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Composition :

Capsule:

– Paracetamol 300mg
– Opium powder 10mg
– Caffeine 30mg

Suppository:

– Paracetamol 500mg
– Opium powder 15mg
– Caffeine 50mg

Indications :

Symptomatic treatment of pain of moderate to intense intensity and/or pain that does not respond to the use of level 1 analgesics (classification WHO).

Dosage:

Reserved for adults.

As with all analgesic drugs, the dosage of Lamaline should be adjusted to the intensity of the pain and the clinical response of each patient. To avoid a risk of overdose, check the absence of paracetamol in the composition of other associated medicines.
The total dose of paracetamol should not exceed 4 g per day (see Overdose).
The total daily dose of paracetamol should not exceed 3 g per day in the following situations:
– Weight < 50 kg,
– mild to moderate hepatocellular insufficiency,
– severe renal impairment (creatinine clearance < 10 ml/min),
– chronic alcoholism,
– chronic malnutrition,
– prolonged fasting,
– elderly subject.
Doses should be spaced at least 4 hours apart.
Renal impairment: In case of severe renal impairment (creatinine clearance less than 10 ml/min), the interval between two doses will be at least 8 hours.

The usual dosage is 3 to 5 capsules per day, at the rate of 1 to 2 capsules per dose, without exceeding 10 capsules per day.

Suppository:

Contraindications:

– Child under 15 years old.
– Hypersensitivity to paracetamol, opium powder or extract or to any of the excipients.
– Severe liver failure.
– Asthma and respiratory failure (due to the presence of opium powder or extract).
– Feeding with milk.
– Combination with certain opioids

Warnings and precautions for use:

Warnings :

This medicine contains paracetamol. To avoid a risk of overdose, check the absence of paracetamol in the composition of other associated medicines. The total dose of paracetamol should not exceed 4 g per day (see Overdose). In the following situations, the total dose of 3 g per day should not be exceeded (see Dosage and Method of administration):
– weight < 50 kg,
– mild to moderate hepatocellular insufficiency,
– severe renal impairment (creatinine clearance < 10 ml/min),
– chronic alcoholism,
– chronic malnutrition,
– prolonged fasting,
– elderly subject.
– Prolonged use and at doses higher than those recommended may lead to a state of drug dependence.
– In predisposed patients, treatment must be carried out under medical supervision.
– Lamaline should only be used after a careful assessment of the risk-benefit ratio, according to the etiology of the pain and the profile of the patient.

Precautions for use:

It is recommended not to exceed the recommended doses and to respect the minimum interval of administration.

Elderly Patients:

In the elderly and very elderly, the particular sensitivity to analgesic effects but also to central (confusion) or digestive effects, associated with a decline in renal function, should encourage caution. The dosage should be reduced by increasing the interval between doses.

Patients with renal impairment:

The dosage should be reduced by increasing the interval between doses.

Patients with hepatic impairment:

Lamaline is not recommended in patients with mild to moderate hepatic impairment.
Powder (capsule) or extract (suppository) of opium can precipitate or aggravate the symptoms of this disease.

Subjects with G6PD deficiency:

Cases of acute haemolysis have been reported in these patients with high doses of paracetamol, i.e. higher than the maximum recommended daily dose. It is important to respect the dosages.

Others :

– If acute viral hepatitis is discovered, treatment should be stopped.
– The absorption of alcohol is not recommended during the treatment.
– Due to the presence of opium, there is a risk of urinary retention.
– There is a risk of increased intracranial pressure being too high
– The co-prescription of sedative or mood modulating treatments, CNS depressants or with an anticholinergic effect increases the occurrence of adverse effects
– It is imperative to ensure the absence of occlusive syndrome before starting the treatment. Constipation is a known side effect of opium powder
– In the patient cholecystectomized, the powder (capsule) or the extract (suppository) of opium can cause an acute abdominal pain syndrome of the biliary or pancreatic type
– In the event of a productive cough, the powder (capsule) or the extract (suppository) of opium can hinder expectoration.
– Due to the presence of caffeine, this medicine may cause insomnia; avoid taking at the end of the day.
– Athletes’ attention should be drawn to the fact that this specialty contains morphine and that this active ingredient is on the list of doping substances.

Interactions:

Drugs interactions :

Related to paracetamol:

Requiring precautions for use:

– Oral anticoagulants: risk of increased effect of oral anticoagulant and risk of bleeding when taking paracetamol at maximum doses (4 g/day) for at least 4 days. Regular monitoring of INR. Possible adaptation of the dosage of the oral anticoagulant during treatment with paracetamol and after its discontinuation.
– Interference with paraclinical examinations:
Taking paracetamol can distort blood sugar levels and blood uric acid levels by certain laboratory methods.

Opium-related:

Contraindicated :

– Certain morphine

Not recommended:

– Alcohol (drink or excipient): alcohol increases the sedative effect of morphine analgesics. Impaired alertness can make driving vehicles and using machines dangerous. Avoid taking alcoholic beverages and medications containing alcohol.

To consider :

– Other morphine analgesics, morphine-like antitussives, true morphine antitussives, barbiturates, benzodiazepines and related drugs: increased risk of respiratory depression, which can be fatal in the event of overdose.
– Other CNS depressants: sedative antidepressants, sedative H1 antihistamines, anxiolytics and hypnotics, neuroleptics, clonidine and related drugs, thalidomide: increase in central depression. Impaired alertness can make driving vehicles and using machines dangerous.

Caffeine-related:

Not recommended:

– Enoxacin: increased plasma concentrations of caffeine which can cause excitations and hallucinations, by decreasing its hepatic metabolism.

Requiring precautions for use:

– Dipyridamole: with dipyridamole by injection: reduction of the vasodilator effect of dipyridamole by caffeine. Interrupt a caffeine-based treatment at least 5 days before myocardial imaging with dipyridamole and avoid the consumption of coffee, tea, chocolate or cola in the 24 hours preceding the test.

To consider :

– Lithium: in the event of abrupt cessation of the consumption of coffee or drugs containing caffeine, risk of an increase in lithemia.
– Stiripentol: possible increase in plasma caffeine concentrations due to decreased hepatic caffeine metabolism.
– Mexiletine, norfloxacin, ciprofloxacin: increased plasma concentrations of caffeine, by decreasing its hepatic metabolism

Pregnancy and breast feeding :

Pregnancy :

If administered at the end of pregnancy, take into account the morphinomimetic properties of this medicinal product and consider neonatal monitoring:
– risk of withdrawal syndrome in the newborn in the event of chronic administration at the end of pregnancy, whatever the dose;
– theoretical risk of respiratory depression in the newborn after high doses, even in brief treatment, before or during delivery.
Therefore, Lamaline should not be used during pregnancy unless clearly necessary.

Feeding with milk :

The passage of this specialty into breast milk is not known. However, due to the presence of morphinomimetic derivatives and the passage of morphine into breast milk, this medication is contraindicated during breastfeeding.

Driving and using machines:

Vehicle drivers and machine users must be careful because there is a risk of drowsiness linked to the presence of opium powder or extract.

Side effects :

Related to paracetamol:

The following side effects have been reported in patients treated with paracetamol alone:
– A few rare hypersensitivity reactions such as anaphylactic shock, angioedema, erythema, urticaria, skin rashes. Their occurrence requires the permanent discontinuation of this drug and related drugs.
– Very rare cases of serious skin reactions. Their occurrence requires the permanent discontinuation of this drug and related drugs.
– Very exceptional cases of thrombocytopenia, leukopenia and neutropenia have been reported.

Related to powder or extract of opium:

The side effects of opium powder (capsule) or extract (suppository) are comparable to those of other opiates. Possibility of :
– Drowsiness, confusion, sedation, excitement, euphoria, dysphoria, nightmares, especially in the elderly, possibly with hallucinations.
– Respiratory depression, bronchospasm .
– Increased intracranial pressure.
– Nausea, vomiting, constipation.
– Acute abdominal pain syndrome of the biliary or pancreatic type occurring particularly in cholecystectomized patients.
– Acute pancreatitis.
– Miosis, dizziness.
– Dysuria and urinary retention.
– Pruritus, urticaria and rash.
– Hyperalgesia: in case of increased sensitivity to pain or worsening of the initial pain after an increase in the dose of the treatment or in case of appearance of abnormal pain, of quality and anatomical location different from initial pain, treatment should be discontinued.
– Drug dependence and withdrawal syndrome (during prolonged use at supra-therapeutic doses).

Caffeine related:

Overdose:

Linked to paracetamol:

The risk of serious poisoning (therapeutic overdose or frequent accidental poisoning), which can lead to severe, potentially fatal liver failure, is particularly high in the elderly, in young children and adolescents, in patients with liver disease , in case of chronic alcoholism, in malnourished patients, in patients weighing less than 50 kg.

Symptoms:

– At an early stage, poisoning may be completely asymptomatic.
– Generally in the first 24 hours appear nausea, vomiting, anorexia, pallor, abdominal pain.
– Within 12 to 48 hours after ingestion, an increase in hepatic transaminases, lactic dehydrogenase, bilirubin and a decrease in prothrombin level may appear.
– An overdose may cause hepatic cytolysis which may lead to hepatocellular insufficiency, metabolic acidosis, encephalopathy which may lead to coma and death.
– Renal toxicity with acute tubular necrosis and renal insufficiency may occur even in the absence of hepatic insufficiency.
– Hyperamylase and more rarely acute pancreatitis have been observed.
– Cardiac arrhythmias have been reported.

Emergency driving:

Immediate transfer to hospital.
Take a tube of blood to make the initial plasma dosage of paracetamol.
Rapid evacuation of the ingested product by gastric lavage.
Treatment of overdose typically includes administering the antidote N-acetylcysteine as early as possible by IV or oral route, if possible before the 10th hour.
Symptomatic treatment.

Related to opium powder (capsule) or extract (suppository):

Symptoms :

– Mild to moderate overdose: euphoria, somnolence, constipation, nausea, vomiting and miosis. Bradycardia or mild hypotension may be present.- Severe overdose: Respiratory depression which may result in apnea, hypoxia, coma, bradycardia, or acute lung injury. Rarely, seizures may occur following the onset of hypoxia. Acute tubular necrosis secondary to rhabdomyolysis and myoglobinuria may occur in patients with prolonged coma or convulsions. These complications can lead to death.

Treatment :

Decontamination:

– An overdose of opiates can be life-threatening. Administration of activated charcoal should be considered promptly after significant oral ingestion, if the patient can protect the airway and does not show severe signs of toxicity. If a patient shows signs of moderate to severe toxicity, activated charcoal should not be administered, due to the risk of inhalation.

Management of Mild to Moderate Poisoning: Patient monitoring may be sufficient.

Management of severe poisoning:

Intensive supportive treatment may be needed to correct respiratory failure and shock. Additionally, the specific antagonist naloxone is used to rapidly reverse severe respiratory depression and coma caused by excessive doses of opioid analgesics. Since naloxone has a shorter duration of action than many opioids, many responder patients should be kept under close observation for signs of relapse and injections should be repeated depending on respiratory rate and severity of the coma. Alternatively, in situations where repeated administration is necessary, for example where a long-acting opioid is the cause or is suspected to be the cause of the symptoms, a continuous intravenous infusion of naloxone can be performed and will be appropriate to the situation. answer. All patients should be monitored for at least 6 hours after the last dose of naloxone. The use of opioid antagonists such as naloxone in people who are physically dependent on opioids can cause withdrawal symptoms.