Decongestant Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Phenylephrine HCl 12.18 mg Tablets Max Strength Decongestant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenylephrine Hydrochloride 12.18mg For excipients, see 6.1
3 PHARMACEUTICAL FORM
Round, bi-convex, red film coated tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of nasal congestion associated with colds and hayfever.
4.2 Posology and method of administration
Adults and children over 12 years: One tablet, up to four times daily. Children under 12 years: Not recommended.
Elderly: There is no need for dosage reduction in the elderly.
4.3 Contraindications
Hypersensitivity to any of the ingredients. Avoid in patients with cardiovascular disease, high blood pressure, 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.
Patients with rare hereditory problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The label will state:
Do not take for more than 7 days, unless your doctor agrees.
If symptoms do not go away talk to your doctor.
Keep all medicines out of the reach and sight of children.
Warning: Do not exceed the stated dose.
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 or Beta-blockers.
This medicine should not be used with 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.
4.9
Overdose
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
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 absorbtion, 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.
6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Lactose, monohydrate (DC)
Microcrystalline Cellulose Powdered Cellulose Magnesium stearate Sodium starch glycollate (Type A)
Silica, colloidal anhydrous
Base coat (containing Macrogol 4000, Titanium dioxide E171, methacrylic acid-ethyl acrylate copolymer and Hypromellose)
Colour coat (containing Hypromellose, Macrogol 4000, Talc, Azorubin E122, Brilliant Ponceau E124, Red lake E 124, Polysorbate 80)
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.
6.5 Nature and contents of container
Phenylephrine Hydrochloride tablets are packed into PVC/ PVdC/ Aluminium foil blisters. Each blister consists of 12 red film coated tablets.
Pack sizes: 12 or 24 tablets.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Galpharm Healthcare Ltd,
Hugh House,
Upper Cliffe Road Dodworth Business Park Dodworth
Barnsley South Yorkshire S75 3SP
8 MARKETING AUTHORISATION NUMBER(S)
PL 16028/0114
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/02/2008
10 DATE OF REVISION OF THE TEXT
21/02/2014