6. Contents of the pack and other information

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany

MOVICOL V Macrogol Norgine Zitronen- und Limettenaroma Pulver zur Herstellung einer Lösung zum Einnehmen

6.5      Nature and contents of container

This product is available in rectangular sachets and tubular (stick-pack) sachets.

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

Pack sizes: boxes of 2, 6, 8, 10, 20, 30, 50, 60 or 100 sachets. 

Not all sachets and pack sizes may be marketed.

10       DATE OF REVISION OF THE TEXT

           06 April 2023

1. Contents of the pack and other information

What Movicol looks like and contents of the pack

Movicol is available in rectangular sachets and tubular (stick-pack) sachets.

Movicol is a white powder.

Movicol is available in boxes of 2, 6, 8, 10, 20, 30, 50, 60 or 100 sachets.

Not all sachets and pack sizes may be marketed.

Manufacturer:

Norgine Limited, New Road, Hengoed, Mid Glamorgan, CF82 8SJ, U.K.

Or

Laboratoires Macors, Rue des Caillottes, Zi De La Plaine Des Isles 89000 Auxerre, France.

Or

Sophartex, 21 rue du Pressoir 28500 Vernouillet France.

Or

Norgine B.V., Antonio Vivaldistraat 150, 1083 HP, Amsterdam, Netherlands.

Or

Recipharm Höganäs AB, Sporthallsvägen 6, Höganäs, 263 35, Sweden.

Or

Delpharm Orleans, 5 avenue de Concyr, ORLEANS CEDEX 2, 45071, France.

This leaflet was last revised in 034/2023

4.5       Interaction with other medicinal products and other forms of interaction

There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics. Therefore, other medicines should not be taken orally for one hour before, during and for one hour after taking Movicol.

5.3       Preclinical safety data

Indirect embryofoetal effects, including reduction in foetal and placental weights, reduced foetal 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.

6.6       Special precautions for disposal

Any unused solution should be discarded within 6 hours.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

10.      DATE OF REVISION OF THE TEXT

28 March 2023

Movicol^® 13.8g sachet, powder for oral solution

(Macrogol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride)

2.        What you need to know before you take Movicol

Other medicines and Movicol

Some medicines, e.g. anti-epileptics, may not work as effectively during use with Movicol. 

You should not take any other medicines by mouth together with Movicol and for one hour before and for one hour after taking Movicol.

5.        How to store MOVICOL

Do not use Movicol after the expiry date which is stated on the sachet and carton. 

The expiry date refers to the last day of that month.

6.        Contents of the pack and other information

The medicinal product medicine is authorised in the Member States of the EEA European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

United Kingdom

(Northern Ireland)

MOVICOL

This leaflet was last revised in 063/202203/2023

6.         Contents of the pack and other information

This leaflet was last revised in 02/202 11/2021

6.Contents of the pack and other information

Manufacturer:

Norgine Limited, New Road, Hengoed, Mid Glamorgan, CF82 8SJ, U.K.

Or

Laboratoires Macors, Rue des Caillottes, Zi De La Plaine Des Isles 89000 Auxerre, France.

Or

Sophartex, 21 rue du Pressoir 28500 Vernouillet France.

Or

Norgine B.V., Antonio Vivaldistraat 150, 1083 HP, Amsterdam, Netherlands.

Or

Recipharm Höganäs AB, Sporthallsvägen 6, Höganäs, 263 34, Sweden.

This leaflet was last revised in 04/2021 08/2021

1        NAME OF THE MEDICINAL PRODUCT

MOVICOL Movicol 13.8g sachet, powder for oral solution

2        QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet of MOVICOL Movicol contains the following active substances:

Macrogol 3350                                                  13.125 g

Sodium chloride                                                 0.3507 g

Sodium bicarbonate                                            0.1785 g

Potassium chloride                                             0.0466 g

The content of electrolyte ions per sachet when made up to 125 ml of solution is as follows:

Sodium                                                              65 mmol/l

Chloride                                                            53 mmol/l

Potassium                                                          5.4 mmol/l

Bicarbonate                                                       17 mmol/l

For the full list of excipients, see section 6.1.

4        CLINICAL PARTICULARS

4.1       Therapeutic indications

For the treatment of chronic constipation. MOVICOL Movicol is also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon.

4.2       Posology and method of administration

Posology

Chronic constipation

A course of treatment for constipation with MOVICOL Movicol does not normally exceed 2 weeks, although this can be repeated if required.

Faecal impaction

A course of treatment for faecal impaction with MOVICOL Movicol does not normally exceed 3 days.

Adults, adolescents and the older people: 8 sachets daily, all of which should be consumed within a 6 hour period.

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

4.4       Special warnings and precautions for use

The fluid content of MOVICOL Movicol when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained.

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

Mild adverse drug reactions are possible as indicated in Section 4.8. If patients develop any symptoms indicating shifts of fluids/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) MOVICOL Movicol should be stopped immediately and electrolytes measured, and any abnormality should be treated appropriately.

The absorption of other medicinal products could transiently be reduced due to an increase in gastro-intestinal transit rate induced by MOVICOL Movicol (see section 4.5).

This medicinal product contains 186.87 mg  (8.125 mmol) sodium per dose, equivalent to 9.3% of the WHO recommended maximum daily intake for sodium. When used for long term constipation the maximum daily dose of this product is equivalent to 28% of the WHO recommended maximum daily intake for sodium. Movicol is considered high in sodium. This should be particularly taken into account for those on a low salt diet.

In patients with swallowing problems, who need the addition of a thickener to solutions to enhance an appropriate intake, interactions should be considered, see section 4.5.

4.5       Interaction with other medicinal products and other forms of interaction

Macrogol raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water. 

There is a possibility that the absorption of other medicinal products could be transiently reduced during use with MOVICOL Movicol (see section 4.4). There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.

MOVICOL Movicol may result in a potential interactive effect ifused with starch-based food thickeners. Macrogol ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.

4.6       Fertility, pregnancy and lactation

Pregnancy

There are limited amount of data from the use of MOVICOL 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 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 Movicol can be used during breast-feeding.

Fertility

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

4.7       Effects on ability to drive and use machines

MOVICOL Movicol has no influence on the ability to drive and use machines.

4.8       Undesirable effects

Reactions related to the gastrointestinal tract occur most commonly.

These reactions may occur as a consequence of expansion of the contents of the gastrointestinal tract, and an increase in motility due to the pharmacologic effects of  MOVICOL Movicol. Mild diarrhoea usually responds to dose reduction.

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 HPRA Pharmacovigilance, Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517. Website: www.hpra.ie., e-mail: medsafety@hpra.ie

5        PHARMACOLOGICAL PROPERTIES

5.1       Pharmacodynamic properties

Pharmacotherapeutic group: Osmotically acting laxatives.

ATC code: A06A D65

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 defecation. 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.

For the indication of faecal impaction controlled comparative studies have not been performed with other treatments (e.g. enemas). In a non-comparative study in 27 adult patients, MOVICOL Movicol cleared the faecal impaction in 12/27 (44%) after 1 day’s treatment; 23/27 (85%) after 2 days’ treatment and 24/27 (89%) at the end of 3 days.

Clinical studies in the use of MOVICOL Movicol in chronic constipation have shown that the dose needed to produce normal formed stools tends to reduce over time.

5.3       Preclinical safety data

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 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.

10      DATE OF REVISION OF THE TEXT

Sept 2019 17 May 2021

2. What you need to know before you take MOVICOL

Other medicines and Movicol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines, e.g. anti-epileptics, may not work as effectively during use with

Movicol. 

If you need to thicken fluids in order to swallow them safely, Movicol may counteract the effect of the thickener.

6. Contents of the pack and other information

What Movicol looks like and contents of the pack

This leaflet was last revised in 042/2021

1. 4.8. Possible side effects

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 676517. Website: www.hpra.ie; E mail: medsafety@hpra.ie.  By reporting side effects you can help provide more information on the safety of this medicine.

6.4.      Special precautions for storage

Sachet: Do not store above 25°C.  This medicinal product does not require any special storage conditions.

10      DATE OF REVISION OF THE TEXT

12 Sept 2019 26 February 2021

4. Possible side effects

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 676517. Website: www.hpra.ie; E mail: medsafety@hpra.ie.  By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Movicol

Do not store above 25°C.  This medicinal product does not require any special storage conditions.

Once you have made up Movicol in water, if you cannot drink it straight away keep it covered and in the fridge (2°C – 8°C). Throw away any solution not used within a 6 hour period.

6.         Contents of the pack and other information

This leaflet was last revised in 05/2020 02/2021

Other sources of information

If you need the information on this leaflet in an alternative format, such as large print, or Braille please ring 0800 198 5000.

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in 05/2020

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:

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’

            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.