Consumer medicine information

APOHEALTH Promethazine Antihistamine for Allergy Relief

Promethazine hydrochloride

BRAND INFORMATION

Brand name

APOHealth Promethazine Allergy Relief

Active ingredient

Promethazine hydrochloride

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APOHEALTH Promethazine Antihistamine for Allergy Relief.

FULL CMI

APOHEALTH Promethazine 10 Antihistamine for Allergy Relief and APOHEALTH Promethazine 25 Antihistamine for Allergy Relief

Active ingredient(s): promethazine hydrochloride (PRO-meth-ar-zine HIGH-dro (h)-CLOR-ride)

Consumer Medicine Information (CMI)

This leaflet provides important information about using APOHEALTH Promethazine Antihistamine for Allergy Relief. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using APOHEALTH Promethazine Antihistamine for Allergy Relief

Where to find information in this leaflet:

1. Why am I using APOHEALTH Promethazine Antihistamine for Allergy Relief?
2. What should I know before I use APOHEALTH Promethazine Antihistamine for Allergy Relief?
3. What if I am taking other medicines?
4. How do I use APOHEALTH Promethazine Antihistamine for Allergy Relief?
5. What should I know while using APOHEALTH Promethazine Antihistamine for Allergy Relief?
6. Are there any side effects?
7. Product details

1. Why am I using APOHEALTH Promethazine Antihistamine for Allergy Relief?

APOHEALTH Promethazine Antihistamine for Allergy Relief contains the active ingredient promethazine hydrochloride.

APOHEALTH Promethazine Antihistamine for Allergy Relief is an antihistamine used to treat a number of conditions:

  • allergies - allergic contact dermatitis, hives, hayfever, bites and stings
  • respiratory symptoms due to allergies - runny nose
  • nausea and vomiting - motion sickness
  • assists in the management of the symptoms of chicken pox and measles by acting as a sedative
  • for short-term use for sedation on the advice of a pharmacist or doctor - do not use for more than 7-10 days

Antihistamines help reduce allergic symptoms by preventing the effects of a substance called histamine. Histamine is produced by the body in response to foreign substances that the body is allergic to.

Your pharmacist or doctor may have recommended APOHEALTH Promethazine Antihistamine for Allergy Relief for another reason.

Ask your pharmacist or doctor if you have any questions about this medicine.

2. What should I know before I use APOHEALTH Promethazine Antihistamine for Allergy Relief?

Warnings

APOHEALTH Promethazine Antihistamine for Allergy Relief must not be used in children under 6 years of age, due to the potential for fatal respiratory depression, psychiatric and CNS events.

Do not use APOHEALTH Promethazine Antihistamine for Allergy Relief if:

  • you are allergic to promethazine hydrochloride, medicines of similar properties or belonging to the specific family of chemicals called phenothiazines, other phenothiazines or any of the ingredients listed at the end of this leaflet.
    Always check the ingredients to make sure you can use this medicine.
    Some of the symptoms of an allergic reaction may Include:
    - shortness of breath
    - wheezing or difficulty breathing
    - swelling of the face, lips, tongue or other parts of the body
    - rash, itching or hives on the skin
    If you take this medicine after the expiry date has passed, it may not work as well.
  • the packaging is torn or shows signs of tampering.

Any person who is unconscious or in a coma must not be treated with APOHEALTH Promethazine Antihistamine for Allergy Relief.

Do not give APOHEALTH Promethazine Antihistamine for Allergy Relief to newborn or premature babies.

Check with your doctor or pharmacist if you:

  • have allergies:
    - any other medicines
    - any other substances, such as food, preservatives or dyes
  • have or have had any medical conditions, especially the following:
    - kidney or liver disease
    - Parkinson's disease
    - underactive thyroid gland (hypothyroidism)
    - tumour growing in adrenal glands (pheochromocytoma)
    - autoimmune disorder (myasthenia gravis)
    - epilepsy
    - cardiovascular disease/cardiac failure
    - blood pressure problems
    - low white blood cell count (agranulocytosis)
    - bladder problems
    - breathing problems
    - glaucoma - an eye condition
    - prostate problems
    - stomach ulcer or blockage
  • develop a fever or an infection to confirm if laboratory tests are required to check your blood count
  • plan to have surgery
  • take sedatives
  • take any medicines for any other condition
  • have any personal or family history of heart disease
  • have an irregular heartbeat

If you experience an allergic reaction, seek medical help right away.

Caution must be exercised when using APOHEALTH Promethazine Antihistamine for Allergy Relief due to the risk of sedation.

If you experience fever, sore throat or any other infection, you should inform your doctor or pharmacist immediately and undergo a complete blood count. Treatment should be discontinued if any marked changed are observed in the blood count.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor or pharmacist if you are a woman of childbearing age and not using effective contraception. Check with your doctor or pharmacist if you are pregnant, might become pregnant or think you may be pregnant.

Do not take APOHEALTH Promethazine Antihistamine for Allergy Relief if you are pregnant or plan to become pregnant.

It may affect your developing baby if you take it during pregnancy. If there is a need to consider APOHEALTH Promethazine Antihistamine for Allergy Relief during your pregnancy, your pharmacist or doctor will discuss the benefits and possible risks of taking the medicine during pregnancy.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

Do not take APOHEALTH Promethazine Antihistamine for Allergy Relief if you are breastfeeding or plan to breastfeed.

It passes into the breast milk and there is a possibility that the baby may be affected.

Use in children

  • Do not give APOHEALTH Promethazine Antihistamine for Allergy Relief to newborn or premature babies.
  • APOHEALTH Promethazine Antihistamine for Allergy Relief must not be used in children under 6 years of age, due to the potential for fatal respiratory depression, psychiatric and CNS events.
  • Because of the risk of choking, the tablets should be avoided in children who have difficulty swallowing tablets.

3. What if I am taking other medicines?

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

Some medicines may interfere with APOHEALTH Promethazine Antihistamine for Allergy Relief and affect how it works.

APOHEALTH Promethazine Antihistamine for Allergy Relief may increase the sedative effect of some medicines. These include:

  • medicines used to treat depression, especially monoamine oxidase inhibitors and tricyclic antidepressants
  • medicines used to help you sleep or relax (sedatives and hypnotics)
  • opioid analgesics, medicines used to treat pain
  • other antihistamines
  • alcohol and alcohol containing medicines
  • medicines for the treatment of irregular heartbeats (antiarrhythmics)
  • medicines that help with your mood (antidepressants)
  • medicines used to help with mental illness (antipsychotics)
  • medicines to treat infections (antimicrobials)
  • medicines used to treat nausea and vomiting like metoclopramide
  • medicines used to relieve muscle spasm like carisoprodol and cyclobenzaprine
  • medicines used for the treatment of epilepsy or seizures
  • medicines used to treat acid indigestion such as magnesium, aluminium and calcium salts, oxides and hydroxides
  • medicines used to smooth muscle contractions in the gastrointestinal tract (antispasmodics)

These medicines may be affected by APOHEALTH Promethazine Antihistamine for Allergy Relief or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect APOHEALTH Promethazine Antihistamine for Allergy Relief.

4. How do I use APOHEALTH Promethazine Antihistamine for Allergy Relief?

How much to take

  • Follow the instructions provided with the medicine. If you do not understand the instructions on the carton or the label, ask your pharmacist or doctor for help.
  • Follow all directions given to you by your pharmacist or doctor carefully.
    They may differ from the information contained in this leaflet.
  • Use this drug only as recommended.
  • Do not exceed the recommended dosage. There have been case reports of promethazine abuse.
  • APOHEALTH Promethazine Antihistamine for Allergy Relief tablets are recommended for adults and children over 6 years of age.
  • APOHEALTH Promethazine Antihistamine for Allergy Relief tablets should not be given to children aged between 6 and 11 years of age, except on the advice of your doctor or pharmacist.
  • It is recommended that the lowest effective dose of APOHEALTH Promethazine Antihistamine for Allergy Relief be used in children 6 years of age or older.

Allergic Disorder

  • Adults and children over 12 years of age: One to three 25mg tablets as a single dose at night, or one to two 10mg tablets, two to three times daily.
  • Children 6-12 years: One to two 10mg tablets as a single dose at night, or one 10mg tablet, two to three times daily.

Sedation

For short term use on the advice of a doctor or pharmacist. Do not take for more than 7 – 10 consecutive days.

  • Adults and children over 12 years of age: One to three 25mg tablets as a single dose at night.
  • Children 6-12 years: One to two 10mg tablets as a single dose at night.

Travel Sickness

  • Adults and children over 12 years of age: One 25mg tablet.
  • Children 6-12 years: One 10mg tablet.

To be taken the night before travel and repeated after 6 to 8 hours on the following day if required.

Nausea and Vomiting

  • Adults and children over 12 years of age: One 25mg tablet every 4 to 6 hours to a maximum daily dose of four 25mg tablets (100 mg in total).
  • Children 6-12 years: One 10mg tablet every 4 to 6 hours to a maximum daily dose of two 10mg tablets (20 mg in total).

Use in Elderly

  • If you are over 65 years of age, talk to your doctor or pharmacist about how much to take.
  • Elderly patients are more likely to have side effects from taking these medicines.

How to take APOHEALTH Promethazine Antihistamine for Allergy Relief

  • Swallow APOHEALTH Promethazine Antihistamine for Allergy Relief whole with a full glass of water.

How long to take

  • APOHEALTH Promethazine Antihistamine for Allergy Relief should not usually be taken for more than 10 days in a row. If your symptoms persist, see your doctor or pharmacist for advice.

If you forgot to take

  • If you are taking APOHEALTH Promethazine Antihistamine for Allergy Relief for an allergic disorder and you forget to take your bedtime dose, you may need to take your dose in two or three smaller doses during the following day. Check with your doctor or pharmacist.
  • If you are taking APOHEALTH Promethazine Antihistamine for Allergy Relief for travel sickness or nausea and vomiting, take your dose as soon as you remember.
  • If you are taking APOHEALTH Promethazine Antihistamine for Allergy Relief for sedation, take your dose as soon as you remember. Be careful because you may still be affected in the morning.

Do not take a double dose to make up for the dose that you missed. This may be harmful.

If you are not sure what to do, ask your pharmacist or doctor.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you use too much APOHEALTH Promethazine Antihistamine for Allergy Relief (overdose)

If you think that you have used too much APOHEALTH Promethazine Antihistamine for Allergy Relief, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

If you take too much APOHEALTH Promethazine Antihistamine for Allergy Relief, you may experience:

Adults

  • drowsiness
  • convulsions and/or tremors
  • difficulty breathing
  • unconsciousness
  • acute anxiety
  • hallucinations
  • heart palpitations, chest pain and/or rapid pulse
  • dizziness
  • nausea
  • cold sweats

Children

  • over-excitement
  • shaky and unsteady movements
  • convulsions and/or tremors
  • hallucinations
  • difficulty breathing
  • unconsciousness
  • high fever
  • heart palpitations, chest pain and/or rapid pulse
  • dizziness
  • nausea
  • cold sweats
  • memory and thinking problems; difficulty with learning new things, concentrating, or making decisions

5. What should I know while using APOHEALTH Promethazine Antihistamine for Allergy Relief?

Things you should do

Remind any doctor, dentist or pharmacist you visit that you are using APOHEALTH Promethazine Antihistamine for Allergy Relief.

APOHEALTH Promethazine Antihistamine for Allergy Relief may cause skin to be more sensitive to the sun. You should protect your skin from sun or exposure to bright sunlight.

If you are about to be started on any new medicine, tell your pharmacist or doctor that you are taking APOHEALTH Promethazine Antihistamine for Allergy Relief.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine.

If you become pregnant while you are taking this medicine, stop taking it and tell your doctor immediately.

Talk to your pharmacist or doctor if your symptoms do not improve.

Your pharmacist or doctor will assess your condition and decide if you should continue to take the medicine

Things you should not do

  • Do not give APOHEALTH Promethazine Antihistamine for Allergy Relief to anyone else, even if they have the same condition as you.
  • Do not take APOHEALTH Promethazine Antihistamine for Allergy Relief to treat any other complaints unless your pharmacist or doctor tells you to.
  • Do not take more than the recommended dose unless your pharmacist or doctor tells you to
  • Do not take APOHEALTH Promethazine Antihistamine for Allergy Relief if you have jaundice.
  • Do not take this medicine if you are receiving or have received high doses of other CNS depressant medications (for example, drugs that are used to treat anxiety and sleep disorders).
  • Do not take this medicine if you have slowed breathing or heart rate of any cause.

Things to be careful of

  • APOHEALTH Promethazine Antihistamine for Allergy Relief is a known sedative and may cause drowsiness in some people.
  • If you have a single dose at bedtime, you may still be affected in the morning.
  • Children and the elderly are especially sensitive to the effects of antihistamines.

Neuroleptic malignant syndrome

A very serious and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Stop treatment and call your doctor right away if you have high fever, muscle cramps or stiffness, dizziness, very bad headache, fast heartbeat, confusion, agitation, hallucinations, or are sweating a lot.

Driving or using machines

APOHEALTH Promethazine Antihistamine for Allergy Relief can cause drowsiness, dizziness and blurred vision.

Make sure you know how you react to APOHEALTH Promethazine Antihistamine for Allergy Relief before you drive a car, operate machinery, or do anything else that could be dangerous if you experience drowsiness, dizziness and blurred vision. If this occurs do not drive or operate machinery.

Be careful before you drive or use any machines or tools until you know how APOHEALTH Promethazine Antihistamine for Allergy Relief affects you.

APOHEALTH Promethazine Antihistamine for Allergy Relief may affect your ability to drive a car or operate machinery or do anything else that could be dangerous if you are drowsy, dizzy or experience blurred vision. If this occurs do not drive or operate machinery.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Do not drink alcohol while taking APOHEALTH Promethazine Antihistamine for Allergy Relief.

The sedation effects of alcohol may be increased.

Looking after your medicine

  • Keep your medicine in the original container until it is time to take it.
  • If you take your medicine out of the pack it will not keep as well.
  • Keep your tablets in a cool dry place where the temperature stays below 30⁰C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it, in a locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Less serious side effects

Less serious side effectsWhat to do
General
  • dry mouth, nose & throat
Nervous system-related
  • tiredness or sleepiness
  • headache
  • involuntary muscle movements (dystonia)
Mental
  • nightmares in children
  • restlessness
  • confusion
  • anxiety
  • aggression
  • hallucination
Gastrointestinal
  • stomach upset
  • loss of appetite
  • nausea or vomiting
  • diarrhoea or constipation
Eye disorders
  • blurred vision
Respiratory
  • congested nose
Skin-related
  • increased sensitivity of the skin to sun
Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

These are mild side effects of the medicine and are short lived.

Serious/rare side effects

Serious side effectsWhat to do
General
  • fever
  • excessive sweating
  • dizziness
  • nausea
  • cold sweats
  • low blood pressure
  • shortness of breath
Urinary
  • difficulty passing urine
Heart
  • irregular heartbeat
  • very fast or forceful heartbeats (palpitations)
  • chest pain
  • rapid pulse
Blood and Lymphatic System Disorders
  • eosinophilia which is an increase in the number of eosinophils (a type of white blood cells) found in the blood test.
  • Thrombocytopenia which is a decrease in the number of platelets (cells in the blood that help with clotting) found in a blood test, which can lead to bleeding and bruising (thrombocytopenic purpura)
Allergy related
  • difficulty breathing
Liver-related
  • jaundice - yellow tinge to skin or Eyes
Nervous system-related
  • tremors or convulsions
  • tinnitus - buzzing, hissing, ringing or other persistent noise in the ears
  • confusion
  • twitching or jerking muscles
  • dizziness, lightheadedness
  • severe headache
  • muscle cramps or stiffness
  • psychomotor hyperactivity
Central nervous system-related
  • anxiety
  • seizures (fits)
  • hallucinations
  • agitation
  • nervousness and irritability
  • neuroleptic malignant syndrome (NMS) – see subheading “Things to be careful of”
  • severe uncontrollable muscular movements
Call your doctor straight away if you notice any of these serious side effects.

The above list includes serious side effects that may require medical attention. Serious side effects are rare.

Very serious side effects

Very serious side effectsWhat to do
Allergy related
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue, or other parts of the body/severe allergic reaction where adrenaline is required for treatment (anaphylaxis)
  • skin rashes
Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/safety/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What APOHEALTH Promethazine Antihistamine for Allergy Relief contains

Active ingredient
(main ingredient)		10mg tablets - 10mg of promethazine hydrochloride per tablet
25mg tablets - 25mg of promethazine hydrochloride per tablet
Other ingredients
(inactive ingredients)
  • magnesium stearate
  • microcelac-100 (containing lactose monohydrate & microcrystalline cellulose)
Potential allergensContains lactose

Do not take this medicine if you are allergic to any of these ingredients.

What APOHEALTH Promethazine Antihistamine for Allergy Relief looks like

APOHEALTH Promethazine Antihistamine for Allergy Relief tablets are available in two strengths:

  • 10mg tablets - round, white to off-white, flat faced, beveled-edged tablets, debossed 10 on one side and plain on the reverse side. (Aust R 337352).
  • 25mg tablets - round, white to off-white, flat faced, beveled-edged tablets, debossed 25 on one side and plain on the reverse side. (Aust R 337353).

Both are available in blister packs of 50 tablets.

Who distributes APOHEALTH Promethazine Antihistamine for Allergy Relief

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel St
Cremorne VIC 3121
Australia
www.arrotex.com.au

This leaflet was prepared in January 2025.

Published by MIMS March 2025

BRAND INFORMATION

Brand name

APOHealth Promethazine Allergy Relief

Active ingredient

Promethazine hydrochloride

Schedule

S3

 

1 Name of Medicine

Promethazine hydrochloride.

2 Qualitative and Quantitative Composition

APOHealth Promethazine 10 Antihistamine for Allergy Relief tablets contain 10 mg of promethazine hydrochloride and APOHealth Promethazine 25 Antihistamine for Allergy Relief tablets contain 25 mg of promethazine hydrochloride.

Excipients with known effect.

Contains sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

APOHealth Promethazine 10 Antihistamine for Allergy Relief 10 mg tablets are round, white to off-white, flat faced, bevelled-edged tablets, debossed 10 on one side and plain on the reverse side.
APOHealth Promethazine 25 Antihistamine for Allergy Relief 25 mg tablets are round, white to off-white, flat faced, bevelled-edged tablets, debossed 25 on one side and plain on the reverse side.

4 Clinical Particulars

4.1 Therapeutic Indications

Allergies.

Treatment of allergic conditions including some allergic reactions to drugs, urticaria and allergic contact dermatitis, and allergic reactions to insect bites and stings.

Upper respiratory tract.

Relief of excessive secretion in the upper respiratory tract as a result of hayfever and allergic rhinitis.

Nausea and vomiting.

Antiemetic for vomiting from various causes, including postoperative vomiting, irradiation sickness, drug induced nausea and motion sickness.

Sedation.

For short-term use under the advice of a doctor or pharmacist. Do not use for more than 7 to 10 consecutive days.

Other.

Promethazine hydrochloride has sedative effects and can be used in the symptomatic management of measles and chickenpox.
Promethazine hydrochloride can be used as a pre-anaesthetic medication for the prevention and control of postoperative vomiting.

4.2 Dose and Method of Administration

This product should not be given to children under 6 years of age (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use). This product is not suitable for children aged 6-12 years unless on pharmacist or medical advice (see Section 4.4 Special Warnings and Precautions for Use). Dosage varies according to the condition being treated and the individual's response.

Allergic disorder.

Adults and children over 12 years of age.

25 to 75 mg as a single dose at night, or 10 to 20 mg two to three times daily.

Children 6-12 years.

10 to 25 mg as a single dose at night, or 10 mg two to three times daily.

Sedation.

Adults and children over 12 years of age.

25 to 75 mg as a single dose at night.

Children 6-12 years.

10 to 25 mg as a single dose at night.

Travel sickness.

Adults and children over 12 years of age.

25 mg.

Children 6-12 years.

10 mg.
To be taken the night before travel and repeated after 6 to 8 hours on the following day if required.

Nausea and vomiting.

Adults and children over 12 years of age.

25 mg every 4 to 6 hours to a maximum daily dose of 100 mg.

Children 6-12 years.

10 mg every 4 to 6 hours to a maximum daily dose of 25 mg.

4.3 Contraindications

APOHealth Promethazine 10 Antihistamine for Allergy Relief and APOHealth Promethazine 25 Antihistamine for Allergy Relief is contraindicated for use in patients with a history of hypersensitivity to the drug substance, substances of similar chemical structure, other phenothiazines or hypersensitivity to the other ingredients in the formulation.
This product is contraindicated for use in:
children under 6 years of age because of the potential for fatal respiratory depression, psychiatric and CNS (central nervous system) evets (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)). Post-marketing cases of respiratory depression, including fatalities, have been reported with the use of promethazine in paediatric patients less than 6 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients. (See Section 4.4 Special Warnings and Precautions for Use);
lactating women;
patients taking monoamine oxidase inhibitors (MAOIs) up to 14 days previously (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions);
jaundice induced by other phenothiazine derivatives;
patients in coma or suffering from CNS depression of any cause or who have received high doses of other CNS depressants.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

4.4 Special Warnings and Precautions for Use

Caution is advised in patients with:
cardiovascular disease;
acute or chronic respiratory impairment as promethazine may thicken or dry lung secretions and impair expectoration;
epilepsy;
hypertensive crisis;
narrow angle glaucoma;
stenosing peptic ulcer;
symptomatic prostatic hypertrophy;
bladder neck obstruction;
pyloroduodenal obstruction.
Hypersensitivity reactions including anaphylaxis, urticaria and angioedema have been reported with promethazine use. In case of allergic reaction, treatment with promethazine must be discontinued and appropriate symptomatic treatment initiated - see Section 4.5.
Promethazine should be avoided in patients with Parkinson's disease, hypothyroidism, cardiac failure, pheochromocytoma, myasthenia gravis, or prostate hypertrophy, or in patients with a history of agranulocytosis.
Caution must be exercised when using H1-antihistamines such as promethazine due to the risk of sedation.
Combined use with other sedative medicinal products is not recommended (see Section 4.5).
Promethazine may delay the early diagnosis of intestinal obstruction or increased intracranial pressure through the suppression of vomiting.
Promethazine may mask the warning signs of ototoxicity caused by ototoxic drugs e.g. salicylates.
Promethazine may increase the effects of alcohol. Alcohol should be avoided during treatment.
QT interval prolongation has been reported with phenothiazines.
Phenothiazine derivatives may potentiate QT interval prolongation which increases the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is potentially fatal (sudden death). QT prolongation is exacerbated, in particular, in the presence of bradycardia, hypokalaemia, and acquired (i.e. drug induced) QT prolongation. If the clinical situation permits, medical and laboratory evaluations should be performed to rule out possible risk factors before initiating treatment with a phenothiazine derivative and as deemed necessary during treatment (see Section 4.8 Adverse Effects (Undesirable Effects)).
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.
Prolonged administration of any phenothiazine may result in tardive dyskinesia, particularly in the elderly and children.
Alcohol and alcohol-containing medicines should be avoided while on this medicine (see Section 4.5).
Phenothiazines may be additive with, or may potentiate the action of, other CNS depressants such as opiates or other analgesics, barbiturates or other sedatives, general anesthetics, or alcohol.
As agranulocytosis has been reported, regular monitoring of the complete blood count is recommended. The occurrence of unexplained infections or fever may be evidence of blood dyscrasia (see Section 4.5), and requires immediate haematological investigation.
All patients should be advised that, if they experience fever, sore throat or any other infection, they should inform their physician immediately and undergo a complete blood count. Treatment should be discontinued if any marked changes (hyperleucocytosis, granulocytopenia) are observed in the blood count.
There have been case reports of drug abuse with promethazine hydrochloride. The risk of abuse is greater in patients with a history of drug abuse.
As with neuroleptics, neuroleptic malignant syndrome (NMS) characterised by hyperthermia, extrapyramidal disorders, muscle rigidity, altered mental status, autonomic nervous instability and elevated CPK, may occur. As this syndrome is potentially fatal, promethazine hydrochloride must be discontinued immediately and intensive clinical monitoring and symptomatic treatment should be initiated.

Hypertensive crisis.

Promethazine hydrochloride should be used with caution, if at all, in these patients.
Solar dermatitis has been reported following oral doses of promethazine hydrochloride in patients with eczema or a tendency to rheumatism.
Due to the risk of photosensitivity, exposure to the sun or ultraviolet light should be avoided during or shortly after treatment.

Epilepsy.

Epileptic patients may experience increased severity of convulsions.

Use in hepatic impairment.

Caution is advised in patients with hepatic insufficiency. It should be avoided in patients with liver dysfunction.

Use in renal impairment.

Caution is advised in patients with renal failure or insufficiency. It should be avoided in patients with renal dysfunction.

Use in the elderly.

The elderly may experience paradoxical excitation with promethazine hydrochloride. The elderly are more likely to have CNS depressive side effects, including confusion and are more susceptible to the anti-muscarinic effects of antihistamines, including hypotension (see Section 4.3 Contraindications).

Paediatric use.

This product should not be used in children under 6 years of age due to the potential for fatal respiratory depression, psychiatric and CNS events (see Section 4.3 Contraindications; Section 4.8 Adverse Effects (Undesirable Effects)).
Caution should be exercised when administering promethazine to children 6 years of age or older because of the potential for fatal respiratory depression, including central and obstructive apnoea and reduced arousal. Respiratory depression and apnoea, sometimes fatal, are associated with promethazine even if individualised weight-based dosing is used.
Concomitant administration of other drugs with respiratory depressant effects should be avoided.
The use of promethazine hydrochloride should be avoided in children and adolescents with signs and symptoms suggestive of Reye's syndrome.
Excessive dosages of antihistamines in children may cause hallucinations, convulsions and sudden death. Children may experience paradoxical excitation with promethazine hydrochloride.
It is recommended that the lowest effective dose of promethazine hydrochloride be used in paediatric patients 6 years of age or older.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Promethazine will enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic. Promethazine hydrochloride may cause drowsiness and will enhance the sedative effects of CNS depressants (including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and neuroleptics), and have additive anti-muscarinic actions with other anti-muscarinic drugs (atropine, tricyclic antidepressants). Interactions between promethazine hydrochloride and monoamine oxidase inhibitors and tricyclic antidepressants (TCAs) may prolong and intensify the anticholinergic and CNS depressive effects. Alcohol should be avoided during treatment. Combination with alcohol enhances the sedative effects of H1 antihistamines. Promethazine may interfere with immunological urine pregnancy tests to produce false-positive or false-negative results.
Special caution is required when promethazine is used concurrently with drugs known to cause QT prolongation (such as antiarrhythmics, antimicrobials, antidepressants, antipsychotics) to avoid exacerbation of risk of QT prolongation.

Cytochrome P450 2D6 metabolism.

Some phenothiazines are moderate inhibitors of CYP2D6. There is a possible pharmacokinetic interaction between inhibitors of CYP2D6, such as phenothiazines, and CYP2D6 substrates. Co administration of promethazine with amitriptyline/ amitriptylinoxide, a CYP2D6 substrate, may lead to an increase in the plasma levels of amitriptyline/ amitriptylinoxide. Monitor patients for dose-dependent adverse reactions associated with amitriptyline/ amitriptylinoxide.
Promethazine should be avoided in patients taking monoamine oxidase inhibitors within the previous 14 days, and monoamine oxidase inhibitors should be avoided while using promethazine.

Seizure threshold-lowering drugs.

Concomitant use of seizure-inducing drugs or seizure threshold lowering drugs should be carefully considered due to the severity of the risk for the patient (see Section 4.4).

Gastro-intestinal agents that are not absorbed (magnesium, aluminium and calcium salts, oxides and hydroxides).

Reduced gastro-intestinal absorption of phenothiazines may occur. Such gastrointestinal agents should not be taken at the same time as phenothiazines (at least 2 hours apart, if possible).

Drugs with anticholinergic properties.

Concomitant use of promethazine with drugs with anticholinergic properties enhances the anticholinergic effect.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There are no relevant fertility data available in animals.
(Category C)
The use of promethazine is not recommended during pregnancy and in women of childbearing potential not using contraception. Promethazine hydrochloride should be used in pregnancy only if the potential benefits to the patient are weighed against the possible risk to the foetus.
Promethazine hydrochloride, owing to its pharmacological effects, has caused or may be suspected of causing harmful effects on the human foetus or neonate without causing malformations. These effects may be reversible.
When promethazine hydrochloride has been given in high doses during late pregnancy, promethazine hydrochloride has caused prolonged neurological disturbances in the infant.
There are no available animal studies regarding reproductive toxicity.
 Promethazine hydrochloride is excreted in breast milk. There are risks of neonatal irritability and excitement. Therefore, it should not be used for breastfeeding women.

4.7 Effects on Ability to Drive and Use Machines

Promethazine considerably affects the ability to drive a vehicle and operate machines. Promethazine hydrochloride may cause drowsiness, dizziness and blurred vision and can considerably affect the ability of driving a vehicle and operating machines. Drowsiness may continue the following day. Those affected should not drive or operate machinery.

4.8 Adverse Effects (Undesirable Effects)

CNS effects.

CNS depressive effects of promethazine hydrochloride include sedation and impaired performance (impaired driving performance, poor work performance, incoordination, reduced motor skills and impaired information processing). Performance may be impaired in the absence of sedation and may persist the morning after a night time dose.
The CNS stimulatory effects of promethazine hydrochloride may include anxiety, hallucinations, appetite stimulation, muscle dyskinesias and activation of epileptogenic foci.
High doses of promethazine hydrochloride may cause nervousness, tremor, insomnia, agitation and irritability.

Anticholinergic effects.

Side effects of promethazine hydrochloride associated with cholinergic blockage include dryness of the eyes, mouth and nose, blurred vision, urinary hesitancy and retention, constipation and tachycardia.

More common reactions.

Gastrointestinal disorders.

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

Nervous system disorders.

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

Eye disorders.

Blurred vision.

Less common reactions.

Cardiovascular.

Tachycardia, bradycardia, faintness.

Skin and subcutaneous tissue disorders.

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

Haematological.

Leucopenia, agranulocytosis, aplastic anaemia, thrombocytopenic purpura.

Nervous system disorders.

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

Respiratory.

Marked irregular respiration.

Reactions with frequency unknown.

Skin and subcutaneous tissue disorders.

Rash, photosensitivity.

Hepatobiliary disorders.

Jaundice cholestatic.

Renal and urinary disorders.

Urinary retention.

Nervous system disorders.

Neuroleptic malignant syndrome, somnolence, dizziness headaches, tic-like movements of the head and face, extrapyramidal symptoms including muscle spasm, dystonia, including oculogyric crisis, usually transitory are commoner in children and young adults, and usually occur within the first 4 days of treatment or after dosage increases. Anticholinergic effects such as ileus paralytic, risk of urinary retention, dry mouth, constipation, accommodation disorder. The elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine. Children less than 6 years of age also experienced psychomotor hyperactivity.

Immune system disorders.

Allergic reactions, including anaphylactic reaction, urticaria, rash, pruritus, angioedema and anaphylactic reaction have been reported.

Metabolism and nutrition disorders.

Anorexia, decreased appetite.

Blood and lymphatic system disorders.

Blood dyscrasias including haemolytic anaemia, agranulocytosis, leukopenia, eosinophilia, thrombocytopenia (including thrombocytopenic purpura).

Psychiatric disorders.

Agitation, confusional state, anxiety. Infants, newborns and premature are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability, restlessness, nightmares, disorientation. Children less than 6 years of age also experienced aggression and hallucinations.

Cardiac disorders.

Palpitations, arrhythmias, QT Prolongation, torsade de pointes.

Respiratory, thoracic and mediastinal disorders.

Respiratory depression, nasal congestion.

Vascular disorders.

Hypotension.

General disorders and administration site conditions.

Tiredness.

Severe or life threatening reactions.

Agranulocytosis, anaphylaxis.

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

4.9 Overdose

Symptoms of severe overdosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, reversible intellectual disability and cognition deficit in children less than 6 years of age, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children: coma or excitement may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is uncommon. The chief sign of acute poisoning from ingestion of an overdose of promethazine hydrochloride is unconsciousness which is commonly delayed. In addition, convulsions, hallucinations, delirium, acute anxiety, psychotic reactions, extreme hyperaesthesia and hyperalgesia with extensor plantar responses may occur. Anticholinergic action may cause tachycardia, flushed skin, dry mouth and sometimes mydriasis and urinary retention.
In adults, CNS depression is more common, with drowsiness, coma, convulsions, progressing to respiratory failure or cardiovascular collapse.
High doses can cause ventricular arrhythmias including QT prolongation and torsade de pointes (see Section 4.8 Adverse Effects (Undesirable Effects)).
In infants and children, CNS stimulation predominates over CNS depression causing ataxia, excitement, tremors, psychoses, hallucinations, convulsions and possibly hyperpyrexia, which may be followed by deepening coma and cardiorespiratory collapse.

Treatment.

Similar to that of other phenothiazines. In the event of overdose of promethazine, take all appropriate measures immediately. Symptomatic supportive therapy is indicated and maintenance of adequate ventilation should be instituted if necessary.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
Symptomatic supportive therapy is indicated and maintenance of adequate ventilation should be instituted if necessary.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Promethazine hydrochloride, a phenothiazine derivative, is a long acting antihistamine with mild atropine-like anticholinergic effects and some anti-serotonin effects, and because of its marked effect on the central nervous system (CNS), it acts as an antiemetic, hypnotic, tranquilliser, and a potentiator of anaesthetics, hypnotics, sedatives and analgesics.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Promethazine hydrochloride is well absorbed after oral administration. Peak plasma concentrations are reached 2 to 3 hours after administration by this route, although there is low systemic bioavailability after oral administration, due to high first-pass metabolism in the liver.

Distribution.

Promethazine hydrochloride crosses the blood brain barrier and the placenta, and is distributed into breast milk. It is highly bound to plasma proteins (76-93%).

Metabolism.

Promethazine hydrochloride undergoes extensive metabolism, predominantly to promethazine sulfoxide and also to N-desmethylpromethazine.

Excretion.

It is excreted slowly via the urine and bile, mainly as metabolites. Elimination half-lives of 5 to 14 hours have been reported. The antihistamine action has been reported to be between 4 and 12 hours.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

APOHealth Promethazine 10 Antihistamine for Allergy Relief and APOHealth Promethazine 25 Antihistamine for Allergy Relief tablets contain the following inactive ingredients: magnesium stearate; microcelac-100 (containing lactose monohydrate and microcrystalline cellulose).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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 30°C.

6.5 Nature and Contents of Container

APOHealth Promethazine 10 Antihistamine for Allergy Relief and APOHealth Promethazine 25 Antihistamine for Allergy Relief tablets are supplied in blister packs (PVC/PVDC/Al) containing 50 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

Promethazine hydrochloride is a white or faintly yellow, practically odourless, crystalline powder. It is very soluble in water, freely soluble in alcohol and in chloroform, and practically insoluble in ether.

Chemical structure.

Its structural formula is:

CAS number.

CAS: 58-33-3.

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist Only Medicine.

Summary Table of Changes