lSIDE-EFFECTS
▶Common or very commonInsomnia.stomatitis.taste
altered.tinnitus.urine abnormalities
▶UncommonFace oedema.seizure.vasculitis.vertigo
▶Frequency not knownAnaemia.appetite decreased.ataxia
.cyanosis.encephalopathy.haematuria.hallucination.
hepatic disorders.hypoprothrombinaemia.idiopathic
pulmonaryfibrosis.lymphadenopathy.macrocytosis.
meningitis aseptic.methaemoglobinaemia.myocarditis
allergic.nephrotic syndrome.parotitis.periorbital
oedema.pseudomembranous enterocolitis.serum
sickness.severe cutaneous adverse reactions (SCARs).
smell disorders.systemic lupus erythematosus (SLE).
yellow discolouration of bodyfluids
SIDE-EFFECTS, FURTHER INFORMATIONIncidence of side-
effects increases with higher doses.
Blood disordersHaematological abnormalities occur
usually in thefirst 3 to 6 months of treatment—
discontinue if these occur.
lPREGNANCYTheoretical risk of neonatal haemolysis in
third trimester; adequate folate supplements should be
given to mother.
lBREAST FEEDINGSmall amounts in milk ( 1 report of
bloody diarrhoea); theoretical risk of neonatal haemolysis
especially in G 6 PD-deficient infants.
lHEPATIC IMPAIRMENTUse with caution.
lRENAL IMPAIRMENTRisk of toxicity, including crystalluria,
in moderate impairment—ensure highfluid intake. Avoid
in severe impairment.
lMONITORING REQUIREMENTS
▶Blood disordersClose monitoring of full blood counts
(including differential white cell count and platelet count)
is necessary initially, and at monthly intervals during the
first 3 months.
▶Renal functionAlthough the manufacturer recommends
renal function tests in rheumatic diseases, evidence of
practical value is unsatisfactory.
▶Liver functionLiver function tests should be performed at
monthly intervals forfirst 3 months.
lPATIENT AND CARER ADVICE
Contact lensesSome soft contact lenses may be stained.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: oral suspension
Oral suspension
CAUTIONARY AND ADVISORY LABELS 14
EXCIPIENTS:May contain Alcohol
▶Sulfasalazine (Non-proprietary)
Sulfasalazine 50 mg per 1 mlSulfasalazine 250 mg/ 5 ml oral
suspension sugar free sugar-free| 500 mlP£ 42. 76 DT = £ 42. 76
Gastro-resistant tablet
CAUTIONARY AND ADVISORY LABELS5, 14, 25
▶Sulfasalazine (Non-proprietary)
Sulfasalazine 500 mgSulfasalazine 500 mg gastro-resistant tablets
| 112 tabletP£ 8. 43 DT = £ 8. 43
▶Salazopyrin EN(Pfizer Ltd)
Sulfasalazine 500 mgSalazopyrin EN-Tabs 500 mg|
112 tabletP£ 8. 43 DT = £ 8. 43
▶Sulazine EC(Genesis Pharmaceuticals Ltd)
Sulfasalazine 500 mgSulazine EC 500 mg tablets| 112 tabletP
£ 6. 74 DT = £ 8. 43
Tablet
CAUTIONARY AND ADVISORY LABELS 14
▶Sulfasalazine (Non-proprietary)
Sulfasalazine 500 mgSulfasalazine 500 mg tablets|
112 tabletP£ 9. 00 DT = £ 7. 83
▶Salazopyrin(Pfizer Ltd)
Sulfasalazine 500 mgSalazopyrin 500 mg tablets| 112 tabletP
£ 6. 97 DT = £ 7. 83Suppository
CAUTIONARY AND ADVISORY LABELS 14
▶Salazopyrin(Pfizer Ltd)
Sulfasalazine 500 mgSalazopyrin 500 mg suppositories|
10 suppositoryP£ 3. 30CORTICOSTEROIDS
eiiiiF 436Budesonide 21-Dec-2017
lDRUG ACTIONBudesonide is a glucocorticoid, which exerts
significant local anti-inflammatory effects.lINDICATIONS AND DOSE
BUDENOFALK®CAPSULES
Mild to moderate Crohn’s disease affecting the ileum or
ascending colon|Collagenous colitis
▶BY MOUTH
▶Child 12–17 years: 3 mg 3 times a day for up to 8 weeks,
reduce dose for the last 2 weeks of treatment
ENTOCORT®CAPSULES
Mild to moderate Crohn’s disease affecting the ileum or
ascending colon
▶BY MOUTH
▶Child 12–17 years: 9 mg once daily for up to 8 weeks;
reduce dose for the last 2 – 4 weeks of treatment, to be
taken in the morning
ENTOCORT®ENEMA
Ulcerative colitis involving rectal and recto-sigmoid
disease
▶BY RECTUM
▶Child 12–17 years: 1 enema daily for 4 weeks, to be
administered at bedtimelUNLICENSED USENot licensed for use in children for
Crohn’s disease, collagenous colitis or ulcerative colitis.
lINTERACTIONS→Appendix 1 : corticosteroids
lSIDE-EFFECTS
▶Common or very common
▶With oral useMuscle twitching.oedema
▶With rectal useDiarrhoea.gastrointestinal disorders
▶Rare or very rare
▶With oral useFatigue.malaise
lHEPATIC IMPAIRMENT
MonitoringWhen used in autoimmune hepatitis liver
function tests should be monitored every 2 weeks for
1 month, then at least every 3 months.
lDIRECTIONS FOR ADMINISTRATIONCapsules can be
opened and the contents mixed with apple or orange juice.
lPRESCRIBING AND DISPENSING INFORMATION
ENTOCORT®CAPSULESDispense modified-release
capsules in original container (contains desiccant).lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Gastro-resistant capsule
CAUTIONARY AND ADVISORY LABELS5, 10, 22, 25
▶Budenofalk(Dr. Falk Pharma UK Ltd)
Budesonide 3 mgBudenofalk 3 mg gastro-resistant capsules|
100 capsuleP£ 75. 05 DT = £ 75. 05
Modified-release capsule
CAUTIONARY AND ADVISORY LABELS5, 10, 25
▶Entocort CR(Tillotts Pharma Ltd)
Budesonide 3 mgEntocort CR 3 mg capsules| 100 capsuleP
£ 84. 15 DT = £ 84. 15
Enema
▶Entocort(Tillotts Pharma Ltd)
Budesonide 20 microgram per 1 mlEntocort 2 mg/ 100 ml enema|
7 enemaP£ 33. 6632 Chronic bowel disorders BNFC 2018 – 2019
Gastro-intestinal system1