Macrogol 3350 Norgine Oral Solution Powder in Single-Dose Pouches for Children
Over-the-counter medication

Macrogol 3350 Norgine Oral Solution Powder in Single-Dose Pouches for Children

Brand : Ides Pharma Ides Pharma

Order Macrogol 3350 Norgine Oral Solution Powder in Single-Dose Pouches for Children without a prescription and share your review. This medication is recommended for the treatment of constipation.

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What is Macrogol 3350 Norgine Oral Solution Powder in Single-Dose Pouches for Children used for?

Macrogol 3350 Norgine for Children is a mild and effective laxative, specifically formulated to meet the needs of young children suffering from occasional or chronic constipation. Thanks to its balanced formulation, it works gently to restore normal bowel movements without causing irritation or abdominal pain. Easy to administer and pleasant-tasting, this oral treatment makes life easier for parents while ensuring the child’s well-being.

This medication is based on an innovative formula containing Macrogol 3350, an osmotic agent known for its hydrating and laxative properties. By retaining water in the colon, macrogol softens stools and stimulates their passage without causing dehydration or electrolyte imbalance. It is not absorbed by the body, ensuring optimal safety and targeted effectiveness in the intestines.

Macrogol 3350 Norgine for Children is enriched with sodium, potassium, and bicarbonate—electrolytes essential for maintaining the body’s fluid and mineral balance. This combination helps prevent any adverse effects on the child’s overall health, particularly during prolonged treatment. The product is therefore an ideal solution for children who need regular support to improve their bowel movements.

Used for temporary constipation, sluggish bowel movements, or hard stools that are difficult to pass, Movicol offers a simple and effective solution. It is also suitable for certain specific medical conditions where gentle bowel evacuation is recommended. By restoring the body’s natural rhythm, it helps children regain daily digestive comfort and a lasting feeling of lightness.

This product is also appreciated for its ease of use: each single-dose packet is pre-measured and dissolves quickly in water. This convenient format makes it easier to adhere to the treatment, even for the most reluctant children. In addition, its mild lemon-lime flavor is well-accepted, which minimizes resistance at mealtime.

Macrogol 3350 NorgineEnfant is a comprehensive and well-designed solution for combating childhood constipation. Thanks to its gentle action, high tolerability, and safe formulation, it becomes a valuable ally for parents seeking to relieve their children’s discomfort with complete confidence. This laxative, which respects the body and its natural functions, is part of a comprehensive approach to supporting digestive health.

To complement the benefits of Macrogol 3350 Norgine or as a natural alternative, we recommend Boldoflorine Natural Laxative (40 tablets), which is perfect for gently complementing or replacing any laxative treatment.

How to use this product?

Directions for Use

Macrogol 3350 Norgine for Children comes in single-dose packets to be dissolved in water. For best results, dissolve 1 packet in 62.5 ml of water (about a quarter of a glass) and mix well before administration. The usual dosage varies depending on age, weight, and the severity of constipation. Generally, treatment begins with 1 to 2 sachets per day, taken in one or two doses, as directed by a doctor.

The effect is generally felt between 24 and 48 hours after the first dose. It is important to follow the prescribed doses and not to exceed the recommended amount without medical advice. Treatment may be continued until regular bowel movements are restored, always under medical supervision.

Share your feedback on the usage instructions and dosage of Macrogol 3350 Norgine Oral Solution Powder in Single-Dose Sachets for Children with our partner “Verified Reviews” after your purchase.

Precautions for Use

Macrogol 3350 Norgine should not be administered to patients allergic to any of its ingredients, nor to children suffering from severe intestinal disorders such as intestinal obstruction, gastrointestinal perforation, or acute inflammatory disorders of the gastrointestinal tract (such as ulcerative colitis or severe Crohn’s disease).

If in doubt, or if your child has unexplained abdominal pain, nausea, vomiting, or a fever, be sure to consult a healthcare professional before use. Treatment must be adjusted and monitored in children under 2 years of age.

It is also not recommended to continue use without medical advice. In the event of prolonged treatment, medical monitoring is recommended to prevent dependence on the product or electrolyte imbalance. Keep the packets out of the reach of children, at room temperature, and protected from moisture.

What are its ingredients?

Macrogol 3350, sodium bicarbonate, potassium chloride, sodium chloride.

Packaging

Macrogol 3350 Norgine for Children is available in a box of 20 single-dose sachets ready to be mixed with water. Each sachet is formulated to provide the ideal dose tailored to children’s bodies, ensuring effectiveness, safety, and ease of use.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Last updated: 05/07/2017

Name of the medicinal product

MOVICOL CHILDREN, powder for oral solution in sachet-dose

Macrogol 3350, sodium bicarbonate, potassium chloride, sodium chloride

framed

Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should talk to your doctor if you do not feel better or feel less well.

What is in this leaflet?

1. What is MOVICOL CHILD, powder for oral solution in a sachet-dose and in which cases it is used?

2. What should I know before taking MOVICOL CHILDREN powder for oral solution in a sachet-dose?

3. How to take MOVICOL CHILDREN, powder for oral solution in a sachet-dose?

4. What are the possible side effects?

5. How to store MOVICOL CHILDREN, powder for oral solution in a sachet-dose?

6. Package contents and other information.

1. WHAT IS MOVICOL CHILDREN, powder for oral solution in a sachet-dose AND WHAT CASES IS IT USED FOR?

Pharmacotherapeutic group - ATC code: A06AD65.

This medication belongs to the class of osmotic laxatives.

This medication is indicated in children from 2 years of age in case of faecal impaction.

Fecal impaction is defined as an accumulation of fecal matter in the rectum with no evacuation for several days.

2. BEFORE YOU TAKE MOVICOL CHILDREN, powder for oral solution in a sachet-dose?

Never take MOVICOL CHILDREN, powder for oral solution in sachet-dose:

· if you or your child are allergic (hypersensitive) to active substances (eg macrogol) or any of the other ingredients of MOVICOL CHILDREN listed in section 6.

· if you or your child are suffering from severe inflammatory bowel or colon disease.

· if you or your child have abdominal pain of indeterminate cause or if you may be suffering from intestinal occlusion (stopping material in a part of the intestine).

Warnings and Precautions

Talk to your doctor or pharmacist before taking MOVICOL CHILDREN, powder for oral solution in a sachet-dose.

The liquid contained in MOVICOL CHILDREN after reconstitution with water does not replace the regular water intake. Sufficient water intake must be maintained.

· Your doctor may decide to discontinue your treatment if you have signs of a change in the amount of mineral salts and water in your body (such as dehydration or heart failure).

· MOVICOL CHILDREN may decrease absorption of other medicines (see Other Medicines and MOVICOL CHILDREN powder for oral solution in sachet-dose).

· One of the active ingredients of this drug is macrogol (also called polyethylene glycol). Very rare allergic manifestations (rash on the skin, itching, swelling) have been reported with products containing polyethylene glycol. If any of these signs occur, contact a doctor immediately.

· In case of diet without salt or low in salt, take into account the sodium content: each sachet contains 95 mg of sodium.

· This medicine contains 13.19 mg of potassium per sachet, tell your doctor if you have kidney failure.

NO PROLONGED USE WITHOUT MEDICAL ADVICE.

The efficacy and safety of MOVICOL CHILDREN in the treatment of fecal matter have not been studied.

children

Not applicable.

Other medicines and MOVICOL CHILDREN, powder for oral solution in sachet-dose

MOVICOL CHILDREN can decrease the absorption of other medicines taken simultaneously, for example medicines treating epilepsy, which can decrease their effectiveness. If you are taking a treatment for epilepsy, talk to your doctor before taking MOVICOL CHILDREN.

Usual oral treatments should not be taken within 1 hour of ingesting MOVICOL CHILDREN.

Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines.

MOVICOL CHILDREN, powder for oral solution in sachet-dose with food and beverages

Not applicable.

Pregnancy and breast feeding

Although the treatment is for children aged 2 to 15 years of age, the following data are provided for information purposes only.

MOVICOL CHILDREN can be used during pregnancy and lactation.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

MOVICOL CHILDREN does not influence the ability to drive or use machines.

MOVICOL CHILDREN, powder for oral solution in sachet-dose contains potassium.

3. HOW TO TAKE MOVICOL CHILDREN, powder for oral solution in sachet-dose?

Dosage

The dosage should be adjusted according to the age of the child.

The recommended dose is divided into 2 daily intakes at the rate of:

· From 2 to 3 years: 4 to 5 sachets-doses per day (2 sachets-morning doses, 2 or 3 sachets-doses evening)

· From 4 to 8 years: 6 to 8 sachets-doses per day (3 or 4 sachets-doses morning and evening, in 2 doses)

· From 9 to 15 years: 8 to 10 sachets-doses per day (4 or 5 sachets-doses morning and evening, in 2 doses)

Always take the dose recommended by your doctor. In case of uncertainty consult your doctor or pharmacist.

Administration mode

Oral use.

Each sachet-dose must be opened and its contents dissolved in half a glass of water (62.5 ml). Activate the dissolution of the powder by mixing with a clean spoon until the solution obtained is clear. Get the solution to your child. The reconstituted solution can be stored for 24 hours in a refrigerated container.

Duration of treatment

Treatment will be continued until a satisfactory evacuation of accumulated feces (an average of 6 days of treatment) with a maximum duration of 7 days is obtained.

If your child took more MOVICOL CHILDREN, powder for oral solution in a sachet-dose than it should have

Diarrhea may occur. This usually disappears 24 to 48 hours after discontinuation or after dose reduction. In case of severe fluid loss by vomiting and / or diarrhea, stomach pain, consult your doctor.

If your child has not taken MOVICOL CHILDREN, powder for oral solution in sachet-dose

Do not give a double dose to make up for the missed dose.

Effects that may occur when treatment with MOVICOL CHILD Powder for oral solution in sachet-dose is discontinued

A risk of recurrence of faecal impaction exists when the treatment is discontinued. This risk should be evaluated with your doctor.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

· Diarrhea,

· Abdominal pain, nausea, vomiting, bloating,

· Very rare cases of allergic manifestations such as rash, itching, urticaria, respiratory disorders and edema or exceptionally anaphylactic reactions,

· redness,

· Headache,

· Hyperkalemia or hypokalaemia,

· Edema (swelling) of the limbs, especially the lower limbs.

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE MOVICOL CHILDREN, powder for oral solution in sachet-dose?

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

Do not use this medicine after the expiry date which is stated on the outer packaging after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

After reconstitution: the reconstituted solution may be stored for up to 24 hours at a temperature between + 2 ° C and + 8 ° C (in a refrigerator) in a closed container.

Any solution not used within 24 hours after reconstitution should be discarded.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What MOVICOL ENFANTS contains, powder for oral solution in sachet-dose

· The active substances are:

Macrogol 3350 ................................................ .................................................. 6.5630 g

Sodium bicarbonate............................................... .................................................. .. 0.0893 g

Potassium chloride............................................... .................................................. .. 0.0233 g

Sodium Chloride ............................................... .................................................. ....... 0.1754 g

For a sachet-dose.

· The other components are: acesulfame potassium (E950); lemon-lime flavor.

What is MOVICOL ENFANTS, powder for oral solution in sachet-dose and contents of the pack

This medication is in the form of a powder for oral solution in a sachet-dose.

Box of 20, 30 or 100 sachets-doses.

Marketing Authorization Holder

NORGINE BV

HOGEHILWEG 7

1101 CA AMSTERDAM ZO

NETHERLANDS

Marketing Authorization Operator

NORGINE SAS

2 RUE JACQUES DAGUERRE

92500 RUEIL-MALMAISON

Maker

NORGINE LIMITED

NEW ROAD

TIR-Y-BERTH HENGOED

MID GLAMORGAN

WALES CF82 8SJ

UK

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

Other

Detailed information on this medicine is available on the ANSM website (France).

HOW TO REDUCE THE RISK OF RECOVERY?

To minimize the risk of recurrence, treatment includes:

· increased dietary intakes of vegetable products (green vegetables, raw vegetables, wholemeal bread, fruits, etc.);

· increased consumption of water and fruit juices;

· an increase in physical activities (sports, walking, etc.);

· rehabilitation of the defecation reflex;

· sometimes, adding sound to the diet.

In all cases and if you have any doubts, do not hesitate to seek advice from your doctor or pharmacist.

VIDAL OF THE FAMILY

MOVICOL

Osmotic laxative

. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

MOVICOL: powder for oral solution (lemon flavoring); box of 20 bags.
Refunded at 30%. - price: 3,18 euro (s).

MOVICOL Chocolate: powder for oral solution (chocolate flavor); box of 20 bags.
Refunded at 30%. - price: 3,18 euro (s).

MOVICOL No flavoring: powder for oral solution; box of 20 bags.
Refunded at 30%. - price: 3,18 euro (s).

MOVICOL Child: powder for oral solution (lemon flavoring, lime); box of 20 bags.
Refunded at 30%. - price: 4,72 euro (s).

Laboratory

COMPOSITION (summary)
p sachet p bag Enf
Macrogol 3350 13.12 g 6.563 g
Potassium chloride 46.6 mg 23.3 mg
Sodium Chloride 350.7 mg 175.4 mg
Sodium bicarbonate 178.5 mg 89.3 mg
Either sodium 190 mg 95 mg

INDICATIONS (summary)
This medicine contains an osmotic laxative . It attracts water into the intestine and increases stool volume.
It is used in the symptomatic treatment of constipation in adults.
It is also used in cases of severe constipation resulting in an accumulation of fecal matter in the rectum.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • inflammatory bowel disease,
  • intestinal occlusion or condition predisposing to occlusion,
  • abdominal pain of unknown cause.
WARNING (Contents)
In case of repetitive or prolonged abdominal pain, this medication should not be taken without medical advice.
This drug contains salt (sodium) in significant quantities.
PREGNANCY AND BREAST-FEEDING (summary)
This medicine contains only presumed safe substances during pregnancy or lactation. However, do not use it prolonged without the advice of your pharmacist or doctor.
DIRECTIONS FOR USE AND DOSAGE (summary)
The contents of the sachets must be diluted in a glass of water.
The laxative effect occurs 24 to 48 hours after taking the medication.

Usual dosage:

Constipation:
  • Adult: 1 to 2 sachets per day, in one dose, in the morning.
In case of severe constipation with stool accumulation:
  • Adult: 4 sachets, morning and evening, for 1 to 3 days.
  • Child 9 to 15 years: 4 or 5 sachets Child, morning and evening, for 6 days on average.
  • Child 4 to 8 years: 3 or 4 sachets Child, morning and evening, for 6 days on average.
  • Child 2 to 3 years: 2 sachets Child in the morning and 2 or 3 sachets Children in the evening, for 6 days on average.
TIPS (summary)
Reconstituted Adults and Children can be stored for up to 6 hours and 24 hours in the refrigerator and in a closed container.
The treatment of constipation is essentially based on hygiene measures: high-fiber food, abundant drinks, regular physical activity and time to get to the saddle.
POSSIBLE ADVERSE EFFECTS (summary)
Abdominal pain.
Diarrhea in case of overdose .
Rarely: allergic reaction ( urticaria , edema ).


GLOSSARY (summary)


osmotic laxative
Laxative to make stools more liquid by retaining water in the contents of the intestine. It is devoid of toxicity.


edema
Accumulation of water or lymph causing localized swelling.


allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


salt
Chemical substance of which the best known is sodium chloride, or table salt. The diet salt does not contain sodium; this is generally replaced by potassium.


overdose
Excessive intake of a drug may result in an increase in the intensity of adverse effects or even in the development of specific adverse effects.
This overdose may result from accidental or voluntary poisoning for suicide, so consult your local Poison Control Center (listed in the appendix to the book). However, in most cases, overdose is the result of an error in the understanding of the prescription, or the search for an increase in efficacy by exceeding the recommended dosage. Finally, untimely self-medication may lead to excessive absorption of the same substance contained in different drugs. Some drugs are particularly prone to this risk because they are (wrongly) considered to be harmless: vitamins A and D, aspirin, etc. Stopping or decreasing drug intake helps to remove the disorders associated with an overdose.


symptomatic treatment
Treatment that suppresses or alleviates the symptoms of a disease without addressing its cause.


urticaria
Eruption of pimples on the skin, whose origin is mostly allergic. The buds look like nettles and their color varies from pale pink to red.

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