS with the possibility of insomnia, unusual excitement, tremors, nervousness and restlessness. These effects are more likely to occur in children.
Other adverse reactions include tachycardia, palpitations, hypotension, blurred vision, urinary difficulty or retention, constipation and increased gastric reflux.

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 http://www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms.

Severe drowsiness, severe dryness of the mouth, nose and throat, flushing or redness in the face, shortness of breath, tachycardia, CNS stimulation, hallucinations, seizures, insomnia, hypotension, delirium, convulsions and fixed and dilated pupils. Coma progressing to respiratory failure and cardiovascular collapse may occur.
Cardiorespiratory collapse and death may occur several days after onset of toxic symptoms.
Children are at higher risk for cardiorespiratory arrest. Rhabdomyolysis and subsequent acute renal failure may also occur in certain individuals (adults).
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Doxylamine succinate is an H1-receptor antagonist antihistamine belonging to the ethanolamine group. This group characteristically produces pronounced sedative effects with low incidence of gastrointestinal disturbance. The significant sedative properties result from inhibition of histamine N-methyltransferase and blockage of central histaminergic receptors. Antagonism of other CNS receptor sites such as those for serotonin, acetyl choline and alpha-adrenergic stimulation may be involved. Anticholinergic activity at muscarinic receptors also occurs.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Following oral administration of a 25 mg dose therapeutic effects start within 15 to 30 minutes and are fully developed within one hour. Peak plasma concentrations of 100 nanogram/mL occurs between two and four hours. The duration of action is six to eight hours. After 24 hours the mean plasma level is 21 nanogram/mL.

Distribution.

The drug is well absorbed from the gastrointestinal tract and it's distributed widely throughout the body.

Metabolism.

Metabolism occurs in the liver by microsomal oxidation. The major metabolic pathway is N-demethylation to N-desmethyldoxylamine and N,N-didesmethyldoxylamine. N-acetyl conjugates of these metabolites have been identified. The activity of these metabolites is unknown. N-glucuronidation has been identified as a minor metabolic route. More detailed pharmacokinetic studies have not been performed.

Excretion.

The elimination half-life has been reported at 10.1 and 12 hours. It is prolonged in geriatric males at 15.5 ± 2.1 hours.

5.3 Preclinical Safety Data

Genotoxicity.

Long-term animal studies to evaluate the mutagenic potential have not been performed.

Carcinogenicity.

Long-term animal studies to evaluate the carcinogenic potential have not been performed.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition; Section 3 Pharmaceutical Form.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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

Blister packs of 20 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.


Chemical name: 2-[(alpha}- 2-diethylaminethocy) (alpha)-methylbenzyl] pyridine succinate.
Molecular formula: C17H22N2O.C4H6O4.
MW: 388.5.

CAS number.

562-10-7.

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist Only Medicine.

Summary Table of Changes