This information is intended for use by health professionals

1. Name of the medicinal product

Praxilene 100mg Capsules

2. Qualitative and quantitative composition

Each capsule contains 100mg naftidrofuryl oxalate equivalent to 81.0 mg naftidrofuryl and 19.0 mg oxalate.

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Capsule

4. Clinical particulars
4.1 Therapeutic indications

Peripheral vascular disorders - intermittent claudication, night cramps, rest pain, incipient gangrene, trophic ulcers, Raynaud's Syndrome, diabetic arteriopathy and acrocyanosis.

4.2 Posology and method of administration

Posology:

One or two capsules three times daily for a minimum of three months, or at the discretion of the physician.

Method of administration:

For oral administration. The capsules should be swallowed whole during meals with a sufficient amount of water (minimum) of one glass.

Paediatric population

The safety and efficacy of Praxilene in the paediatric population have not been established. This drug is not indicated for use in children.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

Patients with a history of hyperoxaluria or recurrent calcium-containing kidney stones.

4.4 Special warnings and precautions for use

The administration of Praxilene may modify the composition of the urine, promoting the formation of calcium oxalate kidney stones (the oxalate content is 19 mg per 100 mg of active ingredient).

A sufficient amount of liquid should be taken during treatment to maintain an adequate level of diuresis.

The administration of Praxilene without liquid before going to bed may cause local oesophagitis. Therefore, it is essential to always take the capsule with a sufficient amount of water.

Cases of liver damage have been reported. In the event of symptoms suggesting liver damage, Praxilene must be discontinued.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

Pregnancy

In the absence of any relevant clinical data, the use of Praxilene is not advisable during pregnancy.

Breast-Feeding

In the absence of specific data concerning the excretion of the drug in human milk, Praxilene should not be used by breast-feeding women.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

According to information collected during clinical trials and spontaneous reports since marketing authorisation, the following undesirable effects may occur under treatment with naftidrofuryl.

The following definitions apply to the frequency terminology used hereafter:

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

frequency not known: cannot be estimated from the available data

Gastro-intestinal disorders:

Uncommon: Diarrhoea, nausea, vomiting and epigastric pain.

Frequency not known: In some patients who took the medicinal product without liquid before going to bed, the capsule being stuck in the throat led to local oesophagitis.

Renal and urinary disorders:

Very rare: Calcium oxalate kidney stones (see section 4.4).

Skin and subcutaneous tissue disorders:

Uncommon: Skin rash.

Hepatobiliary disorders:

Rare: Liver damage

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 at: www.mhra.gov.uk/yellowcard

4.9 Overdose

Signs and symptoms: Depression of cardiac conduction and convulsions may occur.

Treatment: The stomach should be emptied by gastric lavage and emesis. Activated charcoal may be employed if necessary. Cardiovascular function and respiration should be monitored and, in severe cases, electrical pacemaking or the use of isoprenaline should be considered. Convulsions may be managed by diazepam.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: peripheral vasodilator, ATC code: C04AX21.

Naftidrofuryl oxalate has been shown to exert a direct effect on intracellular metabolism. Thus it has been shown in man and animals that it produces an increase of ATP levels and a decrease of lactic acid levels in ischaemic conditions, evidence for an enhancement of cellular oxidative capacity.

Furthermore, naftidrofuryl oxalate is a powerful spasmolytic agent.

5.2 Pharmacokinetic properties

Naftidrofuryl oxalate is well absorbed when given orally. Peak plasma levels occur about 30 minutes after dosing and the half life is about an hour, although inter subject variation is relatively high. Accumulation does not occur at a dose level of 200mg three times daily.

The drug becomes extensively bound to plasma proteins and is excreted principally via the urine, all in the form of metabolites.

5.3 Preclinical safety data

No toxic effects were seen in animal studies which provide additional information to that obtained in man. In repeated dose studies the no effect level was 25mg/kg/day or greater. There was no evidence of effects on reproduction below doses which caused maternal toxicity.

6. Pharmaceutical particulars
6.1 List of excipients

Talc

Magnesium Stearate

Purified Water*

Denatured Ethanol*

Capsule Shells:

Erythrosine (E127)

Titanium Dioxide (E171)

Gelatine

Printing ink:

Black iron oxide (E172)

*Not present in final product

6.2 Incompatibilities

None known.

6.3 Shelf life

24 months.

6.4 Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from light and moisture.

6.5 Nature and contents of container

Pack size 10 (medical sample), 21 and 84 capsules:-

Cardboard carton containing blister strips comprising heat-sealable PVC (250μm)/PVDC 120 g/m2 and aluminium foil (30μm).

Pack size 100:

Polyethylene securitainers with tamper evident closures.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

7. Marketing authorisation holder

Merck Serono Ltd

5 New Square

Bedfont Lakes Business Park

Feltham

Middlesex

TW14 8HA

UK

8. Marketing authorisation number(s)

PL 11648/0064

9. Date of first authorisation/renewal of the authorisation

24 March 2009

10. Date of revision of the text

07/2020