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VEGANIN is a brand name for Acetaminophen (also known as Paracetamol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Codeine-containing products are indicated in patients older than 12 years of age for the short-term treatment of acute moderate pain which is not relieved by other analgesics such as paracetamol or ibuprofen alone. Suitable for migraine, headache, rheumatic pain, period pain, toothache and neuralgia.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults: 2 tablets taken with water every 4-6 hours. No more than 8 tablets in 24 hours. Adolescents aged 16 - 18 years of age: 1-2 tablets taken with water every 6 hours when necessary. Not more than 8 tablets in 24 hours.
Paediatric population:
Children aged 12 - 15 years: 1 tablet taken with water every 6 hours when necessary. Not more than 4 tablets in 24 hours. 4). Do not exceed the stated dose. The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician.
Elderly patients Experience has indicated that normal adult dose of paracetamol is usually appropriate. However in frail, immobile, elderly subjects or in elderly patients with renal or hepatic impairment, a reduction in the amount or frequency of dosing may be appropriate.
The maximum daily dose of paracetamol should not exceed 60mg/kg/day (up to a maximum of 2g per day) in the following situations, unless directed by a physician: • Weight less than 50kg • Chronic alcoholism • Dehydration • Chronic malnutrition Renal Impairment It is recommended, when giving paracetamol to patients with renal impairment, to reduce the dose and to increase the minimum interval between each administration to at least 6 hours unless directed otherwise by a physician.
4). Hepatic Impairment In patients with hepatic impairment or Gilbert’s Syndrome, the dose should be reduced or the dosing interval prolonged. The daily dose of paracetamol should not exceed 2g/day unless directed by a physician. 4). Method of administration For oral administration only.
Adverse reactions reported from extensive post-marketing experience are tabulated below by System Organ Class and frequency. The following convention has been utilized for the classification of undesirable effects: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥ 1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).
Paracetamol:
System Organ Class Frequency Undesirable Effect Blood and lymphatic system disorders Very rare Thrombocytopenia Agranulocytosis Immune system disorder Very rare Anaphylaxis Very rare Allergies (not including angioedema) Respiratory, thoracic and mediastinal disorders Very rare Bronchospasm in patients sensitive to aspirin and other NSAIDs Hepatobiliary disorders Very rare Hepatic dysfunction Very rare Cutaneous hypersensitivity reactions including skin rashes, pruritus, sweating, purpura, urticaria and angioedema.
Skin and subcutaneous tissue disorders Very rare Very rare cases of serious skin reactions have been reported: toxic epidermal necrolysis (TEN), drug- induced dermatitis, Stevens- Johnson syndrome (SJS) acute generalized exanthematous.
pustulosis (AGEP) Renal and urinary disorders Very rare Sterile pyuria (cloudy urine) Caffeine System Organ Class Frequency Undesirable Effect Nervous system disorders Not known Dizziness, headache, tremor Psychiatric disorders Not known Nervousness, irritability When the recommended paracetamol-caffeine-codeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.
Codeine Adverse reactions identified during post-marketing use are listed below by organ system class. System Organ Class Frequency Undesirable Effect Not known Drug dependency can occur after prolonged use of codeine at high doses Psychiatric disorders Rare Hallucinations, nightmares and restlessness Nervous system disorders Not known Dizziness, worsening of headache with prolonged use, drowsiness Eye disorders Not known Blurred or double vision Cardiac disorders Not known Palpitations Vascular disorders Not known Facial flushing, postural hypotension Not known Constipation, nausea, vomiting, dyspepsia, dry mouth, acute pancreatitis in patients with a history of cholecystectomy Gastrointestinal disorders Rare Stomach cramps Not known Pruritus, sweatingSkin and subcutaneous tissue disorder Not known Allergic reactions (itch, skin rash, facial oedema) Renal and urinary disorders Not known Difficulty with micturition (dysuria, increased frequency, decrease in amount) Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important.
Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking paracetamol or codeine. Underlying liver disease increases the risk of paracetamol-related liver damage. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Care should be observed in administering the product to any patients whose condition may be exacerbated by opioids, particularly the elderly, who are especially sensitive to their central and gastro-intestinal effects, those on concurrent CNS depressant drugs and those with prostate hypertrophy.
Patients with a history of cholecystectomy should consult a doctor before using this product as it may cause acute pancreatitis in some patients. Patients should be advised not to exceed the recommended dose as taking a painkiller for headaches too often or for too long can make them worse.
g. coffee, tea and some canned drinks) should be avoided while taking this product Patients with inflammatory or obstructive bowel disorders or acute abdominal conditions should consult a doctor before using this product. Veganin contains codeine whose regular or prolonged use may produce psychological and physical dependence.
, major depression). 9). Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained, and treatment should be discontinued. The diagnosis of 'medication overuse headache' should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.
5) should not take this product. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use o Veganin and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
g. 6); • In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers • In children below the age of 12 years for the symptomatic treatment of cough and/or cold due to an increased risk of developing serious and life-threatening adverse reactions; • In patients with chronic constipation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Because of these risks, concomitant use with these sedative medicines should be under medical supervision and reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Veganin concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5) Do not take with other paracetamol or codeine containing medicines. 9). Codeine, as with other opioids should be used with caution in patients with hypotension, hypothyroidism, head injury or raised intracranial pressure.
CYP2D6 metabolism Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. Estimates indicate that up to 7% of the Caucasian population may have this deficiency.
However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels.
General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal.
3). All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultra-rapid or extensive metabolisers in their ability to metabolise codeine to morphine.
Children with compromised respiratory function Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.
These factors may worsen symptoms of morphine toxicity. This product should be used only when clearly necessary. Prolonged use without medical supervision may be harmful. Do not take for more than 3 days without consulting […]