Consumer medicine information

Demazin Cough Cold and Flu Tablets

Pseudoephedrine hydrochloride; Paracetamol; Dextromethorphan hydrobromide monohydrate

BRAND INFORMATION

Brand name

Demazin Cough Cold and Flu Tablets

Active ingredient

Pseudoephedrine hydrochloride; Paracetamol; Dextromethorphan hydrobromide monohydrate

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Demazin Cough Cold and Flu Tablets.

What is in this leaflet

This leaflet answers some common questions about DEMAZIN Cough Cold & Flu 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 Cough Cold & Flu 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 Cough Cold & Flu is used for

DEMAZIN Cough Cold & Flu provides temporary relief from:

  • nagging cough
  • runny noses
  • blocked noses and sinus
  • sinus pain
  • fever
  • headache
  • body aches and pains

DEMAZIN Cough Cold & Flu contains a combination of three medicines: pseudoephedrine hydrochloride, dextromethorphan and paracetamol.

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, and making it easier to breathe.

Dextromethorphan is a cough suppressant that acts on the cough centre in the brain to suppress a dry cough.

Paracetamol works to stop the pain messages from getting through to the brain. It also acts in the brain to reduce fever.

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/give DEMAZIN Cough Cold & Flu

When you must not take it

Do not take DEMAZIN Cough Cold & Flu tablets if you have an allergy to:

  • any medicine containing pseudoephedrine, paracetamol or dextromethorphan hydrobromide
  • 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 are having an asthma attack.

Do not take this medicine if 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)
  • glaucoma (high pressure in the eyes)
  • 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 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
  • asthma
  • chronic obstructive airways disease
  • pneumonia
  • any other respiratory (breathing) conditions

Tell your pharmacist or doctor if you have a chronic cough.

This medicine may make your cough worse.

Tell your pharmacist or doctor if you have a condition that produces large amounts of mucus.

This medicine may make your condition worse.

Ask your pharmacist or doctor about taking DEMAZIN Cough Cold & Flu 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 Cough Cold & Flu.

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 Cough Cold & Flu may interfere with each other. These include:

  • 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 depression or behavioural disorders
  • phenylephrine, a medicine used to treat congestion
  • appetite suppressants
  • warfarin, a medicine used to prevent blood clots
  • metoclopramide, a medicine used to control nausea and vomiting
  • medicines used to treat epilepsy or fits
  • chloramphenicol, an antibiotic used to treat ear and eye infections
  • monoamine oxidase inhibitors, a medicine used to treat depression, especially if taken within the last 14 days
  • quinidine and amiodarone, medicines used to treat abnormal or irregular heart beat
  • opioid analgesics used to treat pain
  • medicines used to help you relax, sleep or relieve anxiety, such as sedatives

These medicines may be affected by DEMAZIN Cough Cold & Flu 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 Cough Cold & Flu

DEMAZIN Cough Cold & Flu 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: 1-2 tablets

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 to 8 hours, when necessary.

Do not take more than 8 tablets in 24 hours.

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.

How long to take it

Adults:
Take DEMAZIN Cold & Flu tablets for a few days at a time unless your doctor tells you to take it for longer.

Children 12 years & over:
Give DEMAZIN Cold & Flu tablets to children for up to 48 hours unless a doctor has told you to give it for longer.

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 Cough Cold & Flu tablets.

You may need urgent medical attention.

While you are using DEMAZIN Cough Cold & Flu

Things you must do

Tell any doctor or pharmacist who is treating you that you are taking DEMAZIN Cough Cold & Flu tablets.

Keep to the recommended dose.

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 Cough Cold & Flu 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.

Things to be careful of

Be careful driving or operating machinery until you know how DEMAZIN Cough Cold & Flu tablets affect you.

This medicine may cause dizziness in some people. If this happens, do not drive or operate machinery.

Only drink small quantities of alcohol (beer, wine or spirits) while taking DEMAZIN Cough Cold & Flu tablets.

Drinking large quantities of alcohol while taking medicines containing paracetamol may increase the risk of liver side effects.

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 Cough Cold & Flu 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
  • excitation
  • extreme confusion
  • severe nausea and vomiting
  • restlessness
  • irritability
  • nervousness and anxiety

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

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

  • drowsiness
  • difficulty sleeping
  • excitability
  • restlessness
  • dizziness
  • fear or anxiety
  • rapid heart beat
  • tremor
  • hallucinations
  • constipation
  • nervousness
  • nausea, vomiting or dyspepsia
  • fatigue
  • stomach discomfort

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 Cough Cold & Flu

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 Cough Cold & Flu 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 Cough Cold & Flu is a round half inch diameter, shallow convex faced bevelled edge pale yellow tablet with break bar.

DEMAZIN Cough Cold & Flu is available in packs of 24's.

Ingredients

Each DEMAZIN Cough Cold & Flu tablet contains:

Active ingredients:

  • pseudoephedrine hydrochloride 30 mg
  • dextromethorphan hydrobromide 15 mg
  • paracetamol 500 mg

Inactive ingredients

  • Vegetable oil - hydrogenated
  • Povidone
  • Sodium starch glycollate
  • Magnesium stearate
  • Croscarmellose sodium
  • Carnauba wax
  • Starch - pregelatinised maize
  • Cellulose microcrystalline
  • 2472-Opadry Yellow OY-22920

This medicine does not contain lactose or gluten

Supplier

DEMAZIN Cough Cold & Flu tablets are supplied in Australia by:
Merck Sharp & Dohme (Australia) Pty Limited
54 - 68 Ferndell Street
South Granville
NSW 2142
AUSTRALIA

DEMAZIN Cough Cold & Flu tablets: AUST R 97031

Date of preparation:
29 November 2013

(Ref no: PI A140108)

BRAND INFORMATION

Brand name

Demazin Cough Cold and Flu Tablets

Active ingredient

Pseudoephedrine hydrochloride; Paracetamol; Dextromethorphan hydrobromide monohydrate

Schedule

S3

 

Name of the medicine

Pseudoephedrine hydrochloride 30 mg, paracetamol 500 mg and dextromethorphan hydrobromide 15 mg.

Excipients

Hydrogenated vegetable oil, povidone, sodium starch glycollate, magnesium stearate, croscarmellose sodium, carnauba wax, pregelatinised maize starch, microcrystalline cellulose and 2472-Opadry Yellow OY-22920.

Pharmacology

Pharmacokinetics.

Pseudoephedrine.

Pseudoephedrine is readily absorbed from the gastrointestinal tract. It is largely excreted unchanged in the urine together with small amounts of its hepatic metabolite. It has a half-life of about 5-8 hours; elimination is enhanced and half-life reduced accordingly in acid urine. Small amounts are distributed into breast milk.

Paracetamol.

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral administration. Paracetamol is distributed into most body tissues. Plasma protein binding is negligible at usual therapeutic doses but increases with increasing doses. The elimination half-life varies from about 1 to 3 hours.
Paracetamol is metabolised extensively in the liver and excreted in the urine mainly as inactive glucuronide and sulfate conjugates. Less than 5% is excreted unchanged. The metabolites of paracetamol include a minor hydroxylated intermediate which has hepatotoxic activity. This intermediate metabolite is detoxified by conjugation with glutathione, however, it can accumulate following paracetamol overdosage (more than 150 mg/kg or 10 g total paracetamol ingested) and if left untreated can cause irreversible liver damage.
Paracetamol is metabolised differently by premature infants, newborns, infants and young children compared to adults, the sulfate conjugate being predominant.

Dextromethorphan.

Dextromethorphan is well absorbed from the gastrointestinal tract after oral administration. It is metabolised in the liver, exhibiting polymorphic metabolism involving the cytochrome P450 isoenzyme (CYP 2D6). It is excreted in the urine as unchanged dextromethorphan and demethylated metabolites, including dextrorphan, which has some cough suppressant activity. The plasma elimination half-life of dextromethorphan is 1.2 to 3.9 hours. However, the rate of metabolism varies between individuals according to phenotype (extensive v poor metabolisers), with half-life being as long as 45 hours in patients who are poor metabolisers.

Pharmacodynamics/ mechanism of action.

Pseudoephedrine.

Pseudoephedrine has direct and indirect sympathomimetic activity and is an effective decongestant in the upper respiratory tract. It is a stereoisomer of ephedrine and has a similar action, but has been found to have less pressor activity and fewer central nervous system (CNS) effects.
Sympathomimetic agents are used as nasal decongestants to provide symptomatic relief. They act by causing vasoconstriction resulting in redistribution of local blood flow to reduce oedema of the nasal mucosa, thus improving ventilation, drainage and nasal stuffiness.

Paracetamol.

Paracetamol is a ρ-aminophenol derivative that exhibits analgesic and antipyretic activity. It does not possess anti-inflammatory activity. Paracetamol is thought to produce analgesia through a central inhibition of prostaglandin synthesis.

Dextromethorphan.

Dextromethorphan is a nonopioid cough suppressant. It is the methylated dextrorotatory analogue of levorphanol, a codeine analogue. Dextromethorphan acts centrally on the cough centre in the medulla and nucleus tractus solaris to increase the cough threshold. It does not have classical analgesic, sedative or respiratory depressant effects at usual antitussive doses.

Indications

Provides temporary relief of nagging cough and discomfort associated with cold and flu; relieves blocked noses, dries runny noses, provides temporary relief of cough and headache, relieves body aches and pains and reduces fever.

Contraindications

Pseudoephedrine is contraindicated for use in patients with known hypersensitivity or idiosyncratic reaction to pseudoephedrine (or any of the other ingredients in the product);
with severe hypertension or coronary artery disease;
taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs within the previous 14 days.
Paracetamol and dextromethorphan are contraindicated for use in patients with known hypersensitivity or idiosyncratic reaction to paracetamol and dextromethorphan (or any of the other ingredients in the product).
See Interactions with Other Medicines for additional information.

Precautions

Pseudoephedrine.

Pseudoephedrine should be used with caution in patients with hypertension, hyperthyroidism, diabetes mellitus, coronary heart disease, ischaemic heart disease, glaucoma, prostatic hypertrophy, severe hepatic or renal dysfunction.

Paracetamol.

Paracetamol should be used with caution in patients with impaired hepatic function, impaired renal function.

Dextromethorphan.

Dextromethorphan should not be used for chronic persistent cough accompanying a disease state, or for cough associated with excessive secretions.
Dextromethorphan should not be given to patients with or at risk of developing respiratory failure, e.g. asthma, chronic obstructive airways disease and pneumonia. Caution is needed in patients with a history of asthma and it should not be given during an acute attack.
See Interactions with Other Medicines for additional information.

Use in pregnancy.

(Category B2)
Pseudoephedrine has been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals are inadequate or may be lacking, but available data shows no evidence of an increased occurrence of foetal damage.
Paracetamol and dextromethorphan has been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
As Demazin Cough Cold and Flu tablets contain pseudoephedrine, they should be used in pregnancy only if the potential benefits to the patient are weighed against the possible risk to the foetus.

Use in lactation.

Pseudoephedrine is secreted in breast milk in small amounts. It has been estimated that 0.5 to 0.7% of a single dose of pseudoephedrine ingested by the mother will be excreted in the breast milk over 24 hours.
Paracetamol is excreted in small amounts (< 0.2%) in breast milk. Maternal ingestion of paracetamol in usual analgesic doses does not appear to present a risk to the breastfed infants.
It is not known whether dextromethorphan is excreted in breast milk or whether it has a harmful effect on the breastfeeding infant.
Therefore, Demazin Cough Cold and Flu Tablets are not recommended for breastfeeding mothers unless the potential benefits to the patient are weighed against the possible risk to the infant.

Interactions

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.
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.
Cholestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol.
The following interactions with dextromethorphan have been noted.
Dextromethorphan should not be used in patients taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs within the previous 14 days. The use of dextromethorphan with, or within two weeks of, taking MAOIs may increase the risk of serious side effects such as hypertensive crisis, hyperpyrexia and convulsions.
Dextromethorphan when used with SSRIs (such as fluoxetine) or tricyclic antidepressants (such as clomipramine and imipramine) may result in a serotonin syndrome with changes in mental status, hypertension, restlessness, myoclonus, hyper-reflexia, diaphoresis, shivering and tremor.
Serum levels of dextromethorphan may be increased by the concomitant use of inhibitors of cytochrome P450 2D6, such as the antiarrhythmics quinidine and amiodarone, antidepressants such as fluoxetine and paroxetine, or other drugs which inhibit cytochrome P450 2D6 such as haloperidol and thioridazine.
Concomitant use of dextromethorphan and other CNS depressants (e.g. alcohol, narcotic analgesics and tranquillizers) may increase the CNS depressant effects of these drugs.

Adverse Effects

Pseudoephedrine.

Adverse effects 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.

Paracetamol.

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.

Dextromethorphan.

Side effects that may occur with high doses (overdosage) include excitation, confusion, psychosis, nervousness, irritability, restlessness, serotonin syndrome, severe nausea and vomiting and respiratory depression.

Dosage and Administration

Adults and children 12 years and over.

Take 1 to 2 tablets 3 to 4 times a day, when necessary. Maximum 8 tablets in 24 hours.

Use in adults.

Paracetamol should not be taken for more than a few days at a time except on medical advice.

Use in children.

Paracetamol should not be taken for more than 48 hours except on medical advice.

Overdosage

In case of overdose, immediately contact the Poisons Information Centre (in Australia, call 131 126) for advice, or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage.

Presentation

Tablets (round, half inch diameter, shallow convex, bevelled edge, pale yellow, scored): 24's.

Poison Schedule

S3.