Boots Pharmaceuticals Day Cold & Flu Relief Hard Capsules Paracetamol 500 mg Pholcodine 5 mg Pseudoephedrine Hydrochloride 30 mg

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
Paracetamol; Pseudoephedrine hydrochloride; Pholcodine
Available from:
The Boots Company Plc
ATC code:
N02BE; N02BE51
INN (International Name):
Paracetamol; Pseudoephedrine hydrochloride; Pholcodine
Dosage:
500/5/30 milligram(s)
Pharmaceutical form:
Capsule, hard
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Anilides; paracetamol, combinations excl. psycholeptics
Authorization status:
Not marketed
Authorization number:
PA0004/061/001
Authorization date:
2003-11-04

Information for the user

Day Cold & Flu Relief Hard Capsules

(Paracetamol 500 mg, Pholcodine 5 mg, Pseudoephedrine Hydrochloride 30

Please read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to

take it carefully to get the best results from it.

Keep this leaflet, you may need to read it again

Ask your pharmacist if you need more information or advice

What this medicine is for

This medicine contains Paracetamol, an analgesic, which relieves pain and reduces fever,

Pseudoephedrine, a decongestant to relieve a blocked nose and Pholcodine, a cough suppressant to

relieve coughing.

It can be used to relieve the major symptoms of colds and flu including aches and pains, fever,

blocked nose and dry, tickly coughs. Dry coughs do not produce phlegm or mucus on the chest.

For children, simple treatments should be tried first before you give this medicine. Further

information on “Treating coughs and colds in children” is provided at the end of this leaflet.

Before you take this medicine

This medicine can be taken by adults and children of 16 years and over. However, some people

should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:

If you are allergic to any of the ingredients in this medicine (see “What is in this medicine”)

If you are allergic to other decongestants

If you have severe kidney problems or liver failure

If you have heart or blood vessel disease

If you have high blood pressure (including that due to a tumour near your kidneys)

If you have difficulty breathing

If you have long-term lung problems or an infection which produces lots of phlegm on the chest

If you have diabetes

If you have an overactive thyroid

If you have raised pressure in the eye (glaucoma)

If you are hyperactive

If you have difficulty in passing urine

If you are taking any of these medicines:

Monoamine oxidase inhibitors or moclobemide (for depression), or have taken them in the

last 14 days

Medicines which may cause a dry mouth (e.g. tricyclic antidepressants)

Medicines to reduce your appetite or stimulant medicines

Medicines called beta-blockers (normally for heart problems)

Other decongestants or medicines containing Pseudoephedrine

Other cough and cold medicines

If you are a man with prostate problems

If you have ever developed a severe skin rash or skin that peels, blisters and / or sores in the

mouth after taking Boots Day Cold & Flu Relief Hard Capsules or other pholcodine-containing

products.

! Talk to your doctor:

If you have a long-term cough or asthma (do not take this medicine if you are wheezing or if you

are having an asthma attack)

If you have a cough which produces lots of phlegm

If you are under the care of a doctor or taking any other medicines (see “If you take other

medicines”)

! Talk to your pharmacist or doctor:

If you have angina

If you have other kidney or liver problems (including liver problems caused by drinking alcohol)

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

Boots Day Cold & Flu Relief Hard Capsules is not recommended during pregnancy and should not be

used whilst breast-feeding.

Other important information

If you develop a severe rash or any of the skin symptoms below, stop giving this medicine and

contact or see a doctor immediately. Serious skin reactions, including acute generalized

exanthematous pustulosis (AGEP), have been reported with the use of pholcodine and

pseudoephedrine. AGEP is a generalized, red, scaly rash with bumps under the skin and vesicles

associated with fever. Most common location: mainly located on the folds of the skin, the trunk and

the upper limbs. The highest risk of serious skin reactions occurrence is especially during the first

week of treatment.

Sudden abdominal pain or rectal bleeding may occur with Boots Day Cold & Flu Relief Hard Capsules,

due to inflammation of the colon (ischaemic colitis). If you develop these gastro-intestinal

symptoms, stop taking Boots Day Cold & Flu Relief Hard Capsules and contact your doctor or seek

medical attention immediately. See 'Possible side effects' section.

Reduction of blood flow to your optic nerve may occur with this medicine. If you develop sudden

loss of vision, stop taking this medicine and contact your doctor or seek medical attention

immediately. See ‘Possible side effects’ section.

If you are going into hospital for an operation, tell the doctor that you are taking this medicine.

Driving and using machines: This medicine may make you feel drowsy or dizzy. Do not drive or use

machines until you are sure you are not affected.

Do not drink alcohol (e.g. wine, beer, spirits) whilst taking this medicine. Alcohol increases the risk

of side effects occurring and may make you feel more drowsy.

Information about some of the ingredients in this medicine: The colour allura red (E129) may cause

allergic reactions.

If you take other medicines

! This medicine contains paracetamol.

Do not take with any other paracetamol-containing products.

This medicine contains Pseudoephedrine. Do not take with any other products that contain this

ingredient.

Before you take these capsules, make sure that you tell your pharmacist about ANY other medicines

you might be using at the same time, particularly the following:

Medicines to treat high blood pressure

Medicines for heart problems (e.g. digoxin)

Medicines that may make you feel sleepy or drowsy such as strong painkillers, medicines for

epilepsy or medicines for mental health conditions

Ergot alkaloids (for migraine)

Oxytocin (to induce labour and stop excessive bleeding after the birth)

Domperidone or metoclopramide (for feeling sick or being sick)

Colestyramine (for lowering blood fat levels)

Warfarin or other coumarins (for thinning the blood) – if you take warfarin you can take

occasional amounts of this medicine, but talk to your doctor first before you take it on a regular

basis

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes

medicines prescribed by your doctor and medicine you have bought for yourself including herbal and

homeopathic remedies.

How to take this medicine

Check the foil is not broken before use. If it is, do not take that capsule.

Age

How many to take

How often to take them

Adults and children of 16 years

and over

Two capsules

Every 4 hours, if you need to.

Don’t take more than 8

capsules in any 24 hours.

Swallow each capsule whole with water (For oral use).

Do not give to children under 16 years.

Do not exceed the stated dose.

If you are treating a child and their symptoms worsen at any time, talk to a pharmacist or doctor.

Do not take this medicine for more than 5 days, unless your doctor agrees.

If symptoms do not go away talk to your doctor.

Prolonged use except on your doctor’s advice may be harmful.

This product should be used only when clearly necessary.

! If you take too may capsules: Immediate medical advice should be sought in the event of an

overdosage, even if you feel well, because of the risk of irreversible liver damage. Go to your

nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

! If you get any of these serious side effects, stop taking the capsules. See a doctor at once:

Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

Very rare cases of serious skin reactions have been reported. This may include peeling,

blistering and lesions of the skin.

Generalized rash, red and scaly with bumps under the skin and vesicles associated with fever at

the beginning of treatment (acute generalized exanthematous pustulosis). If you develop these

symptoms stop using Boots Day Cold & Flu Relief Hard Capsules and contact or see a doctor

immediately. The frequency cannot be estimated from the available data.

Frequency not known:

Inflammation of the colon due to insufficient blood supply (ischaemic colitis)

Reduced blood flow to the optic nerve, loss of vision (Ischaemic optic neuropathy)

! If you get any of these side effects stop taking the capsules:

Hallucinations

Restlessness

Sleep disturbances

If you get any of the following side effects see your pharmacist or doctor:

Other allergic reactions such as skin rash

Feeling sick, being sick, diarrhoea, constipation, stomach upset, stomach pain

Headache, blurred vision, ringing in the ears, loss of appetite

Anxiety, feelings of paranoia, irritability, feeling excited, confused or nervous, difficulty sleeping,

nightmares

Tremors, fits, sweating, drowsiness, dizziness

Fast, slow or irregular heart beat, palpitations and very rarely chest pain

High blood pressure

A very high temperature

Difficulty in passing urine

Very rarely bowel problems

Phlegm on the chest

Unusual bruising, or infections such as sore throats – this may be a sign of very rare changes in

the blood

If any side effect becomes severe, or if you notice any side effect not listed here, please tell your

pharmacist or doctor.

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist or nurse.

This includes any possible side effects not listed in this leaflet. You can also report side effects

directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax:+353

1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. By reporting side effects you can

help provide more information on the safety of this medicine.

How to store this medicine

Do not store above 25°C.

Store in the original package, in order to protect from moisture.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked

cupboard.

Use by the date on the end flap of the carton or on the foil edge. After this date return any unused

product to your nearest pharmacy for safe disposal.

What is in this medicine

Each hard capsule contains Paracetamol 500 mg, Pholcodine 5 mg, Pseudoephedrine Hydrochloride

30 mg, which are the active ingredients.

As well as the active ingredients, the capsules also contain sodium starch glycolate, magnesium

stearate, sodium laurilsulfate. The hard capsule shell contains gelatin and colours, which are

quinoline yellow (E104), allura red (E129), titanium dioxide (E171), and printing ink containing

propylene glycol, shellac, black iron oxide (E172).

This pack contains 24 orange and yellow hard capsules with 0580 and BOOTS printed in black.

Who makes this medicine

Manufactured for the Marketing Authorisation holder The Boots Company PLC Nottingham NG2

3AA, UK by Famar AVE Anthoussa Attiki 15349 Greece

Leaflet prepared May 2020

If you would like any further information about this product, please contact The Boots Company PLC

Nottingham NG2 3AA, UK

Treating coughs and colds in children

It’s normal for children to get 8 or more colds in a year, however gradually they build up immunity

and get fewer colds. Most colds will get better within a few days and you may not need to do more

than keep your child comfortable until they get over it. Antibiotics will not help to treat a cold as

they are caused by viruses and not bacteria.

Follow these simple steps, which may help your child overcome their cough or cold:

1. If your child is hot or has a fever: Increase the amount of fluid your child normally drinks. Lower

their temperature with a Paracetamol or Ibuprofen medicine, which is suitable for children.

(Paracetamol is not suitable for children under 2 months. Ibuprofen is not suitable for children

under 3 months).

Your pharmacist will be able to help you find a suitable product if in doubt.

2. For coughs: Although it may be distressing to hear your child cough, the coughing itself serves an

important purpose. It helps to clear phlegm on the chest or mucus from the nose. Give your child

plenty of lukewarm clear fluids to drink, which may help loosen the phlegm and relax the airways.

3. To help with breathing: Plain saline nose drops, available from your pharmacy, can help babies

with blocked noses who are having trouble feeding.

Other formats

To request a copy of this leaflet in Braille, large print or audio please call:

1890 708091

(ROI only)

and ask for Boots Medical Information.

Please be ready to give the following information:

Product Name: Boots Day Cold & Flu Relief Hard Capsules

Reference number: 4/61/1

Health Products Regulatory Authority

10 July 2020

CRN009S05

Page 1 of 7

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Boots Pharmaceuticals Day Cold & Flu Relief Hard Capsules Paracetamol 500 mg Pholcodine 5 mg Pseudoephedrine

Hydrochloride 30 mg

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients

Quantity mg/capsule

Paracetamol

Pseudoephedrine hydrochloride

Pholcodine

Excipients:

Allura Red (E129) 0.53 mg

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Capsule, hard

The capsule has an orange cap and yellow body, printed axially in black ink ‘BOOTS’ on the cap and ‘0580’ on the body.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

For the relief of the major symptoms of colds and influenza.

4.2 Posology and method of administration

Take during the day.

For oral administration.

Adults and children over 16 years: Two capsules every four hours, up to a maximum of 4 doses in 24 hours if needed.

Elderly: There is no specific requirement for dosage reduction in the elderly.

Warning: Do not exceed the stated dose.

Keep all medicines out of the sight and reach of children.

4.3 Contraindications

Hypersensitivity to the active substances or any of the excipients.

Severe renal impairment.

Cardiovascular disease including hypertension and ischaemic heart disease

Diabetes mellitus

Phaeochromocytoma

Hyperthyroidism

Closed angle glaucoma

Avoid in patients with hyperexcitability or liver failure.

Prostatic enlargement (patients with prostatic hypertrophy may have increased difficulty in micturation)

Urinary retention

Health Products Regulatory Authority

10 July 2020

CRN009S05

Page 2 of 7

Pholcodine should not be given to subjects in, or at risk of developing respiratory failure.

Patients with chronic bronchitis, COPD, bronchiolitis or bronchiectasis due to sputum retention.

Use in patients who are currently receiving other sympathomimetic drugs (such as other decongestants).

Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (see also section 4.5).

Beta-blockers – (see section 4.5).

Not to be used in children under the age of 16 years.

4.4 Special warnings and precautions for use

Paracetamol

Should be given with caution to patients with renal or hepatic impairment. The hazards of overdose are greater in those with

non-cirrhotic alcoholic liver disease.

Contains paracetamol.

Do not use this product for longer than 5 days unless your doctor agrees.

If symptoms persist consult your doctor.

Do not take with any other paracetamol-containing products.

Label:

Immediate medical advice should be sought in the event of overdosage, even if you feel well. Please read the enclosed leaflet

carefully.

Leaflet or combined label/leaflet:

Immediate medical advice should be sought in the event of overdosage, even if you feel well, because of the risk of irreversible

liver damage.

Pholcodine

Should be used with caution by patients with liver or renal disease.

Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma or are suffering from an acute

asthma attack or where cough is accompanied by excessive secretions.

Do not take with any other cough and cold medicine.

Use of pholcodine with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively

smaller doses.

Severe cutaneous adverse reactions (SCARs) including acute generalized exanthematous pustulosis (AGEP), which can be

life-threatening or fatal, have been reported in patients treated with pholcodine-containing products, most likely in the first

week. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms

suggestive of these reactions appear, Boots Pharmaceuticals Day Cold & Flu Relief Hard Capsules should be withdrawn

immediately.

Pseudoephedrine

If any of the following occur, this medicine should be stopped

Hallucinations

Restlessness

Sleep disturbances

Caution in moderate to severe renal impairment.

Severe Skin reactions

Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing

products. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly

non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper

extremities. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules

Health Products Regulatory Authority

10 July 2020

CRN009S05

Page 3 of 7

are observed, administration of Boots Pharmaceuticals Day Cold & Flu Relief Hard Capsules should be discontinued and

appropriate measures taken if needed.

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.

Ischaemic optic neuropathy

Cases of ischaemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if

sudden loss of vision or decreased visual acuity such as scotoma occurs.

This medicine should be used with great care in patients suffering from angina and in patients receiving phenothiazines or

tricyclic antidepressants.

This product may act as a cerebral stimulant giving rise to insomnia, nervousness, hyperpyrexia, tremor and epileptiform

convulsions.

The physician or pharmacist should reassure himself that sympathomimetic containing preparations are not simultaneously

administered by several routes i.e. orally and topically (nasal, aural and eye preparations).

Information related specifically to the excipients in this formulation (see section 6.1)

The colour Allura Red (E129) in this medicine may cause allergic reactions.

4.5 Interaction with other medicinal products and other forms of interactions

Pholcodine

Not to be used in patients taking MAOIs or within 14 days of stopping treatment.

Interaction with neuromuscular blocking agents (anaphylaxis) has been reported.

The reduction in blood pressure caused by antihypertensives may accentuate the hypotensive effects of pholcodine.

Diuretics may have the same effect.

Pholcodine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics,

narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).

Pseudoephedrine

MAOIs and/or RIMAs: should not be given to patients treated with MAOIs or within 14 days of stopping treatment: increased

risk of hypertensive crisis.

Moclobemide: risk of hypertensive crisis.

Antihypertensives (including adrenergic neurone blockers & beta-blockers): this medicine may block the hypotensive effects.

Cardiac glycosides: increased risk of dysrhythmias.

Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism.

Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension.

Oxytocin: risk of hypertension.

Enhances effects of anticholinergic drugs (such as TCAs).

This product should be used with caution in patients receiving guanethidine, reserpine, or methyldopa.

Concurrent use with halogenated anaesthetic agents such as chloroform, cyclopropane, halothane, enflurane or isoflurane may

provoke or worsen ventricular arrhythmias.

Paracetamol

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by

cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged use of paracetamol

with increased risk of bleeding; occasional doses have no significant effect.

Health Products Regulatory Authority

10 July 2020

CRN009S05

Page 4 of 7

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no adequate data on the use of pseudoephedrine in pregnant women. Animal studies are insufficient with respect to

reproductive toxicity (see section 5.3). Boots Pharmaceuticals Day Cold & Flu Relief Hard Capsules is not recommended during

pregnancy.

The use of pseudoephedrine during the first trimester of pregnancy has been associated with an increased frequency of

gastroschisis (a developmental defect in the abdominal wall with intestinal herniation) and of small intestinal atresia (congenital

obstruction of small intestine).

Due to the vasoconstrictive properties of pseudoephedrine, it should not be used during the third trimester as it can induce a

reduction in uteroplacental circulation.

Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results.

Breast feeding

Pseudoephedrine has been detected in human milk with a small percentage of the maternal dose potentially administered to

the breastfed infant. The use of pseudoephedrine should be avoided during breastfeeding as lactation may be suppressed, and

irritability and disturbed sleep have been reported in breastfed infants.

Boots Pharmaceuticals Day Cold & Flu Relief Hard Capsules should not be used during breast-feeding.

4.7 Effects on ability to drive and use machines

No adverse effects known.

4.8 Undesirable effects

Paracetamol

Immune system disorders: adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur.

Blood and lymphatic system disorders: very rarely there have been reports of blood dyscrasias including thrombocytopaenia

and agranulocytosis, but these were not necessarily causally related to paracetamol.

Skin and subcutaneous tissue disorders: very rare cases of serious skin reactions have been reported.

Pholcodine

The following side effects may be associated with the use of pholcodine:

Gastrointestinal disorders: gastrointestinal disturbances (nausea and constipation), vomiting, diarrhoea, upset stomach,

epigastric pain.

Immune system disorders: hypersensitivity reactions and anaphylaxis.

Nervous system disorders: occasional drowsiness, dizziness, excitation, confusion.

Respiratory, thorasic and mediastinal disorders: sputum retention.

Skin and subcutaneous tissue disorders: skin reactions including rash. Acute generalized exanthematous pustulosis (AGEP)

(see section 4.4) (frequency unknown).

Pseudoephedrine

Cardiovascular disorders: tachycardia, palpitations, other cardiac dysrhythmias.

Very rarely, coronary vasospasm leading to myocardial ischaemia has been reported.

Ear and labyrinth disorders: tinnitus.

Eye disorders: blurred vision. Ischaemic optic neuropathy (frequency unknown).

Gastrointestinal disorders: nausea and/or vomiting.

Frequency unknown: Ischaemic colitis

General disorders and administration site conditions: irritability.

Immune system disorders: hypersensitivity reactions, including cross-sensitivity that may occur with other sympathomimetics.

Metabolism and nutrition disorders: anorexia.

Nervous system disorders: headache, tremor, anxiety, restlessness, excitability, insomnia, hallucinations (particularly in

children) and paranoid delusions.

Psychiatric disorders: sleep disturbance, nightmares.

Renal and urinary disorders: difficulty in micturition including urinary retention.

Skin and subcutaneous tissue disorders: skin reactions including rash, sweating.

Frequency unknown - Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP).

Vascular disorders: hypertension. Very rarely, vasospasm associated with ischaemic colitis has been reported.

Health Products Regulatory Authority

10 July 2020

CRN009S05

Page 5 of 7

Can cause allergic type reactions including asthma. Allergy is more common in those people who are allergic to aspirin. (Allura

Red E129)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

Paracetamol

Paracetamol overdose can result in liver damage which may be fatal.

Symptoms generally appear within the first 24 hours and may comprise: nausea, vomiting, anorexia, pallor and abdominal pain,

or patients may be asymptomatic.

Overdose of paracetamol can cause liver cell necrosis likely to induce complete and irreversible necrosis, resulting in

hepatocellular insufficiency, metabolic acidosis and encephalopathy which may lead to coma and death. Simultaneously,

increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed together with increased

prothrombin levels that may appear 12 to 48 hours after administration.

Liver damage is likely in patients who have taken more than the recommended amounts of paracetamol. It is considered that

excess quantities of toxic metabolite become irreversibly bound to liver tissue.

Some patients may be at increased risk of liver damage from paracetamol toxicity:

Risk factors include:

Patients with liver disease

Elderly patients

Young children

Patients receiving long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St

John’s Wort or other drugs that induce liver enzymes

Patients who regularly consume ethanol in excess of recommended amounts

Patients with glutathione depletion e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia

Acute renal failure with acute tubular necrosis may also develop.

Cardiac arrhythmias and pancreatitis have also been reported.

Emergency Procedure:

Immediate transfer to hospital.

Blood sampling to determine initial paracetamol plasma concentration. In the case of a single acute overdose, paracetamol

plasma concentration should be measured 4 hours post ingestion. Administration of activated charcoal should be considered if

the overdose of paracetamol has been ingested within the previous hour. The antidote N-acetylcysteine, should be

administered as soon as possible in accordance with national treatment guidelines.

Symptomatic treatment should be implemented.

Pholcodine

It is thought to be of low toxicity, but the effects in overdosage will be potentiated by simultaneous ingestion of alcohol and

psychotropic drugs.

Symptoms: These include nausea, drowsiness, restlessness, excitement, ataxia and respiratory depression.

Management: Treatment of overdose should be symptomatic and supportive. Gastric lavage may be of use.

Health Products Regulatory Authority

10 July 2020

CRN009S05

Page 6 of 7

In addition symptomatic and supportive therapy may be necessary, including the administration of the specific narcotic

antagonist naloxone.

Information for children

Naloxone has been used successfully to reverse central or peripheral opioid effects in children (0.01mg/kg body weight). Other

treatment option is activated charcoal (1g/kg body weight) if more than 4mg/kg has been ingested within 1 hour, provided the

airway can be protected.

Other symptoms of overdosage may include headache, tachycardia, arrhythmias, urinary retention, hallucinations, coma,

hyperreflexia, tremor and hypertension. Symptomatic and supportive therapy may be necessary, including the administration of

a beta-blocker if supraventricular tachycardia supervenes.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Paracetamol has analgesic and antipyretic actions.

Pseudoephedrine is a sympathomimetic agent with both direct and indirect effects on adrenergic receptors.

Pholcodine is a cough suppressant with little analgesic activity.

5.2 Pharmacokinetic properties

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to

2 hours after oral administration. Paracetamol is distributed into most body tissues. It crosses the placenta and is present in

breast milk. Plasma protein binding is negligible at usual therapeutic concentrations. Paracetamol is metabolised

predominantly in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates, with about 10% as

glutathione conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half life varies from about 1 to 4

hours.

Pseudoephedrine is absorbed from the gastrointestinal tract. It is resistant to metabolism and is excreted largely unchanged in

the urine. It has a half life of several hours but elimination is enhanced and half life shortened in acid urine.

Pholcodine is rapidly absorbed after oral administration and maximum plasma concentrations are attained at about 4-8 hours.

The elimination half life ranges from 32 to 43 hours. The drug has a large volume of distribution and is only 23.5% protein

bound. Pholcodine is metabolised in the liver but undergoes little conjugation with glucuronide and sulphate.

5.3 Preclinical safety data

Paracetamol

Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development

are not available.

Pseudoephedrine

In a study of a pseudoephedrine/cetirizine combination product, at doses of 160 mg/kg/day in pregnant rats (~7.5 x

therapeutic exposure in humans for pseudoephedrine, and around therapeutic exposure for cetirizine) observations included

decreased pup survival, a small increase in bone deformations, and delay of some development parameters.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium Laurilsulfate

Sodium starch glycolate

Magnesium stearate

Hard gelatin capsule:

(containing: Gelatin, Quinoline yellow (E104), Allura red (E129), Titanium dioxide (E171)

Health Products Regulatory Authority

10 July 2020

CRN009S05

Page 7 of 7

Black printing ink:

(containing: Propylene glycol, Shellac, Iron oxide black (E172).

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from moisture.

6.5 Nature and contents of container

PVC/PVdC blister tray with aluminium foil lid.

Pack sizes: 8, 10, 12, 16, 20 and 24 capsules.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal

product and other handling of the product

No special requirements.

7 MARKETING AUTHORISATION HOLDER

The Boots Company Plc

1 Thane Road West

Nottingham

NG2 3AA

United Kingdom

8 MARKETING AUTHORISATION NUMBER

PA0004/061/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 04 November 2003

Date of last renewal: 04 November 2008

10 DATE OF REVISION OF THE TEXT

July 2020

Similar products

Search alerts related to this product

View documents history

Share this information