Summary of Product Characteristics (SmPC) - Naftidrofuryl 100 mg capsules
1 NAME OF THE MEDICINAL PRODUCT
Naftidrofuryl 100mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100mg of naftidrofuryl hydrogen 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
Size ‘2’ hard gelatin capsules, with pink opaque body and pink opaque cap, printed with A on cap and 14 on body, containing white to off white granular powder.
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 Naftidrofuryl 100mg Capsules 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 Naftidrofuryl 100mg Capsules 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 Naftidrofuryl 100mg Capsules 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, Naftidrofuryl 100mg Capsules must be discontinued.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
Pregnancy
In the absence of any relevant clinical data, the use of Naftidrofuryl 100mg Capsules is not advisable during pregnancy.
Breast-feeding
In the absence of specific data concerning the excretion of the drug in human milk,
Naftidrofuryl 100mg Capsules 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 hydrogen 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 hydrogen oxalate is a powerful spasmolytic agent.
5.2 Pharmacokinetic properties
Naftidrofuryl hydrogen 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 intersubject 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
microcrystalline cellulose
purified talc
stearic acid
povidone
silicified microcrystalline cellulose
colloidal anhydrous silica
magnesium stearate
Capsule shell:
titanium dioxide (E 171),
iron oxide red (E 172)
gelatin
Printing ink:
shellac (E 904),
propylene glycol (E 1520),
strong ammonia solution (E527),
black iron oxide (E 172)
potassium hydroxide (E 525).
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store in the original package.
6.5 Nature and contents of container
Naftidrofuryl 100 mg Capsules are packaged in blister packs composed of PVC/PVDC (250 micron/120gsm) clear film and aluminium foil coated with HSL (30 micron).
They are available in packs of 21, 84 or 100 Capsules.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements for disposal.
7 MARKETING AUTHORISATION HOLDER
Noumed Life Sciences Limited,
Noumed House, Shoppenhangers Road,
Maidenhead, Berkshire, SL6 2RB, United Kingdom.
8 MARKETING AUTHORISATION NUMBER(S)
PL 44041/0232
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
11/09/2024
10 DATE OF REVISION OF THE TEXT
11/09/2024