Fampridine Accord

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 

 
 

 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Fampridine Accord 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, oval shaped, biconvex, bevel-edged, film coated tablets, approximately 
13.1 x 8.1 mm in dimensions, debossed with ‘FH6’ on one side and plain on other side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Fampridine Accord 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 Accord 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 Accord  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 Accord  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 Accord.   
• 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 Accord should be 
discontinued 

• Fampridine Accord should be discontinued if benefit is not reported by patients. 
 
Re-Evaluating Fampridine Accord Treatment 
 
If decline in walking ability is observed, physicians should consider an interruption to treatment in 
order to reassess the benefits of Fampridine Accord (see above). The re-evaluation should include 



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withdrawal of Fampridine Accord and performing an assessment of walking ability. Fampridine 
Accord should be discontinued if patients no longer receive walking benefit.   
 
Missed dose 
The usual dosing regimen should always be followed. A double dose should not be taken if a dose is 
missed. 
 
Elderly Renal function should be checked in  the elderly before starting treatment with Fampridine 
Accord. Monitoring renal function to detect any renal impairment is recommended in  the elderly (see 
section 4.4).  
 
Renal impairment 
Fampridine Accord  is contraindicated in patients with moderate and severe renal impairment 
(creatinine clearance <50 ml/min) (see sections 4.3 and 4.4). 
 
Hepatic impairment 
No dose adjustment is required for patients with hepatic impairment. 
 
Paediatric population 
The safety and efficacy of fampridine  in children aged 0 to 18 years have not been established. No 
data are available. 
 
Method of administration 
 
Fampridine Accord is for oral use. 
 
The tablet must be swallowed whole. It must not be divided, crushed, dissolved, sucked or chewed. 
 
4.3 Contraindications 
 
Hypersensitivity to fampridine or to any of the excipients listed in section 6.1. 
 
Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine). 
 
Patients with prior history or current presentation of seizure. 
 
Patients with moderate or severe renal impairment (creatinine clearance <50 ml/min). 
 
Concomitant use of Fampridine Accord with medicinal products that are inhibitors of Organic Cation 
Transporter 2 (OCT2) for example, cimetidine. 
 
4.4 Special warnings and precautions for use 
 
Seizure risk 
 
Treatment with fampridine increases seizure risk (see section 4.8). 
 
Fampridine Accord should be administered with caution in the presence of any factors which may 
lower seizure threshold. 
 
Fampridine Accord  should be discontinued in patients who experience a seizure while on treatment. 
 
Renal impairment 
 
Fampridine   is primarily excreted unchanged by the kidneys. Patients with renal impairment have 
higher plasma concentrations which are associated with increased adverse reactions, in particular 



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neurological effects. Determining renal function before treatment and its regular monitoring during 
treatment is recommended in all patients (particularly in  the elderly    in whom renal function might 
be reduced). Creatinine clearance can be estimated using the Cockroft-Gault formula. 
 
Caution is required when Fampridine Accord  is prescribed in patients with mild renal impairment or 
in patients using medicinal products that are substrates of OCT2 for example, carvedilol, propranolol 
and metformin. 
 
Hypersensitivity Reactions 
 
In post-marketing experience, serious hypersensitivity reactions (including anaphylactic reaction) 
have been reported, the majority of these cases occurred within the first week of treatment. Particular 
attention should be given to patients with a previous history of allergic reactions. If an anaphylactic or 
other serious allergic reaction occurs, Fampridine Accord should be discontinued and not restarted. 
 
Other warnings and precautions 
 
Fampridine Accord  should be administered with caution to patients with cardiovascular symptoms of 
rhythm and sinoatrial or atrioventricular conduction cardiac disorders (these effects are seen in 
overdose). There is limited safety information in these patients. 
 
The increased incidence of dizziness and balance disorder seen with fampridine may result in an 
increased risk of falls. Therefore, patients should use walking aids as needed. 
 
In clinical studies low white blood cell counts were seen in 2.1% of fampridine patients versus 1.9% 
of patients on placebo. Infections were seen in the clinical studies (see section 4.8) and increased 
infection rate and impairment of the immune response cannot be excluded.  
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Interaction studies have only been performed in adults. 
 
Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine) is 
contraindicated (see section 4.3). 
 
Fampridine is eliminated mainly via the kidneys with active renal secretion accounting for about 60% 
(see section 5.2). OCT2 is the transporter responsible for the active secretion of fampridine. Thus, the 
concomitant use of fampridine with medicinal products that are inhibitors of OCT2 for example, 
cimetidine are contraindicated (see section 4.3) and concomitant use of fampridine with medicinal 
products that are substrates of OCT2 for example, carvedilol, propranolol and metformin is cautioned 
(see section 4.4.) 
 
Interferon: fampridine has been administered concomitantly with interferon-beta and no 
pharmacokinetic medicinal product interactions were observed. 
 
Baclofen: fampridine has been administered concomitantly with baclofen and no pharmacokinetic 
medicinal product interactions were observed. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are limited amount of data from the use of fampridine in pregnant women. 
 
Animal studies have shown reproductive toxicity (see section 5.3). As a precautionary measure it is 
preferable to avoid the use of Fampridine Accord in pregnancy. 



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Breast-feeding 
 
It is unknown whether fampridine is excreted in human or animal milk. Fampridine Accord is not 
recommended during breast-feeding. 
 
Fertility 
 
In animal studies no effects on fertility were seen. 
 
4.7 Effects on ability to drive and use machines 
 
Fampridine Accord has a moderate influence on the ability to drive and use machines because 
fampridine can cause dizziness.   
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The safety of fampridine has been evaluated in randomised controlled clinical studies, in open label 
long term studies and in the post marketing setting. 
 
Adverse reactions identified are mostly neurological and include seizure, insomnia, anxiety, balance 
disorder, dizziness, paraesthesia, tremor, headache and asthenia. This is consistent with fampridine’s 
pharmacological activity. The highest incidence of adverse reactions identified from placebo-
controlled trials in multiple sclerosis patients with fampridine given at the recommended dose, are 
reported as urinary tract infection (in approximately 12% of patients).  
 
Tabulated list of adverse reactions 
 
Adverse reactions are presented below by system organ class and absolute frequency. Frequencies are 
defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥1/1,000 to <1/100); 
rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the 
available data). 
 
Within each frequency grouping, adverse reactions are presented in the order of decreasing 
seriousness. 
 



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MedDRA SOC Adverse Reaction Frequency category 
Infections and infestations Urinary tract infection1 

Influenza1 
Nasopharyngitis1 
Viral infection1 

Very Common 
Common 
Common 
Common 

Immune system disorders Anaphylaxis 
Angioedema 
Hypersensitivity 

Uncommon 
Uncommon 
Uncommon 

Psychiatric disorders Insomnia 
Anxiety 

Common 
Common 

Nervous system disorders Dizziness 
Headache 
Balance disorder 
Vertigo 
Paraesthesia 
Tremor 
Seizure3 
Exacerbation of trigeminal 
neuralgia 

Common 
Common 
Common 
Common 
Common 
Common 
Uncommon 
Uncommon 
 

Cardiac disorders Palpitations Common 
 Tachycardia Uncommon 
Vascular disorders Hypotension2 Uncommon 
Respiratory, thoracic and 
mediastinal disorders 

Dyspnoea Pharyngolaryngeal 
pain 

Common 
Common 

Gastrointestinal disorders Nausea 
Vomiting 
Constipation 
Dyspepsia  

Common 
Common 
Common 
Common 

Skin and subcutaneous tissue 
disorders 

Rash 
Urticaria 

Uncommon 
Uncommon 

Musculoskeletal and connective 
tissue disorders 

Back pain Common  

General disorders and 
administration site conditions 

Asthenia 
Chest discomfort2 

Common 
Uncommon 

1 See section 4.4 
2 These symptoms were observed in the context of hypersensitivity 
3 See sections 4.3 and 4.4 
 
Description of selected adverse reactions 
 
Hypersensitivity 
 
In post-marketing experience, there have been reports of hypersensitivity reactions (including 
anaphylaxis) which have occurred with one or more of the following: dyspnoea, chest discomfort, 
hypotension, angioedema, rash and urticaria. For further information on hypersensitivity reactions, 
please refer to sections 4.3 and 4.4. 
 
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 national reporting system 
listed in Appendix V. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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4.9 Overdose 
 
Symptoms 
 
Acute symptoms of overdose with fampridine were consistent with central nervous system excitation 
and included confusion, tremulousness, diaphoresis, seizure, and amnesia. 
 
Central nervous system side effects at high doses of 4-aminopyridine include dizziness, confusion, 
seizures, status epilepticus, involuntary and choreoathetoid movements. Other side effects at high 
doses include cases of cardiac arrhythmias (for example, supraventricular tachycardia and 
bradycardia) and ventricular tachycardia as a consequence of potential QT prolongation. Reports of 
hypertension have also been received. 
 
Management 
 
Patients who overdose should be provided supportive care. Repeated seizure activity should be treated 
with benzodiazepine, phenytoin, or other appropriate acute anti-seizure therapy. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Other nervous system drugs, ATC code: N07XX07. 
 
Pharmacodynamic effects 
 
Fampridine is a potassium channel blocker. By blocking potassium channels, fampridine  reduces the 
leakage of ionic current through these channels, thereby prolonging repolarization and thus enhancing 
action potential formation in demyelinated axons and neurological function. Presumably, by 
enhancing action potential formation, more impulses might be conducted in the central nervous 
system. 
 
Clinical efficacy and safety 
 
Three phase III, randomised, double-blind, placebo controlled confirmatory studies, (MS-F203 and 
MS-F204 and 218MS305) have been performed. The proportion of responders was independent of 
concomitant immunomodulatory therapy (including interferons, glatiramer acetate, fingolimod and 
natalizumab). The fampridine dose was 10 mg BID. 
 
Studies MS-F203 and MS-F204 
 
The primary endpoint in studies MS-F203 and MS-F204 was the responder rate in walking speed as 
measured by the Timed 25-foot Walk (T25FW). A responder was defined as a patient who 
consistently had a faster walking speed for at least three visits out of a possible four during the double 
blind period as compared to the maximum value among five off-treatment visits. 
 
A significantly greater proportion of fampridine  treated patients were responders as compared to 
placebo (MS-F203: 34.8% vs. 8.3%, p<0.001; MS-F204: 42.9% vs. 9.3%, p<0.001). 
 
Patients who responded to fampridine  increased their walking speed on average by 26.3% vs 5.3% on 
placebo (p<0.001) (MS-F203) and 25.3% vs 7.8% (p< 0.001) (MS-F204). The improvement appeared 
rapidly (within weeks) after starting fampridine. 
 
Statistically and clinically meaningful improvements in walking were seen, as measured by the 12- 
item Multiple Sclerosis Walking Scale. 



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Table 1: Studies MS-F203 and MS-F204 
 
STUDY * MS-F203 MS-F204 
     
 Placebo Fampridine 

10 mg BID 
Placebo                                       

mpridine10 mg BID 
n of subjects  72 224 118 119 

     
Consistent 
improvement 

8.3% 34.8% 9.3% 42.9% 

Difference   26.5%  33.5% 
CI95% 

P-value 
 17.6%, 35.4% 

< 0.001 
 23.2%, 43.9% 

< 0.001 
 

≥20% improvement 11.1% 31.7% 15.3% 34.5% 
Difference   20.6%  19.2% 

CI95% 
P-value 

 11.1%,30.1% 
<0.001 

 8.5%,29.9% 
<0.001 

Walking speed Feet/sec  Ft per sec  Ft per sec Ft per sec  Ft per sec 
Baseline  2.04 2.02 2.21 2.12 
Endpoint 2.15 2.32 2.39 2.43 

Change  0.11 0.30 0.18  0.31 
Difference 0.19 0.12 

p-value 0.010 0.038 
Average  change 5.24 13.88 7.74 14.36 

Difference 8.65 6.62 
p-value < 0.001 0.007 

MSWS-12-score (mean, 
sem)  

    

Baseline 69.27 (2.22) 71.06 (1.34) 67.03 (1.90) 73.81 (1.87) 
Average change -0.01 (1.46) -2.84 (0.878) 0.87 (1.22) -2.77 (1.20) 

Difference 2.83 3.65 
p-value 0.084 0.021 

LEMMT (mean, sem) 
(Lower Extremity 
Manual Muscle Test) 

    

Baseline 3.92 (0.070) 4.01 (0.042) 4.01 (0.054) 3.95 (0.053) 
Average change 0.05 (0.024) 0.13 (0.014) 0.05 (0.024) 0.10 (0.024) 

Difference 0.08 0.05 
p-value 0.003 0.106 

Ashworth Score 
(A test for muscle 
spasticity) 

    

Baseline 0.98 (0.078) 0.95 (0.047) 0.79 (0.058) 0.87 (0.057) 
Average change -0.09 (0.037) -0.18 (0.022) -0.07 (0.033) -0.17 (0.032) 

Difference 0.10 0.10 
p-value 0.021 0.015 

 
Study 218MS305 
 
Study 218MS305 was conducted in 636 subjects with multiple sclerosis and walking disability. 
Duration of double-blind treatment was 24 weeks with a 2 week post–treatment follow-up. The 
primary endpoint was improvement in walking ability, measured as the proportion of patients 



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achieving a mean improvement of ≥ 8 points from baseline MSWS-12 score over 24 weeks. In this 
study there was a statistically significant treatment difference, with a greater proportion of fampridine 
treated patients demonstrating an improvement in walking ability, compared to placebo-controlled 
patients (relative risk of 1.38 (95% CI: [1.06, 1.70]). Improvements generally appeared within 2 to 4 
weeks of initiation of treatment, and disappeared within 2 weeks of treatment cessation. 
 
Fampridine treated patients also demonstrated a statistically significant improvement in the Timed Up 
and Go (TUG) test, a measure of static and dynamic balance and physical mobility. In this secondary 
endpoint, a greater proportion of fampridine treated patients achieved ≥ 15% mean improvement from 
baseline TUG speed over a 24 week period, compared to placebo. The difference in the Berg Balance 
Scale (BBS; a measure of static balance), was not statistically significant. 
 
In addition, patients treated with fampridine  demonstrated a statistically significant mean 
improvement from baseline compared to placebo in the Multiple Sclerosis Impact Scale (MSIS-29) 
physical score (LSM difference -3.31, p<0.001). 
 
Table 2: Study 218MS305 
 
Over 24 weeks Placebo 

N = 318* 
Fampridine 
10 mg BID 
N = 315* 

Difference (95% CI) 
P - value 

Proportion of patients with 
mean improvement of ≥ 8 
points from baseline 
MSWS-12 score 
 

34% 43% 
 

Risk difference: 10.4% 
(3% ; 17.8%) 

0.006 

MSWS-12 score 
Baseline 
Improvement from 
baseline 

 
65.4 
-2.59 

 
63.6 
-6.73 

LSM: -4.14 
(-6.22 ; -2.06) 

<0.001 
 

TUG 
Proportion of patients with 
mean improvement of ≥ 15% 
in TUG speed 
 

35% 43% 
 

Risk difference: 9.2% 
(0.9% ; 17.5%) 

0.03 

TUG 
Baseline 
Improvement from 
baseline (sec) 

 
27.1 
-1.94 

 
24.9 
-3.3 

LSM: -1.36 
(-2.85 ; 0.12) 

0.07 

MSIS-29 physical score 
Baseline 
Improvement from 
baseline 

55.3 
-4.68 

52.4 
-8.00 

 

LSM: -3.31 
(-5.13 ; -1.50) 

<0.001 

BBS score 
Baseline 
Improvement from 
baseline 

 
40.2 
1.34 

 
40.6 
1.75 

 

LSM: 0.41 
(-0.13 ; 0.95) 

0.141 

*Intent to treat population = 633; LSM = Least square mean 
 
The European Medicines Agency has waived the obligation to submit the results of studies with the 
reference medicinal product containing fampridine in all subsets of the paediatric population in 
treatment of multiple sclerosis with walking disability (see section 4.2 for information on paediatric 
use). 
 
 



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5.2 Pharmacokinetic properties 
 
Absorption: 
 
Orally administered fampridine is rapidly and completely absorbed from the gastrointestinal tract. 
Fampridine has a narrow therapeutic index. Absolute bioavailability of fampridine prolonged-release 
tablets has not been assessed, but relative bioavailability (as compared to an aqueous oral solution) is 
95%. The fampridine  prolonged-release tablet has a delay in the absorption of fampridine manifested 
by slower rise to a lower peak concentration, without any effect on the extent of absorption. 
 
When fampridine  tablets are taken with food, the reduction in the area under the plasma 
concentration-time curve (AUC0-∞) of fampridine is approximately 2-7% (10 mg dose). The small 
reduction in AUC is not expected to cause a reduction in the therapeutic efficacy. However, Cmax 
increases by 15-23%. Since there is a clear relationship between Cmax and dose related adverse 
reactions, it is recommended to take fampridine  without food (see section 4.2). 
 
Distribution: 
 
Fampridine is a lipid-soluble medicinal product which readily crosses the blood-brain barrier. 
Fampridine is largely unbound to plasma proteins (bound fraction varied between 3-7% in human 
plasma). Fampridine has a volume of distribution of approximately 2.6 l/kg. 
Fampridine is not a substrate for P-glycoprotein. 
 
Biotransformation: 
 
Fampridine is metabolised in humans by oxidation to 3-hydroxy-4-aminopyridine and further 
conjugated to the 3-hydroxy-4-aminopyridine sulfate. No pharmacological activity was found for the 
fampridine metabolites against selected potassium channels in vitro. 
 
The 3-hydroxylation of fampridine to 3-hydroxy-4-aminopyridine by human liver microsomes 
appeared to be catalyzed by Cytochrome P450 2E1 (CYP2E1). 
 
There was evidence of direct inhibition of CYP2E1 by fampridine at 30 μM (approximately 12% 
inhibition) which is approximately 100 times the average plasma fampridine concentration measured 
for the 10 mg tablet. 
 
Treatment of cultured human hepatocytes with fampridine had little or no effect on induction of 
CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2E1 or CYP3A4/5 enzyme activities. 
 
Elimination: 
 
The major route of elimination for fampridine is renal excretion, with approximately 90% of the dose 
recovered in urine as parent medicinal product within 24 hours. Renal clearance (CLR 370 ml/min) is 
substantially greater than glomerular filtration rate due to combined glomerular filtration and active 
excretion by the renal OCT2 transporter. Faecal excretion accounts for less than 1% of the 
administered dose. 
 
Fampridine is characterized by linear (dose-proportional) pharmacokinetics with a terminal 
elimination half-life of approximately 6 hours. The maximum plasma concentration (Cmax) and, to a 
smaller extent, area under the plasma concentration-time curve (AUC) increase proportionately with 
dose. There is no evidence of clinically relevant accumulation of fampridine taken at the 
recommended dose in patients with full renal function. In patients with renal impairment, 
accumulation occurs relative to the degree of impairment. 
 
Special populations 
 



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Elderly: 
 
Fampridine is primarily excreted unchanged by the kidneys, and with creatinine clearance known to 
decrease with age, monitoring of renal function in elderly patients is recommended (see section 4.2).  
 
Paediatric population: 
 
No data are available. 
 
Patients with renal impairment: 
 
Fampridine is eliminated primarily by the kidneys as unchanged medicinal product and therefore renal 
function should be checked in patients where renal function might be compromised. Patients with 
mild renal impairment can be expected to have approximately 1.7 to 1.9 times the fampridine 
concentrations achieved by patients with normal renal function. Fampridine Accord must not be 
administered to patients with moderate and severe renal impairment (see sections 4.3 and 4.4). 
 
5.3 Preclinical safety data 
 
Fampridine was studied in oral repeat dose toxicity studies in several animal species. 
 
Adverse responses to orally administered fampridine were rapid in onset, most often occurring within 
the first 2 hours post-dose. Clinical signs evident after large single doses or repeated lower doses were 
similar in all species studied and included tremors, convulsions, ataxia, dyspnoea, dilated pupils, 
prostration, abnormal vocalization, increased respiration, and excess salivation. Gait abnormalities 
and hyper-excitability were also observed. These clinical signs were not unexpected and represent 
exaggerated pharmacology of fampridine. In addition, single cases of fatal urinary tract obstructions 
were observed in rats. The clinical relevance of these findings remains to be elucidated, but a causal 
relationship with fampridine treatment cannot be excluded. 
 
In reproduction toxicity studies in rats and rabbits, decreased weight and viability of foetuses and 
offspring were observed at maternally toxic doses. However, no increased risk for malformations or 
adverse effects on fertility was noted. 
 
In a battery of in vitro and in vivo studies fampridine did not show any potential to be mutagenic, 
clastogenic or carcinogenic. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core 
 
Hypromellose (E464)   
Silica, colloidal anhydrous (E551) 
Cellulose microcrystalline (E460) 
Magnesium stearate (E572) 
 
Film-coating 
 
Hypromellose (E464) 
Titanium dioxide (E171) 
Macrogol (E1521) 
 
 



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6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
 
6.4 Special precautions for storage 
 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
Aluminium-aluminium perforated unit-dose blister packs containing 28 x 1 or 56 x 1 tablets. 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U. 
World Trade Center, Moll de Barcelona s/n,  
Edifici Est, 6a Planta,  
Barcelona, 08039 
Spain 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/20/1477/001 
EU/1/20/1477/002 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation:  
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency: http://www.ema.europa.eu/. 

 
 
 
 
 
 
 
 
 



13 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER (S) RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE 

USE OF THE MEDICINAL PRODUCT 
 



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A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Accord Healthcare Polska Sp.z.o.o. 
Ul. Lutomierska 50, 
95-200, Pabianice, Poland 
 
Pharmadox Healthcare Ltd. 
KW20A Kordin Industrial Park, Paola PLA3000, Malta 
 
Laboratori Fundació DAU 
C/ C, 12-14 Pol. Ind. Zona Franca, 08040 Barcelona, Spain 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 
and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk management plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing 
authorisation and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 



15 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ANNEX III 

 
LABELLING AND PACKAGE LEAFLET 



16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BLISTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fampridine Accord 10 mg prolonged-release tablets  
fampridine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 10 mg of fampridine. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Prolonged-release tablets 
28 x 1 prolonged-release tablet  
56 x 1 prolonged-release tablet  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U. 
World Trade Center, Moll de Barcelona s/n,  
Edifici Est, 6a Planta,  
Barcelona, 08039 
Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/20/1477/001 
EU/1/20/1477/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Fampridine Accord 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 

 
 
 
 
 
 
 
 



19 

 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fampridine Accord 10 mg prolonged-release tablets 
fampridine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Accord 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Leave 12 hours between each tablet 
 



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



21 

Package leaflet: Information for the  patient 
 

Fampridine Accord 10 mg 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 Accord is and what it is used for  
2. What you need to know before you take Fampridine Accord  
3. How to take Fampridine Accord 
4. Possible side effects 
5. How to store Fampridine Accord 
6. Contents of the pack and other information 
 
 
1. What Fampridine Accord is and what it is used for  
 
Fampridine Accord 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.  
  
Fampridine Accord 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. 
 
 
2. What you need to know before you take Fampridine Accord 
 
Do not take  Fampridine Accord  
 
− 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 your doctor or nurse has told you that you have moderate or severe kidney problems 
− if you are taking a medicine called cimetidine 
− if you are taking any other medicine containing fampridine. This may increase your risk of 

serious side effects 
 

Tell your doctor and do not take Fampridine Accord if any of these apply to you. 
 



22 

Warnings and precautions 
 
Talk to your doctor or pharmacist before taking Fampridine Accord: 
− if you feel aware of your heartbeat (palpitations) 
− if you are prone to infections 
− you should use a walking aid, such as a cane, as needed 
− because this medicine may make you feel dizzy or unsteady this may result in an increased risk 

of falls 
− if you have any factors or are taking any medicine which affects your risk of fits (seizure). 
− if you have been told by a doctor that you have mild problems with your kidneys. 
 
Tell your doctor before you take Fampridine Accord if any of these apply to you. 
 
Children and in adolescents 
 
Do not give Fampridine Accord to children or adolescents under the age of 18 years. 
 
 Elderly 
Before starting treatment and during treatment your doctor may check that your kidneys are working 
properly. 
 
Other medicines and Fampridine Accord 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Do not take Fampridine Accord if you are taking any other medicine containing fampridine. 
 
Other medicines that affect the kidneys 
 
Your doctor will be especially careful if fampridine is given at the same time as any medicine which 
may affect how your kidneys eliminate medicines for example carvedilol, propranolol  and metformin. 
 
Fampridine Accord with food and drink 
 
Fampridine Accord should be taken without food, on an empty stomach. 
 
Pregnancy and breast-feeding 
 
If you are pregnant, or are planning to become pregnant, tell your doctor before you take 
Fampridine Accord.  
Fampridine Accord is not recommended during pregnancy. 
 
Your doctor will consider the benefit of you being treated with Fampridine Accord 
against the risk to your baby. 
 
You should not breast-feed whilst taking this medicine. 
 
Driving and using machines 
 
Fampridine Accord may have an effect on people’s ability to drive or use machines, it can cause 
dizziness. Make sure you’re not affected before you start driving or use machinery. 
 
 



23 

3. How to take Fampridine Accord 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. Fampridine Accord is only available by prescription and under the supervision of 
doctors experienced in MS. 
 
Your doctor will give you an initial prescription for 2 to 4 weeks. After 2 to 4 weeks the treatment 
will be reassessed. 
 
The recommended dose is 
 
One tablet in the morning and one tablet in the evening (12 hours apart). Do not take more than two 
tablets in a day. You must leave 12 hours between each tablet. Do not take the tablets more often 
than every 12 hours. 
 
Swallow each tablet whole, with a drink of water. Do not divide, crush, dissolve, suck or chew the 
tablet. This may increase your risk of side effects. 
 
If you take more Fampridine Accord than you should 
 
Contact your doctor immediately if you take too many tablets. 
Take the Fampridine Accord box with you if you go to see the doctor. 
In overdose you may notice sweating, minor shaking (tremor), dizziness, confusion, memory loss 
(amnesia) and fits (seizure). You may also notice other effects not listed here. 
 
If you forget to take  Fampridine Accord 
If you forget to take a tablet, do not take two tablets at once to make up for a missed dose. You must 
always leave 12 hours between each tablet. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
If you have a seizure, stop taking Fampridine Accord and tell your doctor immediately. 
 
If you experience one or more of the following allergic (hypersensitivity) symptoms: swollen face, 
mouth, lips, throat or tongue, reddening or itching of the skin, chest tightness and breathing problems 
stop taking Fampridine Accord and see your doctor immediately. 
 
Side effects are listed below by frequency: 
 
Very Common side effects 
 
May affect more than 1 in 10 people: 
• Urinary tract infection 
 
Common side effects 
 
May affect up to 1 in 10 people: 
• Feeling unsteady 
• Dizziness 
• Spinning sensation (vertigo)  



24 

• Headache 
• Feeling weak and tired 
• Difficulty sleeping 
• Anxiety 
• Minor shaking (tremor) 
• Numbness or tingling of skin 
• Sore throat 
• Common cold (nasopharyngitis) 
• Flu (influenza) 
• Difficulty breathing (shortness of breath) 
• Feeling sick (nausea) 
• Being sick (vomiting) 
• Constipation 
• Upset stomach 
• Back pain 
• Heartbeat that you can feel (palpitations) 
 
Uncommon side effects 
 
May affect up to 1 in 100 people 
• Fits (seizure) 
• Allergic reaction (hypersensitivity) 
• Worsening of nerve pain in the face (trigeminal neuralgia) 
• Fast heart rate (tachycardia) 
 
Reporting of side effects 
 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety 
of this medicine. 
 
 
5. How to store Fampridine Accord 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry 
date refers to the last day of that month. 
 
This medicinal product does not require any special storage conditions.  
 
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Fampridine Accord contains  
 
- The active substance is fampridine.  

- Each prolonged-release tablet contains 10 mg of fampridine  
- The other ingredients are:  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


25 

- Tablet core: Hypromellose (E464), silica, colloidal anhydrous (E551), cellulose 
microcrystalline (E460), magnesium stearate (E572);  

- Film coating: hypromellose (E464), titanium dioxide (E171), macrogol (E1521) 
 
What Fampridine Accord looks like and contents of the pack 
 
White to off white, oval shaped, biconvex, bevel-edged, film coated tablets, approximately 
13.1 x 8.1 mm in dimensions, debossed with ‘FH6’ on one side and plain on other side. 
 
Fampridine Accord 10 mg prolonged-release tablets are packed in perforated unit-dose blister packs 
containing 28 x1 or 56 x 1 tablets 
 
Not all pack sizes may be marketed.  
 
Marketing Authorisation Holder 
 
Accord Healthcare S.L.U. 
World Trade Center, Moll de Barcelona s/n,  
Edifici Est, 6a Planta,  
Barcelona, 08039 
Spain 
 
Manufacturer 
Accord Healthcare Polska Sp.z.o.o. 
Ul. Lutomierska 50, 
95-200, Pabianice, Poland 
 
Pharmadox Healthcare Ltd. 
KW20A Kordin Industrial Park, Paola PLA3000, Malta 
 
Laboratori Fundació DAU 
C/ C, 12-14 Pol. Ind. Zona Franca, 08040 Barcelona, Spain 
 
This leaflet was last revised in 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/.     
 
 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
	B. PACKAGE LEAFLET