Changes have been made to the following sections:

 

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION
The word ‘ingredients’ has been replaced by the word ‘substances’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The wording ‘the elderly’ has been replaced by ‘older people’

4.4   Special warnings and precautions for use

The following sentence has been added:

The fluid content of MOVICOL 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:

 

System Organ Class	Adverse Event
Immune system disorders	Allergic reactions, including anaphylactic reaction,  dyspnoea  and skin reactions (see below).
Skin and subcutaneous tissue disorders	Allergic skin reactions including angioedema, urticarial, pruritus, rash, erythema.

 

 

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 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 4.8-  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 4.6:

 

The paragraph on ‘Pregnancy’ was replaced and the paragraph on ‘Fertility’ was added, 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 are no or limited amount of data from the use of MOVICOL in pregnant women.  Studies in animals have shown reproductive toxicity (see section 5.3).

 

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. ‘

 

 

Section 5.3

 

The 2 and 3 paragraph were 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, based on conventional studies of pharmacology, repeated dose toxicity and genotoxicity. 

 

Indirect embryofoetal effects were noted in the rabbit at clinically relevant doses. Treatment caused an increased incidence of malrotated limbs, reduction in foetal and placental weights, reduced foetal viability and abortions at maternally toxic doses.  The safety margin was 1.1 x the maximum recommended dose for faecal impaction in a 60 kg adult for malrotated limb and 2.9 x below the maximum recommended dose for the remaining findings.  Rabbits are sensitive animal test species to the effects of GI acting substances and the studies were conducted under exaggerated conditions with administered high dose volumes. The relevance of these findings to humans is unknown.

 

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:

 

‘May 2011’ was changed to ‘May 2013’

 

 

In section 4.4, the following text was added, "The absorption of other medicinal products could transiently be reduced to an increase in gastro-intestinal transit rate induced by MOVICOL (see section 4.5)."

In section 4.5, the following text was added, "There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics."

In section 4.8, the adverse events were re-formatted according to MeDRA.

 

            2.         Macrogol 3350 (Polyethylene Glycol 3350)    13.125 g

4.1    ………….loading of the rectum and/or colon. confirmed by physical examination of the abdomen and rectum.

4.2    Children below 12 years old: Not recommended. Alternative  Movicol products are available for children.

4.3    Known hypersensitivity to any of these active substances or to any of the excipients. Hypersensitivity to the active ingredients or to any of the excipients.

4.4       Special warnings and precaustions for use

         Diagnosis of impaction/faecal loading of the rectum should be confirmed by physical or radiological examination of the abdomen and rectum.

         There is no clinical trial data on the use of Movicol in children, therefore it is not recommended.

4.5    Macrogol raises the solubility of drugs medicinal products that are soluble in alcohol and relatively insoluble in water.  There is therefore a theoretical possibility that the absorption of such drugs medicinal products could be transiently reduced.

4.7    There is no effect Movicol has no influence on the ability to drive and use machines.

5.1    Pharmacotherapeutic group: Osmotically acting laxatives.

6.1    List of Excipients

         Acesulfame K potassium (E950)

         Lime and lemon flavour*

         (Lime and lemon flavour contains the following constituents: acacia solids, maltodextrin, lime oil, lemon oil, citral, citric acid and water).

6.3    Shelf Life

         The shelf life of the sachets is 3 years.

         Discard any solution not used within Reconstituted solution: 6 hours.

6.4    Reconstituted solution: Store at 2 - 8°C (in a refrigerator and covered).

 

6.5    Nature and contents of container           

Sachet: laminate consisting of four layers: low density polyethylene, aluminium, low density polyethylene and paper.

         13.8g sachets contained in Pack sizes: boxes of 2, 6, 8, 10, 20, 30, 50, 60 or 100 sachets.  Not all pack sizes may be marketed.

6.6    Special precautions for disposal

         None. Any unused solution should be discarded within 6 hours.

10     Date of revision of the text

         August 2002 August 2005 August 2006 March 2007

 

Section 5.1:

Macrogol 3350 acts by virtue of its osmotic action in the gut, which induces a laxative effect.  . .  Macrogol 3350 increases the stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is an improved propulsive colonic transportation of the softened stools and a facilitation of the defaecation. Electrolytes combined with macrogol 3350 are exchanged across the intestinal barrier (mucosa) with serum electrolytes and excreted in faecal water without net gain or loss of sodium, potassium and water.

 Section 5.2:

Macrogol 3350 is unchanged along the gut.  It is virtually unabsorbed from the gastro-intestinal tract. Any macrogol 3350 that is absorbed is excreted via the urine.

Section 10: November 2006