FULL CMI

PHARMACY ACTION Cold & Flu PSE

Active ingredients: Paracetamol, Pseudoephedrine hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using PHARMACY ACTION Cold & Flu PSE. 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 Cold & Flu PSE.

Where to find information in this leaflet:

1. Why am I using PHARMACY ACTION Cold & Flu PSE?
2. What should I know before I use PHARMACY ACTION Cold & Flu PSE?
3. What if I am taking other medicines?
4. How do I use PHARMACY ACTION Cold & Flu PSE?
5. What should I know while using PHARMACY ACTION Cold & Flu PSE?
6. Are there any side effects?
7. Product details

1. Why am I using PHARMACY ACTION Cold & Flu PSE?

PHARMACY ACTION Cold & Flu PSE contains the active ingredients paracetamol and pseudoephedrine hydrochloride. Paracetamol works to stop the pain messages from getting through to the brain. It also acts in the brain to reduce fever. Pseudoephedrine hydrochloride belongs to a group of medicines called sympathomimetic decongestants. It works by reducing congestion in the upper respiratory tract, including the nose, nasal passages and sinuses, making it easier to breathe.

PHARMACY ACTION Cold & Flu PSE is for the temporary relief from the following cold & flu symptoms: nasal congestion, sinus pain, runny nose, headache, body aches & pains. Reduces fever.

2. What should I know before I use PHARMACY ACTION Cold & Flu PSE?

Warnings

Do not use PHARMACY ACTION Cold & Flu PSE if:

• you are allergic to paracetamol, pseudoephedrine hydrochloride, 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 to the symptoms of an allergic reaction 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.
• You have very high blood pressure
• Severe coronary artery disease (heart disease caused by poor blood flow or narrowing of the blood vessels of the heart)
• Taken monoamine oxidase inhibitors, medicines used to treat depression, in the last 14 days.

Check with your doctor or pharmacist if you:

• have any other medical conditions such as:
  - liver or kidney disease
  - high blood pressure
  - overactive thyroid gland
  - diabetes
  - heart disease and poor blood flow in the blood vessels of the heart
  - glaucoma (high pressure in the eyes)
  - prostate problems
• take any medicines for any other condition.
• have allergies to any other medicines, foods, preservatives or dyes.

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

Do not take this medicine if you are pregnant or intend to become pregnant. It may affect your developing baby if you take it during pregnancy.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed. Paracetamol may be used if you are breastfeeding. Small amounts of pseudoephedrine pass into the breast milk.

Your pharmacist or doctor will discuss the potential benefits and risks of taking the medicine if you are pregnant or breastfeeding.

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 Cold & Flu PSE and affect how it works. These include:

• Warfarin, a medicine used to prevent blood clots
• Metoclopramide, a medicine used to control nausea and vomiting
• Medicines use to treat epilepsy or fits
• Chloramphenicol, an antibiotic used to treat ear and eye infections
• Medicines used to treat depression
• Medicines used to treat heart conditions
• Medicines used to treat high blood pressure
• Medicines used to treat urinary tract infections and bladder problems
• Medicines used to treat behavioural disorders
• Phenylephrine, a medicine used to treat congestion
• Appetite suppressants
• Alcohol

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 Cold & Flu PSE.

4. How do I use PHARMACY ACTION Cold & Flu PSE?

How much to take / use

• Adults and Children 12 years & over: Take 2 tablets every 4 to 6 hours.
• No more than 4 doses in 24 hours.
• Follow the instructions provided with the medicine.
• Do not exceed the recommended dosage.

When to take / use PHARMACY ACTION Cold & Flu PSE

• PHARMACY ACTION Cold & Flu PSE should be used every 4 to 6 hours when required.

How to take PHARMACY ACTION Cold & Flu PSE

• Take with water.

If you use too much PHARMACY ACTION Cold & Flu PSE

If you think that you have used too much PHARMACY ACTION Cold & Flu PSE, 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.

5. What should I know while using PHARMACY ACTION Cold & Flu PSE?

Things you should do

• 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 this medicine.

Remind any doctor, dentist or pharmacist you visit that you are using PHARMACY ACTION Cold & Flu PSE.

Things you should not do

• Do not give to children under 12 years.
• Do not exceed the recommended dose unless a pharmacist or doctor has told you to.
• Do not take with other medicines containing paracetamol unless advised to by a doctor or pharmacist.
• Do not take for longer than a few days at a time (adults) or 48 hours (children and adolescents) unless advised to by a doctor.
• If you forget to take it,
  - If it is less than 2-3 hours before your next dose, skip the dose you missed and take your next dose when you are meant to take it.
  - Otherwise, take it as soon as you remember and then go back to taking it as you normally would.
  - Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting unwanted side effects.
• Do not take this medicine to treat any other complaints unless told to by your pharmacist or doctor.
• Do not give your medicine to anyone else, even if they have the same condition as you.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how PHARMACY ACTION Cold & Flu PSE affects you.

PHARMACY ACTION Cold & Flu PSE may cause dizziness in some people. If this happens, do not drive or operate machinery.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Only drink small quantities of alcohol (wine, beer or spirits) while taking this medicine. Drinking large quantities or alcohol while taking paracetamol may increase the risk of liver side effects.

Looking after your medicine

• Store your medicine below 30°C.

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.

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

Serious side effects

Pseudoephedrine may cause sleeplessness if taken up to several hours before going to bed.

Children and people over 65 years of age may have an increased chance of getting 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.

7. Product details

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

What PHARMACY ACTION Cold & Flu PSE contains

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

What PHARMACY ACTION Cold & Flu PSE looks like

PHARMACY ACTION Cold & Flu PSE are white, round tablets with a breakline on one side.

The medicine is sold in a carton containing 24 tablets in blister packs.

(AUST R 295160).

Who distributes PHARMACY ACTION Cold & Flu PSE

PHARMACY ACTION Cold & Flu PSE is supplied in Australia by:

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 December 2022.

Published by MIMS September 2023

1 Name of Medicine

Paracetamol and pseudoephedrine hydrochloride.

2 Qualitative and Quantitative Composition

Each tablet contains the active ingredients:
paracetamol 500 mg; and
pseudoephedrine hydrochloride 30 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Pharmacy Action Cold & Flu PSE tablets are white, round tablets with a break-line.

4 Clinical Particulars

4.1 Therapeutic Indications

Pharmacy Action Cold & Flu PSE is used for temporary relief of the following cold and flu symptoms: nasal congestion, sinus pain, runny nose, headache and body aches and pains. Reduces fever.

4.2 Dose and Method of Administration

Adults and children 12 years and over.

Use in adults.

Use in children.

4.3 Contraindications

Pharmacy Action Cold & Flu PSE is contraindicated for use in patients with the following conditions:
known hypersensitivity or idiosyncratic reaction to paracetamol, pseudoephedrine (or substances of a similar chemical structure) or any of the other ingredients in this medicine;
severe hypertension or coronary artery disease;
taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs within the previous fourteen (14) days.
Also see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

4.4 Special Warnings and Precautions for Use

Pharmacy Action Cold & Flu PSE should be used with caution in patients with the following conditions: impaired hepatic function, impaired renal function, hypertension, hyperthyroidism, diabetes mellitus, coronary heart disease, ischaemic heart disease, glaucoma, prostatic hypertrophy.
This medicine contains pseudoephedrine which may cause sleeplessness if taken up to several hours before going to bed.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The following interactions with paracetamol have been noted:
Anticoagulant drugs (warfarin) - dosage may require reduction if paracetamol and anticoagulants are taken for a prolonged period of time.
Paracetamol absorption is increased by substances that increase gastric emptying, e.g. metoclopramide.
Paracetamol absorption is decreased by substances that decrease gastric emptying, e.g. propantheline, antidepressants with anticholinergic properties, and narcotic analgesics.
Paracetamol may increase chloramphenicol concentrations.
The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes such as alcohol and anticonvulsant agents.
Paracetamol excretion may be affected and plasma concentrations altered when given with probenecid.
Colestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol.
The following interactions with pseudoephedrine have been noted:
Antidepressant medication, e.g. tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs), may cause a serious increase in blood pressure or hypertensive crisis.
Other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants, may cause an increase in blood pressure and additive effects.
Methyldopa and β-blockers - may cause an increase in blood pressure.
Urinary acidifiers enhance elimination of pseudoephedrine.
Urinary alkalinisers decrease elimination of pseudoephedrine.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Side effects of paracetamol are rare and usually mild, although haematological reactions have been reported. Skin rashes and hypersensitivity reactions occur occasionally. Overdosage with paracetamol if left untreated can result in severe, sometimes fatal liver damage and rarely, acute renal tubular necrosis.
Adverse effects of pseudoephedrine include:
cardiovascular stimulation - elevated blood pressure, tachycardia or arrhythmias;
central nervous system (CNS) stimulation - restlessness, insomnia, anxiety, tremors and (rarely) hallucinations;
skin rashes and urinary retention.
Children and the elderly are more likely to experience adverse effects than other age groups.

Reporting suspected adverse effects.

4.9 Overdose

If an overdose is taken or suspected, immediately contact the Poisons Information Centre (in Australia, call 13 11 26) for advice, or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

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

Crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised maize starch, purified water, COMPAP L (PI 910).

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

Pharmacy Action Cold & Flu PSE should be stored below 30°C.

6.5 Nature and Contents of Container

The tablets are presented in PVC/PVDC/Aluminium blister packs which are enclosed in a carton. Each blister pack contains 12 tablets.
The pack sizes* are:
24 tablets (2 x 12 tablet blister packs in a carton).
12 tablets (1 x 12 tablet blister packs in a carton).
* Not all pack sizes may be marketed.

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

Paracetamol is a white or almost white crystalline powder. It is sparingly soluble in water, freely soluble in alcohol and very slightly soluble in methylene chloride.
Pseudoephedrine hydrochloride is a white or almost white crystalline powder or colourless crystals. It is freely soluble in water and in ethanol (96 per cent), sparingly soluble in methylene chloride. Its melting point is at about 184°C.

Chemical structure.

Paracetamol.

Pseudoephedrine hydrochloride.

CAS Number.

Paracetamol.

Pseudoephedrine hydrochloride.

7 Medicine Schedule (Poisons Standard)

(S3) Pharmacist Only Medicine.

Summary Table of Changes