LOTEM SUSPENSION is indicated for fever and the relief of mild to moderate pain.
1. What LOTEM SUSPENSION is and what it is used for.
2. What you need to know before you take/use LOTEM SUSPENSION.
Contraindications
- Impaired hepatic and renal function.
- Peptic ulceration or a history of such ulceration.
- Active or history of recurrent haemorrhage/perforations.
- History of gastrointestinal perforation, ulceration and bleeding (PUB) related to previous NSAID therapy.
- Heart failure.
- Hypersensitivity to any of the active ingredients, aspirin or other non-steroidal anti-inflammatory medicines, including any of the excipients listed in section 6.1. Because of the possibility of cross-sensitivity due to the structural relationships which exist 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.
- Do not use of NSAIDs in women around 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/ foetal renal dysfunction and premature closure of the foetal ductus arteriosus.
- Uncontrolled asthma or bronchospasm.
- Nasal polyps associated with aspirin-induced bronchospasm.
- Patients with bleeding disorders.
- Patients who are receiving coumarin-anticoagulants.
Special warnings and precautions for use
LOTEM SUSPENSION contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately. 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. Use with caution in alcoholism or impaired liver function due to increased risk of hepatotoxicity. Use with caution in alcohol dependence, chronic malnutrition or dehydration.
3. How to take/use LOTEM SUSPENSION.
Posology
Adults and children over twelve years: Take one to two medicine measures (5 to 10 ml) four hourly if necessary and not more than six medicine measures in twenty-four hours. Children 2 to 5 years: 2.5 ml to 5 ml three to four times daily. Children 6 to 12 years: 5ml to 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. Use the lowest effective dose for the shortest possible duration of treatment. Do not exceed the recommended dosage. Shake the bottle before use.
Method of administration
LOTEM SUSPENSION should be taken orally, after meals with sufficient water.
4. Possible side effects.
Summary of the safety profile
The most frequently occurring adverse reactions include dizziness, nausea, abdominal pain, vomiting, diarrhoea, flatulence, constipation, dyspepsia, peptic ulceration, perforation or gastrointestinal bleeding, melena, haematemesis, gastritis (see section 4.8.b).
Tabulated summary of adverse reactions
Side-effects are classified according to MedRA System Organ Class using the following convention: Frequent, Less frequent and frequency unknown*.
*Frequency unknown: the frequency of the side effect cannot be estimated from the available data.
System organ class
Frequency
Undesirable effects
- Blood and lymphatic system disorders: Less frequent - Anaemias, thrombocytopenia, neutropenia, eosinophilia and agranulocytosis. Leucopenia and pancytopenia. Fluid retention may occur.
- Cardiac disorders: Less frequent - Tachycardia, flushing, increase in blood pressure/ hypertension, heart failure.
- Immune system disorders: Less frequent - Hypersensitivity reactions fever, asthma and rashes. Other allergic reactions, may be accompanied by fever and mucosal lesions.
- Hepatotoxicity and aseptic meningitis. Frequency unknown - Drug-induced hypersensitivity syndrome (DIHS), hypersensitivity reactions characterised by urticaria, dyspnoea, and hypotension (see Section 4.4).
- Nervous system disorders: Frequent - Dizziness. Less frequent - Headache, nervousness, tinnitus, depression, drowsiness and insomnia.
- Eye disorders: Less frequent - Blurred vision, changes in colour perception and toxic amblyopia.
- Gastrointestinal disorders: Frequent - Nausea, abdominal pain, vomiting, diarrhoea, flatulence, constipation, dyspepsia, peptic ulceration, perforation or gastrointestinal bleeding, melena, haematemesis, gastritis. Less frequent - Pancreatitis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease.
- Hepatobiliary disorders: Less frequent - Hepatitis.
- Renal and urinary disorders: Less frequent - Oedema, impairment of renal function, acute reversible renal impairment. Frequency unknown - Nephrotoxicity interstitial nephritis, nephrotic syndrome and renal failure.
- Skin and subcutaneous tissue disorders: Frequency unknown - Allergic dermatitis, erythema multiforme, bullous reactions including Stevens-Johnson syndrome, skin rashes, urticarial rash and toxic epidermal necrolysis. Drug reaction with eosinophilia and systemic symptoms (DRESS) (see section 4.4).
- Fixed drug eruptions (FDE) (see section 4.4).
- Metabolism and nutrition disorders: Frequency Unknown - Hypokalaemia.
- Renal and urinary disorders: Frequency Unknown - Renal tubular acidosis.
Post-marketing experience: The following side effects have been reported, and frequencies are unknown: Fixed drug eruptions (FDE) and drug-induced hypersensitivity syndrome (DIHS) (see Section 4.4).
Description of Selected Adverse Reactions: Renal tubular acidosis and hypokalaemia have been reported in the post-marketing setting typically following prolonged use of the ibuprofen component at higher than recommended doses.
5. How to store LOTEM SUSPENSION.
Special precautions for storage
Store at or below 30 °C in well-closed containers. Protect from light.