About SNUZAID®
Brand Information
Brand name: SNUZAID ®TABS
Active Ingredient: Diphenhydramine Hydrochloride
CONSUMER MEDICINE INFORMATION (CMI) LEAFLET
Please read this leaflet carefully before you start using SNUZAID ®TABS.
What is in this leaflet?
This leaflet answers some common questions about SNUZAID ®TABS. 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 SNUZAID®TABS are used for
SNUZAID®TABS help relieve insomnia. They are intended for short term use to re-establish regular sleep patterns. Do not use them 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 medicines
How do SNUZAID®TABS work?
SNUZAID®TABS belong to a group of medicines called antihistamines. Some antihistamines, including diphenhydramine cause the central nervous system to slow down and this provides relief for insomnia. There is no evidence that SNUZAID®TABS are addictive.
Establishing Regular Sleep Patterns
In addition to taking SNUZAID®TABS, 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 (eg. 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 SNUZAID®TABS
Do not take SNUZAID®TABS if you have ever had an allergic reaction to:
• SNUZAID®TABS or any of the ingredients listed at the end of this leaflet.
• Other medications containing antihistamines eg. travel sickness preparations such as Dramamine
Do not take SNUZAID®TABS 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
• porphyria
Do not take SNUZAID®TABS if you are taking or being given 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 2 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 SNUZAID®TABS 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 SNUZAID®TABS to a child under 12 years of age.
Do not take SNUZAID®TABS 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 SNUZAID®TABS if the packaging is torn or shows signs of tampering.
While you are using SNUZAID®TABS
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 SNUZAID®TABS as the effects of drowsiness and incoordination may be increased
How to take SNUZAID®TABS
SNUZAID®TABS will cause drowsiness and should be used only at bedtime.
Adults
Take one (1) tablet 20 minutes before bed when necessary. Swallow 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 SNUZAID®TABS 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
SNUZAID®TABS help most people with sleeplessness, but they 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 SNUZAID®TABS. 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
• nightmares
• ringing in the ears
• excitation
• faintness
• blurred vision
• increased gastric reflux
Overdose
If you think that you or anyone else may have taken too many SNUZAID®TABS 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 many SNUZAID®TABS 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 3
• hallucinations
• seizures
• convulsions
• insomnia
• dilated pupils
• delirium
After using SNUZAID®TABS
Storage
Keep your tablets in a cool dry place where the temperature stays below 30°C.
Do not store them or any other medicine in the bathroom or near a sink.
Keep them where children cannot reach them.
Disposal
If your doctor tells you to stop taking SNUZAID®TABS ask your pharmacist what to do with any tablets that are left over.
Product Description
SNUZAID®TABS are white bi-convex tablets with a break bar on one side.
Active ingredients:
Diphenhydramine hydrochloride 50 mg per tablet.
Other ingredients:
• microcrystalline cellulose
• crospovidone
• povidone
• colloidal anhydrous silica
• pregelatinized maize starch
• magnesium stearate
Who makes SNUZAID®TABS?
SNUZAID®TABS are made for:
H.W. Woods Pty.Ltd.
8 Clifford Street Huntingdale
VIC
3166
Email:
info@hwwoods.com.au
Australian Registration Number: AUSTR 129483
This leaflet was updated in February 2024.
AUSTRALIAN PRODUCT INFORMATION (PI) LEAFLET
AUSTRALIAN PRODUCT INFORMATION - SNUZAID®TABS
DIPHENHYDRAMINE HYDROCHLORIDE
1.NAME OF THE MEDICINE
Diphenhydramine hydrochloride
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg diphenhydramine hydrochloride
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
For oral administration
Adults: One (1) tablet twenty minutes before bed when necessary. Swallow tablet with a glass of water.
Snuzaid Tabs 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: Use with caution. Dosage reduction may be necessary
4.3 CONTRAINDICATIONS
Hypersensitivity to diphenhydramine or any other component. Diphenhydramine should not be given to newborn infants due to their heightened sensitivity towards anticholinergic side effects. It is contraindicated in patients with severe hepatic, renal or respiratory insufficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid concurrent use with alcohol and other 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 bladder neck obstruction, urinary retention, chronic bronchitis, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, porphyria, asthma and epilepsy. The antiemetic properties of diphenhydramine may mask the symptoms of certain serious medical conditions e.g. appendicitis.
Use in hepatic impairment:
Use with caution. The elimination half-life in cirrhotic patients has been demonstrated to be longer in one study.
Use in renal impairment:
Use with caution
Use in the elderly:
Use with caution due to enhanced susceptibility to adverse effects.
Paediatric Use:
Do not give to children under 12 years of age due to heightened sensitivity towards paradoxical stimulation.
Effects on laboratory tests:
Diphenhydramine 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
Anticholinergic effects are prolonged and intensified when used with MAOIs, tricyclic antidepressants and atropine like drugs. Concurrent use with other sedatives (e.g. benzodiazepines and barbiturates), tranquilizers, opioid analgesics and antipsychotics enhances the effects of CNS depression. Use with ototoxic medications e.g. aminoglycoside antibiotics may mask the symptoms of ototoxicity. These include tinnitus, dizziness and vertigo.
4.6 FERTILITY, PREGNANCY AND LACTATION
Effects on fertility
Diphenhydramine crosses the placenta. Therapeutic doses during pregnancy are considered unlikely to pose a substantial teratogenic risk. Studies in rats and rabbits at doses up to five times the human dose have revealed no evidence of impaired fertility or harm to the fetus but no well controlled studies in pregnant women have been done.
Use in pregnancy
Category A: Diphenhydramine hydrochloride 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 fetus having been observed.
Use in lactation
Medical or pharmacist advice is required before use in breastfeeding. Small amounts of diphenhydramine are excreted into breast milk. Use is not recommended because of the risk of adverse effects in infants i.e. unusual excitement or irritability.
Anticholinergic effects may inhibit lactation.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Drowsiness and hangover effects may affect the ability to drive and operate machinery the day following use.
4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)
More common reactions:
Dizziness, disturbed coordination, lassitude, headache, muscular weakness and psychomotor impairment. Anticholinergic effects include dry nose, throat and mouth and thickened respiratory tract secretions.
Less common reactions:
Paradoxical stimulation of the CNS may occur and is much more likely to occur in children.
Symptoms are nervousness, restlessness, unusual excitement, tinnitus, nightmares and irritability. Other adverse effects include tachycardia, palpitations, increased sweating and hypotension (particularly in the elderly). Less common anticholinergic effects are 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 overdosage include severe drowsiness and dryness of the mouth, nose and throat, redness or flushing in the face, shortness of breath, tachycardia, cardiac arrhythmia, dilated pupils, delirium and seizures. Rhabdomyolysis is a possible complication.
In children, CNS stimulation predominates over depression causing ataxia, excitement, tremors, psychoses, hallucinations and convulsions.
For information on the management of overdose, contact the Poisons information Centre on 13 11 26 for advice.
5. PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
Mechanism of Action:
Diphenhydramine is a 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-methyl transferase and blockage of the central histaminergic receptors. Antagonism of other CNS receptor sites such as those for serotonin, acetylcholine and alpha-adrenergic stimulation may be involved. Anticholinergic activity at muscarinic receptors also occurs.
Clinical Trials
No data available
5.2 PHARMACOKINETIC PROPERTIES
Absorption: Diphenhydramine is well absorbed after oral administration. In one study, following administration of an oral dose of 50mg, the peak plasma concentration was measured at 66ng/ml after 2.3 hours. Other studies show peak concentrations occur between 2 and 4 hours with duration of activity between 4 and 6 hours.
Distribution: It is distributed throughout the body with high concentrations found in the lungs. It is up to 85% protein bound (76% in Asians). The volume of distribution is in the range 3.3-6.9L/kg (6.9L/kg for Asians). The high Vd for Asians may be explained by the reduced protein binding.
Metabolism: Metabolism occurs in the liver via the P-450 system. A high first pass effect is observed following oral administration with at least half metabolized before reaching the general circulation. Two successive N-demethylations occur to produce a primary amine, which is further oxidized to diphenylmethoxyacetic acid. This appears in the urine as glutamine and glucuronide conjugates as well as in the unconjugated form. Less than 1% is excreted unchanged in the urine. None of the metabolites are active.
Excretion: Approximately 65% of a dose is excreted in the urine within four days, almost entirely as metabolites. The terminal elimination half-life ranges between 3 and 9 hours
5.3 PRECLINICAL SAFETY DATA
Genotoxicity
Long term animal studies to evaluate the genotoxic 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
microcrystalline cellulose, crospovidone, povidone, colloidal anhydrous silica, pre-gelatinized maize starch, magnesium stearate
6.2 INCOMPATIBILITIES
Incompatibilities were not assessed as part of the registration of the medicine. Refer to 4.5 Interactions with Other Medicines for information on incompatibilities.
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 10 tablets in a PVC/PVDC blister platform
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:
2- (diphenyl methoxy)-N, N-dimethyl ethylamine hydrochloride
Diphenhydramine hydrochloride is a water soluble, white, odourless crystalline powder
Chemical Formula:
C17H21NOHCl
Molecular weight:
291.82
CAS Number:
147-24-0
7. MEDICINES SCHEDULE (POISONS STANDARD)
Schedule 3 (S3)
8. SPONSOR
H.W. Woods Pty. Ltd.
8 Clifford Street Huntingdale Victoria 3166.
03 9544 6466
info@hwwoods.com.au
9. DATE OF FIRST APPROVAL:
13 July 2006
10. DATE OF REVISION
15 February 2024
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
15 February 2024 4.6 Fertility, Pregnancy and Lactation Removal of advice on use in pregnancy.