Consumer medicine information

Avomine Tablets

Promethazine theoclate

BRAND INFORMATION

Brand name

Avomine Tablets

Active ingredient

Promethazine theoclate

Schedule

S3

 

Consumer medicine information (CMI) leaflet

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

What is in this leaflet

This leaflet answers some common questions about Avomine tablets.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist who have more detailed information.

All medicines have risks and benefits.

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

Keep this leaflet with the medicine as you may want to read it again.

What Avomine is used for

Avomine belongs to a group of medicines called phenothiazines.

Avomine is used to prevent or treat motion sickness.

Avomine is also used to prevent or treat nausea (feeling sick) and vomiting associated with other causes including:

  • other medicines
  • radiation treatment
  • migraine (severe headache)
  • infectious diseases
  • problems with balance

Do not give Avomine to children 9 years of age or under.

Before you take Avomine

When you must not take it

Do not take Avomine if you have an allergy to Avomine or any of the ingredients listed at the end of the leaflet.

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

Do not take Avomine after the expiry date printed on the pack.

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

Do not give Avomine to children 9 years of age or under.

Do not give Avomine to children or adolescents with signs or symptoms of Reye's Syndrome.

Symptoms include feeling sick, vomiting, tiredness, lack of energy, and indifference.

Tell your pharmacist or doctor if:

  • you are pregnant or intend to become pregnant
  • you are breastfeeding or plan to breastfeed
  • you are allergic to any other medicines, foods, dyes or preservatives

Tell your pharmacist or doctor if you have or have had any medical conditions, especially the following:

  • asthma, bronchitis or a persistent cough
  • epilepsy, seizures or fits
  • liver or kidney disease
  • fast or irregular heart beat
  • stomach problems
  • difficulty passing urine
  • glaucoma, a condition in which there is usually a build up of fluid in the eye
  • severe heart disease, caused by poor blood flow in the blood vessels of the heart. The first symptom is usually angina or heart attack

Taking other medicines

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

Do not take Avomine if you are taking or being given any of the following medicines:

  • Sedatives or hypnotics, medicines used to produce calmness or to help you sleep
  • Anticholinergic agents, including medicines used to treat stomach cramps, travel sickness or Parkinson's Disease
  • Antidepressants, medicines used to treat depression
  • Other antihistamines, medicines used to prevent the symptoms of allergy (such as hay fever)
  • Alcohol

These medicines may be affected by Avomine, or may affect how well it works. Your pharmacist or doctor will have more information on medicines to be careful with or avoid while taking Avomine.

If you are not sure whether you should start taking Avomine, contact your pharmacist or doctor.

How to take Avomine

Adults:
Prevention of travel sickness:
For long journeys swallow one tablet with water each night at bedtime, starting the night before travelling. For short journeys, swallow one tablet 1 to 2 hours before the start of the journey.

Treatment of travel sickness:
Swallow one tablet with water and then a second tablet the same evening. A third tablet should then be taken on the following evening. Additional tablets may be taken to prevent travel sickness or when they appear to be needed. It is rare to need to take more than 1 tablet in 8 hours. Do not take more than 4 tablets in 24 hours.

Nausea and vomiting due to other causes:
Swallow one tablet with water as required. One tablet at bedtime is usually enough.

Do not take more than 4 tablets in 24 hours.

Children:

Do not give Avomine to children 9 years of age or under.

Avomine Tablets may be crushed and then mixed with water before administering to children or any individual that has difficulty swallowing tablets.

Phenergan Elixir is more suitable for use in young children.

Children over 10 years of age:give the corresponding adult dose.

Do not take more than the recommended dose.

If you do not understand the instructions, ask your pharmacist or doctor for help.

If you forget to take them

If you miss your dose and you do not feel sick take your next dose when you are meant to.

If you miss your dose, and you feel sick, take the missed dose as soon as possible, then go back to taking your Avomine tablets as you would normally. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

What do I do in case of Overdose?

Immediately telephone your doctor or pharmacist 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. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using Avomine

Things you must do

Tell any other doctors, dentists, and pharmacists who are treating you that you are taking Avomine.

Things you must not do

Do not give Avomine to anyone else, even if their symptoms seem to be the same as yours.

Do not take Avomine to treat any other complaints unless your pharmacist or doctor tells you to.

Things to be careful of

Avomine may cause drowsiness in some people. Make sure you know how your react to Avomine before you drive a car, operate machinery, or do anything else that could be dangerous if you are drowsy. If this occurs do not drive or operate machinery.

Avoid alcohol while you are taking Avomine.

Tell your doctor if you need to take a pregnancy or skin allergy test. Avomine may interfere with the test results.

Side Effects

Tell your pharmacist or doctor as soon as possible if you do not feel well while taking Avomine.

Like all other medicines, Avomine may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. Your pharmacist or doctor will be able to answer any questions you may have.

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

  • tiredness, sleepiness
  • anxiety, restlessness
  • dizziness
  • constipation or diarrhoea
  • loss of appetite
  • nausea or vomiting
  • stomach upset
  • dry mouth
  • blurred vision

Tell your doctor immediately or go to accident and emergency at the nearest hospital if you notice any of the following:

  • fast or irregular heart beat
  • tremors or convulsions
  • swelling of the face, lips or tongue
  • wheezing or trouble breathing
  • skin rash or hives

These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.

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.

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

After using Avomine

Storage

Keep your tablets in a cool, dry place where the temperature stays below 30°C.

Do not store Avomine or any other medicine in the bathroom or near a sink. Do not leave it in the car on hot days or on window sills.

Heat and dampness can destroy some medicines.

Keep your tablets in a safe place out of the reach of children.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your pharmacist or doctor has told you to stop taking Avomine or it has passed the expiry date, ask your pharmacist what to do with any that are left over.

Product Description

What do Avomine tablets look like?

Avomine tablets are white, plain on one side and with a line on the other.

Avomine tablets are available in blister packs of 30 tablets.

What are the ingredients in Avomine tablets?

Each tablet contains 25 mg of promethazine theoclate (the active ingredient), wheat starch, lactose, dextrin, talc and magnesium stearate.

Avomine contains lactose and gluten.

Manufacturer

Avomine is supplied in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113

Avomine is supplied in New Zealand by:
sanofi-aventis new zealand limited
Level 8, James & Wells Tower
56 Cawley Street
Ellerslie, Auckland

Avomine 25 mg tablets AUST R 27484
30 tablet Pack

Date of Preparation: July 2009

BRAND INFORMATION

Brand name

Avomine Tablets

Active ingredient

Promethazine theoclate

Schedule

S3

 

Name of the medicine

Promethazine theoclate.

Actions

Antihistamine, antinauseant.

Indications

Although the primary indication for Avomine is the prevention and treatment of motion sickness, It has also been used in the treatment and prevention of nausea and vomiting due to other causes, including gastroenteritis, vestibular disturbance, drug intolerance, migraine, infectious diseases and radiation therapy.

Contraindications

Avomine should not be used in patients who are in a coma or suffering from CNS depression of any cause. It must not be given to patients hypersensitive to phenothiazines. Avomine should be avoided in patients who have been taking monoamine oxidase inhibitors within the previous 14 days.

Use in children.

Avomine should not be used in children less than 10 years of age.

Precautions

Care is necessary with patients who take alcohol, anticholinergic agents, tricyclic antidepressants, sedatives or hypnotics, as such agents are enhanced by Avomine. It may cause mild and temporary confusion or disorientation in certain individuals. It should, therefore, be used with caution in persons in charge of vehicles until their reaction to the drug is known.
Avomine may thicken or dry lung secretions and impair expectoration; it should, therefore, be used with caution in patients with asthma, bronchitis or bronchiectasis. Use with care in patients with severe coronary artery disease, narrow angle glaucoma, epilepsy or hepatic and renal insufficiency. Caution should be exercised in patients with bladder neck or pyloroduodenal obstruction. Promethazine may mask the warning signs of ototoxicity caused by ototoxic drugs, e.g. salicylates.
It may also delay the early diagnosis of intestinal obstruction or raised intracranial pressure through the suppression of vomiting.
Avomine may interfere with immunological urine pregnancy tests to produce false positive or false negative results. Avomine should be discontinued at least 72 hours before the start of skin tests using allergen extracts as it may inhibit the cutaneous histamine response thus producing false negative results.
In nausea and vomiting of unknown origin, it is essential to establish the diagnosis before giving an antiemetic, to ensure that a serious underlying condition is not masked.

Use in pregnancy.

(Category C)
When given in high doses during late pregnancy, phenothiazines have caused prolonged extrapyramidal disturbances in the child. There is inadequate evidence of safety of the drug in human pregnancy, but it has been in wide use for many years without apparent ill consequence; animal studies having shown no hazard.

Use in children

Postmarketing cases of respiratory depression, including fatalities, have been reported with the use of promethazine in paediatric patients less than 2 years of age. Excessive dosages of antihistamines in children may cause hallucinations, convulsions and sudden death. The use of Avomine should be avoided in children and adolescents with signs and symptoms suggestive of Reye's syndrome.

Adverse Effects

More common reactions.

Gastrointestinal.

Dry mouth, epigastric distress, loss of appetite, nausea, vomiting, diarrhoea, constipation.

Nervous system.

Sedation, restlessness, dizziness, lassitude, incoordination, fatigue.

Ocular.

Blurred vision.

Less common reactions.

Cardiovascular.

Tachycardia, bradycardia, faintness, palpitations, hypotension, arrhythmias.

Dermatological.

Contact dermatitis (topical), photosensitisation, urticaria, angioneurotic oedema.

Haematological.

Leucopenia, agranulocytosis, aplastic anaemia, thrombocytopenic purpura.

Hepatic.

Jaundice.

Musculoskeletal.

Extrapyramidal symptoms.

Nervous system.

Tinnitus, euphoria, nervousness, insomnia, convulsive seizures, oculogyric crises, excitation, catatonic-like states, hysteria, extrapyramidal symptoms, tardive dyskinesia.

Respiratory.

Marked irregular respiration.

Other.

Anaphylaxis, headaches, nightmares, urinary retention.

Serious or life threatening reactions.

Agranulocytosis. Care is needed in the intramuscular administration of promethazine to children. A severe neurological reaction resulting in coma is possible.

Dosage and Administration

Adults. Travel sickness.

Prevention.

Long journeys.

1 tablet each night at bedtime commencing on the night before travelling.

Short journeys.

1 tablet to be taken one to two hours before the journey commences.

Treatment.

1 tablet followed by a second tablet the same evening and a third tablet on the following evening. Prompt treatment is important. Additional tablets may safely be taken as a preventive or when they appear to be needed but it will seldom be necessary to give more than four tablets in 24 hours or to repeat a dose in less than eight hours.

Nausea and vomiting due to other causes.

1 tablet repeated as required. Often 1 tablet at bedtime is sufficient. The maximum dose in 24 hours is 100 to 150 mg (four to six tablets) in divided doses.

Children.

Travel sickness, nausea and vomiting due to other causes.

Over 10 years.

Corresponding adult dose.

Overdosage

Symptoms.

The chief symptom of acute poisoning from the ingestion of promethazine is unconsciousness which is, however, commonly delayed. In addition, convulsions have occurred, with unconsciousness in the intervening periods.

Treatment.

An immediate first aid measure is to induce vomiting mechanically or to give an emetic, the value of which, however, is limited by the antiemetic activity of Avomine once absorbed. The most important step in treatment must be, therefore, to remove as much as possible of the unabsorbed material by means of gastric lavage with warm sodium bicarbonate solution. Some sodium bicarbonate solution should be left in the stomach to precipitate insoluble promethazine base, thus delaying its absorption. Should convulsions occur, special care must be taken with the use of sedatives, which may increase the depression of respiration. Intravenous amphetamine or intramuscular ephedrine should be given for CNS stimulation, if indicated. Oxygen under pressure should be given if respiration is depressed. The administration of an antibiotic as a prophylactic against pneumonia should be considered.

Presentation

Tablets, 25 mg (white, scored): 30's.

Storage

Store below 30°C. Protect from light.

Poison Schedule

S3.