WAGNER HEALTH PROMETHAZINE

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

This leaflet provides important information about using Wagner Health Promethazine. 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 Wagner Health Promethazine.

Where to find information in this leaflet:

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

Wagner Health Promethazine contains the active ingredient promethazine hydrochloride.

Wagner Health Promethazine 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 Wagner Health Promethazine for another reason.

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

Warnings

Wagner Health Promethazine must not be used in children under 6 years of age, due to the potential for fatal respiratory depression.

Do not use Wagner Health Promethazine 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 show signs of tampering.

Any person who is unconscious or in a coma must not be treated with Wagner Health Promethazine.

Do not give Wagner Health Promethazine 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 any other 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 Wagner Health Promethazine 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 Wagner Health Promethazine 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 Wagner Health Promethazine during your pregnancy, Your pharmacist or doctor will discuss the benefits and possible risks of taking the medicine during pregnancy.

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

Do not take Wagner Health Promethazine if you are breastfeeding or plan to breastfeed.

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

Use in Children

• Do not give Wagner Health Promethazine to newborn or premature babies.
• Wagner Health Promethazine must not be used in children under 6 years of age, due to the potential for fatal respiratory depression.
• Because of the risk of choking, the tablets should be avoided in children who have difficulty swallowing tablets.

Use in Elderly

• If you are over 65 years of age, talk to you pharmacist or doctor about how much to take.
• Elderly patients are more likely to have side effects from taking these 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 Wagner Health Promethazine and affect how it works.

Wagner Health Promethazine 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 Wagner Health Promethazine 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 Wagner Health Promethazine.

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

Allergic Disorder

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

Sedation

• For short term use on the advice of a pharmacist or doctor.
• Adults and children 12 years and over: One to three 25 mg tablets as a single dose at night.
• Children 6-12 years: One to two 10 mg tablets as a single dose at night.

Travel Sickness

• Adults and children 12 years and over: One 25 mg tablet.
• Children 6-12 years: One 10 mg tablet.
• To be taken the night before travel and repeated after 6-8 hours on the following day if required.

Nausea and Vomiting

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

How to take Wagner Health Promethazine

• Swallow Wagner Health Promethazine tablets whole with a full glass of water.

How to long to take Wagner Health Promethazine

• Wagner Health Promethazine 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 use Wagner Health Promethazine

If you are taking Wagner Health Promethazine 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 Wagner Health Promethazine for travel sickness or nausea and vomiting, take your dose as soon as you remember.

If you are taking Wagner Health Promethazine 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 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 Wagner Health Promethazine (overdose)

If you think that you have used too much Wagner Health Promethazine, 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 Wagner Health Promethazine, 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

Things you should do

• Wagner Health Promethazine 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 Wagner Health Promethazine.
• 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.

Remind any doctor, dentist or pharmacist you visit that you are using Wagner Health Promethazine.

Things you should not do

• Do not give Wagner Health Promethazine to anyone else, even if they have the same condition as you.
• Do not take Wagner Health Promethazine 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

• Wagner Health Promethazine 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

Wagner Health Promethazine can cause drowsiness, dizziness and blurred vision. Make sure you know how you react to Wagner Health Promethazine 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 Wagner Health Promethazine affects you.

Wagner Health Promethazine 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 Wagner Health Promethazine.

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

Store it in a cool dry place below 30°C 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.

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 disposal.

Do not use this medicine after the expiry date.

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 about side effects.

Less serious side effects

Serious side effects

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.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

This medicine is only available with a doctor's prescription.

What Wagner Health Promethazine contains

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

What Wagner Health Promethazine looks like

Wagner Health Promethazine 10mg tablets – round, pale blue to blue, film coated tablets, plain on both sides (Aust R 351892).

Wagner Health Promethazine 25mg tablets – round, pale blue to blue, film coated tablets, plain on both sides (Aust R 351891).

Pack size of 50 tablets.

Who distributes Wagner Health Promethazine

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Tel: 1800 726 369

This leaflet was revised in September 2022.

Published by MIMS November 2022

1 Name of Medicine

Promethazine hydrochloride.

2 Qualitative and Quantitative Composition

Each Wagner Health Promethazine 10 contains 10 mg promethazine hydrochloride.
Each Wagner Health Promethazine 25 contains 25 mg promethazine hydrochloride.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Wagner Health Promethazine tablets are pale blue to blue, round coated tablets, plain on both sides.

4 Clinical Particulars

4.9 Overdose

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.
In adults, CNS depression is more common, with drowsiness, coma, convulsions, progressing to respiratory failure or cardiovascular collapse.
High dose 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.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).
Symptomatic supportive therapy is indicated and maintenance of adequate ventilation should be instituted if necessary.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Promethazine hydrochloride is a white or faintly yellow, practically colourless, crystalline powder. It is very soluble in water, freely soluble in alcohol and in chloroform, and practically insoluble in ether.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPROHYD.gif Chemical name: (2RS)-N,N-Dimethyl-1-(10H-phenothiazin-10-yl) propan-2-amine hydrochloride.
Molecular formula: C₁₇H₂₀N₂S.HCl.
Molecular weight: 320.88.
CAS number. 58-33-3.

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/WAHPROST.gif