Naftidrofuryl Capsules Bp 100mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NAFTIDROFURYL CAPSULES BP 100mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gelatin capsule contains 100mg Naftidrofuryl oxalate Ph.Eur.
3 PHARMACEUTICAL FORM
Pink hard gelatin capsules (size 2) printed “C” and “NL” in black.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
1) Peripheral vascular disorders (intermittent claudication, night cramps, rest pain, incipient gangrene, trophic ulcers, Raynaud’s syndrome, diabetic arteriopathy and acrocyanosis).
2) Cerebral vascular disorders (cerebral insufficiency and cerebral atherosclerosis, particularly where these manifest themselves as mental deterioration and confusion in the elderly).
4.2 Posology and method of administration
Posology
The capsules should be administered with a sufficient amount of water (one glass) during or after food.
Adults and the elderly:
Peripheral vasular disorders: One or two 100mg capsules three times daily for a minimum of three months, or at the discretion of the physician.
In patients with renal impairment a dose adjustment may be considered.
Cerebral vasular disorders: One 100mg capsule three times daily for a minimum of three months, or at the discretion of the physician.
Method of Administration For oral use (swallowing).
4.3 Contraindications
Known hypersensitivity to naftidrofuryl oxalate or other ingredients in the capsule.
Patients with a history of hyperoxaluria or recurrent calcium-containing stones.
Contains soya lecithin. Purified soya oil may contain peanut protein. Therefore, Naftidrofuryl capsules are contraindicated in patients who are allergic to peanut or soya.
4.4 Special warnings and precautions for use
Should be used with caution in patients with renal or hepatic disorders as the drug is metabolised in the liver and excreted mainly in the urine.
A sufficient amount of liquid should be taken during treatment to maintain an adequate level of diuresis.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Pregnancy and lactation
There is no, or inadequate evidence of safety of naftidrofuryl oxalate in human pregnancy, but it has been in wide use for many years without apparent ill consequence, animal studies having shown no hazard. If drug therapy is needed in pregnancy, the benefits should be weighed against the potential risks.
There is no information available on the secretion of this drug in breast milk, and its use is therefore best avoided.
4.7 Effects on ability to drive and use machines
As Naftidrofuryl can cause dizziness patient should make sure they are not affected before driving or operating machinery.
4.8 Undesirable effects
Naftidrofuryl is normally well tolerated in the dosage recommended. Occasionally nausea, epigastric pain, diarrhoea and rashes have been noted. Rarely has hepatitis and hepatic failure been reported.
Central Nervous System symptoms of dizziness, headache, agitation and sleep disorders have been reported.
Very rarely the presence of calcium oxalate kidney stones has been reported. 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
4.9 Overdose
Depression of cardiac conduction and convulsions may occur. 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 with diazepam.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC code: C04A X 21
Naftidrofuryl oxalate is a powerful vasodilator agent with an antagonist effect on 5-HT2 receptors of the smooth muscle cells. The vasodilator effect, which occurs in both the cerebral and peripheral circulation, is probably the main action. However, the drug has also been shown to activate intracellular aerobic metabolism as demonstrated by a reduction in the level of lactic acid level and an increased level of ATP. It is claimed that this action protects cells against the metabolic effects of ischaemia.
5.2 Pharmacokinetic properties
Peak plasma levels are attained at 0.5-0.75 hours after oral dose. Some 24% of the drug (range 17-32%) is absorbed from the gastrointestinal tract. There is some pre-systemic metabolism. The plasma half-life is approximately 1 hour (range 0.8-1.6 hours). The drug penetrates brain and other tissues. It is, however, 80% bound to albumin. Cumulation does not occur at a dose level of 200mg three times daily.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6.1 List of excipients
The capsule contains: maize starch, microcrystalline cellulose (E460), sodium starch glycollate, colloidal silica, stearic acid, magnesium stearate, water.
The capsule shell contains: erythrosine (El 27), titanium dioxide (El 71), water, gelatin.
The printing ink contains: IMS 740P, shellac (E904), iron oxide black (E172), N-Butyl alcohol, soya lecithin MC thin (E3 22), antifoam DC 1510, water.
6.2 Incompatibilities
None known
6.3 Shelf life
Shelf-life
Two years from the date of manufacture.
Shelf-life after dilution/reconstitution Not applicable.
Shelf-life after first opening Not applicable.
6.4 Special precautions for storage
Store below 25°C in a dry place.
Protect from light.
6.5 Nature and contents of container
The product containers are rigid injection moulded polypropylene containers with snap-on polyethylene lids.
The product may also be supplied in blister packs in cartons:
a) Carton: Printed carton manufactured from white folding box board.
b) Blister pack: (i) 250pm white rigid PVC/PVdC. (ii) Surface printed 20pm hard temper aluminium foil with 5-7g/M2 PVC and PVdC compatible heat seal lacquer on the reverse side.
Pack sizes
Al/PVC/PVDC: 28s, 30s, 56s, 60s, 84s, 90s, l00s, 112s, 120s, 168s, 180s
PP Tablet Container: 100s, 250s, 500s, 1000s
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Actavis UK Limited (Trading style: Actavis)
Whiddon Valley BARNSTAPLE North Devon EX32 8NS
8 MARKETING AUTHORISATION NUMBER(S)
PL 00142/0429
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22/12/1998 / 30/01/2004
10 DATE OF REVISION OF THE TEXT
31/03/2015