SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

Cold Relief Capsules

Superdrug Paracetamol Cold Relief with Decongestant

Sudafed Blocked Nose & Headache Capsules

Non-Drowsy Decongestant with Paracetamol

Wilko Non-Drowsy Decongestant with Paracetamol

Tesco Sinus Dual Relief Capsules

Teva Cold Relief Capsules

Boots Blocked Nose & Headache Relief Capsules

Health Essentials Cold Relief Capsules

Boots Cold & Flu Relief Capsules

Sainsbury’s Healthcare Sinus Dual Relief Capsules

Independent Cold Relief Capsules

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

INGREDIENT	QTY	UNIT	DOSE
Paracetamol	300	mg	Capsule
Caffeine	25	mg	Capsule
Phenylephrine Hydrochloride	5	mg	Capsule

3. PHARMACEUTICAL FORM

Capsule, hard [Capsule].

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the relief of the symptoms of colds and flu, including headache, feverishness, nasal and sinus congestion and its associated, pressure and pain, catarrh, aches and pains.

4.2 Posology and method of administration

Route of administration: Oral.

Adults, the elderly and children 12 years and over:

2 capsules every 4 to 6 hours as required, up to a maximum of 12 capsules in any 24 hour period.

This product is contraindicated in children under the age of 12 years (see section 4.3).

4.3 Contraindications

Hypersensitivity to paracetamol and/or other constituents.

Concurrent administration of monoamine oxidase inhibitors and tricyclic antidepressants, severe hypertension, myocardial infarction, hyperthyroidism and pregnancy.

Not to be used in children under the age of 12 years.

4.4 Special warnings and precautions for use

PARACETAMOL

Paracetamol should be used with caution in patients with hepatic or renal impairment and alcohol dependence as the hazards of overdose are greater in those with noncirrhotic alcoholic liver disease.

The following warnings will appear on the pack:

CONTAINS PARACETAMOL

-    If symptoms persist consult your doctor.

-    Do not exceed the stated dose.

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

The pack shall also say “Do not take with any other paracetamol containing products and “Immediate medical advice should be sought in the event of an overdose, even if you feel well”.

Care is advised in the administration of paracetamol to patients with severe renal or hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

The leaflet shall say “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

PARACETAMOL

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone. Colestyramine may reduce the speed of absorption of paracetamol.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

PHENYLEPHRINE HYDROCHLORIDE

Phenylephrine hydrochloride may cause hypertension, sometimes severe, where used concurrently with both monoamine oxidase and tricyclic type antidepressants, ganglion blocking agents, adrenergic blocking drugs, and methyldopa.

4.6 Pregnancy and lactation

PREGNANCY

Although epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, patients should follow the advice of their doctor regarding the use of paracetamol during pregnancy.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

PHENYLEPHRINE HYDROCHLORIDE

The safety of phenylephrine hydrochloride in pregnancy has not been established and unless advised medically its use should be avoided.

Although excreted in breast milk, provided maternal intake is not excessive, no harm should come to the neonate during lactation.

4.7 Effects on ability to drive and use machines

None stated

4.8 Undesirable effects

PARACETAMOL

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

CAFFEINE

Nausea and insomnia have been noted.

PHENYLEPHRINE HYDROCHLORIDE

Rarely phenylephrine hydrochloride may elevate blood pressure with headache, palpitation and vomiting; tachycardia or reflex bradycardia; tingling and coolness of the skin.

4.8 Undesirable Effects

PARACETAMOL

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

CAFFEINE

Nausea and insomnia have been noted.

PHENYLEPHRINE HYDROCHLORIDE

Rarely phenylephrine hydrochloride may elevate blood pressure with headache, palpitation and vomiting; tachycardia or reflex bradycardia; tingling and coolness of the skin.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

PARACETAMOL

Analgesic:

The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting a prostaglandin synthesis in the central nervous system (CNS) and to a lesser extent through a peripheral action by blocking pain-impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.

Antipyretic:

Paracetamol probably produces antipyresis by acting on the hypothalamic heatregulating centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.

CAFFEINE

Central nervous system stimulant - Caffeine stimulates all levels of the CNS, although its cortical effects are milder and of shorter duration than those of amfetamines. Analgesia Adjunct:

Caffeine constricts cerebral vasculature with an accompanying decrease in cerebral blood flow and in the oxygen tension of the brain. It is believed that caffeine helps to relieve headache by providing a more rapid onset of action and/or enhanced pain relief with lower doses of analgesic. Recent studies with ergotamine indicate that the enhancement of effect by the addition of caffeine may also be due to improved gastrointestinal absorption of ergotamine when administered with caffeine.

PHENYLEPHRINE HYDROCHLORIDE

Sympathomimetic amines, such as phenylephrine, act on alpha-adrenergic receptors of the respiratory tract to produce vasoconstriction, which temporarily reduces the swelling associated with inflammation of the mucous membranes lining the nasal and sinus passages. This allows the free drainage of the sinusoidal fluid from the sinuses.

In addition to reducing mucosal lining swelling, decongestants also suppress the production of mucus, therefore preventing a build up of fluid within the cavities which could otherwise lead to pressure and pain.

5.2 Pharmacokinetic properties

PARACETAMOL Absorption and Fate:

Paracetamol is rapidly absorbed from the gastro-intestinal tract with peak plasma concentrations occurring between 10 and 120 minutes after oral administration. It is metabolised in the liver and excreted in the urine mainly as the glucoronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about 1 to 4 hours.

Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.

A minor hydroxylated metabolite which is usually produced in very small amounts by mixed - function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following paracetamol overdosage and cause liver damage.

CAFFEINE Absorption and Fate:

Caffeine is absorbed readily after oral administration and is widely distributed throughout the body. Caffeine is metabolised almost completely via oxidation, demethylation, and acetylation, and is excreted in the urine as 1-methyluric acid, 1-methylxanthine, 7-methylxanthine, 1 ,7-dimethylxanthine (paraxanthine), 5-acetylamino-6-formylamino-3-methyluracil (AFMU), and other metabolites with only about 1% unchanged.

PHENYLEPHRINE HYDROCHLORIDE Absorption and Fate:

Phenylephrine has reduced bioavailability from the gastro-intestinal tract owing to irregular absorption and first-pass metabolism by monoamine oxidase in the gut and liver.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber additional to that already covered in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Capsule contents Maize Starch Croscarmellose Sodium Sodium Lauryl Sulphate Magnesium Stearate

Capsule

Gelatin

Titanium Dioxide (E171)

Iron Oxide Yellow (E172)

Patent Blue V (E131)

Quinoline Yellow (E104)

6.2 Incompatibilities

None other than those listed in 4.3 and 4.5

6.3 Shelf life

3 years

6.4 Special precautions for storage

None

6.5 Nature and contents of container

White opaque UPVC/aluminium foil blisters in cartons of 8, 10, 12, 16, 24, 32 and 48. 30 micron pyramidally embossed hard temper aluminium (with 250 micron PVC blisters).

6.6 Special precautions for disposal

None

7    MARKETING AUTHORISATION HOLDER

Wrafton Laboratories Limited

Wrafton

Braunton

North Devon EX33 2DL

8    MARKETING AUTHORISATION NUMBER

PL 12063/0003

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

05/07/1993    / 27/08/2004

10 DATE OF REVISION OF THE TEXT

15/11/2010

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

05/07/1993    / 27/08/2004

DATE OF REVISION OF THE TEXT

04/02/2015