Coldrex PE Phenylephrine Cough, Cold & Flu

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Guaifenesin 100 mg;  ; Paracetamol 250 mg;  ;  ;  ; Phenylephrine hydrochloride 5 mg;  ;  
Available from:
GlaxoSmithKline Consumer Healthcare New Zealand ULC
INN (International Name):
Guaifenesin 100 mg
Pharmaceutical form:
Film coated tablet
Composition:
Active: Guaifenesin 100 mg   Paracetamol 250 mg       Phenylephrine hydrochloride 5 mg     Excipient: Colloidal silicon dioxide Lactose monohydrate Maize starch Microcrystalline cellulose Opadry white OY-LS-28913 Potassium sorbate Povidone Pregelatinised maize starch Purified talc Purified water Stearic acid
Units in package:
Blister pack, white opaque PVC/LDPE/PVDC/Al blisters, 16 tablets
Class:
General sale
Prescription type:
General sale
Manufactured by:
Zhejiang Haizhou Pharmaceutical Co Ltd
Therapeutic indications:
Effective, temporary relief of pain and discomfort associated with cold & flu symptoms: headache, blocked or runny nose, painful sinuses, sore throat, chesty productive cough, shivers, aches and pains. Reduces fever.
Product summary:
Package - Contents - Shelf Life: Blister pack, white opaque PVC/LDPE/PVDC/Al blisters - 16 tablets - 36 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-7426
Authorization date:
2005-04-20

COLDREX

®

PE Phenylephrine Cough,

Cold & Flu Caplets

250 mg Paracetamol / 100 mg Guaifenesin / 5 mg Phenylephrine hydrochloride

CONSUMER MEDICINE INFORMATION

Please read this information before you start using this medicine.

What is in this leaflet

This leaflet answers some common

questions about COLDREX PE

PHENYLEPHRINE COUGH,

COLD & FLU. 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.

If you have any concerns about

using this medicine, ask your

pharmacist or doctor.

Keep this leaflet with the medicine.

You may need to read it again.

What COLDREX PE

PHENYLEPHRINE

COUGH, COLD & FLU

is used for

Paracetamol is used for the fast

effective temporary relief of pain and

discomfort associated with sinus pain

or headache.

Paracetamol works to stop the pain

messages from getting through to the

brain. It also acts in the brain to

reduce fever.

Guaifenesin has an expectorant

action. It is thought to reduce sputum

viscosity by increasing the volume

and water content of the bronchial

secretion, thereby facilitating the

expectoration of sputum.

Phenylephrine HCl works to reduce

nasal stuffiness.

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 use

COLDREX PE

PHENYLEPHRINE

COUGH, COLD & FLU

Taking too much paracetamol can

cause serious harm to your liver.

When you must not use it

Do not use COLDREX PE

PHENYLEPHRINE COUGH,

COLD & FLU if you have an

allergy to:

Any medicine containing

paracetamol, Guaifenesin,

phenylephrine HCl or other

medicines for the relief of cough

and colds, congestion or blocked

nose

Any of the ingredients listed at

the end of this leaflet

Do not use COLDREX PE

PHENYLEPHRINE COUGH,

COLD & FLU:

If you are taking any other

prescription or non-prescription

medicines containing

paracetamol to treat pain, fever,

symptoms of cold and flu, or to

aid sleep

If you are allergic to

paracetamol, phenylephrine,

Guaifenesin, other medicines,

foods, preservatives, dyes or any

of the other ingredients in the

product

If you are taking or have taken

in the past two weeks drugs

called monoamine oxidase

inhibitors (MAOI’s) usually

used to treat depression

Within several hours of going to

bed as it may cause

sleeplessness.

If you have high blood pressure,

heart problems or are taking

antidepressant medicines unless

your doctor has told you to.

If you have or have had asthma,

bronchitis, chronic obstructive

pulmonary disease (COPD),

emphysema, smokers’ cough,

porphyria (a rare blood pigment

disorder).

In children under 12 years of

age.

Always read and follow the label.

Do not use 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.

If you are not sure whether you

should start using this medicine,

talk to your pharmacist or doctor.

Before you start to use it

Tell your pharmacist or doctor if

you have or have had any of the

following medical conditions:

liver or kidney disease

hypertension

heart problems

diabetes

an overactive thyroid

high pressure in the eye (angle

closure glaucoma)

tumour of the adrenal gland

(pheochromocytoma)

enlarged prostate gland

Raynaud’s Phenomenon

are underweight or

malnourished

regularly drink alcohol

You may need to avoid using

this product altogether or limit

the amount of paracetamol that

you take

a severe infection as this may

increase the risk of metabolic

acidosis

Signs of metabolic acidosis

include:

deep, rapid, difficult

breathing

feeling sick (nausea), being

sick (vomiting

loss of appetite.

Contact a doctor

immediately if you get a

combination of these

symptoms

Ask your pharmacist or doctor

about using this medicine if you

are pregnant or plan to become

pregnant, or breastfeeding.

This medicine should not be taken if

you are pregnant or breastfeeding

unless your doctor has told you to.

If you have not told your

pharmacist or doctor about any of

the above, tell them before you use

COLDREX PE

PHENYLEPHRINE COUGH,

COLD & FLU.

Using other medicines

Tell your pharmacist or doctor if

you are using any other medicines,

including any that you get without

a prescription from your

pharmacy, supermarket or health

food shop.

Some medicines and paracetamol,

guaifenesin or phenylephrine HCl

may interfere with each other. These

include:

Warfarin or similar medicines

used to thin the blood

Medicines to treat anxiety or

help you sleep

Medicines used to control your

blood pressure such as beta

blockers

Digoxin and other medicines

used to treat heart problems

Other decongestant or cough and

cold medicines

Appetite suppressants

Medicines to treat depression

such as tricyclic antidepressants

e.g. amitriptyline

Your pharmacist and doctor will

have more information on these and

other medicines to be careful with or

avoid while using this medicine.

How to use COLDREX

PE PHENYLEPHRINE

COUGH, COLD & FLU

Follow all directions given to you

by your pharmacist or doctor

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box, ask your

pharmacist or doctor for help.

Do not exceed the stated dose or

frequency of dosing.

Always use the lowest effective

dose to relieve your symptoms

How much to use

Adults and children aged 12 years

and over:

Take 2 caplets every four to six

hours as needed. Do not take more

than 8 caplets in 24 hours.

How to use it

Swallow with water or other fluid.

How long to use it

Adults:

Only take this medicine for a few

days at a time unless your doctor

tells you to take it for longer.

Children 12 to 17 years:

Only give this medicine to children

for up to 48 hours unless a doctor has

told you to give it for longer.

If you use too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 0800 764 766) for

advice, or go to Accident and

Emergency at the nearest hospital,

if you think that you or anyone else

may have taken too much

COLDREX PE

PHENYLEPHRINE COUGH,

COLD & FLU. Seek medical

advice immediately even if there

are no signs of discomfort or

poisoning because of the risk of

liver failure.

You may need urgent medical

attention.

While you are using

COLDREX PE

PHENYLEPHRINE

COUGH, COLD & FLU

Things you must 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 the

medicine.

Things you must not do

Children 12 to 17 years:

Do not give COLDREX PE

PHENYLEPHRINE COUGH,

COLD & FLU for more than 48

hours unless a doctor has told you

to.

Adults:

Do not use for more than a few

days at a time unless your doctor

tells you to.

Do not give to children under 12

years of age.

Do not take more than the

recommended dose unless your

doctor tells you to.

Do not use COLDREX PE

PHENYLEPHRINE COUGH,

COLD & FLU to treat any other

complaints unless your pharmacist

or doctor tells you to.

Things to be careful of

This product may cause dizziness.

If affected, do not drive or operate

machinery.

This medicine may cause

sleeplessness and increased heart

rate.

Side Effects

Tell your pharmacist or doctor as

soon as possible if you do not feel

well while you are using

COLDREX PE

PHENYLEPHRINE COUGH,

COLD & FLU. This medicine helps

most people with various types of

pain but they may have unwanted

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.

Do not be alarmed by the following

lists of side effects. These side

effects are rare and 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,

stop using the product, tell your

pharmacist or doctor immediately

or go to Accident and Emergency

at your nearest hospital if you

experience:

Shortness of breath

Wheezing or difficulty breathing

Swelling of the face, lips,

tongue, throat or other parts of

the body

Rash, peeling itching or hives on

the skin or mouth ulcers

Previous breathing problems

with aspirin or non-steroidal

anti-inflammatories and

experience a similar reaction

with this product

Unexplained bruising or

bleeding

Unusually fast pulse rate or a

sensation of an unusually fast or

irregular heartbeat

loss of vision, which may be due

to abnormally high blood

pressure in the eye. This is more

likely to occur in those with

glaucoma.

Difficulty in passing water. This

is more likely to occur in men

with a enlarged prostate gland

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

These side effects are very rare for

low doses of this medicine and when

used for a short period of time.

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.

When using this product you may

experience headache, dizziness,

nervousness, difficulty sleeping,

increased blood pressure, nausea and

vomiting.

After using COLDREX

PE PHENYLEPHRINE

COUGH, COLD & FLU

Storage

Keep your medicine in the original

pack until it is time to take it.

Keep your medicine in a cool dry

place where the temperature stays

below 25ºC.

Do not store COLDREX PE

PHENYLEPHRINE COUGH,

COLD & FLU or any other

medicine in the bathroom or near

a sink. Do not leave it on a

window sill or in a car.

Heat and dampness can destroy some

medicines.

Keep it where children cannot see

or 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

COLDREX PE

PHENYLEPHRINE COUGH,

COLD & FLU Caplets are white

film coated, capsule-shaped tablet

(caplet) with flat edges, one face

with PANADOL marking. They

come in blister packs of 16 caplets.

Ingredients

COLDREX PE

PHENYLEPHRINE COUGH,

COLD & FLU Caplets contain 250

mg paracetamol, 100 mg guaifenesin

and 5 mg phenylephrine

hydrochloride as the active

ingredients.

They also contain:

Colloidal silicon dioxide

Lactose monohydrate

Maize starch

Microcrystalline cellulose

Opadry white OY-LS-28913

Potassium sorbate

Povidone

Pregelatinised maize starch

Purified talc

Purified water

Stearic acid

Manufacturer/Supplier

COLDREX PE

PHENYLEPHRINE COUGH,

COLD & FLU Caplets is supplied

in New Zealand by:

GlaxoSmithKline Consumer

Healthcare

Auckland, New Zealand

Date of preparation: September

2015

COLDREX is a registered trade

mark of the GSK group of

companies or its licensor.

COLDREX

PE COUGH COLD & FLU – DATA SHEET Page 1 of 13

COLDREX

®

PE PHENYLEPHRINE COUGH, COLD & FLU

DATA SHEET

Paracetamol (BP) 250 mg, Phenylephrine hydrochloride (BP) 5 mg, Guaifenesin BP 100

Presentation

White film-coated capsule-shaped tablets (caplets) with flat edges and a B engraved on

one side.

Indications

Effective, temporary relief of pain and discomfort associated with cold & flu symptoms:

headache, blocked or runny nose, painful sinuses, sore throat, chesty, productive

cough, shivers, aches and pains. Reduces fever.

Dosage and Administration

Adults and children aged 12 years and over

2 tablets every four to six hours as necessary. Maximum of 8 tablets in 24 hours.

Do not use for more than a few days at a time in adults without medical advice.

Do not use for more than 48 hours in children aged 12 to 17 except on medical advice.

Do not use in children below the age of 12.

Take with water or other fluid.

Do not exceed the stated dose or frequency of dose.

The lowest dose necessary to achieve efficacy should be used.

Should not be used with other medicines containing paracetamol, guaifenesin or

phenylephrine or if using other cough, cold and decongestant products.

Minimum dosing interval: 4 hours.

COLDREX

PE COUGH COLD & FLU – DATA SHEET Page 2 of 13

Renal and Hepatic impairment

Patients who have been diagnosed with liver or kidney impairment must seek medical

advice before taking this medication. (See WARNINGS AND PRECAUTIONS.)

Contraindications

This product is contraindicated in patients:

with a previous history of hypersensitivity to paracetamol, guaiphenesin,

phenylephrine hydrochloride, other medicines, foods, preservatives or dyes or

any of the excipients.

who are taking, or have taken within the last two weeks, monoamine oxidase

inhibitors. (See INTERACTIONS.)

Warnings and precautions

Medical advice should be sought before taking this product in patients with these

conditions:

Asthma

Bronchitis

Chronic obstructive pulmonary disease (COPD)

Emphysema

Smoker’s cough

Porphyria, a rare blood pigment disorder

Hypertension

Cardiovascular disease

Diabetes

Hyperthyroidism

Angle closure glaucoma

Phaeochromocytoma

An enlargement of the prostate gland

Occlusive vascular disease (eg Raynaud’s Phenomenon)

Liver and kidney impairment. Underlying liver disease increases the risk of

paracetamol-related liver damage. Patients who have been diagnosed with liver

or kidney impairment must seek medical advice before taking this medication.

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PE COUGH COLD & FLU – DATA SHEET Page 3 of 13

Glutathione depleted states such as sepsis, the use of paracetamol may increase

the risk of metabolic acidosis

Use with caution in patients taking:

Beta-blockers and other antihypertensive drugs

Tricyclic antidepressants

Cases of hepatic dysfunction/failure have been reported in patients with depleted

glutathione levels, such as those who are severely malnourished, anorexic, have a low

body mass index or are chronic heavy users of alcohol.

This product should not be used by patients taking other sympathomimetics (such as

decongestants, appetite suppressants and amphetamine-like psychostimulants). (See

INTERACTIONS.)

If symptoms persist, medical advice must be sought.

Keep out of sight and reach of children.

Contains lactose. Patients with rare hereditary problems of galactose intolerance, the

Lapp lactose deficiency or glucose-galactose malabsorption should not take this

medicine.

Use in Pregnancy

This product should not be used during pregnancy without medical advice.

Phenylephrine - Category B2

Drugs which have 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 show no

evidence of an increased occurrence of foetal damage.

Paracetamol and Guaiphenesin – Category A

Drugs which have 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.

Paracetamol crosses the placental barrier. Animal studies with paracetamol have not

identified any risk to pregnancy or embryo-foetal development.

COLDREX

PE COUGH COLD & FLU – DATA SHEET Page 4 of 13

The safety of guaifenesin during pregnancy has not been established.

Use in Lactation

This product should not be used while breastfeeding without medical advice.

Paracetamol is excreted in breast milk. Human studies with paracetamol have not

identified any risk to lactation or the breast-fed offspring.

Phenylephrine may be excreted in breast milk.

Use in children

Do not use in children under 12 years of age.

Effects on ability to drive and use machines

Patients should be advised not to drive or operate machinery if affected by dizziness.

Adverse Effects

Adverse events from historical clinical trial data are both infrequent and from small

patient exposure. Accordingly, events reported from extensive post-marketing

experience at therapeutic/labelled dose and considered attributable are tabulated below

by System Organ Class and frequency.

The following convention has been utilised for the classification of undesirable effects:

very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare

(≥1/10,000, <1/1,000), very rare (<1/10,000), not known (cannot be estimated from

available data).

Adverse event frequencies have been estimated from spontaneous reports received

through post-marketing data.

Paracetamol

The frequency of these reactions is unknown but considered likely to be very rare.

Body System

Undesirable Effect

Blood and lymphatic system disorders

Thrombocytopenia

Immune system disorders

Anaphylaxis

Cutaneous hypersensitivity reactions

including skin rashes, angioedema

COLDREX

PE COUGH COLD & FLU – DATA SHEET Page 5 of 13

and Stevens Johnson syndrome

Respiratory, thoracic and mediastinal

disorders

Bronchospasm, especially in patients

sensitive to aspirin and other NSAIDs

Hepatobiliary disorders

Hepatic dysfunction

Phenylephrine

The following adverse events have been observed in clinical trials with phenylephrine

and may therefore represent the most commonly occurring adverse events.

Body System

Undesirable Effect

Psychiatric disorders

Nervousness

Nervous system disorders

Headache, dizziness, insomnia

Cardiac disorders

Increased blood pressure

Gastrointestinal disorders

Nausea, vomiting

Adverse reactions identified during post-marketing use are listed below.

Body System

Undesirable Effect

Frequency

Eye disorders

Mydriasis, acute angle closure

glaucoma, most likely to occur in

those with closed angle glaucoma

(See WARNINGS & PRECAUTIONS.)

Rare

Cardiac disorders

Tachycardia, palpitations

Rare

Skin and subcutaneous

disorders

Allergic reactions (eg rash, urticaria,

allergic dermatitis)

Rare

Renal and urinary

disorders

Dysuria, urinary retention. This is

most likely to occur in those with

bladder outlet obstruction such as

prostatic hypertrophy.

Rare

COLDREX

PE COUGH COLD & FLU – DATA SHEET Page 6 of 13

Guaiphenesin

Adverse events identified during post-marketing use are listed below. The frequency of

these events is unknown but considered likely to be rare.

Body System

Undesirable Effect

Immune system

disorders

Allergic reactions, angioedema,

anaphylactic reactions

Respiratory, thoracic and

mediastinal disorders

Dyspnoea*

Gastrointestinal disorders

Nausea, vomiting, abdominal

discomfort

Skin and subcutaneous

disorders

Rash urticaria

*Dyspnoea has been reported in association with other symptoms of hypersensitivity

Post Marketing Experience

Adverse reactions identified during post-marketing use are listed below.

Body System

Undesirable Effect

Frequency

Immune system

disorders

Allergic reactions,

angioedema, anaphylactic

reactions

Rare

Respiratory, thoracic

and mediastinal

disorders

Dyspnoea*

Rare

Gastrointestinal

disorders

Nausea, vomiting, abdominal

discomfort

Rare

Skin and

subcutaneous

disorders

Rash urticaria

Rare

*Dyspnoea has been reported in association with other symptoms of hypersensitivity

COLDREX

PE COUGH COLD & FLU – DATA SHEET Page 7 of 13

Interactions

The following interactions with paracetamol have been noted:

Coumarins (including warfarin)

Anticoagulant effect may be enhanced

by prolonged regular daily use of

paracetamol with increased risk of

bleeding. Anticoagulant dosage may

require reduction if treatment with

paracetamol containing medication is

prolonged.

Substances that increase gastric

emptying (eg metoclopramide)

These substances increase

paracetamol absorption.

Substances that decrease gastric

emptying (eg propantheline,

antidepressants with anticholinergic

properties, narcotic analgesics)

These substances decrease

paracetamol absorption.

Chloramphenicol

Concentrations may be increased by

paracetamol

Potentially hepatotoxic drugs or drugs

that induce liver microsomal enzymes

(eg alcohol, anticonvulsants)

Risk of paracetamol toxicity may be

increased.

Probenecid

May affect paracetamol excretion and

alter paracetamol plasma

concentrations.

Colestyramine

Reduces the absorption of paracetamol

if given within one hour of paracetamol.

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PE COUGH COLD & FLU – DATA SHEET Page 8 of 13

Phenylephrine should be used with caution in combination with the following drugs as

interactions have been reported.

Monoamine oxidase inhibitors

Hypertensive interactions occur between

sympathomimetic amines such as

phenylephrine and monoamine oxidase

inhibitors (See CONTRAINDICATIONS.)

Sympathomimetic amines

Concomitant use of phenylephrine with

other sympathomimetic amines can

increase the risk of cardiovascular side

effects (See WARNINGS &

PRECAUTIONS.)

Beta-blockers and other

antihypertensives (including

debrisoquine, guanethidine, reserpine,

methyldopa)

Phenylephrine may reduce the efficacy

of beta-blocking drugs and

antihypertensive drugs. The risk of

hypertension and other cardiovascular

side effects may be increased. (See

WARNINGS & PRECAUTIONS.)

Tricyclic antidepressants (eg

amitriptyline)

May increase the risk of cardiovascular

side effects with phenylephrine (See

WARNINGS & PRECAUTIONS.)

Digoxin and cardiac glycosides

Increase the risk of irregular heartbeat or

heart attack.

No significant interactions with other drugs have been noted for guaifenesin.

Overdosage

Symptoms and signs

Paracetamol overdose may cause liver failure.

Phenylephrine overdosage is likely to result in effects similar to those listed under

ADVERSE EFFECTS. Additional symptoms may include irritability, restlessness,

hypertension and possibly reflux brachycardia. In severe cases confusion,

hallucinations, seizures and arrhythmias may occur. However the amount required to

produce serious phenylephrine toxicity would be greater than required to cause

paracetamol-related liver toxicity.

Very large doses of guaifenesin cause nausea and vomiting.

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PE COUGH COLD & FLU – DATA SHEET Page 9 of 13

Treatment

Immediate medical management is required in the event of an overdose, even if the

symptoms of overdose are not present.

If an overdose is taken or suspected, contact the Poisons Information Centre

immediately for advice (0800 764 766), or the patient should go to the nearest hospital

straight away. This should be done even if they feel well because of the risk of delayed,

serious liver damage. (See ADVERSE EFFECTS.)

Administration of N-acetylcysteine may be required.

In cooperative adults, activated charcoal may reduce absorption of the medicine if given

within one hour after ingestion.

Treatment of phenylephrine overdosage should be as clinically appropriate. Severe

hypertension may need to be treated with an alpha blocking drug such as phentolamine.

Vomiting caused by guaifenesin overdosage would be treated by fluid replacement and

monitoring of electrolytes if indicated.

Further Information

Actions

Pharmacotherapeutic group:

Other analgesics and antipyretics, paracetamol, combinations excluding psycholeptics.

Mechanism of action

Paracetamol is a para-aminophenol derivative that exhibits analgesic and anti-pyretic

activity. Its mechanism of action is believed to include inhibition of prostaglandin

synthesis, primarily within the central nervous system. It does not possess anti-

inflammatory activity.

Phenylephrine hydrochloride is a sympathomimetic agent with mainly direct effects

on adrenergic receptors (predominantly alpha-adrenergic activity) producing nasal

decongestion.

Guaifenesin has an expectorant action. It is thought to reduce sputum viscosity by

increasing the volume and water content of the bronchial secretion, thereby facilitating

the expectoration of sputum.

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PE COUGH COLD & FLU – DATA SHEET Page 10 of 13

Pharmacodynamic effects

The lack of peripheral prostaglandin inhibition by paracetamol confers important

pharmacological properties such as the maintenance of the protective prostaglandins

within the gastrointestinal tract. Paracetamol is, therefore, particularly suitable for

patients with a history of disease or on concomitant medication, where peripheral

prostaglandin inhibition would be undesirable (such as, for example, those with a history

of gastrointestinal bleeding or the elderly).

Pharmacokinetics

Absorption

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract.

Food intake delays paracetamol absorption.

Phenylephrine is irregularly absorbed from the gastrointestinal tract.

Guaifenesin is well-absorbed after oral administration.

Distribution

Paracetamol is distributed into most body tissues. Binding to the plasma proteins is

minimal at therapeutic concentrations but increases with increasing doses.

No information is available on the distribution of guaifenesin in humans.

Metabolism

Paracetamol is metabolised in the liver.

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

200 mg/kg or 10 g total paracetamol ingested) and, if left untreated, can cause

irreversible liver damage.

Phenylephrine undergoes first-pass metabolism by monoamine oxidases in the gut and

liver; orally administered phenylephrine thus has reduced bioavailability.

Guaifenesin appears to undergo both oxidation and demethylation.

Elimination

Paracetamol is excreted in the urine mainly as the glucuronide and sulphate

conjugates. Less than 5% is excreted as unmodified paracetamol with 85% to 90% of

COLDREX

PE COUGH COLD & FLU – DATA SHEET Page 11 of 13

the administered dose eliminated in the urine within 24 hours of ingestion. The

elimination half-life varies from one to three hours. The mean plasma half life is about

2.3 hours.

Phenylephrine is excreted in the urine almost entirely as the sulphate conjugate.

Guaifenesin is excreted in the urine. It has a plasma half-life of approximately one

hour and is not detectable in the blood after 8 hours. The mean plasma half life is about

4.9 hours.

Other

Chemical Structure

Paracetamol (C

8

H

9

NO

2

)

Phenylephrine Hydrochloride (C9H

13

NO

2

. HCl)

Guaiphenesin

COLDREX

PE COUGH COLD & FLU – DATA SHEET Page 12 of 13

List of Excipients

Colloidal silicon dioxide

Lactose monohydrate

Maize starch

Microcrystalline cellulose

Opadry white OY-LS-28913

Potassium sorbate

Povidone

Pregelatinised maize starch

Purified talc

Purified water

Stearic acid

Pharmaceutical Precautions

Shelf life

36 months from date of manufacture.

Special storage precautions

Store below 25ºC.

Incompatibilities

Not applicable

Use and handling

No special requirements

Package Quantities

Blister pack of 16 tablets. Each tablet contains 250 mg Paracetamol, 100 mg

Guaiphenesin and 5 mg Phenylephrine Hydrochloride.

Medicine Schedule

General Sale

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PE COUGH COLD & FLU – DATA SHEET Page 13 of 13

Sponsor Details

GlaxoSmithKline Consumer Healthcare,

11th Floor, Zurich House,

21 Queen St

Auckland, New Zealand

Date of Preparation

11 NOV 2015

COLDREX is a registered trade mark of the GSK group of companies or it licensor.

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