1 NAME OF THE MEDICINAL PRODUCT

Paramed Max Strength Congestion Relief 12.2 mg Capsules Tesco Max Strength Congestion Relief 12.2 mg Capsules Wilko Max Strength Congestion Relief 12.2 mg Capsules Morrisons Max Strength Congestion Relief 12.2 mg Capsules Superdrug Max Strength Congestion Relief 12.2 mg Capsules Lloydspharmacy Max Strength Congestion Relief 12.2 mg Capsules Asda Max Strength Congestion Relief 12.2 mg Capsules Teva Max Strength Congestion Relief 12.2 mg Capsules, hard Numark Max Strength Congestion Relief 12.2 mg Capsules Galpharm Max Strength Congestion Relief 12.2 mg Capsules Tesco Blocked Nose Relief Capsules Galpharm Blocked Nose Relief 12.2 mg Capsules

Sainsbury’s Healthcare Max Strength Congestion Relief 12.2 mg Capsules

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient mg/capsule Phenylephrine Hydrochloride 12.2 Also contains lactose, see 4.4

For a full list of excipients, see 6.1.

3    PHARMACEUTICAL FORM

Capsule, Hard

Capsule with opaque yellow body and cap.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the relief of nasal congestion, particularly when associated with colds and flu or hayfever.

4.2 Posology and method of administration

Adults and children over 12 years: For oral use, one capsule, if necessary, up to four times daily.

Children under 12 years: Not recommended.

The Elderly: Normal adult dosage is appropriate.

Hypersensitivity to any of the ingredients. Avoid in patients with cardiovascular disease, hypertension, diabetes mellitus, closed angle glaucoma, hyperthyroidism, prostatic enlargement and phaeochromocytoma. Patients being treated with monoamine oxidase inhibitors or within 14 days of ceasing such treatment (see section 4.5).

4.4 Special warnings and precautions for use

This medicine should be used with caution in patients with occlusive vascular disease including Raynaud's Phenomenon.

Do not take for longer than 7 days, unless your doctor agrees.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

If symptoms do not go away seek a doctors advice.

4.5 Interaction with other medicinal products and other forms of interaction

Should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment. May enhance the effects of anticholinergic drugs such as tricyclic antidepressants. May increase the possibility of arrhythmias in digitalised patients. May enhance the cardiovascular effects of other sympathomimetic amines (e.g. decongestants).

This medicine should not be taken together with vasodilators, Beta-blockers or enzyme inducers such as alcohol.

4.6 Pregnancy and lactation

The safety of this medicine during pregnancy and lactation has not been established but in view of a possible association of foetal abnormalities with first trimester exposure to phenylephrine, the use of the product during pregnancy should be avoided. In addition, because phenylephrine may reduce placental perfusion, the product should not be used in patients with a history of pre-eclampsia. In view of the lack of data on the use of phenylephrine during lactation, this medicine 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

Adverse effects may include tachycardia, cardiac arrhythmias, palpitations, hypertension, nausea, vomiting, headache and occasionally urinary retention in males.

Symptoms of overdosage include irritability, restlessness, palpitations, hypertension, difficulty in micturition, nausea, vomiting, thirst and convulsions. In severe overdosage gastric lavage and aspiration should be performed. Symptomatic and supportive measures should be undertaken, particularly with regard to cardiovascular and respiratory systems. Convulsions should be controlled with intravenous diazepam. Chlorpromazine may be used to control marked excitement and hallucinations. Severe hypertension may need to be treated with an alpha-adrenoreceptor blocking drug, such as phentolamine. A beta blocker may be required to control cardiac arrhythmias.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic Group (ATC classification)

R01BA03

Phenylephrine is a sympathomimetic agent with mainly direct effects on adrenergic receptors. It has predominantly alpha adrenergic activity and is without stimulating effects on the central nervous system. The sympathomimetic effect of phenylephrine produces vasoconstriction, which in turn relieves nasal congestion.

5.2    Pharmacokinetic properties

Phenylephrine is readily absorbed after oral administration but is subject to extensive presystemic metabolism, much of which occurs in the enterocytes. As a consequence, systemic bioavailability is only about 40%. Following oral administration, peak plasma concentrations are achieved in 1-2 hours. The mean plasma half life is in the range 2-3 hours. Penetration into the brain appears to be minimal.

Following absorption, the drug is extensively metabolised in the liver. Both phenylephrine and its metabolites are excreted in the urine.

The volume of distribution is between 200 and 500 litres, but there are no data on the extent of plasma protein binding.

5.3    Preclinical safety data

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

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Maize Starch Lactose Monohydrate Pregelatinised Starch Magnesium Stearate (E470b) Hard Gelatin Capsule: Quinoline Yellow (E104) Titanium Dioxide (e171) Gelatin

6.2 Incompatibilities

None known.

6.3. Shelf life

36 months.

6.4 Special precautions for storage

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

6.5 Nature and contents of container

250 pm white opaque PVC blisters lidded with 20 pm hard temper Aluminium foil. Each pack contains 12 capsules.

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Wrafton Laboratories Limited

Wrafton

Braunton

North Devon

EX33 2DL.

8    MARKETING AUTHORISATION NUMBER(S)

PL 12063/0075

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

24/08/2007

10    DATE OF REVISION OF THE TEXT

20/02/2015