Gastroenterology Today Autumn 2023

Optimising
maintenance therapy
for ulcerative colitis:
Real
choices
When mesalazine doesn’t seem to be working, stepping
up to immunosuppressants isn’t the only option
Together we know more.
Together we do more.
Real
solution
Salofalk Granules are easy to take, they have a
pleasant vanilla flavour, and they’re a proven way to
help patients get the most from their mesalazine 1-3
Optimising therapy with once-daily Salofalk Granules in patients
who were inadequately maintained on previous mesalazine resulted in: 2
69% 45% 50%
fewer
days
off work
fewer
GP visits
due to UC
fewer
steroid
courses used
Mesalazine, the Dr Falk way
Prescribing Information Information (refer (refer to to full full SPC SPC before before prescribing): prescribing):
Salofalk
Presentation:
gastro-resistant
Salofalk 250mg
prolonged-release
gastro-resistant tablets:
granules
gastro-resistant tablet
containing 250mg mesalazine. Salofalk 500mg and 1g gastro-resistant tablet
Presentation: (UK ONLY) containing Stick-formed 500mg or and round, 1g mesalazine greyish white respectively. gastro-resistant Salofalk
prolonged-release 500mg/1000mg/1500mg/3000mg granules in sachets prolonged-release containing granules: 500mg, prolongedrelease
or granules 3g mesalazine containing per 500mg,1000mg, sachet. Indications: 1500mg or Treatment 3000mg mesalazine of acute
1000mg,
1.5g
episodes per sachet. and Indications: the maintenance Salofalk 250mg of remission tablets (UK): of ulcerative treatment colitis. and
Dosage: maintenance Adults: of remission Once daily of 1 mild/moderate sachet of 3g granules, ulcerative 1 colitis. or 2 sachets Salofalk of
1.5g 250mg granules tablets or (Ireland): 3 sachets as of an 1000mg anti-inflammatory 500mg granules in the management (equivalent of to
1.5
ulcerative
– 3.0g
colitis
mesalazine
and in
daily)
the treatment
preferably
of Crohn’s
taken in
disease.
the morning,
Salofalk
according
500mg
tablets (UK): treatment and maintenance of remission of ulcerative colitis.
to
Salofalk
individual
1g tablets
clinical
(UK):
requirement.
treatment
May
of acute
be taken
episodes
in three
of mild/moderate
divided doses
(1 ulcerative sachet colitis. of 500mg Salofalk granules granules: three treatment times daily of acute or 1 sachet episodes of 1000mg and the
granules maintenance three of remission times daily) of mild if more to moderate convenient. ulcerative Maintenance: colitis. Dosage: 0.5g
mesalazine Salofalk 250mg three tablets times - Adults daily and elderly: (morning, acute treatment midday 6 -12 and tablets evening) daily
corresponding 3 divided doses. to Maintenance a total dose treatment of 1.5g mesalazine 6 tablets daily per in day. 3 divided For patients doses.
known Salofalk to 500mg be at tablets increased (UK only): risk for 1 relapse or 2 tablets for 3 medical times daily. reasons Maintenance: or due to
difficulties 1 tablet 3 times to adhere daily. Salofalk to three 1g tablets daily doses, (UK only): give 1 tablet 3.0g mesalazine three times daily. as a
Salofalk granules – adults: acute treatment – once daily 1 sachet of 3g
single daily dose, preferably in the morning. Children: There is only
granules, 1 or 2 sachets of Salofalk 1.5g granules, 3 sachets of 500mg
granules limited documentation or 3 sachets of for 1000mg an effect granules in children (equivalent (age to 6-18 1.5 – years). 3.0g
mesalazine Children 6 daily), years preferably of age and taken older: in the Active morning. disease: Alternatively, To be the determined dose can
be individually, taken divided starting three with doses. 30-50mg/kg/day Maintenance treatment once daily – 1 preferably sachet of 500mg in the
granules morning 3 or times in divided daily (1.5g doses. mesalazine Maximum daily). dose: Where 75mg/kg/day. needed, 3.0g per The day total in
a dose single should morning not dose exceed may be taken. the maximum Method of administration: adult dose. Maintenance oral. Tablets
treatment: - taken whole To without be determined chewing, with individually, liquid, one starting hour before with meals. 15-30mg/kg/day Granules
in
- taken
divided
on the
doses.
tongue
The
and
total
swallowed,
dose should
without
not
chewing,
exceed
with
the
plenty
recommended
of liquid.
Duration of treatment is usually 8 weeks. To be determined by physician.
adult
Children
dose.
(all formulations):
It is generally
there
recommended
is only limited
that
documentation
half the adult
for
dose
an effect
may
be in children given to (age children 6-18 years). up to a Children body weight 6 years of and 40kg; older: and active the normal disease – adult on
dose individual to those basis starting above with 40kg. 30-50mg/kg/day Method of administration: either once daily Taken (granules) on the or
tongue in divided and doses swallowed, (tablets and without granules). chewing, Maximum with 75mg/kg/day. plenty of liquid. Total Contraindications:
should not exceed Hypersensitivity recommended to adult salicylates dose. Maintenance or any of the - on excipients. individual
dose
Severe basis starting impairment with 15-30mg/kg/day of renal or hepatic in divided function. doses. Warnings/Precautions:
Total dose should not
Blood
exceed
tests
recommended
and urinary
adult
status
dose.
(dip
Generally
sticks) should
recommended
be determined
that half
prior
the
adult dose may be given to children up to a body weight of 40kg and the
to
normal
and
adult
during
dose
treatment.
to those above
Caution
40kg.
is
Contra-indications:
recommended in
Hypersensitivity
patients with
impaired to salicylates hepatic or any of function. the excipients. Should Severe not impairment be used of in renal patients or hepatic with
impaired function. Warnings/Precautions: renal function. Mesalazine-induced Blood tests and urinary renal toxicity status (dip should sticks) be
considered should be determined if renal function prior deteriorates to and during during treatment. treatment. Caution Cases is of
recommended in patients with impaired hepatic function. Should not be
used in patients with impaired renal function. Mesalazine-induced renal
toxicity should be considered if renal function deteriorates during treatment
- stop treatment immediately in such cases. Cases of nephrolithiasis
reported; ensure good hydration. Serious blood dyscrasias have been
reported very rarely with mesalazine. Hematological investigations should
be performed if patients suffer from unexplained haemorrhages, bruises,
purpura, anaemia, fever or pharyngolaryngeal pain. Salofalk should be
nephrolithiasis
discontinued in case
reported;
of suspected
ensure
or confirmed
good hydration.
blood dyscrasia.
Patients
Cardiac
with
hypersensitivity reactions (myocarditis, and pericarditis) induced by
pulmonary
mesalazine have
disease,
been rarely
in
reported.
particular
Salofalk
asthma,
should
should
then be
be
discontinued
carefully
monitored. immediately. Patients with with pulmonary a history disease, of adverse in particular drug asthma, reactions should to
preparations be carefully monitored. containing Severe sulphasalazine cutaneous should adverse be reactions kept under (SCARs), close
medical including surveillance. drug reaction with If acute eosinophilia intolerance and systemic reactions symptoms e.g., abdominal (DRESS),
cramps, Stevens-Johnson acute abdominal syndrome pain, (SJS) and fever, toxic severe epidermal headache necrolysis and (TEN), rash, occur, have
stop been reported. treatment Discontinue immediately. treatment Severe at the cutaneous first appearance adverse of signs reactions and
(SCARs), symptoms of including severe skin Stevens-Johnson reactions, such as skin syndrome rash, mucosal (SJS) lesions, and or toxic any
other sign of hypersensitivity. Patients with a history of adverse drug reactions
epidermal necrolysis (TEN), have been reported. Discontinue
to preparations containing sulphasalazine should be kept under close
treatment medical surveillance. at the first If appearance acute intolerance of signs reactions and symptoms e.g., abdominal of severe cramps, skin
reactions, acute abdominal such pain, as skin fever, rash, severe mucosal headache lesions, and rash or occur, any stop other treatment sign of
hypersensitivity. immediately. Tablets Salofalk may granules be excreted contain undissolved aspartame, in patients a source with the of
phenylalanine ileocecal valve removed. that may Salofalk be harmful granules: for patients contain with aspartame, phenylketonuria. a source of
Salofalk phenylalanine. granules May contain be harmful sucrose: to patients 0.02mg, with phenylketonuria. 0.04mg, 0.06mg Granules and
0.12mg also contain (500mg/1g/1.5g sucrose: 0.04mg, and 0.08mg, 3g granules 0.12mg, respectively). 0.24mg (500mg/1g/1.5g
Interactions:
Specific
and 3g granules
interaction
respectively).
studies have
Salofalk
not
tablets:
been performed.
For patients on
Lactulose
a sodiumcontrolled
diet: the 250mg and 500mg tablets contain 48mg and 49mg of
or
similar
sodium,
preparations
equivalent to 2.4%
that
and
lower
2.5%
stool
of the recommended
pH: possible
maximum
reduction
daily
of
mesalazine intake for sodium. release Urine from may granules be discoloured due to red-brown decreased after pH contact caused with by
bacterial sodium hypochlorite metabolism bleach of lactulose. used in toilets. With Interactions: concomitant Specific treatment interaction with
azathioprine, studies have not 6-mercaptopurine been performed. or thioguanine With concomitant consider treatment a possible with
increase azathioprine, in their 6-mercaptopurine myelosuppressive or thioguanine, effects. There consider is weak a possible evidence increase that
mesalazine their myelosuppressive might decrease effects. the anticoagulant There is weak effect evidence of warfarin. that mesalazine Use in
pregnancy might decrease and the lactation: anticoagulant There are effect no of adequate warfarin. data. Salofalk Do granules not use
(additionally): lactulose, or similar preparations which lower stool pH:
during pregnancy unless the potential benefit outweighs the possible
possible reduction of mesalazine release from granules due to decreased pH
risks. caused Limited by bacterial experience metabolism in the of lactulose. lactation Use period. in pregnancy Use during and lactation: breastfeeding
do not use only Salofalk if the during potential pregnancy benefit unless outweighs the potential the possible benefit risks; outweighs if the
infant the possible develops risks. Limited diarrhoea, experience breast-feeding the lactation should period. be Salofalk discontinued. should
Undesirable only be used during effects: breast-feeding Headache, if dizziness, the potential peri- benefit and outweighs myocarditis, the
abdominal possible risks; pain, if the diarrhoea, breast-fed dyspepsia, infant develops flatulence, diarrhoea, nausea, breast-feeding vomiting,
aplastic should be discontinued. anaemia, agranulocytosis, Undesirable effects: pancytopenia, altered blood counts neutropenia, (aplastic
leukopenia,
anaemia, agranulocytosis,
thrombocytopenia,
pancytopenia,
peripheral
neutropenia,
neuropathy, allergic
leukopenia,
and
thrombocytopenia), hypersensitivity reactions such as allergic exanthema,
fibrotic
drug fever,
lung
lupus
reactions
erythematosus
(including
syndrome,
dyspnoea,
pancolitis,
cough,
headache,
bronchospasm,
dizziness,
alveolitis, peripheral neuropathy, pulmonary peri- eosinophilia, and myo-carditis, lung infiltration, allergic and pneumonitis), fibrotic lung
acute reactions pancreatitis, (including dyspnoea, impairment cough, of renal bronchospasm, function including alveolitis, pulmonary acute and
chronic eosinophilia, interstitial lung infiltration, nephritis pneumonitis), and renal insufficiency, abdominal nephrolithiasis,
pain, diarrhoea,
dyspepsia, flatulence, nausea, vomiting, acute pancreatitis, cholestatic
hepatitis, hepatitis, rash, pruritus, photosensitivity – especially with preexisting
skin conditions, alopecia, severe cutaneous adverse reactions
(SCARs) including drug reaction with eosinophilia and systemic symptoms
(DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis
(TEN), arthralgia, myalgia, impairment of renal function including acute and
chronic interstitial nephritis and renal insufficiency, nephrolithiasis, asthenia,
fatigue, oligospermia (reversible), changes in hepatic function parameters,
photosensitivity
changes in pancreatic
especially
enzymes,
with
eosinophil
pre-existing
count
skin
increased.
conditions,
Legal
alopecia,
category:
POM. Cost (UK - basic NHS price; Ireland - PtW): Salofalk 250mg tablets
Stevens-Johnson
(100s) £16.19; €13.48.
syndrome
Salofalk
(SJS),
500mg
toxic
tablets
epidermal
(100s) £32.38.
necrolysis
Salofalk
(TEN),
1g
myalgia, tablets (90s) arthralgia, £58.50. Salofalk hypersensitivity 500mg granules reactions (100 sachets) such £28.74; as allergic €27.93.
exanthema, Salofalk 1000mg drug granules fever, lupus (50 sachets) erythematosus £28.74; €32.87. syndrome, Salofalk pancolitis, 1500mg
changes granules in (60 hepatic sachets) function £48.85; parameters, €49.66. Salofalk hepatitis, 3g granules cholestatic (60 hepatitis sachets)
and £97.70; oligospermia €101.64. (reversible), Product licence asthenia, number: fatigue, Salofalk changes 250mg in pancreatic tablets:
enzymes, PL10341/0004; eosinophil PA573/4/3. count Salofalk increased. 500mg Legal tablets: category: PL08637/0019. POM. Salofalk Basic
cost: 1g tablets: Salofalk PL08637/0027. 500mg granules, Salofalk pack size 500mg 100 sachets granules: - £28.74; PL08637/0007; €30.39.
PA573/3/1. Salofalk 1000mg granules: PL08637/0008; PA573/3/2. Salofalk
Salofalk 1000mg granules, pack size 50 sachets – £28.74; 32.87€.
1500mg granules: PL08637/0016; PA573/3/7. Salofalk 3g granules:
Salofalk PL08637/0025; 1.5g Granules, PA573/3/6. pack Product size 60 licence sachets holder: - £48.85; Salofalk €50.02. 250mg Salofalk tablets
3g in Granules the UK: Dr pack Falk size Pharma 60 sachets UK Ltd, - Bourne £97.70; End €102.62 Business (UK- Park, NHS Cores price; End IE
- Road, PtW). Bourne Product End, SL8 licence 5AS. Salofalk number: 500mg Salofalk and 1g tablets 500mg and granules all granules: –
PL08637/0007; Dr Falk Pharma GmbH, PA573/3/1. Leinenweberstr.5, Salofalk 1000mg D-79108 granules Freiburg, – PL08637/0008;
Germany. Date
PA573/3/2. of preparation: Salofalk January 1.5g 2023 granules PL08637/0016; PA573/3/7. Salofalk
3g granules PL08637/0025; PA573/3/6.Product licence holder: Dr Falk
Pharma Further GmbH, information Leinenweberstr.5, is available on D-79108 request. Freiburg, Germany. Date of
preparation: January 2022.
Further Adverse information events should is available be reported. on request. In the UK: Reporting forms
and information can be found at https://yellowcard.mhra.gov.
Adverse uk/ In events Ireland: should Reporting be reported. forms Reporting and information forms and can information be found
can at be https://www.hpra.ie/homepage/about-us/report-an-issue/
found at https://yellowcard.mhra.gov.uk/ (UK residents) or in
Ireland human-adverse-reaction-form
at https://www.hpra.ie/homepage/about-us/report-anissue/human-adverse-reaction-form
reported to Dr Falk Pharma UK Ltd Adverse at PV@drfalkpharma.co.uk.
events should also be
Adverse events should also be
reported to Dr Falk Pharma UK Ltd at PV@drfalkpharma.co.uk
References:
References: 1. Salofalk Granules. Summary of Product Characteristics.
1. 2. Salofalk Aldulaimi Granules. D et al. Summary Poster DRF16/057 of Product presented Characteristics. at the
2. Aldulaimi BSG Annual D et Meeting, al. Poster June DRF16/057 2016, Liverpool presented UK. at the BSG Annual
3. Meeting, Keil R et June al. Scand 2016, J Liverpool Gastroenterol UK. 2018; 21: 1-7.
3. Keil R et al. Scand J Gastroenterol 2018; 21: 1-7.
UC: ulcerative colitis
UC: ulcerative colitis
Date of preparation: March 2023
Date
UI--2300070
of preparation: March 2022
UI--2200080
To find out more about Salofalk Granules
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