Movicol

Package leaflet: Information for the patient

MOVICOL 13.8 g, powder for oral solution

Macrogol 3350, Sodium chloride, Sodium hydrogen carbonate, Potassium chloride
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Movicol is and what it is used for
2. What you need to know before taking Movicol
3. How to take Movicol
4. Possible side effects
5. How to store Movicol
6. Contents of the pack and other information

1. What Movicol is and what it is used for

The name of this medicine is Movicol, 13.8 g sachet, powder for oral solution. It is a laxative for the
treatment of constipation in adults, adolescents and the elderly. It is not recommended for children under
12 years of age.
Movicol helps you achieve adequate bowel evacuation even if constipation has been present for a long time.
Movicol is also effective in the treatment of severe constipation, known as fecal impaction.

2. What you need to know before taking Movicol

Do not take Movicol if your doctor has told you that you have:

• intestinal blockage (intestinal obstruction, ileus)
• perforation of the intestinal wall
• a serious inflammatory bowel disease such as ulcerative colitis, Crohn's disease, or toxic megacolon
• an allergy to the active substances or to any of the other ingredients of Movicol (listed in section 6).

Warnings and precautions
When taking Movicol, you must continue to drink plenty of fluids. The fluid content of Movicol does not replace the need for regular fluid intake.
Cardiac conditions
If you are taking Movicol for faecal impaction, follow the special instructions provided in section 3.
Other medicines and Movicol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines, for example antiepileptics, may become less effective while taking Movicol.
You must not take other oral medicines at the same time, or within one hour before or one hour after taking Movicol.
If you need to thicken liquids in order to swallow them safely, Movicol may counteract the effect of the thickening agent.
Pregnancy and breastfeeding
Movicol may be taken during pregnancy and while breastfeeding.
If you are pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking Movicol.
Driving and using machines
Movicol does not affect your ability to drive or operate machinery.
Movicol contains sodium
Talk to your doctor or pharmacist if you need to take 3 or more sachets per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.
Movicol contains 186.87 mg of sodium (the main component of table salt) per sachet. This corresponds to 9.3% of the maximum daily dietary intake recommended for an adult.

3. How to take Movicol

This medicine can be taken at any time, with or without food.
Dissolve the contents of each sachet in 125 ml (half a glass) of water and drink.

Constipation
A dose of Movicol is 1 sachet dissolved in 125 ml (half a glass) of water.
Take 1 sachet 1 to 3 times a day, depending on the severity of your constipation.

Faecal impaction
Before taking Movicol for faecal impaction, it must be confirmed that you have this condition.
For the treatment of faecal impaction, a dose of 8 sachets per day of Movicol is required. Each sachet must
be dissolved in 125 ml (half a glass) of water. The 8 sachets should be taken within 6 hours, if necessary for
up to 3 days. If you have a heart condition, do not take more than 2 sachets per hour.

How to mix:
Open the sachet and pour the contents into a glass. Add approximately 125 ml of water to the glass (half a
glass). Stir well until all the powder has dissolved and the Movicol solution is clear or slightly cloudy, then
drink the solution. If you are taking Movicol for faecal impaction, it may be easier to dissolve 8 sachets in
1 litre of water.

Duration of treatment:
Constipation
Treatment with Movicol usually lasts about 2 weeks. If you need to take Movicol for longer, consult your doctor.
If your constipation is caused by a disease such as Parkinson’s disease or multiple sclerosis, or if you are
taking medicines that cause constipation, your doctor may recommend that you take Movicol for longer than
2 weeks. If you need to take Movicol for longer, consult your doctor.
Generally, during long-term treatment, the dose may be reduced to 1 or 2 sachets per day.

Faecal impaction
Treatment with Movicol may last up to 3 days.

If you take more Movicol than you should
You may experience excessive diarrhoea, which could lead to dehydration. In this case, stop treatment with
Movicol and drink plenty of fluids. If you are concerned, consult your doctor or pharmacist.

If you forget to take Movicol
Take the missed dose as soon as you remember.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately and stop taking Movicol if:

• you have a severe allergic reaction causing difficulty breathing, or swelling of the face, lips, tongue or throat.

Other side effects include:
allergic reactions which may cause skin rashes, itching, redness of the skin or hives, swelling of the hands, feet or ankles, headache, and high or low levels of potassium in the blood.
You may sometimes experience indigestion, stomach ache or gurgling noises. You may also feel bloated, suffer from flatulence, nausea or vomiting. Additionally, when you first start taking Movicol, you may experience anal discomfort and mild diarrhoea. These side effects usually improve by reducing the dose of Movicol you are taking.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Movicol

Keep this medicine out of the sight and reach of children.
Do not use Movicol after the expiry date stated on the sachet and outer carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Once the Movicol solution has been prepared in water, if you are unable to drink it all at once, store it in the refrigerator (2°C – 8°C) and keep it covered. Discard any unused solution after 6 hours.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Movicol contains
Each 13.8 g sachet of Movicol contains:
Macrogol 3350 13.125 g
Sodium chloride 0.3507 g
Sodium hydrogen carbonate 0.1785 g
Potassium chloride 0.0466 g
Movicol also contains lime and lemon flavouring, and potassium acesulfame as sweetener. The lime and lemon flavouring consists of the following ingredients: acacia gum, maltodextrin, lime oil, lemon oil, citral, citric acid and water.
When dissolved in 125 millilitres of water, each sachet provides the equivalent of:
Sodium 65 millimoles/litre
Chloride 53 millimoles/litre
Potassium 5.4 millimoles/litre
Bicarbonate 17 millimoles/litre

Description of the appearance of Movicol and package contents
Movicol is available in rectangular sachets and tubular sachets (stick-packs).
Movicol is a white powder.
Movicol is available in packs containing 2, 6, 8, 10, 20, 30, 50, 60 or 100 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Norgine Italia S.r.l., Piazza Gae Aulenti, 1 Torre B, 20154 Milano, Italy

Responsible manufacturer for batch release:
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, The Netherlands
or
Meribel Pharma Höganäs AB, Sporthallsvägen 6, 263 35 Höganäs, Sweden.

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria MOVICOL - Pulver
Belgium MOVICOL
Germany Macrogol Norgine Zitronen- und Limettenaroma Pulver zur Herstellung einer Lösung zum Einnehmen
Finland MOVICOL
Ireland MOVICOL
Italy MOVICOL 13.8 g powder for oral solution
Portugal MOVICOL
Spain MOVICOL
Sweden MOVICOL

Patient information leaflet

MOVICOL Children 6.9 g, powder for oral solution, Chocolate flavour

Macrogol 3350, Sodium chloride, Sodium hydrogen carbonate, Potassium chloride
Please read this leaflet carefully before you start giving this medicine to your child, as it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist or nurse.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If your child experiences any side effects, including those not listed in this leaflet, speak to your doctor, pharmacist or nurse. See section 4.
• Consult your doctor if you do not notice any improvement or if symptoms worsen.

Contents of this leaflet

1. What Movicol Children Chocolate flavour is and what it is used for
2. What you need to know before giving Movicol Children Chocolate flavour
3. How to give Movicol Children Chocolate flavour
4. Possible side effects
5. How to store Movicol Children Chocolate flavour
6. Contents of the pack and other information

1. What Movicol Children Chocolate Flavour is and what it is used for

The name of this medicine is Movicol Children Chocolate Flavour, 6.9 g sachet, powder for oral solution.
It is a laxative used for the treatment of chronic constipation in children aged 2 to 11 years and for the treatment of severe constipation (called fecal impaction) in children aged 5 to 11 years.
Movicol Children Chocolate Flavour helps your child achieve proper bowel evacuation even if constipation has been present for a long time.

2. What you should know before giving Movicol Children Chocolate Flavour

Do not give Movicol Children Chocolate Flavour if the doctor has told you that your child has:

• intestinal blockage (intestinal obstruction, ileus)
• perforation of the intestinal wall
• a severe inflammatory bowel disease such as ulcerative colitis, Crohn's disease, or toxic megacolon
• an allergy to the active substances or to any of the other ingredients of Movicol Children Chocolate Flavour (listed in section 6)

If your child has heart or kidney problems, an impaired pharyngeal reflex, or reflux esophagitis (heartburn caused by stomach contents flowing back into the esophagus), consult your doctor before giving Movicol Children Chocolate Flavour.

Warnings and precautions
When taking Movicol Children Chocolate Flavour, ensure your child continues to drink plenty of fluids.
The fluid content of Movicol does not replace the need for regular fluid intake.

Other medicines and Movicol Children Chocolate Flavour
Inform your doctor if your child is taking, has recently taken, or might take any other medicines.
Some medicines, e.g. antiepileptics, may be less effective during treatment with Movicol Children Chocolate Flavour. When your child is taking large volumes of Movicol Children Chocolate Flavour (e.g. for faecal impaction), other medicines may be expelled through the gastrointestinal tract.
Your child should not take any other oral medicines during, one hour before, or one hour after taking Movicol Children Chocolate Flavour.
If you need to thicken liquids to make them easier to swallow, Movicol Children Chocolate Flavour may interfere with the thickening agent's effect.

Pregnancy and breastfeeding
Movicol Children Chocolate Flavour may be given during pregnancy and during breastfeeding. Consult your pharmacist or doctor before giving Movicol Children Chocolate Flavour.

Movicol Children Chocolate Flavour contains benzyl alcohol and sodium
Movicol Children Chocolate Flavour contains 7.0 mg of benzyl alcohol per sachet. Benzyl alcohol may cause allergic reactions.
Do not use for more than one week in young children (under 3 years of age) unless otherwise advised by a doctor or pharmacist.
Consult your doctor or pharmacist if your child has liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause unwanted effects (such as metabolic acidosis).
Movicol Children Chocolate Flavour contains 93.4 mg (4.062 mmol) of sodium (a main component of table salt) per sachet. This corresponds to 4.6% of the maximum daily recommended dietary intake of sodium for an adult.

3. How to administer Movicol Children Chocolate Flavour

This medicine can be taken at any time, with or without food.
Dissolve the contents of each sachet in 62.5 ml (a quarter of a glass) of water and drink.

Chronic constipation
The dose of Movicol Children Chocolate Flavour depends on the child's age and response to treatment.

• As an initial dose, children aged 2 to 6 years should be given one sachet (= 1 dose) daily.
• Children aged 7 to 11 years should be given two sachets daily. Your doctor may instruct you to increase the number of sachets until your child produces soft stools. If an increase in dose is needed, it should be done on alternate days. This usually does not require more than 4 sachets per day. It is not necessary to take the entire solution at once; if preferred, the child may drink half in the morning and the other half in the evening.

Faecal impaction
Before your child takes Movicol Children Chocolate Flavour for the treatment of faecal impaction, a doctor must confirm that your child has this condition.
A treatment cycle with Movicol Children Chocolate Flavour is as follows:

Number of Movicol Children Chocolate-flavour sachets
Age (years)	Day 1	Day 2	Day 3	Day 4	Day 5	Day 6	Day 7
5 -11	4	6	8	10	12	12	12

The daily number of sachets must be taken divided into doses, all consumed within a 12-hour period (e.g., 8:00–20:00). Each sachet must be dissolved in 62.5 ml (a quarter of a glass) of water. The treatment regimen may be interrupted once the medicine has taken effect. This occurs when your child produces a large amount of stools and/or watery diarrhea.

How to mix:

• Open the sachet and pour the contents into a glass. Add a quarter of a glass of water (approximately 62.5 ml) to the glass. Stir well until all the powder has dissolved and the Movicol Children Chocolate Flavour solution is clear or slightly cloudy, then give it to your child to drink.
• If preferred, you can alter the taste of the drink by adding, for example, orange juice. If your child is taking Movicol Children Chocolate Flavour for faecal impaction, it may be easier to dissolve 12 sachets in 750 ml of water.

Duration of treatment:
Chronic constipation
Treatment should last for a prolonged period, at least 6–12 months.
Faecal impaction
Treatment with Movicol Children Chocolate Flavour may last up to 7 days.

If your child takes more Movicol Children Chocolate Flavour than they should:
Your child may experience excessive diarrhoea, which could lead to dehydration. In this case, stop treatment with Movicol Children Chocolate Flavour and drink plenty of fluids. If you are concerned, contact your doctor or pharmacist.

If you forget to give Movicol Children Chocolate Flavour:
Give the missed dose as soon as you remember.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately and stop giving Movicol Children Chocolate Flavour to your child if:

• your child has a severe allergic reaction causing difficulty breathing, or swelling of the face, lips, tongue or throat.

Very common side effects (affects more than 1 in 10 people):

• stomach pain
• stomach rumbling

Common side effects (affects more than 1 in 100 but less than 1 in 10 people):

• diarrhoea
• vomiting (feeling sick)
• nausea (feeling of being sick)
• anal irritation (discomfort around the anus)

If your child is being treated for chronic constipation, diarrhoea usually improves by reducing the dose.

Uncommon side effects (affects more than 1 in 1,000 but less than 1 in 100 people):

• bloated stomach
• flatulence

Rare side effects (affects less than 1 in 1,000 people):

• allergic reactions, which may include shortness of breath or difficulty breathing

Other reported side effects include:
rash, itching, skin redness or hives, swelling of hands, feet or ankles, headache, indigestion, high or low blood potassium levels.

Reporting of side effects
If your child experiences any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Movicol Children Chocolate Flavour

Keep this medicine out of the sight and reach of children.

• Do not use Movicol Children Chocolate Flavour after the expiry date stated on the sachet and carton. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Once the Movicol Children Chocolate Flavour solution has been prepared with water, if your child cannot drink it all at once, store it in the refrigerator (2°C - 8°C) and keep it covered. Discard any unused solution after 24 hours.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Movicol Paediatric Chocolate Flavour contains
Each 6.9 g sachet of Movicol Paediatric Chocolate Flavour, powder for oral solution, contains:
Macrogol 3350 6.563 g
Sodium chloride 0.1754 g
Sodium hydrogen carbonate 0.0893 g
Potassium chloride 0.0159 g
Movicol Paediatric Chocolate Flavour contains chocolate flavour (containing benzyl alcohol E1519, see
section 2 “Movicol Paediatric Chocolate Flavour contains benzyl alcohol”) and acesulfame potassium E950 as
sweetener.
When dissolved in a quarter glass of water (62.5 ml), each sachet provides the following equivalent amounts:
Sodium 65 millimoles/litre
Chloride 51 millimoles/litre
Potassium 5.4 millimoles/litre
Bicarbonate 17 millimoles/litre

Description of the appearance of Movicol Paediatric Chocolate Flavour and contents of the pack
Movicol Paediatric Chocolate Flavour is available in rectangular sachets and tubular sachets (stick-packs).
Movicol Paediatric Chocolate Flavour is a powder ranging in colour from white to light brown.
Movicol Paediatric Chocolate Flavour is available in packs of 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Norgine Italia S.r.l., Piazza Gae Aulenti, 1 Torre B, 20154 Milano, Italy.

Manufacturer responsible for batch release:
Norgine B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, The Netherlands
or
Meribel Pharma Höganäs AB, Sporthallsvägen 6, 263 35 Höganäs, Sweden

This medicinal product is authorised in the European Economic Area countries under the following
names:
Belgium MOVICOL Junior Aroma / MOVICOL Junior Arôme
Germany Macrogol Norgine Junior Schokoladengeschmack
Finland Movicol Junior Chocolate
Ireland Movicol Paediatric Chocolate flavour
Italy Movicol Bambini 6.9 g powder for oral solution, Chocolate flavour
Portugal Movicol Pediátrico Chocolate
Spain MOVICOL Pediátrico Sabor Chocolate
Sweden Movicol Junior Choklad

Distributor:
NOOS (logo)
Via Campello sul Clitunno 34
00181 - Roma, Italy

Patient information leaflet

MOVICOL Children 6.9 g, powder for oral solution, Unflavoured

Macrogol 3350, Sodium chloride, Sodium hydrogen carbonate, Potassium chloride
Please read this leaflet carefully before you start giving this medicine to your child
as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor,
pharmacist or nurse has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If your child experiences any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.
• Contact your doctor if you do not notice improvement or if symptoms worsen.

Contents of this leaflet

1. What Movicol Children Unflavoured is and what it is used for
2. What you need to know before giving Movicol Children Unflavoured
3. How to give Movicol Children Unflavoured
4. Possible side effects
5. How to store Movicol Children Unflavoured
6. Contents of the pack and other information

1. What Movicol Children Unflavoured is and what it is used for

The name of this medicine is Movicol Children Unflavoured, 6.9 g sachet, powder for oral solution.
It is a laxative for the treatment of chronic constipation in children aged 1 to 11 years, and for the treatment of severe constipation (called faecal impaction) in children aged 5 to 11 years.
Movicol Children Unflavoured helps your child achieve proper bowel evacuation even if constipation has been ongoing for a long time.

2. What you need to know before giving Movicol Bambini Senza Aroma to your child

Do not give Movicol Bambini Senza Aroma if your doctor has told you that your child has:

• intestinal blockage (intestinal obstruction, ileus)
• perforation of the intestinal wall
• a severe inflammatory bowel disease such as ulcerative colitis, Crohn's disease, or toxic megacolon
• an allergy to the active substances in Movicol Bambini Senza Aroma (listed in section 6)

If your child has heart or kidney problems, an impaired pharyngeal reflex, or reflux esophagitis
(heartburn caused by stomach contents returning into the esophagus), consult your doctor before giving
Movicol Bambini Senza Aroma.
Warnings and precautions
When taking Movicol Bambini Senza Aroma, your child should continue to drink plenty of fluids.
The fluid content in Movicol does not replace the need for regular fluid intake.
Other medicines and Movicol Bambini Senza Aroma
Inform your doctor if your child is taking, has recently taken, or might take any other medicines.
Some medicines, e.g. antiepileptics, may be less effective during treatment with Movicol Bambini Senza Aroma. When your child is taking large volumes of Movicol Bambini Senza Aroma (e.g. for fecal impaction), other medicines may be expelled through the digestive tract. Your child should not take any other oral medicines during, one hour before, or one hour after taking Movicol Bambini Senza Aroma.
If you need to thicken liquids to allow easier swallowing, Movicol Bambini Senza Aroma may counteract the thickening agent's effect.
Pregnancy and breastfeeding
Movicol Bambini Senza Aroma may be given during pregnancy and while breastfeeding.
Ask your pharmacist or doctor for advice before giving Movicol Bambini Senza Aroma.
Movicol Bambini Senza Aroma contains sodium
Movicol Bambini Senza Aroma contains 93.4 mg (4.062 mmol) of sodium (the main component of table salt) per sachet. This corresponds to 4.6% of the maximum daily recommended dietary intake for an adult.

3. How to take Movicol Children Without Flavor

This medicine can be taken at any time, with or without food.
Dissolve the contents of each sachet in 62.5 ml (a quarter of a glass) of water and drink.

Chronic constipation
The dose of Movicol Children Without Flavor depends on the child's age and response to treatment.

• As an initial dose, children aged 1 to 6 years should receive 1 sachet (= 1 dose) daily.
• Children aged 7 to 11 years should receive 2 sachets daily. Your doctor may instruct you to increase the number of sachets until your child produces soft stools. If it is necessary to increase the dose, this should be done on alternate days. For children under 2 years of age, no more than 2 sachets per day should be taken. For children aged between 2 and 11 years, normally no more than 4 sachets per day are required.

It is not necessary to drink the entire solution at once; if preferred, the child may drink half in the morning and the other half in the evening.

Faecal impaction
Before your child takes Movicol Children Without Flavor for the treatment of faecal impaction, a doctor must confirm that your child actually has this condition.
A treatment cycle with Movicol Children Without Flavor is as follows:

Number of sachets of Movicol Children Unflavoured
Age (years)	Day 1	Day 2	Day 3	Day 4	Day 5	Day 6	Day 7
5 -11	4	6	8	10	12	12	12

The daily number of sachets should be taken as divided doses, all consumed within a 12-hour period (e.g. 8:00–20:00). Each sachet must be dissolved in 62.5 ml (a quarter of a glass) of water. The treatment regimen may be discontinued once the medicine has taken effect. This occurs when your child produces a large amount of stools and/or watery diarrhoea.

How to mix

• Open the sachet and pour the contents into a glass. Add a quarter of a glass of water (approximately 62.5 ml) to the glass. Stir well until all the powder has dissolved and the Movicol Children Unflavoured solution is clear or slightly cloudy, then give it to your child to drink.
• If desired, you may improve the taste of the drink by adding, for example, orange juice. If your child is taking Movicol Children Unflavoured for faecal impaction, it may be easier to dissolve 12 sachets in 750 ml of water.

Duration of treatment
Chronic constipation:
Treatment should continue for a prolonged period, at least 6–12 months.
Faecal impaction:
Treatment with Movicol Children Unflavoured may last up to 7 days.

If your child takes more Movicol Children Unflavoured than they should
Your child may experience excessive diarrhoea, which could lead to dehydration. In this case, stop treatment with Movicol Children Unflavoured and drink plenty of fluids. If you are concerned, consult your doctor or pharmacist.

If you forget to give Movicol Children Unflavoured
Give the missed dose as soon as you remember.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately and stop giving Movicol Children Unflavoured to your child if they:

• have a severe allergic reaction causing difficulty breathing, or swelling of the face, lips, tongue or throat.

Very common side effects (affects more than 1 in 10 people):

• stomach pain
• stomach rumbling

Common side effects (affects more than 1 in 100 but less than 1 in 10 people):

• diarrhoea
• vomiting (feeling sick)
• nausea (feeling like being sick)
• anal irritation (feeling of discomfort around the anus)
  If your child is being treated for chronic constipation, diarrhoea normally improves by reducing the dose.

Uncommon side effects (affects more than 1 in 1,000 but less than 1 in 100 people):

• bloated stomach
• flatulence

Rare side effects (affects less than 1 in 1,000 people):

• allergic reactions, which may include shortness of breath or difficulty breathing

Other reported side effects include:
rash, itching, redness of the skin or hives, swelling of hands, feet or ankles, headache, indigestion, high or low levels of potassium in the blood.

Reporting of side effects
If your child experiences any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Movicol Children Flavour Free

Keep this medicine out of the sight and reach of children.

• Do not use Movicol Children Flavour Free after the expiry date stated on the sachet and the box. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Once the solution of Movicol Children Flavour Free has been prepared in water, if your child cannot drink it all at once, store it in the refrigerator (2°C - 8°C) and keep it covered. Discard any unused solution after 24 hours. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Movicol Bambini Senza Aroma contains
Each 6.9 g sachet of Movicol Bambini Senza Aroma, powder for oral solution, contains:
Macrogol 3350 6.563 g
Sodium chloride 0.1754 g
Sodium hydrogen carbonate 0.0893 g
Potassium chloride 0.0251 g
Movicol Bambini Senza Aroma does not contain colouring agents, flavours or sweeteners.
When dissolved in a quarter glass of water (62.5 ml), each sachet provides the equivalent of:
Sodium 65 millimoles/litre
Chloride 53 millimoles/litre
Potassium 5.4 millimoles/litre
Bicarbonate 17 millimoles/litre

Description of the appearance of Movicol Bambini Senza Aroma and contents of the pack
Movicol Bambini Senza Aroma is available in rectangular sachets and tubular sachets (stick-packs).
Movicol Bambini Senza Aroma is a white powder.
Movicol Bambini Senza Aroma is available in packs of 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Norgine Italia S.r.l., Piazza Gae Aulenti, 1 Torre B, 20154 Milano, Italy.

Responsible producer for batch release:
Norgine B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, The Netherlands
or
Meribel Pharma Höganäs AB, Sporthallsvägen 6, 263 35 Höganäs, Sweden

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria MOVICOL Junior aromafrei
Belgium MOVICOL Junior Neutral
Finland MOVICOL Junior Plain
Germany Macrogol Norgine Junior Neutral Pulver zur Herstellung einer Lösung zum Einnehmen
Ireland MOVICOL Paediatric Plain
Italy Movicol Bambini 6.9 g powder for oral solution, Senza Aroma
Luxembourg MOVICOL Junior Neutral
Malta MOVICOL Paediatric Plain
Spain MOVICOL Pediátrico Sabor Neutro
Sweden Movicol Junior Neutral
Portugal Movicol Pediátrico Sabor Neutro

Marketing Authorisation Holder and Distributor:
NOOS (logo)
Via Campello sul Clitunno 34
00181 - Roma, Italy

Patient information leaflet

MOVICOL 13.7 g, oral solution powder, Unflavoured

Macrogol 3350, Sodium chloride, Sodium hydrogen carbonate, Potassium chloride
Please read this leaflet carefully before starting to take this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Movicol Unflavoured is and what it is used for
2. What you need to know before taking Movicol Unflavoured
3. How to take Movicol Unflavoured
4. Possible side effects
5. How to store Movicol Unflavoured
6. Contents of the pack and other information

1. What Movicol Sugar Free is and what it is used for

The name of this medicine is Movicol Sugar Free, 13.7 g sachet, powder for oral solution. It is a
laxative for the treatment of constipation in adults, adolescents and the elderly. It is not recommended for children
under 12 years of age.
Movicol Sugar Free helps you achieve adequate bowel evacuation even if constipation has been present
for a long time. Movicol Sugar Free is also effective in the treatment of severe constipation, known as
fecal impaction.

2. What you need to know before taking Movicol Without Flavor

Do not take Movicol Without Flavor if your doctor has told you that you have:

• intestinal blockage (intestinal obstruction, paralysis of the intestine (ileus))
• perforation of the intestinal wall
• a serious inflammatory bowel disease such as ulcerative colitis, Crohn's disease, or toxic megacolon
• an allergy to the active substances of Movicol Without Flavor (listed in section 6).

Warnings and precautions
When taking Movicol Without Flavor, you must continue to drink plenty of fluids. The fluid content
in Movicol does not replace the regular intake of fluids.
Cardiac conditions
If you are taking Movicol Without Flavor for fecal impaction, follow the special instructions provided in section 3.
Other medicines and Movicol Without Flavor
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines, e.g. antiepileptics, may be less effective during treatment with Movicol Without Flavor.
You must not take other oral medicines at the same time, or within one hour before or one hour after taking Movicol Without Flavor.
If you need to thicken liquids in order to swallow them safely, Movicol Without Flavor may interfere with the thickening agent's effect.
Pregnancy and breastfeeding
Movicol Without Flavor may be taken during pregnancy and while breastfeeding.
If you are pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking Movicol Without Flavor.
Driving and using machines
Movicol Without Flavor does not affect your ability to drive or operate machinery.
Movicol Without Flavor contains sodium
Talk to your doctor or pharmacist if you need to take 3 or more sachets per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.
Movicol Without Flavor contains 186.87 mg of sodium (main component of table salt) per sachet.
This corresponds to 9.3% of the recommended maximum daily dietary intake for an adult.

3. How to take Movicol Unflavoured

This medicine can be taken at any time, with or without food.
Dissolve the contents of each sachet in 125 ml (half a glass) of water and drink.

Constipation:
A dose of Movicol Unflavoured is 1 sachet dissolved in 125 ml (half a glass) of water.
Take 1 sachet 1 to 3 times a day, depending on the severity of your constipation.

Faecal impaction:
Before taking Movicol Unflavoured for the treatment of faecal impaction, it must be confirmed that you suffer from this condition.
For the treatment of faecal impaction, a dose of 8 sachets per day of Movicol Unflavoured is required. Each sachet must be dissolved in 125 ml (half a glass) of water. The 8 sachets should be taken within 6 hours, if necessary for up to 3 days. If you have a heart condition, do not take more than 2 sachets per hour.

How to mix:
Open the sachet and pour the contents into a glass. Add about 125 ml of water to the glass (half a glass). Stir well until all the powder has dissolved and the Movicol Unflavoured solution is clear or slightly cloudy, then drink the solution. If you are taking Movicol Unflavoured for faecal impaction, it may be easier to dissolve 8 sachets in 1 litre of water.

Duration of treatment

Constipation:
Treatment with Movicol Unflavoured usually lasts about 2 weeks. If you need to take Movicol Unflavoured for longer, consult your doctor. If your constipation is caused by a disease such as Parkinson's disease or multiple sclerosis, or if you are taking medicines that cause constipation, your doctor may recommend that you take Movicol Unflavoured for longer than 2 weeks.
If you need to take Movicol Unflavoured for longer, consult your doctor. Generally, in long-term treatment, the dose may be reduced to 1 or 2 sachets per day.

Faecal impaction:
Treatment with Movicol Unflavoured may last up to 3 days.

If you take more Movicol Unflavoured than you should
You may experience excessive diarrhoea, which could lead to dehydration. In this case, stop treatment with Movicol Unflavoured and drink plenty of fluids. If you are concerned, consult your doctor or pharmacist.

If you forget to take Movicol Unflavoured
Take the missed dose as soon as you remember.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately and stop taking Movicol Senza Aroma if:

• you have a severe allergic reaction causing difficulty breathing or dizziness, or swelling of the face, lips, tongue or throat.

Other side effects include:
allergic reactions which may cause skin rashes, itching, redness of the skin or hives, swelling of the hands, feet or ankles, headache, and high or low levels of potassium in the blood.
You may sometimes experience stomach pain or gurgling noises. You may also feel bloated, suffer from flatulence, nausea or vomiting. In addition, when you first start taking Movicol Senza Aroma, you may experience anal discomfort and mild diarrhoea. These side effects usually improve by reducing the dose of Movicol Senza Aroma you are taking.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Movicol Unflavoured

Keep this medicine out of the sight and reach of children.
Do not use Movicol Unflavoured after the expiry date stated on the sachet and carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Once the Movicol Unflavoured solution has been prepared in water, if you are unable to drink it all at once, store it in the refrigerator (2°C – 8°C) and keep it covered. Discard any unused solution after 24 hours.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Movicol Without Flavour contains
Each 13.7 g sachet of Movicol Without Flavour contains:
Macrogol 3350 13.125 g
Sodium chloride 0.3508 g
Sodium hydrogen carbonate 0.1786 g
Potassium chloride 0.0502 g

When dissolved in 125 millilitres of water, each sachet provides the equivalent of:
Sodium 65 millimoles/litre
Chloride 53 millimoles/litre
Potassium 5.4 millimoles/litre
Hydrogen carbonate 17 millimoles/litre

Description of the appearance of Movicol Without Flavour and contents of the pack
Movicol Without Flavour is available in rectangular sachets and tubular sachets (stick-packs).
Movicol Without Flavour is a white powder.
Movicol Without Flavour is available in packs of 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Norgine Italia S.r.l., Piazza Gae Aulenti, 1 Torre B, 20154 Milano, Italy.

Responsible producer for batch release:
Norgine B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, The Netherlands
or
SOPHARTEX, 21 rue du Pressoir, 28500 VERNOUILLET, France

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium MOVICOL Neutral
Finland MOVICOL Plain
Ireland MOVICOL Plain
Italy MOVICOL 13.7 g, powder for oral solution, Without Flavour
Spain MOVICOL Sabor Neutro polvo para solución oral en sobre
Sweden Movicol Neutral

Patient Information Leaflet

MOVICOL oral solution sachet

Macrogol 3350, Sodium Chloride, Sodium Hydrogen Carbonate, Potassium Chloride
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Movicol oral solution is and what it is used for
2. What you need to know before taking Movicol oral solution
3. How to take Movicol oral solution
4. Possible side effects
5. How to store Movicol oral solution
6. Package contents and other information

1. What Movicol Oral Solution is and what it is used for

The name of this medicine is Movicol Oral Solution in sachet form. It is a laxative used for the treatment of constipation in adults, adolescents and the elderly. It is not recommended for children under 12 years of age. Movicol Oral Solution helps you achieve adequate bowel evacuation, even if constipation has been present for a long time. Movicol Oral Solution is also effective in the treatment of severe constipation, known as fecal impaction.

Consult your doctor if you do not feel better within 2 weeks or if you feel worse.

2. What you need to know before taking Movicol oral solution

Do not take Movicol oral solution if your doctor has told you that you have:

• intestinal blockage (intestinal obstruction, ileus)
• intestinal perforation (a hole in the wall of the intestine)
• a severe inflammatory bowel disease such as ulcerative colitis, Crohn's disease or toxic megacolon
• an allergy to the active substances or to any of the other ingredients of Movicol oral solution (listed in section 6).

Warnings and precautions
When taking Movicol oral solution, you should continue to drink plenty of fluids.
The fluid content in Movicol does not replace the need for regular fluid intake.
Cardiac conditions
If you are taking Movicol oral solution for faecal impaction, follow the special instructions provided in section 3.
Other medicines and Movicol oral solution
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines, for example antiepileptics, may be less effective during treatment with Movicol oral solution.
You must not take other oral medicines at the same time, or within one hour before or one hour after taking Movicol concentrated oral solution.
If you need to thicken liquids in order to swallow them safely, Movicol oral solution may interfere with the effect of the thickening agent.
Pregnancy and breastfeeding
Movicol oral solution may be taken during pregnancy and while breastfeeding.
If you are pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking Movicol oral solution.
Driving and using machines
Movicol oral solution does not affect your ability to drive or operate machinery.
Movicol oral solution contains sodium
Talk to your doctor or pharmacist if you need to take 3 or more sachets per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.
Movicol oral solution contains 186.87 mg of sodium (the main component of table salt) per sachet.
This corresponds to 9.3% of the maximum recommended daily dietary intake for an adult.

3. How to take Movicol oral solution

This medicine can be taken at any time, with or without food or drinks.
Drink Movicol oral solution directly from the sachet. It is not necessary to dilute it in water.
It is recommended to drink an adequate amount of fluids (generally 2 to 2.5 litres per day) to maintain good health and a healthy bowel.
Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Constipation
One dose of Movicol oral solution is one 25 ml sachet.
Take 1 to 3 sachets per day, divided into doses, depending on your response to Movicol oral solution.

Faecal impaction
Before taking Movicol oral solution for faecal impaction, it must be confirmed that you have this condition.
For the treatment of faecal impaction, 8 sachets per day of Movicol oral solution are required. The 8 sachets should be taken within a 6-hour period. If you have a heart condition, do not take more than 2 sachets per hour.
If you have severe constipation (called faecal impaction), it is recommended that you drink an additional 1 litre of fluid per day.

Duration of treatment:

Constipation
Treatment with Movicol oral solution usually lasts about 2 weeks. If you need to take Movicol oral solution for a longer period, consult your doctor. If your constipation is caused by a disease such as Parkinson's disease or multiple sclerosis, or if you are taking medicines that cause constipation, your doctor may advise you to take Movicol oral solution for longer than 2 weeks.
Generally, in long-term treatment, the dose may be reduced to 1 or 2 sachets per day.

Faecal impaction
Treatment with Movicol oral solution may last up to 3 days.

If you take more Movicol oral solution than you should
You may experience excessive diarrhoea, which could lead to dehydration. In this case, stop treatment with Movicol oral solution and drink plenty of fluids. If you are concerned, contact your doctor or pharmacist.

If you forget to take Movicol oral solution
Take the missed dose as soon as you remember.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately and stop taking Movicol oral solution if:
you have a severe allergic reaction causing difficulty breathing, or swelling of the face, lips, tongue or throat.

Other side effects include:
allergic reactions which may cause skin rashes, itching, redness of the skin or hives, swelling of the hands, feet or ankles, headache, and high or low blood potassium levels.

You may sometimes experience indigestion, stomach ache or rumbling noises in the stomach. You may also feel bloated, suffer from flatulence, nausea or vomiting. Additionally, when you first start taking Movicol oral solution, you may experience anal discomfort and mild diarrhoea. These side effects usually improve by reducing the dose of this medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Movicol oral solution

Keep this medicine out of the sight and reach of children.
Do not use Movicol oral solution after the expiry date stated on the sachet and carton. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not refrigerate or freeze.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Movicol oral solution contains
Each 25 ml sachet of Movicol oral solution contains the following active substances:
Macrogol 3350 13.125 g
Sodium chloride 0.3508 g
Sodium hydrogen carbonate 0.1786 g
Potassium chloride 0.0502 g
Movicol oral solution also contains sucralose, purified water, and strawberry-banana flavouring, which contains
natural flavouring substances (containing strawberry and banana extracts), flavouring preparations (containing
celery), and propylene glycol.
Each 25 ml sachet provides the following equivalents:
Sodium 8.125 mmol
Chloride 6.675 mmol
Potassium 0.675 mmol
Hydrogen carbonate 2.125 mmol

Description of the appearance of Movicol oral solution and contents of the pack
Movicol oral solution is a clear, colourless to light yellow liquid.
Movicol oral solution is available in packs containing 10, 20, 30 and 50 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Norgine Italia S.r.l., Piazza Gae Aulenti, 1 Torre B, 20154 Milano, Italy

Responsible producer for batch release:
Norgine Pharma, 29 Rue Ethé Virton, 28100 Dreux Cedex, France

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium MOVICOL Unidose
Finland MOVICOL Ready to Take
Germany Macrogol Norgine trinkfertig Lösung zum Einnehmen im Beutel
Ireland MOVICOL Ready to Take
Italy MOVICOL
Portugal MOVICOL
Spain MOVICOL solución oral en sobre
Sweden Movicol oral lösning i dospåse

Package leaflet: Information for the patient

MOVICOL 13.9 g/25 ml oral solution concentrate, Orange flavour

Macrogol 3350, Sodium chloride, Sodium hydrogen carbonate, Potassium chloride
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Movicol oral solution concentrate is and what it is used for
2. What you need to know before taking Movicol oral solution concentrate
3. How to take Movicol oral solution concentrate
4. Possible side effects
5. How to store Movicol oral solution concentrate
6. Contents of the pack and other information

1. What Movicol Concentrate for Oral Solution Is and What It Is Used For

The name of this medicine is Movicol Concentrate for Oral Solution, Orange flavour. It is a laxative for the
treatment of chronic constipation in adults, adolescents and the elderly. It is not recommended for children under
12 years of age.
Movicol Concentrate for Oral Solution helps you achieve adequate bowel evacuation even if constipation has persisted for a long time.
Do not take Movicol Concentrate for Oral Solution if you have severe constipation, known as faecal impaction.

2. What you need to know before taking Movicol oral solution concentrate

Do not take Movicol oral solution concentrate if your doctor has told you that you have:

• intestinal blockage (intestinal obstruction, paralytic ileus)
• perforation of the intestinal wall
• a severe inflammatory bowel disease such as ulcerative colitis, Crohn's disease, or toxic megacolon
• an allergy to the active substances or to any of the other ingredients of Movicol oral solution concentrate (listed in section 6)

Warnings and precautions
When taking Movicol oral solution concentrate, you should continue to drink plenty of fluids. The fluid content
of Movicol does not replace the regular intake of fluids.
Other medicines and Movicol oral solution concentrate
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
Some medicines, e.g. antiepileptics (medicines for epilepsy), may be less effective during treatment with Movicol oral solution concentrate.
You should not take other oral medicines at the same time, or within one hour before or one hour after taking Movicol oral solution concentrate.
If you need to thicken liquids in order to swallow them safely, Movicol oral solution concentrate may interfere with the thickening agent's effect.
Pregnancy and breastfeeding
Movicol oral solution concentrate may be taken during pregnancy and while breastfeeding.
If you are pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking Movicol oral solution concentrate.
Driving and using machines
Movicol oral solution concentrate does not affect the ability to drive or operate machinery.
Movicol oral solution concentrate contains ethyl parahydroxybenzoate, methyl parahydroxybenzoate,
alcohol (ethanol), benzyl alcohol, and sodium
This medicine contains ethyl and methyl parahydroxybenzoates, which may cause allergic reactions, including delayed reactions.
This medicine contains 74.6 mg of alcohol (ethanol) in 25 ml of oral solution concentrate, equivalent to 3.0 mg of alcohol (ethanol) per ml. The amount in 25 ml of oral solution concentrate 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 produce significant effects.
This medicine contains 45.6 mg of benzyl alcohol in each diluted dose of 125 ml.
Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice if you have liver or kidney disease, if you are pregnant, or if you are breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause unwanted effects (such as metabolic acidosis).
Talk to your doctor or pharmacist if you need 3 doses per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.
Movicol oral solution concentrate contains 186.87 mg of sodium (a main component of table salt) per 25 ml dose. This corresponds to 9.3% of the maximum daily intake recommended in an adult's diet.
Do not exceed the recommended dose.

3. How to take Movicol concentrate for oral solution

This medicine can be taken at any time, with or without food.
This product must be diluted before use.
One dose of Movicol concentrate is 25 ml of product diluted in 100 ml of water.
Take this dose 1–3 times a day, depending on the severity of your constipation.
How to mix:
Open the bottle and measure 25 ml or five 5-ml teaspoons. Pour the liquid into a glass and add 100 ml (about half a glass) of water. Mix well until the liquid is completely and evenly blended and the diluted Movicol concentrate solution becomes clear, then drink the solution.
Rinse the dosing cap after use and replace it on the bottle.
Duration of treatment
Treatment with Movicol concentrate usually lasts about 2 weeks. If you need to take Movicol concentrate for a longer period, consult your doctor. If your constipation is caused by a disease such as Parkinson's disease or multiple sclerosis, or if you are taking medicines that cause constipation, your doctor may recommend taking Movicol concentrate for longer than 2 weeks. Generally, in long-term treatment, the dose may be reduced to 1 or 2 doses per day.
If you take more Movicol concentrate for oral solution than you should
You may experience excessive diarrhoea, which could lead to dehydration. In this case, stop treatment with Movicol concentrate and drink plenty of fluids. If you are concerned, consult your doctor or pharmacist.
If you forget to take Movicol concentrate for oral solution
Take the missed dose as soon as you remember.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately and stop taking Movicol Concentrate if you have a severe allergic reaction causing difficulty breathing, or swelling of the face, lips, tongue or throat.
Other allergic reactions may cause skin rash, itching, redness of the skin or hives, swelling of the hands, feet or ankles, and headache.
Other side effects include indigestion, stomach ache and rumbling stomach, and high or low levels of potassium in the blood. You may also feel bloated, suffer from flatulence, nausea or vomiting. In addition, when you first start taking Movicol Concentrate, you may experience anal discomfort and mild diarrhoea. These side effects usually improve by reducing the dose of Movicol Concentrate you are taking.
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Movicol concentrate for oral solution

Keep this medicine out of the sight and reach of children.
Do not use Movicol concentrate after the expiry date stated on the bottle. The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
Discard any unused product 30 days after first opening the bottle.
Once the Movicol concentrate solution has been prepared in water, if you are unable to drink it all at once, keep it covered.
Discard any unused solution within 24 hours.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Movicol Concentrate for Oral Solution contains
25 ml of Movicol concentrate for oral solution contains:
Macrogol 3350 13.125 g
Sodium chloride 0.3507 g
Sodium hydrogen carbonate 0.1785 g
Potassium chloride 0.0466 g

Movicol concentrate for oral solution also contains purified water, orange flavour, potassium acesulfame (E950) and sucralose (E955) as sweeteners. It also contains a preservative which includes benzyl alcohol (E1519), methyl parahydroxybenzoate (E218) and ethyl parahydroxybenzoate (E214). See section 2 “Movicol concentrate for oral solution contains ethyl parahydroxybenzoate, methyl parahydroxybenzoate, alcohol (ethanol), benzyl alcohol and sodium”.

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

When a 25 ml dose is diluted with 100 millilitres of water, it provides the following equivalent concentrations:
Sodium 65 millimoles/litre
Chloride 53 millimoles/litre
Potassium 5.4 millimoles/litre
Hydrogen carbonate 17 millimoles/litre

Description of the appearance of Movicol concentrate for oral solution and contents of the pack
Movicol concentrate for oral solution is a clear, colourless liquid.
Each pack consists of a box containing one plastic bottle of Movicol concentrate with 500 ml of solution and a plastic dosing cap.

Marketing Authorisation Holder:
Norgine Italia S.r.l., Piazza Gae Aulenti, 1 Torre B, 20154 Milano, Italy

Responsible manufacturer for batch release:
Norgine Pharma Dreux, 29, Rue Ethé Virton, 28109 Dreux Cedex, France

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria MOVICOL Liquid Orange
Belgium MOVICOL Vloeibaar Sinaasappelsmaak /
MOVICOL Liquide Goût orange /
MOVICOL Flüssig Orangengeschmack
Germany Macrogol Norgine Orangengeschmack Konzentrat zur Herstellung einer Lösung zum Einnehmen
Finland MOVICOL Appelsiini
Ireland MOVICOL Liquid Orange flavour
Italy MOVICOL 13.9 g/25 ml concentrate for oral solution, orange flavour
Portugal MOVICOL Laranja
Spain Movicol Sabor Naranja concentrado para solución oral
Sweden Movicol Apelsin