FONCITRIL 4000 Granules in Sachet-Dose 30Sachet/10g

Citric acid monohydrate

Corresponding quantity of anhydrous citric acid .................................................................... 1,1890 g

Monopotassium citrate anhydrous ................................................................................................. 1,7300 g

Monosodium citrate anhydrous ...................................................................................................... 1,8450 g

For one sachet-dose

One sachet-dose contains 200.6 mg of sodium, 293 mg of potassium and 5.1 g of sucrose.

Excipient(s) with known effect: sucrose, sodium, potassium, sunset yellow S (E110)

• Promotes urinary alkalinisation in the treatment and prevention of uric and cystine lithiasis.
• Used as an alkalinising agent during uricosuric and uricolytic treatments.
• Prevention of metabolic acidosis.

Dosage

FOR ADULTS ONLY

Oral use.

Initial treatment: 3 to 4 sachets per day to be dissolved in a large glass of water in combination with specific medicines, to be taken after meals.

Maintenance treatment: 1 to 2 sachets per day.

This medicinal product is contraindicated:

• in case of hypersensitivity to any of the constituents
• in case of alkalosis

This medicine contains sucrose. Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency.

This medicine contains 5,1 g of sucrose per sachet, which must be taken into account in the daily ration in case of a low-sugar diet or diabetes.

This medicine contains 200 mg of sodium per sachet, which is equivalent to 10 % of the maximum recommended daily dietary intake of sodium by the WHO of 2 g of sodium per adult.

In initial treatment, the maximum daily dose of this medicine is equivalent to 40 % of the maximum recommended daily dietary intake of sodium by the WHO.

In maintenance treatment, the maximum daily dose of this medicine is equivalent to 20 % of the maximum recommended daily dietary intake of sodium by the WHO.

FONCITRIL 4000 is considered high in sodium. To be taken into account in patients following a low-sodium diet.

This medicine contains potassium. This medicine contains 293 mg of potassium per sachet. To be taken into account in patients with renal insufficiency or in patients following a hypokalaemic diet.

This medicine contains an azo agent (E110) and may cause allergic reactions.

Abundant diuresis will be ensured during treatment.

This medication requires monitoring of urinary pH (which must be maintained between 6,5 and 7,4) and of the blood electrolyte panel.

Urinary cytobacteriological examinations will be repeated.

An increase in urinary pH may be achieved with a diet low in protein and rich in vegetables with alkaline residue, notably citrus fruits.

The data available to date do not suggest the existence of clinically significant interactions.

Pregnancy

In clinical practice, no particular malformative or fetotoxic effect has appeared to date. However, the follow-up of pregnancies exposed to this medication is insufficient to exclude any risk.

As a result, use of this medicine should only be considered during pregnancy if necessary.

Breast-feeding

In the absence of kinetic data, this medication must not be administered during breastfeeding.

No effect on the ability to drive vehicles or use machines has been observed.

Gastrointestinal disorders: digestive disorders, notably of the diarrhea type, may occur with high doses of FONCITRIL 4000.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website:www.ansm.sante.fr.

No cases of overdose have been observed. Due to the presence of potassium, monitoring of kalemia and heart rhythm is recommended in case of massive ingestion.

Pharmacotherapeutic class: OTHER UROLOGICAL MEDICATIONS (G: Genito-urinary system and sex hormones)

3 years.

No special precautions for storage.

No special requirements for disposal.