RISOPET Film coated tablet Ref.[115165] Active ingredients: Ethambutol Isoniazid Pyrazinamide Rifampicin

The recommended treatment dosages, based on the patient’s body weight, given daily for the 2 month initial-phase treatment in adults and children older than 13 years of age are as follows:

• 30-37 kg 2 tablets
• 38-54 kg 3 tablets
• 55-70 kg 4 tablets
• 71 kg and over 5 tablets

Special populations

Use in patients with body weight less than 30 kg

RISOPET is not a suitable dosage form for use in the treatment of patients with a body weight of less than 30 kg (see section 4.4).

Elderly

No special dosage regimen is necessary, but concurrent hepatic and/or renal insufficiency should be taken into account. Supplementation of pyridoxine (vitamin B₆) may be useful.

Hepatic insufficiency

RISOPET should be used with caution and under strict medical supervision in impaired liver function (see section 4.4) and is contraindicated in patients with a history of medicine induced hepatitis as well as in patients with acute liver diseases (see section 4.3).

Renal insufficiency

RISOPET should be used with caution in patients with moderate renal impairment (creatinine clearance 30-60 ml/min, see section 4.4). RISOPET is contraindicated in patients with severe renal impairment (creatinine clearance <30 ml/min, see section 4.3).

Paediatric population

RISOPET is not a suitable dosage form for use in the treatment of children with a body weight of less than 30 kg and is not recommended in children under 13 years of age because of risk of aspiration and possible difficulties in evaluation of changes of visual acuity (see sections 4.3 and 4.4).

Method of administration

RISOPET tablets should be taken with a full glass of water 1 hour before, or 2 hours after a meal. If RISOPET tablets result in gastrointestinal irritation, it may be taken with food. If aluminium-containing antacids are taken, RISOPET tablets should be administered one hour after the antacid tablet dose.

Missed dose

Doctors should advise patients who forget to take RISOPET to take a dose as soon as possible and then continue with the normal dose. Patients should not take a double dose to compensate for the missed dose.

Signs and symptoms

The symptoms of an overdose with RISOPET are unknown, but may include diarrhoea, nausea, vomiting, abdominal cramps, anorexia, reddish-orange discolouration of secretions, myopathy, muscle weakness, oedema, peripheral neuropathy, constipation, dry mouth, arthralgia and hyperuricaemia, jaundice, rash and fever, elevated liver enzymes with the clinical signs of hepatitis, visual impairment.

Rifampicin

Nausea, vomiting, abdominal pain, pruritus, headache and increasing lethargy will probably occur within a short time after acute ingestion; unconsciousness may occur when there is severe hepatic disease. Transient increases in liver enzymes and/or bilirubin may occur.

Brownish-red or orange discolouration of the skin, urine, sweat, saliva, tears and faeces will occur and its intensity is proportional to the amount ingested. Facial or periorbital oedema has also been reported in paediatric patients. Hypotension, sinus tachycardia, ventricular dysrhythmias, seizures and cardiac arrest were reported in some fatal cases.

Nonfatal acute overdoses in adults have been reported with doses ranging from 9 g to 12 g rifampicin. Fatal acute overdoses in adults have been reported with doses ranging from 14 g to 60 g. Non-fatal overdoses in paediatric patients ages 1 to 4 years old of 100 mg/kg for one or two doses have been reported.

Isoniazid

Isoniazid overdosage produces signs and symptoms within 30 minutes to 3 hours after ingestion. Nausea, vomiting, dizziness, slurring of speech, blurring of vision and visual hallucinations are among the early manifestations. With marked overdosage, respiratory distress and CNS depression, progressing rapidly from stupor to profound coma are to be expected, along with severe, intractable seizures. Severe metabolic acidosis, acetonuria and hyperglycaemia are typical laboratory findings.

Pyrazinamide

There is limited information related to pyrazinamide overdosage. Liver toxicity and hyperuricaemia may occur with overdosage.

h3.Ethambutol

There is limited information related to ethambutol overdose. Loss of appetite, gastro-intestinal disturbances, fever, headache, dizziness, confusion and hallucinations may occur.

h3.Management of overdose

Symptomatic and supportive therapy is required.

Intensive support measures should be instituted, including airway patency and individual symptoms treated as they arise.

2 years.

Store in a cool place, at or below 25°C in a well closed container.

Protect from light.

Keep the blisters in the outer carton until required for use.

Amber PVC/ACLAR & ALU/ALU blister packs of 28, 56, 84 and 112 tablets, packed into an outer cardboard carton.

No special requirements.