Naftidrofuryl 100mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Naftidrofuryl oxalate

Available from:

DE Pharmaceuticals

ATC code:

C04AX21

INN (International Name):

Naftidrofuryl oxalate

Dosage:

100mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060400

Patient Information leaflet

No. of colours
Colours
Non-Print
Colours
Date:
Time:
Equate CMYK
with
Description
Component Type
Affiliate Item Code
Superceded Affiliate Item Code
TrackWise PR No.
MA No.
Packing Site/Printer
Supplier Code
Sign-offs
Pharma Code
SAP No.
Vendor Job No.
Proof No.
Client Market
Keyline/Drawing No.
Barcode Info
Dimensions
Main Font
Body Text Size
Page Count
05 Nov 2014
1/2
15:39
Naftidrofuryl Oxalate 100mg 84
Leaflet
421851
N/A
421851
N/A
N/A
TBC
TBC
N/A
228707
3
UK
N/A
N/A
1
PMS
xxx
Black
Myriad Pro
170 x 240mm
10pt
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your
doctor or pharmacist or nurse.
-
This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
-
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1. What Naftidrofuryl oxalate is and what
it is used for
2. What you need to know before you take
Naftidrofuryl oxalate
3. How to take Naftidrofuryl oxalate
4. Possible side effects
5. How to store Naftidrofuryl oxalate
6. Contents of the pack and other information
1.
WHAT NAFTIDROFURYL OXALATE IS
AND WHAT IT IS USED FOR
Naftidrofuryl oxalate belongs to a group of
medicines known as 'metabolic activators’.
These are used to treat different types of
blood circulation problems.
Naftidrofuryl oxalate allows your body to make
better use of the oxygen in your blood.
Naftidrofuryl oxalate is used to treat peripheral
vascular disorders (blood circulation problems
outside the brain and heart).
If you have circulation problems, you may be
suffering from any of the following symptoms:
•
Cramp-like pains, usually in your calves
when you walk. (The medical name for
this is intermittent claudication)
•
Cramps in your legs at night
•
Severe pa

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Naftidrofuryl Oxalate 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
Naftidrofuryl oxalate
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 oxalate 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 oxalate 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 oxalate must be discontinued.
4.5.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4