INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo NAPAMOL TABLETS
NAPAMOL ELIXIR

SCHEDULING STATUS:
Not scheduled:        50 mL and 100 mL Napamol Elixir.
S1 - Napamol Tablets and 2,5 L Napamol Elixir.

PROPRIETARY NAME
(and dosage form):

NAPAMOL TABLETS
NAPAMOL ELIXIR

COMPOSITION:
Each tablet contains:
Paracetamol         500 mg
Preservative: 
Nipastat 0,125% m/m
Each 5 mL elixir contains:
Paracetamol         120 mg
Alcohol 10,125% v/v
Preservartives: 
Methylparaben 0,110% m/v
Propylparaben 0,015% m/v
Napamol Elixir contains TARTRAZINE

PHARMACOLOGICAL CLASSIFICATION:
A 2.7 Anti-pyretic or anti-pyretic and anti-inflammatory analgesics.

PHARMACOLOGICAL ACTION:
Paracetamol has analgesic and antipyretic properties.

INDICATIONS:
For the symptomatic treatment of mild to moderate pain and fever.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. Patients with severe liverfunction impairment.

WARNINGS:
Dosages in excess of those recommended may cause severe liver damage.
Patients suffering from liver or kidney disease should take paracetamol under medical supervision. Consult a doctor if no relief is obtained from the recommended dosage.Do not use continuously for more than 10 days without consulting a doctor.
Napamol Elixir contains TARTRAZINE which may cause allergic type reactions (including bronchial asthma) in certain susceptible individuals. The overall incidence of TARTRAZINE sensitivity is low. It is however frequently seen in patients who also haveaspirin sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
Do not exceed the stated dose.
Adults:                1 or 2 tablets every 4 to 6 hours as required but not more than 8 tablets to be taken daily.
Children:        Not more than 4 doses daily.
6 to 12 years: ½ to 1 tablet or 2 - 4 medicine measures elixir (10 - 20 mL) given 3 to 4 times daily as required.
1 to 5 years: 1- 2 medicine measures elixir (5 - 10 mL) 3 to 4 time daily as required.
3 months to 1 year: ½ to 1 medicine measure eliir (2,5 - 5 mL) 3 to 4 times daily asrequired.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Pancreatitis, skin rashes and other allergic reactions may occur. Therash is usually erythematous or urticarial but sometimes more serious and may be accompanied by drug fever and haematological reactions including pancytopenia, neutropenia, leucopenia, thrombocytopenia and agranuiocytosis.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT :
Symptoms of paracetamol overdosage in the first 24 hours are 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. Acute renal failure with acutetubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported. Symptoms during the first 2 days of acute poisoning do not reflect the potential seriousness of the overdosage. Nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Liver injury may become manifest on the second day, (or later) initially byelevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. The liver damage may progress to encephalopathy coma and death. Cerebral oedema and non-specific myocatrdial depression have also occurred. In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible. Prompt treatment is essential. Any patient who ingested about 7,5 g of paracetamol in the preceding 4 hours should undergo gastric lavage. Specific therapy with an antidite such as acetylcystjineor methionine may be necessary. If decided upon, acetylcysteine should be adminstered as soon as possible, preferably within 8 hours of overdosage.
IV: An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over 15 minutes, followed by intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next 4 hours, and then 100 mg/kg in 1000 mL over the next 16 hours. The volume of intravenous fluids should be modified for children.
Orally: 140 mg/kg as a 5 % solution initially, followed by a 70 mg/kg solution every 4 hours for 17 doses. Acetylcysteine is effective if administered within 8 hours of overdosage.

IDENTIFICATION:
Napamol Tablets: White, round, flat tablet with bevelled edges and bisectedon one side.
Napamol Elixir: Viscous, clear, green liquid, with an odour and taste of peppermint.

PRESENTATION:
Napamol Tablets:
100 tablets in securitainer
1000 tablets in HDPE bottle
5000 tablets in HDPE bucket
Napamol Elixir:
50 mL and 100 mL in PVC bottles
2,5 Lin HDPE polycan

STORAGE INSTRUCTIONS:
Napamol Tablets: Store in well-closed containers, below 25°C. Protect from light andmoisture.
Napamol Elixir: Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
Napamol Tablets:         B/2.7/1404
Napamol Elixir:         B/2.7/1409

NAME AND BUSINESS ADDRESS OF THE APPLICANT.
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Ave
Bryanston
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
15 April 1991

New addition to this site: May 2004
Source: Pharmaceutical Industry

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