HIDRASEC

Posology For adults only. The first day: one tablet straightaway regardless of the time of day, then, depending on the time of the first intake, up to a maximum of 2 tablets spread over the day, counting in these 2 tablets the first tablet taken straightaway.

Taken should preferably be done before meals. e. 2 tablets per day, preferably before meals. Treatment should be continued until two normal stools are recorded. Treatment should not exceed 7 days.

Special populations:

Paediatric population: The safety and efficacy of racecadotril 175 mg film-coated tablets in children and adolescents have not been established. No data are available. More appropriate formulations of racecadotril indicated for use in paediatric patients, such as granules in sachet, should be used.

2). Caution is advised in patients with hepatic or renal impairment. Method of administration Oral route. Swallow with a glass of water.

As part of clinical acute diarrhoea studies, data are available for 2193 adult patients treated with racecadotril and 282 treated with placebo. The following adverse effects listed below have occurred with racecadotril more often than with placebo, or have been reported during post-marketing surveillance.

Tabulated list of adverse reactions Adverse reactions reported are presented in table below. Adverse reactions are listed according to MedDRA primary system organ class. Within each system organ class, adverse reactions are ranked by frequency.

Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. The frequency of adverse reactions was defined using the convention: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), not known (cannot be estimated from the available data).

4). System Organ Class Frequency Adverse reactions Nervous system disorders Common headache uncommon rash, erythema Skin and subcutaneous tissue disorders not known erythema multiforme, tongue oedema, face oedema, lip oedema, eyelid oedema, angioedema, urticaria, erythema nodosum, rash papular, prurigo, pruritus, toxic skin eruption, drug reaction with eosinophilia and systemic symptoms (DRESS) Immune system disorder Not known Anaphylactic shock 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

The administration of Hidrasec 175mg does not modify the usual rehydration regimens and dietary measures. The presence of bloody or purulent stools and fever may indicate the presence of invasive bacteria as a reason for diarrhoea or the presence of other severe disease.

Also, racecadotril has not been assessed in antibiotic-associated diarrhoea, therefore racecadotril should not be administered under these conditions Chronic diarrhoea has not been sufficiently studied with this medicinal product. There is a possible reduced bioavailability in patients with prolonged vomiting.

Renal and hepatic impairment:

There are limited data in patients with renal or hepatic impairment. 2). 4 mmol) of lactose anhydrous. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Hypersensitivity:

Occurrence of skin reactions has been reported with the use of the product. In most cases, these are mild and do not require treatment. However, in some cases they can be severe, even life-threatening. Association with racecadotril cannot be fully excluded.

When experiencing severe skin reactions, the treatment has to be stopped immediately. Hypersensitivity/Angioneurotic Oedema have been reported in patients with racecadotril. This may occur at any time during therapy. Angioedema of the face, extremities, lips, mucous membranes may occur.

Where there is angioedema associated with upper airway obstruction, such as tongue, glottis and/or larynx, emergency therapy should be administered promptly. Racecadotril should be discontinued and the patient should be under close medical supervision with appropriate monitoring initiated and continued until complete and sustained resolution of symptoms has occurred.

Racecadotril should not be reintroduced.

Bradykinin angioedema:

Racecadotril or some therapeutic classes are likely to cause a vascular reaction such as angioedema of the face and neck, resulting from the inhibition of the degradation of bradykinin. The outcomes of angioedema can sometimes be fatal, due to airway obstruction.

Angioedema can occur independently of a simultaneous association between these medicines if the patient has been previously exposed to one of the two protagonists. It will be necessary to search for the history of the occurrence of this effect and to determine the need for this type of association.

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Severe cutaneous adverse reactions (SCARs):

Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported in association with racecadotril treatment. Patients should be advised of the signs and symptoms and monitored closely for skin reactions.

If signs and symptoms suggestive of DRESS appear, racecadotril should be withdrawn immediately and an alternative treatment considered. If the patient has developed DRESS with the use of racecadotril, treatment with racecadotril must not be restarted in these patients at any time.

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