Consumer medicine information

Demazin Original 6 hour Relief

Chlorphenamine maleate (chlorpheniramine maleate); Pseudoephedrine sulfate

BRAND INFORMATION

Brand name

Demazin Original 6 Hour Relief Tablets

Active ingredient

Chlorphenamine maleate (chlorpheniramine maleate); Pseudoephedrine sulfate

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Demazin Original 6 hour Relief.

What is in this leaflet

This leaflet answers some common questions about DEMAZIN 6 hour relief tablets.

It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor.

All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you taking Demazin 6 hour relief against the benefits they expect it will have for you.

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

Keep this leaflet with the medicine. You may need to read it again.

What DEMAZIN 6 hour relief is used for

DEMAZIN 6 hour provides effective relief from:

  • runny nose
  • blocked nose & sinus
  • sneezing
  • watery, itchy eyes

DEMAZIN 6 hour relief contains a combination of two medicines; pseudoephedrine sulfate and chlorpheniramine maleate.

Pseudoephedrine sulfate 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, and making it easier to breathe.

Chlorpheniramine maleate belongs to a group of medicines called 'antihistamines'. 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.

Ask your pharmacist or doctor if you have any questions about this medicine. Your pharmacist or doctor may have given it for another reason.

Before you take DEMAZIN 6 hour relief

When you must not take it

Do not take DEMAZIN 6 hour relief tablets if you have an allergy to:

  • any medicine containing pseudoephedrine, chlorpheniramine maleate or other antihistamines
  • any of the ingredients listed at the end of this leaflet

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.

Do not take this medicine if you have or have had any of the following medical conditions:

  • very high blood pressure
  • severe coronary artery disease (heart disease caused by poor blood flow or narrowing of the blood vessels of the heart)
  • glaucoma (high pressure in the eyes)
  • stomach or duodenal ulcer, or other stomach problems
  • prostate problems
  • bladder problems

Do not take this medicine if you are pregnant or plan to become pregnant. It may affect your developing baby if you take it during pregnancy. Your pharmacist or doctor will discuss the benefits and possible risks of taking the medicine during pregnancy.

Do not take this medicine if you are also taking monoamine oxidase inhibitors, a type of medicine used to treat depression, or if you have taken it in the last 14 days.

Do not give this medicine to newborn or premature babies or children under 12 years of age.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

Talk to your pharmacist or doctor if you are not sure whether you should start taking this medicine.

Before you start to take it

Tell your pharmacist or doctor if you have allergies to any other medicines, foods, preservatives or dyes.

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

  • high blood pressure
  • overactive thyroid gland
  • diabetes
  • heart disease or poor blood flow in the blood vessels of the heart
  • glaucoma (high pressure in the eyes)
  • prostate problems
  • liver or kidney disease
  • epilepsy

Ask your pharmacist or doctor about taking DEMAZIN 6 hour relief tablets if you are breastfeeding. Your pharmacist or doctor will discuss the potential benefits and risks of taking the medicine if you are breastfeeding.

Tell your pharmacist or doctor if you are pregnant or plan to become pregnant Your pharmacist or doctor will discuss the benefits and possible risks of taking the medicine during pregnancy.

If you have not told your pharmacist or doctor about any of the above, tell him/her before you start taking DEMAZIN 6 hour relief tablets.

Taking other medicines

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

Some medicines and DEMAZIN 6 hour relief tablets may interfere with each other. 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
  • phenytoin, a medicine used to treat epilepsy
  • 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

These medicines may be affected by DEMAZIN 6 hour relief tablets or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist will have more information on medicines to be careful with or avoid while taking this medicine.

How to take DEMAZIN 6 hour relief

DEMAZIN 6 hour relief tablets are only available from your pharmacist.

Follow all directions given to you by your pharmacist or doctor carefully. They may differ from the information contained in this leaflet.

Ask your pharmacist or doctor for help if you do not understand the instructions on the box.

How much to take

The recommended dose is:

  • Adults and children 12 years and over: one tablet as directed

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.

When to take it

Take your dose every 6 hours, when necessary.

Do not take more than the recommended dose.

Pseudoephedrine sensitive individuals should take the last dose a few hours before bed time. If you are sensitive to the effects of pseudoephedrine, you may experience sleeplessness if you take it just before going to bed.

How to take it

Swallow the tablet with a glass of water.

Do not crush or chew the tablet before swallowing.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

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 take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too many DEMAZIN 6 hour relief tablets.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using DEMAZIN 6 hour relief

Things you must do

Tell any doctor or pharmacist who is treating you that you are taking DEMAZIN 6 hour relief tablets.

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.

Things you must not do

Do not take DEMAZIN 6 hour relief tablets to treat any other conditions unless your pharmacist or doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not take more than the recommended dose unless your pharmacist or doctor tells you to.

Do not drink alcohol while taking DEMAZIN 6 hour relief tablets. Drinking alcohol while taking this medicine will make you more drowsy.

Things to be careful of

Be careful driving or operating machinery until you know how DEMAZIN 6 hour relief tablets affect you. This medicine may cause dizziness and/or sleepiness in some people. If this happens, do not drive or operate machinery.

Side effects

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking DEMAZIN 6 hour relief tablets.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your pharmacist or doctor to answer any questions you may have.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • Not passing any or very little urine
  • 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

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 as soon as possible if you notice any of the following:

  • difficult or painful urination
  • seizures (fits)

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

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

  • drowsiness or sleepiness
  • difficulty sleeping
  • excitability
  • restlessness
  • dizziness
  • fear or anxiety
  • rapid/fast heart beat
  • tremor
  • hallucinations
  • dry mouth, nose and throat
  • constipation
  • nervousness and irritability
  • twitching or jerking muscles

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

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

Tell your pharmacist or doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After using DEMAZIN 6 hour relief

Storage

Keep your medicine in the original pack until it is time to take it.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store DEMAZIN 6 hour relief tablets or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

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

Disposal

Ask your pharmacist what to do with any medicine that is left over, or if the expiry date has passed.

Product description

What it looks like

DEMAZIN 6 hour relief is a round, convex, blue, tablet plain on one side and score line on the other side.

DEMAZIN 6 hour relief is available in packs of 12 and 4 tablets.

Ingredients

Each DEMAZIN 6 hour relief tablet contains:

Active Ingredients:

  • pseudoephedrine sulfate 60 mg
  • chlorpheniramine maleate 4 mg

Inactive ingredients:

  • Brilliant Blue CFC
  • Starch maize
  • Magnesium stearate
  • Povidone
  • Lactose

This medicine does not contain sugar or gluten.

This medicine contains lactose.

Supplier

DEMAZIN 6 hour relief tablets are supplied in Australia by:

BAYER AUSTRALIA LTD
875 Pacific Highway,
Pymble NSW 2073 AUSTRALIA

DEMAZIN 6 hour Relief tablets: AUST R 18815

Date of preparation:
28 August 2017

Published by MIMS April 2023

BRAND INFORMATION

Brand name

Demazin Original 6 Hour Relief Tablets

Active ingredient

Chlorphenamine maleate (chlorpheniramine maleate); Pseudoephedrine sulfate

Schedule

S3

 

1 Name of Medicine

Chlorphenamine maleate and pseudoephedrine sulfate.

2 Qualitative and Quantitative Composition

Each Demazin Original 6 Hour Relief Tablet contains chlorphenamine maleate 4 mg and pseudoephedrine sulfate 60 mg.

Excipients with known effect.

Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tablet.
A round, convex, blue tablet plain on one side and score-line on the other.

4 Clinical Particulars

4.1 Therapeutic Indications

Relief of upper respiratory mucosal congestion and hypersecretion accompanying conditions such as the common cold, nasal allergy, hayfever, and sinusitis.

4.2 Dose and Method of Administration

Adults and children 12 years and over.

One tablet every 6 hours, when necessary.

4.3 Contraindications

Hypersensitivity to chlorphenamine, pseudoephedrine or to other drugs of similar chemical structure.
Traditional antihistamines, such as chlorphenamine are contraindicated in patients taking an antihypertensive agent or an antidepressant medication containing a monoamine oxidase inhibitor (MAOI).
Sympathomimetic agent decongestants such as pseudoephedrine are contraindicated in patients with severe hypertension, coronary heart disease and also in patients receiving MAOI therapy (and for 14 days after cessation of MAOI therapy).
Demazin Original 6 Hour Relief should not be used in children under 12 years of age (see Section 4.4, Paediatric use).

4.4 Special Warnings and Precautions for Use

Identified precautions.

Chlorphenamine.

Use with caution in patients with narrow angle glaucoma, stenotic peptic ulcer, pyloroduodenal obstruction and urinary bladder obstruction due to symptomatic prostatic hypertrophy and narrowing of the bladder neck. (Also see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 4.7 Effects on Ability to Drive and Use Machines).

Pseudoephedrine.

Use with caution in patients with a history of hypertension, coronary artery disease, narrow angle glaucoma, diabetes, hyperthyroidism or prostatic hypertrophy.
In some patients pseudoephedrine may cause side effects of sympathomimetic origin such as nausea, dizziness, weakness, tachycardia, insomnia, palpitations and mydriasis.

Ischaemic colitis.

Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued, and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.

Use in the elderly.

Elderly patients (approximately 60 years and older) are more likely to experience dizziness, sedation and hypotension with medicines containing chlorphenamine.

Paediatric use.

Demazin Original 6 Hour Relief should not be used in children under 12 years of age.
Chlorphenamine may cause excitation in children.
Antihistamines should not be given to newborn or premature infants.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The sedative effect of chlorphenamine may be potentiated by the concomitant use with alcohol, tricyclic antidepressants, barbiturates or other CNS depressants.
MAOI's prolong and intensify the effects of antihistamines.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
Safe use of Demazin preparations during pregnancy has not been established. Therefore, the product should be used only if the potential benefit justifies the potential risk to the foetus. Chlorphenamine maleate should not be used in the third trimester of pregnancy because newborn and premature infants may have severe reactions to antihistamines.
As it is not known whether the components of Demazin are excreted in human milk, caution should be exercised when Demazin is administered to nursing mothers.

4.7 Effects on Ability to Drive and Use Machines

May cause drowsiness. Patients should be warned against engaging in mechanical operations which require alertness, such as driving a motor vehicle, until response to the medicine has been determined.

4.8 Adverse Effects (Undesirable Effects)

Drowsiness, sedation, dizziness, ataxia, nausea and headache may occur. Disturbances of the cardiovascular, haematological, gastrointestinal (ischaemic colitis - frequency unknown) and nervous system may occur.

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

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.

Antihistamine plus decongestant.
Demazin contains an antihistamine (chlorphenamine) for prophylaxis and treatment of allergy symptoms and a decongestant (pseudoephedrine) for relief of nasal and sinus congestion.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Brilliant blue FCF, lactose monohydrate, magnesium stearate, maize starch, povidone.

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 moisture.

6.5 Nature and Contents of Container

Blister pack: 12's and 4's (sample pack).

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.

Pseudoephedrine sulfate: 7460-12-0.
Chlorphenamine maleate: 113-92-8.

7 Medicine Schedule (Poisons Standard)

S3.

Summary Table of Changes