About RESTAVIT™

Brand Information

Brand name: RESTAVIT™

Active ingredient: Doxylamine succinate

Please read this leaflet carefully before you start using RESTAVIT™

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What is in this leaflet?
This leaflet answers some common questions about RESTAVIT™.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

If you have any concerns about taking this medicine, consult your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again.

What RESTAVIT™ is used for
RESTAVIT™helps relieve insomnia. It is intended for short term use to re-establish regular sleep patterns. Do not use it for more than a few days at a time.

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 does RESTAVIT™ work?
RESTAVIT™ 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 RESTAVIT™ is addictive.

Establishing Regular Sleep Patterns
In addition to taking RESTAVIT™, 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 RESTAVIT™
Do not take RESTAVIT™ if you have ever had an allergic reaction to:
• RESTAVIT™ or any of the ingredients listed at the end of this leaflet.
• Dimetapp night time capsules, Dramamine or similar medicines.

Do not take RESTAVIT™ 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

Do not take RESTAVIT™ if you are taking any of the following medicines as they may interfere with each other:
• antidepressant medicines known as monoamine oxidase inhibitors (MAOIs). 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

Consult your doctor or pharmacist if you are breast feeding or plan to breast feed.

Small amounts of RESTAVIT™ pass into breast milk. There is a possibility that the breast-fed baby may become unusually excited or irritable. It is also possible that breast milk supply will be affected.

Do not give RESTAVIT™ to a child under 12 years of age.

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

If you take this medicine after the expiry date has passed, it may not work as well.

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

While you are using RESTAVIT™

Things to be careful of:
Drowsiness on the day following use 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 RESTAVIT™. The effects of alcohol can be increased by some antihistamine medicines including Restavit.

How to take RESTAVIT™
RESTAVIT™ will cause drowsiness and should be used only at bedtime.

Adults
Take one or two tablets 20 minutes before bed. Swallow Restavit with a glass of water. Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

How long to take it
Do not take RESTAVIT™for more than a few days at a time. If sleeplessness persists continuously for longer than this, tell your doctor. Insomnia might be a sign of another medical problem.

Side Effects
RESTAVIT™ helps most people with sleeplessness, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious; most of the time they are not. If you are over 65 years of age, you may have an increased chance of getting side effects.

These are the more common side effects of RESTAVIT™. Mostly these are mild and short-lived.
• drowsiness on the day following use
• dizziness
• incoordination
• dry mouth, nose, and/or throat
• headache
• muscle weakness
• thicker nasal discharge

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

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 immediately if you notice any of the following:
• fast, pounding or irregular heartbeats
• difficulty passing urine
• constipation
• tremors
• nervousness
• restlessness
• excitation
• faintness
• blurred vision
• increased gastric reflux

Overdose
If you think that you or anyone else may have taken too much RESTAVIT™, 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 RESTAVIT™, 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

After using RESTAVIT™

Storage
Store RESTAVIT™ in a cool, dry place where the temperature stays below 30°C.

Do not store it or any other medicine in the bathroom or near a sink.

Keep it where children cannot reach it.

Disposal
If your doctor tells you to stop taking RESTAVIT™, ask your pharmacist what to do with any tablets that are left over.

Product Description
RESTAVIT™ is a white biconvex tablet with a break bar on one side.

Active ingredients:
Doxylamine succinate: 25mg per tablet.

Other ingredients:
• lactose
• maize starch
• microcrystalline cellulose
• magnesium stearate

RESTAVIT™does not contain gluten.

Who makes RESTAVIT™?
RESTAVIT™ is made for
H.W. Woods Pty.Ltd.
8 Clifford Street
Huntingdale
VIC 3166
Email: info@hwwoods.com.au
Australian Registration Number: 13336

This leaflet was updated in October 2023.

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AUSTRALIAN PRODUCT INFORMATION-RESTAVIT (DOXYLAMINE

SUCCINATE)

1.NAME OF THE MEDICINE

Doxylamine succinate

2.QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 25mg doxylamine succinate.

For the full list of excipients, see Section 6.1 List of excipients

3. PHARMACEUTICAL FORM

White uncoated biconvex tablets with a break bar on one side.

4.CLINICAL PARTICULARS

4.1 THERAPEUTIC INDICATIONS

Temporary relief of insomnia

4.2 DOSE AND METHOD OF ADMINISTRATION

Adults: One or two tablets twenty minutes before bed. Swallow tablets with a glass of water.

Restavit should not be used for more than a few days at a time as insomnia may be symptomatic of a serious underlying medical condition.

Children: Do not give to children under 12 years of age

Impaired hepatic and renal function: Dosage reduction may be necessary.

4.3 CONTRAINDICATIONS

Patients with hypersensitivity to doxylamine, other antihistamines in the ethanolamine class, lactose or any other component should not use this product.

Doxylamine should not 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 with 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 with caution.

Use in renal impairment

Use with caution.

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

Use in pregnancy

Category A

Doxylamine Succinate has been taken by a large number of pregnant women and

women of childbearing age without any proven increase in the frequency of

malformations or other direct or indirect harmful effects on the foetus having been

observed.

Use in lactation

Medical or pharmacist advice is required before use in 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 hang-over affects 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 of overdose include 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 Poisons Information Centre on 13 11 26 (Australia)

5. PHARMACOLOGICAL PROPERTIES

5.1 PHARMACODYNAMIC PROPERTIES

Mechanism of Action

Doxylamine is an H1 receptor antagonist antihistamine belonging to the ethanolamine group. This group characteristically produce 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: The drug is well absorbed from the gastrointestinal tract. Following oral administration of a 25mg dose therapeutic effects start within 15 to 30 minutes and are fully developed within one hour. Peak plasma concentration of 100ng/ml7occurs between 2 and 4 hours. The duration of action is 6-8 hours. After 24 hours, the mean plasma level is 21ng/ml.

Distribution: The drug is well absorbed from the gastrointestinal tract and is widely distributed throughout the body.

Metabolism: Metabolism occurs in the liver. The major metabolic pathway is Ndemethylation to N-desmethyldoxylamine and N, N-didesmethyldoxylamine. Nacetyl conjugates of these metabolites have been identified. The activity of these metabolites is unknown. N-glucuronidation has been identified as a minor metabolic route. Additional metabolic pathways found in animal studies include N-oxidation, aromatic hydroxylation and ether cleavage.

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

5.3 PRECLINICAL SAFETY DATA

Genotoxicity

Doxylamine succinate is considered not to be genotoxic

Carcinogenicity

There is inadequate evidence in humans for the carcinogenicity of doxylamine succinate. There is limited evidence in experimental animals for the carcinogenicity of doxylamine succinate

6. PHARMACEUTICAL PARTICULARS

6.1 LIST OF EXCIPIENTS

Lactose, maize starch, microcrystalline cellulose, magnesium stearate

6.2 INCOMPATIBILITIES

Incompatibilities were not assessed as part of the registration of the medicine

6.3 SHELF LIFE

Three years

6.4 SPECIAL PRECAUTIONS FOR STORAGE

Store below 30°C in a dry place

6.5 NATURE AND CONTENTS OF CONTAINER

Cartons containing 20 tablets in two PVC/PVDC blister platforms of 10 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 PHYSIOCOCHEMICAL PROPERTIES

Chemical Structure

2-[(alpha)-(2-dimethylaminoethoxy) (alpha)-methylbenzyl] pyridine succinate

Doxylamine succinate is a white or almost white powder, very soluble in water and

freely soluble in alcohol.

Chemical Formula:

C17H22N2OC4H6O4

Molecular Weight:

388.5

CAS Number

562-10-7

7.MEDICINES SCHEDULE (POISONS STANDARD)

Schedule 3 (S3)

8.SPONSOR

H.W. Woods Pty. Ltd

8 Clifford Street Huntingdale

Victoria 3166.

03 9544 6466

Email: info@hwwoods.com.au

9. DATE OF FIRST APPROVAL:

20 March 2003

10. DATE OF REVISION

5 October 2023 Summary table of changes

Date Section changed Summary of new information

19 July 2019 4.2 Dose and method of administration Updated information on duration of use

19 July 2019 4.6 Fertility, Pregnancy and Lactation Updated information on use in pregnancy and lactation

19 July 2019 5.2 Pharmacokinetic PropertiesMetabolism

Amended information on metabolism

19 July 2019 5.3 Preclinical safety data Amended information on genotoxicity and carcinogenicity

5 October 2023

4.6 Fertility, Pregnancy and Lactation Removal of advice on use in

pregnancy