BOOTS COLD & FLU MAX DIRECT SACHETS LEMON FLAVOUR

Active substance: PHENYLEPHRINE HYDROCHLORIDE

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1.

NAME OF THE MEDICINAL PRODUCT
Boots Cold & Flu Max Direct Sachets Lemon Flavour or
Boots Maximum Strength Cold & Flu Relief Direct Dose Lemon

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients

mg/Sachet

Paracetamol
1000.0
Phenylephrine hydrochloride * 12.2
*This is equivalent to 10 mg phenylephrine base.
For excipients, see 6.1.

3.

PHARMACEUTICAL FORM
Oral powder.
A white to off-white unit-dose powder with the odour and flavour of lemons.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications
For relief of symptoms associated with the common cold and influenza, including the relief
of aches and pains, sore throat, headache, nasal congestion and lowering of temperature.

4.2.

Posology and method of administration
Oral administration.
Adults and children 12 and over: One single-dose container. The product is taken orally
without water.
The dose may be repeated every 4 hours.
No more than four doses should be taken in 24 hours.
Children under 12 years: Not to be given to children under 12 without medical advice.

Elderly: There is no indication that dosage need be modified in the elderly.

4.3.

Contraindications
Severe coronary heart disease and cardiovascular disorders. Hypertension. Hyperthyroidism.
Contraindicated in patients currently receiving or within two weeks of stopping therapy with
monoamine oxidase inhibitors. Hypersensitivity to paracetamol, phenylephrine or any other
ingredient.

4.4.

Special warnings and precautions for use
Use with caution in patients with Raynaud's phenomenon or diabetes mellitus. Care is
advised in the administration of paracetamol to patients with severe renal or severe hepatic
impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver
disease. Patients should be advised not to take other paracetamol-containing products
concurrently.
Label warnings: Do not exceed the stated dose. Keep all medicines out of the reach and sight
of children. Contains paracetamol (panel). If symptoms persist consult your doctor. If you
are pregnant or are being prescribed medicine by your doctor, seek his advice before taking
this product.
Do not take with any other paracetamol-containing products. Immediate medical advice
should be sought in the event of an overdose, even if you feel well.
Leaflet: Immediate medical advice should be sought in the event of an overdose, even if you
feel well, because of the risk of delayed, serious liver damage.

4.5.

Interaction with other medicinal products and other forms of interaction
Phenylephrine may adversely interact with other sympathomimetics, vasodilators and βblockers. Drugs which induce hepatic microsomal enzymes, such as alcohol, barbiturates,
monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity
of paracetamol, particularly after overdose. Contraindicated in patients currently receiving
or within two weeks of stopping therapy with monoamine oxidase inhibitors because of a
risk of hypertensive crisis.
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 regular daily use of
paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6.

Pregnancy and lactation

Due to the vasoconstrictive properties of phenylephrine the product should be used with
caution in patients with a history of pre-eclampsia. Phenylephrine may reduce placental
perfusion and the product should be used in pregnancy only if the benefits outweigh the risk.
There is no information on use in lactation.
Epidemiological studies in human pregnancy have shown no ill-effects due to paracetamol
used in the recommended dosage, but patients should follow the advice of their doctor
regarding its use. Paracetamol is excreted in breast milk, but not in a clinically significant
amount. Available published data do not contraindicate breast-feeding.

4.7.

Effect on ability to drive and use machines
None known.

4.8.

Undesirable effects
Paracetamol: Adverse effects of paracetamol are rare, but hypersensitivity including skin
rash may occur. There have been a few reports of blood dyscrasias including
thrombocytopenia and agranulocytosis, but these were not necessarily causally related to
paracetamol.
Phenylephrine hydrochloride: Rarely, high blood pressure with headache, vomiting and
palpitations, which are only likely to occur with overdose. Also rare reports of allergic
reactions.

4.9.

Overdose
Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting,
anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after
ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe
poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal
failure with acute tubular necrosis may develop even in the absence of severe liver damage.
Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults
who have taken 10 g or more of paracetamol. It is considered that excess quantities of a
toxic metabolite (usually adequately detoxified by glutathione when normal doses of
paracetamol are ingested) become irreversibly bound to liver tissue.
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack
of significant early symptoms, patients should be referred to hospital urgently for immediate
medical attention and any patient who has ingested around 7.5 g or more of paracetamol in
the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or
intravenous N-acetylcysteine, which may have a beneficial effect up to at least 48 hours
after the overdose, may be required. General supportive measures must be available.

Features of severe overdose of phenylephrine include haemodynamic changes and
cardiovascular collapse with respiratory depression. Treatment includes early gastric lavage
and symptomatic and supportive measures. Hypertensive effects may be treated with an i.v.
α-receptor blocking agent.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties
Paracetamol: Paracetamol has both analgesic and antipyretic activity which is believed to be
mediated principally through its inhibition of prostaglandin synthesis within the central
nervous system.
Phenylephrine: Phenylephrine is a post-synaptic α-receptor agonist with low cardioselective
β-receptor affinity and minimal central stimulant activity. It is a recognised decongestant
and acts by vasoconstriction to reduce oedema and nasal swelling.

5.2.

Pharmacokinetic properties
Paracetamol: Paracetamol is absorbed rapidly and completely mainly from the small
intestine producing peak plasma levels after 15-20 minutes following oral dosing. The
systemic availability is subject to first-pass metabolism and varies with dose between 70%
and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated
from plasma with a T½ of approximately 2 hours. The major metabolites are glucuronide
and sulphate conjugates (>80%) which are excreted in urine.
Phenylephrine: Phenylephrine is absorbed from the gastrointestinal tract, but has reduced
bioavailability by the oral route due to first-pass metabolism. It retains activity as a nasal
decongestant when given orally, the drug distributing through the systemic circulation to the
vascular bed of nasal mucosa. When taken by mouth as a nasal decongestant phenylephrine
is usually given at intervals of 4-6 hours.

5.3.

Preclinical safety data
No preclinical findings of relevance have been reported.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients

Ethyl cellulose, ascorbic acid, glyceryl tristearate, tartaric acid, sodium carbonate anhydrous,
aspartame, lemon flavour, sweet flavour and xylitol.

6.2.

Incompatibilities
None known.

6.3

Shelf life

6.4.

36 months
Special precautions for storage
Do not store above 25°C and store in the original package.

6.5.

Nature and contents of container
Polyethylene terephthalate/aluminium/ polyethylene sachets.
Pack size: 10

6.6.

Instructions for use and handling
There are no special instructions for handling.

7.

MARKETING AUTHORISATION HOLDER
The Boots Company Plc
1 Thane Road West
Nottingham
NG2 3AA
United Kingdom

8.

MARKETING AUTHORISATION NUMBER(S)
PL 00014/0634

9.

DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
19 July 2002

10

DATE OF REVISION OF THE TEXT
24/04/2007

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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