Source: Web Search Revision Year: 2012 Publisher: Manufacturer: S.C. Europharm S.A., 2 Panselelor str., Brasov, county of Brasov, 500419, Romania Marketing authorization holder: GlaxoSmithKline Consumer Healthcare, United Kingdom, 980 Great West Road, Brentford, Middlesex, TW8 9GS
Medicine should not be administered concurrently with other paracetamol-containing products, decongestions or product for treatment of cold and flu, tricyclic antidepressants, beta-blockers or other anti-hypertonic drugs, inhibitors of MAO (including the period of 14 days after stopping of administration), sympathomimetics (such as appetite suppressors, amphetamine-like psycostimulators), it should not be taken in patients hypersensitive to ingredients that constitute this medicine, patients with hereditary absence of glucose-6-phosphate dehydrogenase, diseases of blood system, severe liver or kidney dysfunction, cardio-vascular diseases (ischemic heart disease, infarct of myocardium, aortic stenosis, evident atherosclerosis, arrhythmia, decompensated cardiac failure), hypertrophy or adenoma of prostate gland, closed angle glaucoma, phaeochromocytoma, vasospastic diseases (example, Raynaud's syndrome), thyrotoxicosis, diabetes, arterial hypertension, children age below 12 years, pregnancy and lactation.
In order to avoid toxic damage of liver by paracetamol this product should not be taken together with alcoholic drinks, as well as by people chronically consuming alcohol.
Excessive intake of coffee and tea should be avoided while taking this product, since it may result in excitement, sleeping disorders, tachycardia, cardiac arrhythmia.
Consult a doctor before taking this medicine if you have cardio-vascular disease.
Patients should be advised not to take other paracetamol-containing products concurrently.
Keep out of the reach and sight of children.
Pack Label:
Immediate medical advice should be sought in the event of overdose, even if you feel well. Do not take with any other paracetamol-containing products.
Patient Information Leaflet:
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.
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhances by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Inhibitors of monoamineoxidase: concurrent use may result in hypertension, hypertonic crisis. Tricyclic antidepressants, sympathomimetics: concurrent use of phenylephrine may increase the risk of development of cardio-vascular adverse effects.
Beta-blockers and other anti-hypertensives: phenylephrine may decrease the efficacy of beta- blockers and other anti-hypertensives, increasing the risk of development of cardio-vascular adverse effects, including hypertension.
Degoxin and other cardiac glycosides: concurrent use of phenylephrine may increase the risk of arrhythmia and heart attack.
Paracetamol-caffeine is not recommended for use during pregnancy due to the possible increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption.
This product should not be used while breast-feeding without advice.
Phenylephrine may be excreted in breast milk. Caffeine in breast milk may potentially have a stimulating effect on breast fed infants but significant toxicity has not been observed.
Patients should be advised not to drive or operate machinery if affected by dizziness.
Rare (<1/1000):
Mydriasis, closed angle glaucoma (possibility is high in patients with closed angle glaucoma)
CNS: Nervousness, headache, dizziness, insomnia, increased excitement, irritability, anxiety, psyco-motoric excitement.
Very rare (<1/10000):
Immune system: allergic dermatitis, skin rash, urticaria, Stevens-Johnsons syndrome (toxic epidermic necrolysis), edema, anaphylaxis.
Hematopoietic system: thrombocytopenia, agranulacytosis.
Respiratory system: bronchospasm in patients hypersensitive to aspirin or other NSAID's.
Cardio-vascular diseases: palpitation, increased blood pressure.
Gastro-intestinal tract: nausea, vomiting, liver dysfunction,
Excretory system: disuria, urine retention (mostly possible in patients with obstruction of excretory tracts, example, prostate adenoma).
Report to your doctor about all adverse reactions.
None.
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