2.         Qualitative and Quantitative Composition

The word ‘ingredients’ has been replaced by the word ‘substances’ as follows:

Each 25 ml of MOVICOL Liquid Orange flavour contains the following active substances:

4.2       Posology and method of administration

The insertion of the title ‘Posology’ as a heading beneath the main heading above.

The wording ‘the elderly’ has been replaced by ‘older people’ as follows:

Adults, adolescents and older people: 25 ml diluted in 100 ml of water 1-3 times daily in divided doses, according to individual response.

 4.4          Special warnings and precautions for use

The following sentence has been added:

The fluid content of MOVICOL Liquid when re-constituted with water does

not replace regular fluid intake and adequate fluid intake must be maintained.

4.8 Undesirable Effects

Updated as follows for the 1^st two Classes:

4.9       Overdose

The word ‘abdominal’ has been added as follows:

Severe abdominal pain or distension can be treated by nasogastric aspiration. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.

10        DATE OF REVISION OF THE TEXT

January 2016

MOVICOL Liquid SmPC

Changes have been made to the following sections:

Section 2 – addition to the statement - For the full list of excipients, see section 6.1.

Section 4.2 – addition of the title -  Method of administration

Section 4.3-  addition to the statement re hypersensitivity. Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Section 4.6 – Lowercase  text used for the word ‘pregnancy’.

 Section 4.8-  addition of the subheading - Skin and subcutaneous tissue disorders- Erythema has been added .

Information regarding the methods of reporting side effects has been added.

 Section 6.6 – Addition of  to the title - Special precautions for disposal

Section 10- Revision of the date text

Section 4.6:

The paragraphs on ‘Pregnancy, Lactation and Fertility’ were replaced, as follows:

Pregnancy

There are limited amount of data from the use of MOVICOL in pregnant women.  Studies in animals have shown indirect reproductive toxicity (see section 5.3). Clinically, no effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible.

MOVICOL can be used during pregnancy.

Breastfeeding

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Macrogol 3350 is negligible.

MOVICOL can be used during breast-feeding.

Fertility

There are no data on the effects of MOVICOL on fertility in humans. There were no effects on fertility in studies in male and female rats (see section 5.3).

Previous information in section 4.6:

Pregnancy

There is no experience of the use of MOVICOL Liquid Orange flavour during pregnancy. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).

MOVICOL Liquid Orange flavour should not be used during pregnancy unless clearly necessary.

Lactation

It is unknown whether MOVICOL Liquid Orange flavour is excreted in human milk.

A risk to the suckling child cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from MOVICOL Liquid Orange flavour therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

There are no data on the effects of MOVICOL on fertility.

Section 5.3

The 2 paragraph was added and 3 paragraph was replaced (as highlighted in red), as follows:

‘Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential, based on conventional studies of pharmacology, repeated dose toxicity and genotoxicity. 

There were no direct embryotoxic or teratogenic effects in rats even at maternally toxic levels that are a multiple of 66 x the maximum recommended dose in humans for chronic constipation and 25 x for faecal impaction. Indirect embryofetal effects, including reduction in fetal and placental weights, reduced fetal viability, increased limb and paw hyperflexion and abortions, were noted in the rabbit at a maternally toxic dose that was 3.3 x the maximum recommended dose in humans for treatment of chronic constipation and 1.3 x for faecal impaction. Rabbits are a sensitive animal test species to the effects of GI-acting substances and the studies were conducted under exaggerated conditions with high dose volumes administered, which are not clinically relevant. The findings may have been a consequence of an indirect effect of MOVICOL related to poor maternal condition as the result of an exaggerated pharmacodynamic response in the rabbit. There was no indication of a teratogenic effect.

There are long-term animal toxicity and carcinogenicity studies involving macrogol 3350. Results from these and other toxicity studies using high levels of orally administered high molecular weight macrogols provide evidence of safety at the recommended therapeutic dose.’

Previous information in section 5.3:

‘Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential,  although no tests of its effects on reproduction or genotoxicity have been conducted.

There are no long-term animal toxicity or carcinogenicity studies involving macrogol 3350, although there are toxicity studies using high levels of orally administered high molecular weight macrogols that provide evidence of safety at the recommended therapeutic dose.’

Section 10:

’6^th January 2012’ was changed to ‘May 2013’