The product must not be administered to infants less than 3 months old, as there are no clinical trials in this population.

The product must not be administered to children with renal or liver impairment, whatever the degree of severity, due to a lack of information on these patient populations.

Because of possible reduced bioavailability, the product must not be administered in cases of prolonged or uncontrolled vomiting.

Occurrence of skin reactions has been reported with the use of the product. These are in most cases mild and do not require treatment but 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.

4.5 Interaction with other medicinal products and other forms of interaction
No interactions with other active substances have been described in humans to date.

In humans, joint treatment with racecadotril and loperamide or nifuroxazide does not modify the kinetics of racecadotril.

4.6 Fertility, pregnancy and lactation
Fertility:

Fertility studies conducted with racecadotril on Rats demonstrate no impact on fertility.

Pregnancy:

There are no adequate data from the use of racecadotril in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, fertility, embryo- foetal development, childbirth/delivery or postnatal development. However, since no specific clinical studies are available, racecadotril should not be administered to pregnant women.

Lactation:

Due to the lack of information regarding racecadotril excretion in human milk, this medicinal product should not be administered to breastfeeding women.

4.7 Effects on ability to drive and use machines
Not relevant.

Racecadotril has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects
Data from clinical acute diarrhoea studies are available for 860 paediatric patients treated with racecadotril, and 441 treated with placebo.

The following adverse drug reactions listed below have occurred with racecadotril more often than with placebo or have been reported during post-marketing surveillance. The frequency of adverse reactions is defined using the following convention: 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).

Infections and infestations:

- Uncommon: tonsillitis.

Skin and subcutaneous tissue disorders:

See section 4.4)-

- Uncommon: rash, erythema.

- Unknown: erythema multiforme, tongue oedema, face oedema, lip oedema, eyelid oedema, angioedema, urticaria, erythema nodosum, rash papular, prurigo, pruritus.

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 Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard.

4.9 Overdose