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Hidrasec + ORS :

The first and only treatment targeting the cause of acute diarrhoea in infants * and children.1-3

*>3 months.
Prescribing information can be found on the last page.

Diarrhoea is a leading cause of illness in infants and young children1

1. National Institute of Health and Care Excellence. NICE clinical guideline 84. Diarrhoea and vomiting caused by gastroenteritis: diagnosis, assessment and management in children younger than 5 years. NICE: April 2009. 4. Van Damme P, Giaquinto C, Huet F, et al. J Infect Dis. 2007 May 1;195 Suppl 1:S4-S16. 5. Armon K, Stephenson T, Gabriel V, et al. Arch Dis Child. 2001 May;84(5):390-2. 6. Rautenberg TA, Zerwes U, Foerster D, Aultman R. Clinicoecon Outcomes Res. 2012;4:109-16. doi: 10.2147/CEOR.S31238. 7. National Institute of Health and Care Excellence. Evidence summary: new medicine. ESNM12: Acute diarrhoea in children: racecadotril as an adjunct to oral rehydration. NICE: 12 March 2013. 8. Lorgelly PK, Joshi D, Iturriza GÓmara M, et al. Epidemiol Infect. 2008 Jan;136(1):34-43. 9. Rodrigues LC, Lordan G, Roberts J et al. The Economic Impact of Gastroenteritis on the Island of Ireland. Report to safefood (The Food Safety Promotion Board). London School of Hygiene & Tropical Medicine/Trinity College Dublin. September 2007.

The most severe threat posed by diarrhoea is dehydration caused by hypersecretion10

In patients with diarrhoea, dehydration results from pathological hypersecretion of water and electrolytes from the small intestine11

Dehydration can develop rapidly and may be life threatening1

Dehydration is the major cause of death in children with acute diarrhoea11

Children aged under 1 year face the greatest risk of dehydration1

1. National Institute of Health and Care Excellence. NICE clinical guideline 84 Diarrhoea and vomiting caused by gastroenteritis: diagnosis, assessment and management in children younger than 5 years. NICE: April 2009. 10. World Health Organization. Diarrhoeal disease. Fact sheet N°330. WHO: April 2013. 11. Salazar-Lindo E, Santisteban-Ponce J, Chea-Woo E, Gutierrez M. N Engl J Med. 2000 Aug 17;343(7):463-7.

Hypersecretion: the real cause of diarrhoea

In gastroenteritis, regulation of fluid levels within the small intestine becomes deranged, leading to a pathological state of net secretion, known as “hypersecretion”12

12. Hodges K, Gill R. Gut Microbes. 2010 Jan;1(1):4-21.

Oral rehydration salts (ORS) have no impact on hypersecretion6

ORS effectively counteract fluid loss but do not alleviate diarrhoea symptoms because ORS does not affect fluid secretion from the wall of the intestine6

Lack of effect on diarrhoeal symptoms and illness duration is considered to be a factor in the underuse of ORS13

Drugs that directly target hypersecretion – the primary pathophysiological mechanism in acute diarrhoea – may be preferable to antimotility agents and also reduce the risk that infectious agents are retained in the gut14

There is limited availability of alternative therapies, especially those indicated for infants and children,to reduce the duration and severity of diarrhoea6

ORS

6. Rautenberg TA, Zerwes U, Foerster D, Aultman R. Clinicoecon Outcomes Res. 2012;4:109-16. doi: 10.2147/CEOR.S31238. 13. Guarino A, Albano F, Guandalini S. J Pediatr Gastroenterol Nutr. 2001 Oct;33 Suppl 2:S2-12. 14. Eberlin M, MÜck T, Michel MC. Front Pharmacol. 2012 May 30;3:93.

Introducing Hidrasec : The first and only treatment targeting the cause of acute diarrhoea in infants * and children1-3





1. National Institute of Health and Care Excellence. NICE clinical guideline 84 Diarrhoea and vomiting caused by gastroenteritis: diagnosis, assessment and management in children younger than 5 years. NICE: April 2009. 2. Hidrasec Summary of Product Characteristics. Date of Revision of the Text 11/09/2012. 3. Paediatric Formulary Committee. BNF for Children, 2014-2015. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2014 6. Rautenberg TA, Zerwes U, Foerster D, Aultman R. Evaluating the cost utility of racecadotril for the treatment of acute watery diarrhoea in children: the RAWD model. Clinicoecon Outcomes Res. 2012;4:109-16. doi: 10.2147/CEOR.S31238. 7. National Institute of Health and Care Excellence. Evidence summary: new medicine. ESNM12: Acute diarrhoea in children: racecadotril as an adjunct to oral rehydration. NICE: 12 March 2013. 12. Hodges K, Gill R. Gut Microbes. 2010 Jan;1(1):4-21. 15. Turck D, Berard H, Fretault N, Lecomte JM. Aliment Pharmacol Ther. 1999 Dec;13 Suppl 6:27-3. 16. Lecomte JM. An overview of clinical studies with racecadotril in adults. Int J Antimicrob Agents. 2000;14(1):81-,87 17. World Gastroenterology Organisation. WGO Practice guideline: Acute diarrhoea. WGO: March 2008. 18. Guarino A, Ashkenazi S, Gendrel D, et al. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):132-52. 19. Koletzko S, Lentze MJ. Akute Infektiöse Gastroenteritis 2008. *>3 months.

Mode of Action

Evidence supports the clinical efficacy of Hidrasec + ORS11,20-23

First author, year of publication

Lehert 201120

Emparanza
Knörr 200821

Szajewska 200722

Cezard 200123

Salazar-Lindo 200011

Study Type*

Meta-analysis of individual patient data (9 RCT's,1,384 children)

Systematic review (2 RCT's 307 children)

Systematic review (3 RCT's 471 children)

RCT (175 children)

RCT (135 children)

Treatment allocation

Hidrasec + ORS vs ORS + placebo

Hidrasec vs placebo

Hidrasec vs placebo or no intervention

Hidrasec + ORS vs ORS + placebo

Hidrasec + ORS vs ORS + placebo

Hidrasec efficacy results (all p<0.01)

diarrhoea duration
stool output
stool number

stool volume

diarrhoea duration
stool output
intake of ORS

stool output
dehydrated patients

diarrhoea duration
stool output
intake of ORS


*Age range for total 5 studies: 3 months -, 4 years. 11. Salazar-Lindo E, Santisteban-Ponce J, Chea-Woo E, Gutierrez M. N Engl J Med. 2000 Aug 17;343(7):463-7. 20. Lehert P, Chéron G, Calatayud GA, et al. Dig Liver Dis. 2011 Sep;43(9):707-13. 21. Emparanza Knörr JI, Ozcoidi Erro I, Martínez Andueza MC, et al. An Pediatr (Barc). 2008 Nov;69(5):432-8. 22. Szajewska H, Ruszczyński M, Chmielewska A, Wieczorek J. Aliment Pharmacol Ther. 2007 Sep 15;26(6):807-13. 23. Cézard JP, Duhamel JF, Meyer M, et al. Gastroenterology. 2001 Mar;120(4):799-805.

Hidrasec + ORS is significantly more effective than ORS alone in treating diarrhoeal symptoms20

Meta-analysis of 9 RCTs: 1,384 children, median age 12 months20

Compared with ORS + placebo,
Hidrasec + ORS offers significant improvements in: 20

Diarrhoea duration 1.75 vs 2.81 days, p < 0.001

Proportion of recovered children (hazard ratio: p < 0.001)

Stool output (Hidrasec/placebo ratio: 0.59, p < 0.001)

Stool number (Hidrasec/placebo ratio: 0.63, p < 0.001)

Hidrasec efficacy is independent of baseline dehydration severity and rotavirus infection

20. Lehert P, Chéron G, Calatayud GA, et al. Dig Liver Dis. 2011 Sep;43(9):707-13

Likelihood of a short diarrhoea duration ( < 2 days) with Hidrasec + ORS vs ORS + placebo, results adjusted for baseline rotavirus and dehydration20

Hidrasec vs loperamide*: similar efficacy, reduced incidence of rebound constipation15

102 children aged 2-10 years with acute diarrhoea randomised to receive Hidrasec (1.5 mg/kg) or loperamide (0.03 mg/kg) t.d.s.

EFFICACY

Hidrasec significantly reduced the number of stools and duration of diarrhoea, as did loperamide

15. Turck D, Berard H, Fretault N, Lecomte JM. Aliment Pharmacol Ther. 1999 Dec;13 Suppl 6:27-3 *loperamide is not recommended for the treatment of acute diarrhoea in children under 12 years – Paediatric Formulary Committee. BNF for Children. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications.


TOLERABILITY AND SAFETY

Constipation was significantly less frequent with Hidrasec (36.5% vs 58.0%)

Percentage of patients treated with racecadotril (n-52) or loperamide (n-50) who suffered from constipation during the study. The most commonly reported adverse events were vomiting and fever, which may have occurred as a consequence of the underlying illness rather than racecadotril.

Quicker resolution
of diarrhoea
means cost-savings
for the NHS6

Cost-utility of Hidrasec from UK NHS perspective in children under 5 years old (2011 data)6

Hidrasec + ORS is cost-saving versus ORS alone

£379 total cost-saving, driven by reduction in secondary care costs

+0.0008 gain in quality-adjusted life years, largely due to timely resolution of symptoms with Hidrasec

6. Rautenberg TA, Zerwes U, Foerster D, Aultman R. Clinicoecon
Outcomes Res. 2012;4:109-16. doi: 10.2147/CEOR.S31238

Hidrasec has a good safety profile2,24


2. Hidrasec Summary of Product Characteristics. Date of Revision of the Text 11/09/2012.
24. Baumer P, Joulin Y. J Pediatr Gastroenterol Nutr 2009;48:E99.

Pre- and post-marketing data support the good safety and tolerability of Hidrasec24

Since launch in 2000, safety surveillance of 14.54 million patients in 25 countries received just 43 individual case safety reports (mostly non-serious rash and urticaria)24

Hidrasec is kind to the child:

  • Antidiarrhoeal action without modifying the duration of intestinal transit2
  • No abdominal distension2
  • A reduced risk of rebound constipation when compared to loperamide2
  • No effect on the central nervous system (does not pass the blood-brain barrier when given orally)2
Kind Artwork

Summary

Hidrasec is the first and only anti-secretory drug in the UK for the symptomatic treatment of acute diarrhoea1-3

Licensed for use in infants over 3 months and children as an adjunct to ORS2

Hidrasec effectively restores water and electrolyte balance, reducing diarrhoeal symptoms without risk of constipation15

Hidrasec has supporting efficacy data11,20-23 and is administered with ORS in line with WHO guidelines10

Clinical study programme and post marketing experience shows Hidrasec is well tolerated24

Effective resolution of symptoms translate into proven cost-savings for the NHS6

Hidrasec is recommended by major international bodies as an adjunct to ORS in children with acute diarrhoea17-19


Information for prescribers

Information for prescribers

Licensed for use in infants over 3 months, children and adults, as an adjunct to ORS 1

DOSAGE FOR INFANTS

Below 9kg - Hidrasec 10mg

  • One sachet immediately and
  • A sachet morning, midday and evening

9kg - 13kg - Hidrasec 10mg

  • Two sachets immediately and
  • Two sachets morning, midday and evening

DOSAGE FOR CHILDREN

13kg - 27kg - Hidrasec 30mg

  • One sachet immediately and
  • A sachet morning, midday and evening

Above 27kg - Hidrasec 30mg

  • Two sachets immediately and
  • Two sachets morning, midday and evening
Hidrasec



1. National Institute of Health and Care Excellence. NICE clinical guideline 84. Diarrhoea and vomiting caused by gastroenteritis: diagnosis, assessment and management in children younger than 5 years. NICE: April 2009. 2. Hidrasec Summary of Product Characteristics. Date of Revision of the Text 11/09/2012. 3. Paediatric Formulary Committee. BNF for Children, 2014-2015. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2014 6. Rautenberg TA, Zerwes U, Foerster D, Aultman R. Clinicoecon Outcomes Res. 2012;4:109-16. doi: 10.2147/CEOR.S31238. 10. World Health Organization. Diarrhoeal disease. Fact sheet N°330. WHO: April 2013. 11. Salazar-Lindo E, Santisteban-Ponce J, Chea-Woo E, Gutierrez M. N Engl J Med. 2000 Aug 17;343(7):463-7. 15. Turck D, Berard H, Fretault N, Lecomte JM. Aliment Pharmacol Ther. 1999 Dec;13 Suppl 6:27-3. 17. World Gastroenterology Organisation. WGO Practice guideline: Acute diarrhoea. WGO: March 2008. 18. Guarino A, Ashkenazi S, Gendrel D, et al. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):132-52. 19. Koletzko S, Lentze MJ. Akute InfektiÖse Gastroenteritis 2008. 20. Lehert P, Chéron G, Calatayud GA, et al. Dig Liver Dis. 2011 Sep;43(9):707-13. 21. Emparanza Knörr JI, Ozcoidi Erro I, Martínez Andueza MC, et al. An Pediatr (Barc). 2008 Nov;69(5):432-8. 22. Szajewska H, Ruszczyński M, Chmielewska A, Wieczorek J. Aliment Pharmacol Ther. 2007 Sep 15;26(6):807-13. 23. Cézard JP, Duhamel JF, Meyer M, et al. Gastroenterology. 2001 Mar;120(4):799-805. 24. Baumer P, Joulin Y. J Pediatr Gastroenterol Nutr 2009;48:E99.

References

1 National Institute of Health and Care Excellence. NICE clinical guideline 84. Diarrhoea and vomiting caused by gastroenteritis: diagnosis, assessment and management in children younger than 5 years. NICE: April 2009.Available at http://www.nice.org.uk/guidance/cg84/chapter/introduction (accessed 16 November 2014).

2 Hidrasec Summary of Product Characteristics. Date of Revision of the Text 11/09/2012. Available at http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1415945253594.pdf (accessed 16 November 2014)

3 Paediatric Formulary Committee. BNF for Children, 2014-2015. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2014.

4 Van Damme P, Giaquinto C, Huet F, et al. Multicenter prospective study of the burden of rotavirus acute gastroenteritis in Europe, 2004-2005: the REVEAL study. J Infect Dis. 2007 May 1;195 Suppl 1:S4-S16.

5 Armon K, Stephenson T, Gabriel V, et al. Determining the common medical presenting problems to an accident and emergency department. Arch Dis Child. 2001 May;84(5):390-2.

6 Rautenberg TA, Zerwes U, Foerster D, Aultman R. Evaluating the cost utility of racecadotril for the treatment of acute watery diarrhoea in children: the RAWD model. Clinicoecon Outcomes Res. 2012;4:109-16. doi: 10.2147/CEOR. S31238.

7 National Institute of Health and Care Excellence. Evidence summary: new medicine. ESNM12: Acute diarrhoea in children: racecadotril as an adjunct to oral rehydration. NICE: 12 March 2013. Available at https://www.nice.org.uk/advice/esnm12 (accessed 16 November 2014)

8 Lorgelly PK, Joshi D, Iturriza Gómara M, et al. Infantile gastroenteritis in the community: a cost-of-illness study. Epidemiol Infect. 2008 Jan;136(1):34-43.

9 Rodrigues LC, Lordan G, Roberts J et al. The Economic Impact of Gastroenteritis on the Island of Ireland. Report to safefood (The Food Safety Promotion Board). London School of Hygiene & Tropical Medicine/Trinity CollegeDublin. September 2007.

10 World Health Organization. Diarrhoeal disease. Fact sheet N°330. WHO: April 2013. Available at: http://www.who.int/mediacentre/factsheets/fs330/en/# (accessed 16 November 2014)

11 Salazar-Lindo E, Santisteban-Ponce J, Chea-Woo E, Gutierrez M. Racecadotril in the treatment of acute watery diarrhoea in children. N Engl J Med. 2000 Aug 17;343(7):463-7.

12 Hodges K, Gill R. Infectious diarrhoea: Cellular and molecular mechanisms. Gut Microbes. 2010 Jan;1(1):4-21

13 Guarino A, Albano F, Guandalini S; Working Group on Acute Gastroenteritis. Oral rehydration: toward a real solution. J Pediatr Gastroenterol Nutr. 2001 Oct;33 Suppl 2:S2-12.

14 Eberlin M, MÜck T, Michel MC. A comprehensive review of the pharmacodynamics, pharmacokinetics, and clinical effects of the neutral endopeptidase inhibitor racecadotril. Front Pharmacol. 2012 May 30;3:93.

15 Turck D, Berard H, Fretault N, Lecomte JM. Comparison of racecadotril and loperamide in children with acute diarrhoea. Aliment Pharmacol Ther. 1999 Dec;13 Suppl 6:27-3 16 Lecomte JM. An overview of clinical studies with racecadotril in adults. Int J Antimicrob Agents. 2000;14(1):81-,87

17 World Gastroenterology Organisation. WGO Practice guideline: Acute diarrhoea. WGO: March 2008. Available at http://www.worldgastroenterology.org/assets/downloads/en/pdf/guidelines/01_acute_diarrhea.pdf (accessed 16 November 2014)

18 Guarino A, Ashkenazi S, Gendrel D, et al. European Society for Pediatric Gastroenterology, Hepatology, and Nutrition/European Society for Pediatric Infectious Diseases evidence-based guidelines for the management of acute gastroenteritis in children in Europe: update 2014. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):132-52.

19 Koletzko S, Lentze MJ. Akute InfektiÖse Gastroenteritis 2008. Available at: http://www.awmf.org/uploads/tx_szleitlinien/068-003_S1_Akute_infektioese_Gastroenteritis_04-2008_04-2013.pdf (accessed 16 November 2014)

20 Lehert P, Chéron G, Calatayud GA, et al. Racecadotril for childhood gastroenteritis: an individual patient data meta-analysis. Dig Liver Dis. 2011 Sep;43(9):707-13

21 Emparanza Knörr JI, Ozcoidi Erro I, Martínez Andueza MC, et al. [Systematic review of the efficacy of racecadotril in the treatment of acute diarrhoea]. An Pediatr (Barc). 2008 Nov;69(5):432-8.

22 Szajewska H, Ruszczyński M, Chmielewska A, Wieczorek J. Systematic review: racecadotril in the treatment of acute diarrhoea in children. Aliment Pharmacol Ther. 2007 Sep 15;26(6):807-13.

23 Cézard JP, Duhamel JF, Meyer M, et al. Efficacy and tolerability of racecadotril in acute diarrhoea in children. Gastroenterology. 2001 Mar;120(4):799-805.

24 Baumer P, Joulin Y. Pre- and postmarketing safety profiles of racecadotril sachets, a "new" antidiarrhoeal drug. Abstract PG4-15, presented at European Society for Paediatric Gastroenterology, Hepatology and Nutrition Annual Meeting June 3-,6, 2009 Budapest, Hungary. J Pediatr Gastroenterol Nutr 2009;48:E99.


Lincoln Medical Hidrasec

Abbreviated Prescribing Information

HIDRASEC INFANTS 10 mg, Granules for oral suspension and

HIDRASEC CHILDREN 30 mg, Granules for oral suspension

Please refer to the appropriate Summary of Product Characteristics (SmPC) before prescribing HIDRASEC

Presentation: Each HIDRASEC INFANTS 10 mg, Granules for oral suspension sachet contains 10 mg of racecadotril. Each HIDRASEC CHILDREN 30 mg, Granules for oral suspension sachet contains 30 mg of racecadotril. Indications: For the symptomatic treatment of acute diarrhoea in infants (older than 3 months) and in children together with oral rehydration when causal treatment is not possible. If causal treatment is possible, racecadotril can be administered as a complementary treatment. Dosage and Administration: HIDRASEC INFANTS 10 mg intended for children < 13 kg. Dose is determined by body weight: 1.5 mg/kg per dose (corresponding to 1 to 2 sachets), three times daily. In infant less than 9 kg: one 10 mg sachet 3 times daily. In infant from 9 kg to 13 kg: two 10 mg sachets 3 times daily. HIDRASEC CHILDREN 30 mg: dose is determined by body weight: 1.5 mg/kg per dose (corresponding to 1 to 2 sachets), three times daily. In children from 13 kg to 27 kg: 30mg or one sachet per dose 3 times daily. In children of more than 27kg: 2x30 mg or two sachets per dose 3 times daily. Continue until two normal stools are recorded. Maximum 7 days. Contraindications: Must not be administered to infants less than 3 months old. Must not be administered to children with renal or liver impairment. Hypersensitivity to the active substance, or to any of the excipients. Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or saccharase-isomaltase deficiency should not take this medicine. Precautions and Warnings: Administration of racecadotril does not modify the usual rehydration regimens. Essential that the child drinks abundant liquids. In the event of serious or prolonged diarrhoea with important vomiting or a lack of appetite, intravenous rehydration should be considered. Bloody or purulent stools and fever, racecadotril should not be administered. Chronic diarrhoea has not been sufficiently studied. Racecadotril has not been tested in antibiotic associated diarrhoea. Possible reduced availability in patients with prolonged vomiting. Patients with diabetes: HIDRASEC INFANTS 10 mg each sachet contains 0.966 g of sucrose. HIDRASEC CHILDREN 30 mg each sachet contains 2.899 g of sucrose. If the quantity of sucrose (source of glucose and fructose) present in the daily dose of HIDRASEC INFANTS 10 mg/HIDRASEC CHILDREN 30 mg exceeds 5 g a day, the latter should be taken into account in the daily sugar ration. Interactions: No interactions with other medicinal products. Concomitant treatment with racecadotril and loperamide, or nifuroxazide does not modify the kinetics of racecadotril. Pregnancy: Should not be administered to pregnant women. Fertility: studies conducted with racecadotril (on rats) demonstrate no impact on fertility. Lactation: Should not be administered to breastfeeding women. Undesirable Effects: Uncommon adverse reactions include tonsillitis, rash and erythema. Unknown adverse reactions include erythema multiforme, tongue oedema, face oedema, lip oedema, eyelid oedema, angioedema, urticaria, erythema nodosum, rash papular, prurigo, pruritus, toxic skin eruption. Legal Category: POM. Marketing Authorisation Nos: HIDRASEC INFANTS 10 mg PL 39418/0001. HIDRASEC CHILDREN 30 mg PL 39418/0002. Basic NHS Price: 10mg/sachet, 20 = £8.42. 30mg/sachet, 20 = £8.42. Marketing Authorisation Holder: Bioprojet Europe Ltd., 29 Earlsfort Terrace, Dublin 2, IRELAND. Additional information and full prescribing information is available on request from the Marketing Authorisation Holder. Date of Preparation: April 2015. Date of the Text: 09/2012.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Bioprojet Europe Ltd or Lincoln Medical Ltd email: hidrasec@pilglobal.com, Tel: 01748 827277


Hidrasec

Date of preparation: December 2015

HIDWEB20151201

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