PARAMOL

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.

Posology Adults:

One or two tablets every four to six hours. Do not exceed 8 tablets in any 24 hour period. Do not take for more than 3 days continuously without medical review.

Paediatric Population Adolescents 16 years old and over:

One or two tablets every four to six hours. Do not exceed 8 tablets in any 24 hour period. Do not take for more than 3 days continuously without medical review.

Adolescents 12–15 years old:

One tablet every four to six hours. Do not exceed 4 tablets in any 24 hour period. Do not take for more than 3 days continuously without medical review. 4). 4). Dosage should be reduced in chronic hepatic disease. 4). 4). A healthcare professional should be consulted to determine if a dosage reduction is necessary.

Method of Administration For oral administration. Paramol Tablets should, if possible be taken during or after meals.

Paracetamol Adverse effects of paracetamol are rare. Dihydrocodeine Regular prolonged use of dihydrocodeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is stopped. Prolonged use of a painkiller for headaches can make them worse.

Adverse events which have been associated with paracetamol at OTC doses (maximum 4000 mg per day) and dihydrocodeine tartrate, in short term use, are given below, tabulated by system organ class and frequency.

Frequencies are defined as:

Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class Frequenc y Adverse Events Blood and Lymphatic System Disorders Not known Thrombocytopeniaa, agranulocytosisa1 Immune System Disorders Not known Urticariab, pruritusb, face oedemab. Metabolism and Nutrition Disorders Not known High anion gap metabolic acidosis2 Decreased appetiteb Psychiatric Disorders Not known Depressionb, hallucinationb, confusional stateb, dependenceb, mood alteredb, restlessnessb, nightmareb Nervous System Disorders Not known Dizzinessb, drowsinessb, convulsionb, intracranial pressure increasedb, headacheb , dyskinesiab Eye Disorders Not known Vision blurredb, diplopiab, miosisb Ear and Labyrinth Disorders Not known Vertigob Cardiac Disorders Not known Bradycardiab, palpitationsb, tachycardiab Vascular Disorders Not known Orthostatic hypotensionb Respiratory, Thoracic and Mediastinal Not known Respiratory depressionb, dyspnoeab, cough System Organ Class Frequenc y Adverse Events Disorders suppressionb Gastrointestinal Disorders Not known Abdominal painb, nauseab, constipationb, vomitingb, dry mouthb, incontinenceb, diarrhoeab, large intestinal obstructionb, faecalomab, pancreatitisb Hepatobiliary Disorders Not known Biliary colicb, sphincter of Oddi dysfunctionb Not known Rashab, flushingb Skin and Subcutaneous Tissue Disorders Very rare Cases of serious skin reactions have been reported.

Paramol Tablets should be given with caution to patients with allergic disorders and should not be given during an attack of asthma. Dosage should be reduced in hypothyroidism and in chronic hepatic disease. An overdose can cause hepatic necrosis.

Paracetamol Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Do not take with any other paracetamol-containing products.

9). Do not take concurrently with any other codeine-containing compounds. g. chronic alcoholism), who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended.

The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors. g. peptic ulcer) or a history of a peptic ulcer, recent gastrointestinal surgery, gallstones and diseases of the biliary tract, myasthenia gravis, a history of arrhythmias, convulsions and in also patients with a history of drug abuse, acute alcoholism, or emotional instability.

This product should be avoided in patients with risk of paralytic ileus. Dosage should be reduced in the elderly. Elderly patients may metabolise or eliminate opioid analgesics more slowly than younger adults. 2). Prolonged regular use of dihydrocodeine, except under medical supervision, may lead to physical and psychological dependence (addiction) and result in withdrawal symptoms, such as restlessness and irritability once the drug is stopped.

If you are being prescribed medicines, seek the advice of a doctor before taking this product. Care is advised in the administration of this product in patients with severe renal or severe hepatic impairment (hepatic disease). Dihydrocodeine is partially metabolised by CYP2D6.

1 Diarrhoea caused by poisoning until the toxic material has been eliminated, or diarrhoea associated with pseudomembranous colitis. Acute alcoholism, convulsive disorders, head injuries, and conditions in which intracranial pressure is raised.

Administration of pethidine and possibly other opioid analgesics to patients taking a monoamine oxidase inhibitor (MAOI) has been associated with very severe and sometimes fatal reactions. 6). Obstructive airways disease Respiratory depression.

Delayed gastric emptying and paralytic ileus. 4). In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.