Winamol

Paracetamol.

Tab 500 mg: Paracetamol 500 mg.
Preservative: Potassium Sorbate 0.10% w/w.
Tab 650 mg: Paracetamol 650 mg.
Preservative: Potassium Sorbate 0.10% w/w.
FC tab 500 mg: Paracetamol 500 mg.
Preservative: Potassium Sorbate 0.10% w/w.
Oral drops: Each 1 ml contains: Paracetamol 100 mg.
Preservative: Methyl Paraben 0.09% w/v, Propyl Paraben 0.009% w/v.

Pharmacology: Pharmacodynamics: Tablet: Paracetamol is a centrally acting analgesic and antipyretic with minimal anti-inflammatory properties.
Analgesic: The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (specifically cyclooxygenase (COX)-2) 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 sensitize pain receptors to mechanical or chemical stimulation.
Antipyretic: Paracetamol act centrally on the hypothalamic heat-regulating center to produce peripheral vasodilatation resulting in increase blood flow through the skin, sweating and heat loss.
Paracetamol reduces fever by inhibiting the formulation and release of prostaglandins in the CNS and by inhibiting endogenous pyrogens at the hypothalamic thermoregulator center.
Oral drops: Paracetamol has analgesic and antipyretic actions probably due to the inhibition of prostaglandin biosynthesis.
Pharmacokinetics: Tablet: Following oral administration paracetamol is rapidly absorbed.
Paracetamol absorption takes place mainly in the small intestine and therefore the rate of absorption is depending on the rate of gastric emptying. It has been shown that drugs which delay gastric emptying also delay the absorption of paracetamol whereas metoclopramide (a drug which increases the rate of gastric emptying) accelerates absorption of the analgesic through the total amount absorbed doses not increase.
The presence of food in the stomach has also been reported to reduce the rate of absorption of paracetamol. Alterations in gastric pH have no appreciable effect on paracetamol absorption.
During absorption, the amount of paracetamol which is inactivated is negligible and it has been shown that paracetamol dose not affect gastric mucosal permeability and does not produce mucosal bleeding. Peak plasma concentrations are reached 1 hour after absorption. The plasma half life is 1 to 3 hours.
Paracetamol penetrates the brain and is present in breast milk of human.
Paracetamol is metabolized by the microsomal enzyme system of the liver. This metabolism is mainly to the glucuronide and sulphate conjugates, accounting for approximately 49% and 26% of the ingested dose respectively. About 4% is excreted as free paracetamol. Other minor pathways include the production of catechol derivatives and cysteine conjugates (via glutathione). Paracetamol excretion is rapid and occurs via the urine.
Oral drops: Paracetamol is readily absorbed from the gastro-intestinal tract and peak plasma concentrations usually occur 30 minutes to 2 hours after ingestion. Paracetamol is metabolised in the liver and largely excreted in the urine as sulphate and glucuronide conjugates. Less than 5% is excreted unchanged. The elimination half-life varies from about 1 to 4 hours.

Tab 500 mg & 650 mg: For relief of fever.
For relief from mild-to-moderate pain including: Headache, Migraine, Muscle ache, Dysmennorhoea, Sore throat, Musculoskeletal pain, Fever and pain after vaccination, Pain after dental procedures/tooth extraction, Toothache, Pain of osteoarthritis.
FC tab 500 mg: For the relief of mild to moderate pain including: headache, migraine, backache, musculoskeletal pain, myalgia and neuralgia, dysmenorrhea, pain of osteoarthritis, toothache, pain after dental procedures/tooth extraction, pain after vaccination and discomfort from colds, influenza and sore throats.
Oral drops: For the relief of fever and mild to moderate pain. WINAMOL Drops is an analgesic in teething.

Tab 500 mg: Above 12 years & adult: 1-2 tablets every 4-6 hours as required. Maximum of 4 doses in 24 hours.
Tab 650 mg: Adult: 1-1.5 tablets, 3-4 times a day or as directed by physician. Do not exceed 6 tablets a day.
FC tab 500 mg: Children above 12 years & adult:1-2 tablets every 4-6 hours as required. Maximum 8 tablets in 24 hours.
Oral drops: 1 - 3 months (4 - 6 kg): 0.6 - 0.9 ml (60 - 90mg); 3 - 6 months (6 - 8 kg): 0.9 - 1.2 ml (90 - 120mg); 6 - 12 months (8 - 10 kg): 1.2 - 1.5 ml (120 - 150mg); 1 - 2 years (10 - 12 kg): 1.5 - 1.8 ml (150 - 180mg).
For an accurate dosing, weigh the child and work out the dosage to be given based on a paracetamol 15 mg for every kg body weight.
Do not give more than 4 doses in any 24 hour period.
Leave at least 4 hours between doses.
Do not give this medicine to a child for more than 3 days without speaking to a doctor or pharmacist.
Mode/Route of Administration: Oral.

Symptoms: Tablet: Toxic symptoms include vomiting, abdominal pain, hypotension and sweating. The most serious adverse effect of acute overdose of paracetamol is a dose-dependent, potentially fatal hepatic necrosis.
Clinical and laboratory evidence of hepatoxicity may be delayed for up to one week. Major manifestations of liver failure such as jaundice, hypoglycemia and metabolic acidosis may take at least 3 days to develop.
Oral drops: Early symptoms of paracetamol overdosage include pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.
Treatment: Tablet: In cases of overdose, methods of reducing the absorption of ingested drug are important. Gastric lavage is essential even if several hours have elapsed. Prompt administration of 50g activated charcoal and 500ml iced mannitol 20% by mouth, may reduce absorption. If the history suggests that 15g Paracetamol or more has been ingested, administer one of the following antidotes: Acetylcysteine 20% i.v.: Administer intravenously, 20% acetlcysteine immediately without waiting for positive urine test or plasma level results: initial dose of 150mg/kg over 15 minutes, followed by continuous infusion of 50mg/kg in 500ml 5% glucose/dextrose over 4 hours and 100mg/kg in 1L 5% glucose/dextrose over 16 hours; OR
Oral Methionine: 2.5g immediately followed by three further doses of 2.5g at four hourly intervals. For a 3 year old child, 1g methionine every four hours for four doses has been used;
OR Oral Acetylcysteine 5%: 140mg/kg as a loading dose, then 70mg/kg every 4 hours for a total of 17 maintenance doses. If more than ten hours have elapsed since the overdosage was taken, the antidote may be in ineffective.
Oral drops: Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Any patient who has ingested around 7 .5g or more of paracetamol in the preceding 2 hours should undergo gastric lavage. Administration of oral methionine or intravenous n-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

Tablet: Hypersensitivity to paracetamol or any of the other ingredients/components of the product.
Severe and active hepatic impairment.
Oral drops: Contra-indicated in patients with a known hypersensitivity to paracetamol or any of the other constituents.

This preparation contains PARACETAMOL.
Do not take any other paracetamol containing medicines at the same time.
Allergy alert: Paracetamol may cause severe skin reactions. Symptoms may include skin reddening, blisters or rash.
These could be signs of a serious condition. If these reactions occur, stop use and seek medical assistance right away.

Tablet: Keep out reach of children.
Do not take if allergic to paracetamol.
Patients should contact their healthcare provider if symptoms persist (if the pain last for more than 10 days, if there is redness or fever lasts more than 3 days).
Paracetamol should be given with care to patients with impaired kidney or liver function.
Large doses should be avoided in patients with hepatic impairment. Paracetamol overdose may harm the liver.
Do not exceed recommended dose.
It should be given with care to patients with alcohol dependence.
Paracetamol provides symptomatic relief only, additional therapy to treat the cause of the pain or fever should be instituted when necessary.
Effects on Ability to Drive and Use Machines: It is unlikely to impair a patient's ability to drive or use machinery.
Oral drops: Consult the physician before use if the child has liver or kidney problems and if the child's symptoms do not improve. Do not exceed the stated dose.
WINAMOL Drops for Infants contains paracetamol. It should not be used with other paracetamol-containing products.

Use in pregnancy: Tablet: Considered to be the analgesic of choice in pregnant patients.
Although it crosses placenta, paracetamol is considered to be safe in normal therapeutic doses for short-term use as a minor analgesic/antipyretic in pregnancy.
Oral drops: Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.
Use in lactation: Tablet: Excreted in breast milk.
Maternal ingestion of paracetamol in normal therapeutic doses does not appear to present a risk to the nursing infant.
Oral drops: Paracetamol is excreted in breast milk but not in a clinically significant amount.
Available published data do not contra-indicate breast feeding.

Tablet: Adverse effects of paracetamol are rare and usually mild, although haematological reactions have been reported.
Cutaneous hypersensitivity reactions including skin rashes, angioedema, Stevens Johnson Syndrome or Toxin Epidermal Necrolysis have been reported.

Oral drops: Cutaneous hypersensitivity reactions including skin rashes, angioedema, Stevens Johnson Syndrome/Toxic Epidermal Necrolysis have been reported.
Stop taking WINAMOL Drops for Infants and inform the physician immediately if the child: Experience allergic reactions eg. skin rash or itching. sometimes with breathing problems or swelling of the lips, tongue, throat or face; experience a skin rash or peeling, or mouth ulcers; have previously experienced breathing problems with aspirin or nonsteroidal anti-inflammatory drugs, and experience a similar reaction with WINAMOL Drops for Infants; experience unexplained bruising or bleeding, these reactions are rare.

Tablet: The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Oral drops: Before taking WINAMOL Drops for Infants, make sure to consult the physician if the patient is taking warfarin or similar medicines used to thin the blood.

Tablet: Store below 30°C & Protect from light.
Shelf Life: 60 months.
Oral drops: Keep the bottle tightly closed protected from light. Store below 30°C.

Analgesics (Non-Opioid) & Antipyretics

N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.

NP