RANCLAV Film-coated tablet Ref.[115275] Active ingredients: Amoxicillin Clavulanic acid

Posology

Tablets should be taken immediately before a meal.

During the administration of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to prevent any possibility of amoxicillin crystalluria.

Dosages

General Information: For infections caused by amoxicillin sensitive organisms the dosage is that approved for amoxicillin as the clavulanic acid component does not contribute to the therapeutic effect.

Adults

For severe infections and infection of the respiratory tract, the adult dose for RANCLAV 1 g is one RANCLAV 1 g tablet every 12 hours at the start of a meal. Since Ranclav 375, 625 and 1 g tablets contain the same amount of clavulanic acid (125 g as the potassium salt), two Ranclav 375 tablets are not equivalent to one Ranclav 625 tablet and two Ranclav 625 tablets are not equivalent to one Ranclav 1 g. Therefore two Ranclav 375 tablets should not be substituted for one Ranclav 625 tablet or two Ranclav 625 tablets for one Ranclav 1 g tablet for the treatment of more severe infections.

Special populations

Impaired renal function

Both amoxicillin and clavulanic acid are excreted by the kidneys and the serum half-life of each increases in patients with renal failure. Therefore, the dose may need to be reduced or the interval extended. Dosage adjustments are based on the maximum recommended level of amoxicillin. The following schedule is proposed.

RANCLAV 1 g should not be used in patients with a glomerular filtration rate of <30 ml/minute.

Haemodialysis decreases serum concentrations of both amoxicillin and clavulanic acid and an additional dose should be administered at the end of dialysis.

Dosage guide:

Adults:

Adults:

Paediatric population

Other pharmaceutical forms/strengths may be more appropriate for administration to this population.

Method of administration

Oral use.

Tablets should be taken immediately before a meal.

Symptoms and signs

Overdosage with amoxicillin is usually asymptomatic. However, gastro-intestinal effects such as nausea, vomiting and diarrhoea may be evident.

Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see section 4.4).

Management

Symptoms of water and electrolyte imbalance should be treated symptomatically. Adequate fluid intake and urinary output must be maintained to minimize the possibility of crystalluria. In patients with bladder catheters, a regular check of patency should be maintained (see sections 4.8 and 4.9).

Amoxicillin may be removed from the circulation by haemodialysis. The molecular weight, degree of protein binding and pharmacokinetic profile of clavulanic acid together with information from a single patient with renal insufficiency all suggest that this compound may also be removed by haemodialysis.

24 months.

Store below 25°C in the original package, protected from moisture.

Carton contains 10 tablets packed in a PVC/PVdC blister pack within a 4-layered laminated bag containing a desiccant sachet.

PVC/PVdC blister pack in a 4-layered laminated bag:

Clear PVC film coated with PVdC on the inner side with the lidding of hard tempered, aluminium foil coated with heat seal lacquer on the inner side.

One blister to be put into a 4-layered laminated bag containing a desiccant sachet.

The structure of the four layered laminated bag is as follows: Polyester film/ Aluminium foil/Polyester film/Polyethylene.

No special requirements.