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

Logo LOTEM SUSPENSION

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

LOTEM SUSPENSION

COMPOSITION:
Each 10 mL contains:

Ibuprofen         200 mg
Paracetamol         250 mg
Preservative 
Sodium benzoate 0,1% m/v
(Contains sodium metabisulphite)

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic Combinations

PHARMACOLOGICAL ACTION:
LOTEM SUSPENSION
has an analgesic, anti-inflammatory and anti-pyretic action.

INDICATIONS:
LOTEM SUSPENSION
is indicated for fever and the relief of mild to moderate pain.

CONTRA-INDICATIONS:
Impaired hepatic and renal function, peptic ulceration or a history of such ulceration. Cardiovascular disease.
Hypersensitivity to any of the active ingredients, aspirin or other non-steroidal anti-inflammatory medicines. Because of the possibility of cross-sensitivity due to the structural relationships which exists among non-steroidal anti-inflammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds.
LOTEM SUSPENSION is not recommended for use by pregnant or breastfeeding women and in children under the age of two years.

WARNINGS:
The safety of continuous administration of LOTEM SUSPENSION has not been established for a period greater than four weeks.
Paracetamol:
Dosages in excess of those recommended may cause severe liver damage.
Consult a doctor if no relief is obtained from the recommended dosage.
Do not use for more than ten days without consulting a doctor.

DOSAGE AND DIRECTIONS FOR USE:
Do not exceed the recommended dosage.
Shake the bottle before use.
Adults and children over twelve years:
Take one to two medicine measures (5-10 mL) four hourly if necessary and not more than six medicine measurefuls in twenty-four hours.
Children:
2 - 5 years        2,5 mL - 5 mL three to four times daily.
6 - 12 years 5 mL - 10 mL three to four times daily.
Safety in children under two years of age has not been proven.
Consult your doctor if no relief is obtained with the recommended dosage,

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Ibuprofen:
The commonest side-effects are generally gastro-intestinal disturbances which are usually mild and reversible but in some patients peptic ulcer and severe gastro-intestinal bleeding have been reported.
Central nervous system related side-effects include headache, dizziness, nervousness, tinnitus, depression, drowsiness and insomnia. Hypersensitivity reactions may occur ocassionally and include fever, asthma and rashes. Hepatotoxicity and aseptic meningitis which occur rarely may also be hypersensitivity reactions. Visual disturbances, blurred vision, changes in colour perception and toxic amblyopia may occur.
Haematological adverse effects include anaemias, thrombocytopenia, neutropenia, eosinophilia and agranulocytosis.
Other adverse effects include nephrotoxicity such as interstitial nephritis, nephrotic syndrome and renal failure. Fluid retention may occur.
Ibuprofen must be given with care to patients with bleeding disorders, cardiovascular disease, peptic ulceration or a history of suchulceration. Caution is advised in those patients who are receiving coumarin anticoagulants.
Ibuprofen should be given with care to the elderly, to patients with asthma or bronchospasm, bleeding disorders, cardiovascular disease or in liver or renal failure. Patients with congestive heart failure, cirrhosis, diuretic-induced volume depletion, or renal insufficiency require local synthesis of vasodilating prostaglandins to maintain renal perfusion and therefore these patients are at greater risk of developing renal dysfunction due to NSAID-induced inhibition of renal prostaglandin synthesis.
Ibuprofen should be discontinued in patients who experience blurred or diminished vision or changes in colour vision. Patients with collagen disease may be at increased risk of developing aseptic meningitis.
Paracetamol:
Haematological reactions including thrombocytopenia, leucopenia, pancytopenia. neutropenia and agranulocytosis have been reported. Skin rashes and other hypersensitivity reactions occur occasionally. Pancreatis, skin rashes and other allergic reactions may occur. The rash is usually erythematous or urticarial but sometimes more serious, and may be accompanied by fever and mucosal lesions.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Paracetamol:
Symptoms of paracetamol overdosage in the first twenty-four hours are pallor, nausea, vomiting, anorexia, and abdominal pain. Liver damage may become apparent twelve to forty-eight hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported, Symptoms during the first two 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 by elevation 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 nonspecific myocardial 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 has ingested about 7,5 g of paracetamol in the preceding four hours should undergo gastric lavage. Specific therapy with an antidote such as acetylcysteine or methionine may be necessary, If decided upon, acetylcysteine should be administered IV (intravenously) as soon as possible.
Acetylcysteine: Acetylcysteine should be administered as soon as possible, preferably within eight hours of overdosage.
IV:        An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over fifteen minutes, followed by an intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next four hours, and then 100 mg/kg in 1000 mL over the next sixteen 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 four hours for 17 doses. Acetylcysteine is effective if administered within eight hours of overdosage.
Ibuprofen:
The most likely symptoms of overdosage are epigastric pain and nausea.

IDENTIFICATION:
A yellow homogenous suspension with a banana taste and odour.

PRESENTATION:
Amber glass bottles of 100 mL and 200 mL.

STORAGE INSTRUCTIONS:
Store below 30°C in well-closed containers. Protect from light. Keep out of reach of children.

REGISTRATION NUMBER:
30/2.8/0391

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext.77
2152
Private Bag X69, Bryanston
2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
3/07/1996

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

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