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Sudafed Blocked Nose & Headache 16 Capsules |
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SUDAFED® Blocked Nose & Headache Capsules are formulated to relieve symptoms including headache, fever, nose and sinus congestion, aches and pains.
The capsules contain paracetamol to help reduce pain and fever, as well as caffeine, a well-known stimulant that helps combat tiredness and aid pain relief, and phenylephrine hydrochloride, which acts fast on congestion.
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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
INGREDIENT
QTY
UNIT
DOSE
Paracetamol
300
mg
Capsule
Caffeine
25
mg
Capsule
Phenylephrine Hydrochloride
5
mg
Capsule
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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
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Hypersensitivity to paracetamol and/or other constituents.
Not to be used in children under the age of 12 years.
Concurrent administration of monoamine oxidase inhibitors and tricyclic antidepressants, severe hypertension, myocardial infarction, hyperthyroidism and pregnancy.
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 non-cirrhotic 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”.
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.
PREGNANCY
Although epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended doses, 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 contra indicate 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.
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 heat-regulating 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.
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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
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