Fampridine Rowa 10 mg prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fampridine

Available from:

Rowa Pharmaceuticals Limited

ATC code:

N07XX07

INN (International Name):

Fampridine

Pharmaceutical form:

Prolonged-release tablet

Therapeutic area:

fampridine

Authorization status:

Not marketed

Authorization date:

2022-07-01

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER FAMPRIDINE ROWA 10MG PROLONGED-RELEASE TABLETS
fampridine
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.
•
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 Fampridine Rowa is and what it is used for
2.
What you need to know before you take Fampridine Rowa
3.
How to take Fampridine Rowa
4.
Possible side effects
5.
How to store Fampridine Rowa
6.
Contents of the pack and other information
1. WHAT FAMPRIDINE ROWA IS AND WHAT IT IS USED FOR
Fampridine Rowa contains the active substance fampridine which belongs
to a group of medicines
called
potassium channel blockers. They work by stopping potassium leaving
the nerve cells which
have been damaged by MS. This medicine is thought to work by letting
signals pass down the nerve
more
normally, which allows you to walk better.
Fampridine Rowa is a medicine used to improve walking in adults (18
years and over) with Multiple
Sclerosis (MS) related walking disability. In multiple sclerosis,
inflammation destroys the protective
sheath
around the nerves leading to muscle weakness, muscle stiffness and
difficulty walking.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FAMPRIDINE ROWA
DO NOT TAKE FAMPRIDINE ROWA
–
if you are
ALLERGIC
to fampridine or any of the other ingredients of this medicine (listed
in
section 6)
–
if you have a seizure or have ever had a
SEIZURE
(also referred to as a fit or convulsion)
–
if you have
KIDNEY PROBLEMS
–
if you are taking a medicine called cimetidine
–
if you are
TAKING ANY OTHER MEDICINE CONTAINING FAMPRIDINE
. This m

Summary of Product characteristics

Health Products Regulatory Authority
25 July 2023
CRN00D8MF
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fampridine Rowa 10 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 10 mg of fampridine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
White to off-white colored, approx. 13 mm x 8 mm, oval shaped film
coated tablets debossed with "L10" on one side and plain
on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fampridine Rowa is indicated for the improvement of walking in adult
patients with multiple sclerosis with walking disability
(EDSS 4-7).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Fampridine Rowa is restricted to prescription and
supervision by physicians experienced in the management of
MS.
Posology
The recommended dose is one 10 mg tablet, twice daily, taken 12 hours
apart (one tablet in the morning and one tablet in the
evening). Fampridine Rowa should not be administered more frequently
or at higher doses than recommended (see section
4.4). The tablets should be taken without food
(see section 5.2).
Starting and Evaluating Fampridine Rowa Treatment

Initial prescription should be limited to two to four weeks of therapy
as clinical benefits should generally be
identified within two to four weeks after starting Fampridine Rowa

An assessment of walking ability, e.g. the Timed 25 Foot Walk (T25FW)
or Twelve Item Multiple Sclerosis Walking
Scale (MSWS-12), is recommended to evaluate improvement within two to
four weeks. If no improvement is
observed, Fampridine Rowa should be discontinued

Fampridine Rowa should be discontinued if benefit is not reported by
patients.
Re-Evaluating Fampridine Rowa Treatment
If decline in walking ability is observed, physicians should consider
an interruption to treatment in order to reassess the
benefits of Fampridine Rowa (see above). The re-evaluation should
include withdrawal of Fampridi