NAFTIDROFURYL Capsules (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
NAFTIDROFURYL CAPSULES BP 100mg.
Qualitative and quantitative composition
Each hard gelatin capsule contains 100mg Naftidrofuryl oxalate PhEur.
Pharmaceutical form
Pink hard gelatin capsules. Pink hard gelatin capsules (size 2) printed C and NL in black.
Therapeutic indications
Peripheral vascular disorders (intermittent claudication, night cramps, rest pain, incipient gangrene, trophic ulcers, Raynauds syndrome, diabetic arteriopathy and acrocyanosis).
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 ...
Contraindications
Known hypersensitivity to naftidrofuryl oxalate or other ingredients in the capsule. Patients with a history of hyperoxaluria or recurrent calcium-containing stones.
Special warnings and precautions for use
The administration of Naftidrofuryl may modify the composition of the urine, promoting the formation of calcium oxalate kidney stones (the oxalate content is 19mg per 100mg of active ingredient). Should ...
Interaction with other medicinal products and other forms of interaction
None known.
Pregnancy and lactation
Pregnancy In the absence of any relevant clinical data, the use of Naftidrofuryl is not advisable during pregnancy. Lactation In the absence of specific data concerning the excretion of the drug in human ...
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.
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 ...
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: peripheral vasodilator ATC code: C04AX21 Naftidrofuryl oxalate is a powerful vasodilator agent with an antagonist effect on 5-HT<sub>2</sub> receptors of the smooth muscle cells. ...
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 ...
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 ...
List of excipients
The capsule contains: Maize starch Microcrystalline cellulose (E460) Sodium starch glycollate Colloidal silica Stearic acid Magnesium stearate The capsule shell contains: Erythrosine (E127) Titanium dioxide ...
Incompatibilities
None known.
Shelf life
Two years from the date of manufacture. Shelf-life after dilution/reconstitution: Not applicable. Shelf-life after first opening: Not applicable.
Special precautions for storage
Store below 25°C in a dry place. Protect from light.
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 ...
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
Marketing authorization number(s)
PL 0142/0429
Date of first authorization / renewal of the authorization
22.12.98
Date of revision of the text
19/08/2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
