LEVOCARNITINE PAEDIATRIC 30% Oral solution Ref.[6409] Active ingredients: L-carnitine

While improving glucose utilisation, the administration of levocarnitine to diabetic patients receiving either insulin or hypoglycaemic oral treatment may result in hypoglycaemia. Plasma glucose levels in these subjects must be monitored regularly in order to adjust the hypoglycaemic treatment immediately, if required.

The safety and efficacy of oral levocarnitine has not been evaluated in patients with renal insufficiency. Chronic administration of high doses of oral levocarnitine in patients with severely compromised renal function or in end stage renal disease (ESRD) patients on dialysis may result in an accumulation of the potentially toxic metabolites, trimethylamine (TMA) and trimethylamine-N-oxide (TMAO), since these metabolites are usually excreted in the urine. This situation has not been observed following intravenous administration of levocarnitine.

There have been very rare reports of International Normalised Ratio (INR) increased in patients treated concomitantly with levocarnitine and coumarinic drugs. See section 4.5 ‘Interactions’ and Section 4.8 ‘Undesirable Effects’.

Excipients

The 30% oral solution contains sucrose and sorbitol. This must be considered when treating diabetics or patients who are following diets to reduce calorie intake. Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

The 30% oral solution contains Sodium propyl hydroxybenzoate (E217) and Sodium methyl hydroxybenzoate (E219). It may cause hypersensitivity (anaphylactoid) reactions (possibly delayed).

There have been very rare reports of International Normalised Ratio (INR) increased in patients treated concomitantly with levocarnitine and coumarinic drugs (see Section 4.4 ‘Special Warnings and Precautions’ and Section 4.8 ‘Undesirable Effects’). INR – or other appropriate test of coagulation – should be checked weekly until they become stable, and monthly thereafter, in patients taking such anticoagulants together with levocarnitine.

Pregnancy

Reproductive studies were performed in rats and rabbits. There was no evidence of a teratogenic effect in either species. In the rabbit but not in the rat there was a statistically insignificant greater number of post implantation losses at the highest dose tested (600mg/kg daily) as compared with control animals. The significance of these findings in man is unknown. There is no experience of use in pregnant patients with primary systemic carnitine deficiency.

Taking into account the serious consequences in a pregnant woman who has primary systemic carnitine deficiency stopping treatment, the risk to the mother of discontinuing treatment seems greater than the theoretical risk to the foetus if treatment is continued.

Breast-feeding

Levocarnitine is a normal component of human milk. Use of levocarnitine supplementation in nursing mothers has not been studied.

None known.

Adverse reactions from any source are listed in the table below by MedRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency. Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness. In addition the corresponding frequency category for each adverse drug reaction is based on the following conventions: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000).

Gastrointestinal disorders

Very rare: Vomiting, Nausea, Diarrhoea, Abdominal cramp

General disorders and administration site conditions

Very rare: Body odour

Investigations

Very rare: International Normalised Ratio increased*

* There have been very rare reports of International Normalised Ratio (INR) increased in patients treated concomitantly with levocarnitine and coumarinic drugs (acenocumarol and warfarin) – see Section 4.4 ‘Special Warnings’ and Section 4.5 ‘Interactions’.

Decreasing the dosage often diminishes or eliminates drug related patient body odour or gastro-intestinal symptoms when present. Tolerance should be monitored very closely during the first week of administration and after any dosage increase.

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 Yellow Card Scheme – Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

None known.