- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
Non-Drowsy Sudafed Congestion Relief CapsulesSudafed Blocked Nose Capsules
2. Qualitative and quantitative composition
3. Pharmaceutical form
Capsule, hard. Capsules description: A yellow cap and body printed 'Sudafed 0593' in black.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of nasal congestion associated with colds and hay fever.
4.2 Posology and method of administration
Adults and children over 12 years: One capsule if necessary, up to four times daily.Children under 12 years: Not recommended.Elderly: There is no need for dosage reduction in the elderly.
Hypersensitivity to any of the ingredients. Avoid in patients with cardiovascular disease, diabetes mellitus, closed angle glaucoma, hyperthyroidism, prostatic enlargement and phaeochromocytoma.
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.If symptoms do not go away talk to your doctor.Keep all medicines out of the reach 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, 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 educe 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
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.
6. Pharmaceutical particulars
6.1 List of excipients
Pregelatinised maize starch Dried maize starch Lactose monohydrate Magnesium stearate Hard Gelatin Capsule (Gelatin, Quinoline yellow E104, Titanium dioxide E171) Ink (Black iron oxide E172, Shellac, propylene glycol and ammonium hydroxide)
6.3 Shelf life
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
Blister pack of pigmented 250 micron PVC coated with 40gsm PVdC and 20 micron aluminium foil.Pack sizes: 5, 6, 7, 10, 12, 14, 18, 20, 21, 24, 25, 28, 30, 36, 48, 50.
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
McNeil Products LimitedFoundation ParkRoxborough WayMaidenheadBerkshire SL6 3UGUnited Kingdom
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
8 June 2004
10. Date of revision of the text
McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG
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