2 QUALITATIVE AND QUANTITATIVE COMPOSITION

This corresponds to the following amount of each electrolyte in each diluted dose of

125 ml:

Sodium                                                                     8.125 mmol

Chloride                                                                     6.625 mmol

Potassium                                                                  0.675 mmol

Hydrogen carbonate                                                  2.125 mmol

Excipients with known effect:

74.65 mg alcohol (also known as ethyl alcohol) ethyl alcohol per 25 ml

11.3 mg methyl parahydroxybenzoate (E218) per 25 ml

5.6 mg ethyl parahydroxybenzoate (E214) per 25 ml

45.6 mg benzyl alcohol per 25 ml

For a full list of excipients, see section 6.1.

4.4 Special warnings and precautions for use

This medicinal product contains 45.6 mg of benzyl alcohol in each 25 ml dose which is equivalent to 1.825 mg/ml.  Benzyl alcohol may cause anaphylactoid reactions.

High volumes of benzyl alcohol should be used with caution and only if necessary, especially in subjects with kidney or liver impairment and during pregnancy/breast feeding because of the risk of accumulation and toxicity (metabolic acidosis) of benzyl alcohol.

This medicine contains 74.6 mg of ethanol in 25 mL concentrate for oral solution, which is equivalent to 3.0 mg of ethanol per mL. The amount in 25 mL concentrate for oral solution of this medicine is equivalent to less than 2 mL of beer or 1 mL of wine. The small amount of alcohol in this medicine will not have any noticeable effects.

6.1 List of excipients

Acesulfame potassium E950

Sucralose E955

Benzyl alcohol

Methyl parahydroxybenzoate E218

Ethyl parahydroxybenzoate E214

Orange flavour (contains flavouring substances, flavouring preparations and a small amount of ethanol) Purified water

10 DATE OF REVISION OF THE TEXT

28 March 2023 7 July 2023

2. What you need to know before you take Movicol Liquid Orange flavour

Movicol Liquid Orange flavour contains ethyl parahydroxybenzoate, methyl parahydroxybenzoate, alcohol (ethanol), benzyl alcohol and sodium.

This medicineal product contains ethyl and methyl parahydroxybenzoate which may cause allergic reactions, possibly delayed.

This medicine contains 74.6 mg of alcohol (ethanol) in 25 mL concentrate for oral solution, which is equivalent to 3.0 mg of alcohol (ethanol) per mL. The amount in 25 mL concentrate for oral solution of this medicine is equivalent to less than 2 mL of beer or 1 mL of wine. The small amount of alcohol in this medicine will not have any noticeable effects.

This medicine contains 45.6mg of benzyl alcohol in each diluted dose of 125ml.

It also contains

• small amounts of ethanol (alcohol), less than 100 mg per 25 ml dose.
• 45.6 mg of benzyl alcohol in each diluted dose of 125 ml.

6. Contents of the pack and other information

Movicol Liquid Orange flavour also contains purified water, orange flavour, and acesulfame potassium (E950) and sucralose (E955) as sweeteners.

It also contains a preservative which contains benzyl alcohol (E1519), methyl parahydroxybenzoate (E218) and ethyl parahydroxybenzoate (E214). See section 2 “Movicol Liquid Orange flavour contains ethyl parahydroxybenzoate, methyl parahydroxybenzoate, alcohol(ethanol), benzyl alcohol and sodium”.

Orange flavour contains the following ingredients: flavouring substances, flavouring preparations and a small amount of alcohol (ethanol). (alcohol).

This leaflet was last revised in 03/2023. 05/2023.

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 Liquid Orange flavour.

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 24 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^® Liquid Orange flavour, Concentrate for oral solution

(Macrogol 3350, Sodium Chloride, Sodium Hydrogen Carbonate, Potassium Chloride)

2.        What you need to know before you take Movicol Liquid Orange flavour

Other medicines and Movicol Liquid Orange flavour

Some medicines, e.g. anti-epileptics (medicines for epilepsy), may not work as effectively during use with Movicol Liquid Orange flavour. 

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

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 Liquid Orange flavour

This leaflet was last revised in 03/2023

6.        Contents of the pack and other information

Manufacturer:

Norgine Pharma Dreux, 29, Rue Ethé Virton, 28109 Dreux Cedex, France.

Or

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

This leaflet was last revised in 03/2022 09/2022.

4.4       Special warnings and precautions for use

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 long term for constipation the maximum daily dose of this product is equivalent to 28% of the WHO recommended maximum daily intake for sodium. Movicol Liquid Orange flavour 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 Liquid Orange flavour (see section 4.4). There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.

Movicol Liquid Orange flavour may result in a potential interactive effect if used 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.

4.8       Undesirable effects

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

10      DATE OF REVISION OF THE TEXT

17 November 201917 May 2021

Other medicines and Movicol Liquid Orange flavour

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

Some medicines, e.g. anti-epileptics (medicines for epilepsy), may not work as effectively during use with Movicol Liquid Orange flavour.

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

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 6762517. 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.

What Movicol Liquid Orange flavour looks like and contents of the pack

This leaflet was last revised in 05/2020 04/2021

Other sources of information

If you need the information on this leaflet in an alternative format, such as large print, please ring 00 44 1895 826 606.

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

This leaflet was last revised in 05/2020

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’