FULL CMI

Pharmacy Action Allerelief

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 Pharmacy Action Allerelief. 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 Pharmacy Action Allerelief.

Where to find information in this leaflet:

1. Why am I using Pharmacy Action Allerelief?
2. What should I know before I use Pharmacy Action Allerelief?
3. What if I am taking other medicines?
4. How do I use Pharmacy Action Allerelief?
5. What should I know while using Pharmacy Action Allerelief?
6. Are there any side effects?
7. Product details

1. Why am I using Pharmacy Action Allerelief?

Pharmacy Action Allerelief contains the active ingredient promethazine hydrochloride.

Pharmacy Action Allerelief 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 Pharmacy Action Allerelief for another reason.

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

2. What should I know before I use Pharmacy Action Allerelief?

Warnings

Pharmacy Action Allerelief must not be used in children under 6 years of age, due to the potential for fatal respiratory depression. A liquid alternative should be considered in children 2-6 years of age.

Do not use Pharmacy Action Allerelief 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 Pharmacy Action Allerelief.

Do not give Pharmacy Action Allerelief to newborn or premature babies.

Check with your doctor or pharmacist if you:

• have allergies to:
  - any other medicines
  - any other substances, such as foods, 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 Pharmacy Action

Allerelief 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 Pharmacy Action Allerelief 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 Pharmacy Action Allerelief 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 Pharmacy Action Allerelief 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 Pharmacy Action Allerelief to newborn or premature babies.
• Pharmacy Action Allerelief 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 Pharmacy Action Allerelief and affect how it works.

Pharmacy Action Allerelief 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

These medicines may be affected by Pharmacy Action Allerelief 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 Pharmacy Action Allerelief.

4. How do I use Pharmacy Action Allerelief?

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.
• Pharmacy Action Allerelief tablets are recommended for adults and children over 6 years of age.
• It is recommended that the lowest effective dose of Pharmacy Action Allerelief be used in children 6 years of age or older.

Allergic Disorder

• Adults and children 12 years of age and over: 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 or one 10mg tablet, two to three times daily.

Sedation

• For short term use on the advice of a pharmacist or doctor.
• Adults: One to three 25mg tablets as a single dose at night.
• Children 6-12 years: One to two 10mg tablets at night. For no more than a few days

Travel Sickness

• Adults: 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: One 25mg tablet every 4 to 6 hours to a maximum daily dose of four 25mg tablets.
• Children 6-12 years: One 10mg tablet, every 4 to 6 hours to a maximum daily dose of two 10mg tablets.

Use in the Elderly

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

How to take Pharmacy Action Allerelief

• Swallow Pharmacy Action Allerelief tablets whole with a full glass of water.

How long to take it

Pharmacy Action Allerelief should not usually be taken for more than 10 days in a row. If your symptoms persist, see your pharmacist or doctor for advice.

If you forget to take it

If you are taking Pharmacy Action Allerelief 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 pharmacist or doctor.

If you are taking Pharmacy Action Allerelief for travel sickness or nausea and vomiting, take your dose as soon as you remember.

If you are taking Pharmacy Action Allerelief 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 Pharmacy Action Allerelief

If you think that you have used too much Pharmacy Action Allerelief, 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 Pharmacy Action Allerelief, 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 Pharmacy Action Allerelief?

Things you should do

Remind any doctor, dentist or pharmacist you visit that you are using Pharmacy Action Allerelief.

Pharmacy Action Allerelief may cause your skin to be more sensitive to the sun. You should protect your skin from exposure to bright sunlight.

If you are about to be started on any new medicine, tell your pharmacist or doctor that you are taking Pharmacy Action Allerelief.

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 Pharmacy Action Allerelief to anyone else, even if they have the same condition as you.
• Do not take Pharmacy Action Allerelief 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.

Things to be careful of

• Pharmacy Action Allerelief 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

Be careful before you drive or use any machines or tools until you know how Pharmacy Action Allerelief affects you.

Pharmacy Action Allerelief can cause drowsiness, dizziness and blurred vision. Make sure you know how you react to Pharmacy Action Allerelief 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 Pharmacy Action Allerelief affects you.

Pharmacy Action Allerelief 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 Pharmacy Action Allerelief.

The sedation effects of alcohol may be increased.

Looking after your medicine

• Keep your medicine in the pack until it is time to take it.
• If you take your medicine out of the pack it will not keep as well.
• Store Pharmacy Action Allerelief tablets below 25°C.
  Protect from light.

Follow the instructions on 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 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 disposal.

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

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

Serious side effects

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

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/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 Pharmacy Action Allerelief contains

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

What Pharmacy Action Allerelief looks like

Pharmacy Action Allerelief are blue coloured, round, biconvex, film coated tablets plain on both sides.

Both tablet strengths are available in blister packs of 50 tablets.

Australian Registration Numbers

PHARMACY ACTION ALLERELIEF 25 promethazine hydrochloride 25 mg tablet AUST R 328720

PHARMACY ACTION ALLERELIEF 25 promethazine hydrochloride 10 mg tablet AUST R 328721

Who distributes Pharmacy Action Allerelief

Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
Australia
  [email protected]
  +61 3 9809 7900
  www.generichealth.com.au

This leaflet was prepared in September 2024

Published by MIMS June 2025

Notes

Distributed by Generic Health Pty Ltd

1 Name of Medicine

Promethazine hydrochloride.

2 Qualitative and Quantitative Composition

Pharmacy Action Allerelief 10.

Pharmacy Action Allerelief 25.

3 Pharmaceutical Form

Pharmacy Action Allerelief 10 mg and 25 mg are blue coloured, round, biconvex, film-coated tablets which are plain on both sides.

4 Clinical Particulars

4.1 Therapeutic Indications

Allergies.

Upper respiratory tract.

Nausea and vomiting.

Sedation.

Other.

4.2 Dose and Method of Administration

This product should not be given to children under 6 years of age. This product should be given to children aged between 6 and 11 years only on the advice of a doctor, pharmacist or nurse practitioner (see Section 4.4 Special Warnings and Precautions for Use). Dosage varies according to the condition being treated and the individual's response.

Allergic disorders.

Children 6-12 years.

Adults and children over 12 years.

Sedation.

Children 6-12 years.

Adults and children over 12 years.

Travel sickness prevention.

Children 6-12 years.

Adults and children over 12 years.

Travel sickness treatment.

Children 6-12 years.

Adults and children over 12 years.

Nausea and vomiting.

Children 6-12 years.

Adults and children over 12 years.

4.3 Contraindications

Promethazine is contraindicated for use in patients with a history of hypersensitivity to the drug substance, substances of similar chemical structure or hypersensitivity to the other ingredients.
Promethazine is contraindicated for use in:
newborns or premature infants;
children under 6 years of age (see Section 4.4 Special Warnings and Precautions for Use);
women who are lactating/breastfeeding;
patients taking monoamine oxidase inhibitors (MAOIs) (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions);
jaundice induced by other phenothiazine derivatives;
patients who have received high doses of other CNS depressants and/or are comatose.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

4.4 Special Warnings and Precautions for Use

Caution is advised in patients with:
cardiovascular disease;
acute or chronic respiratory impairment, promethazine may thicken or dry lung secretions and impair expectoration;
epilepsy, as epileptic patients may experience increased severity of convulsions;
hypertensive crisis or a history of hypertensive crisis;
narrow-angle glaucoma;
stenosing peptic ulcer;
symptomatic prostatic hypertrophy;
bladder neck obstruction;
pyloroduodenal obstruction;
eczema or a tendency to rheumatism, as solar dermatitis has been reported following oral doses of promethazine in these patients;
a history of drug abuse, as cases of drug abuse have been reported with promethazine.
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 prolongation.

Other precautions.

Hypertensive crisis.

Epilepsy.

Skin reactions.

Neuroleptic malignant syndrome.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

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 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 antimuscarinic actions with other antimuscarinic drugs (atropine, tricyclic antidepressants). Interactions between promethazine and monoamine oxidase inhibitors and tricyclic antidepressants (TCAs) may prolong and intensify the anticholinergic and CNS depressive effects.
Alcohol should be avoided during treatment.
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.

Seizure threshold-lowering drugs.

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

Drugs with anticholinergic properties.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

This medication may cause drowsiness and may increase the effects of alcohol. Patients receiving promethazine hydrochloride for the first time should not be in control of vehicles or machinery for the first few days until it is established that they are not hypersensitive to the central nervous effects of the medicine and do not suffer from disorientation, confusion or dizziness. Those affected should not drive a motor vehicle or operate machinery.

4.8 Adverse Effects (Undesirable Effects)

CNS effects.

Anticholinergic effects.

More common reactions.

Gastrointestinal.

Nervous system.

Ocular.

Less common reactions.

Cardiovascular.

Dermatological.

Haematological.

Hepatic.

Musculoskeletal.

Nervous system.

Respiratory.

Severe or life-threatening reactions.

Reactions with frequency unknown.

Skin and subcutaneous tissue disorders.

Hepatobiliary disorders.

Renal and urinary disorders.

Nervous system disorders.

Immune system disorders.

Metabolism and nutrition disorders.

Blood and lymphatic system disorders.

Psychiatric disorders.

Cardiac disorders.

Respiratory, thoracic and mediastinal disorders.

Vascular disorders.

General disorders and administration site conditions.

Reporting suspected adverse effects.

4.9 Overdose

The chief sign of acute poisoning from ingestion of an overdose of promethazine is unconsciousness, which is commonly delayed. In addition, convulsions, hallucinations, delirium, acute anxiety, psychotic reactions, extreme hyperesthesia and hyperalgesia with extensor plantar responses may occur.
Anticholinergic action may cause tachycardia, flushed skin, dry mouth and sometimes mydriasis and urinary retention.
Symptoms of severe overdosage are variable. The chief sign of acute poisoning from ingestion of an overdose of promethazine 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.
High doses can cause ventricular arrhythmias including QT prolongation and torsade de pointes (see Section 4.8 Adverse Effects (Undesirable Effects)).
In adults, CNS depression is more common, with drowsiness, coma, convulsions, progressing to respiratory failure or cardiovascular collapse.
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.
Symptomatic supportive therapy is indicated and maintenance of adequate ventilation should be instituted if necessary.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Following are the list of excipients present in the formulation of 10 mg and 25 mg promethazine hydrochloride tablets: povidone; maize starch; lactose monohydrate; magnesium stearate; Opadry complete film coating system 03B505083 blue (PI 114196).

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 25°C. Protect from light.

6.5 Nature and Contents of Container

Aluminium/opaque PVC film blisters in packs of 50 tablets.

Australian registration numbers.

Pharmacy Action Allerelief 10.

Pharmacy Action Allerelief 25.

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.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 3 - Pharmacist Only Medicine.

Summary Table of Changes