Bimotil Infantil 6.9 g powder for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Bimotil Infantil 6.9 g powder for oral solution

macrogol 3350/sodium chloride/sodium bicarbonate/potassium chloride

Read all of this leaflet carefully before you start giving this medicine to your child, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only for the child and must not be given to other people, even if they have the same symptoms as the child, since it could harm them.
• If the child experiences any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Bimotil Infantil is and what it is used for

The name of this medicine is Bimotil 6.9 g oral solution powder.

It is a laxative for the treatment of chronic constipation in children aged 1 to 11 years, and for the treatment of severe constipation (known as fecal impaction) in children aged 5 to 11 years.

Bimotil Infantil helps the child achieve regular bowel movements, even if the constipation is long-standing.

2. What you need to know before starting Bimotil Infantil

Do not give Bimotil Infantil to the child if your doctor has indicated that your child has:

• an allergy to the active substances in Bimotil Infantil or to any of the other components of this medicine (listed in section 6).
• intestinal blockage (intestinal obstruction, intestinal paralysis [ileus]),
• perforation of the intestinal wall,
• severe inflammatory bowel disease such as ulcerative colitis, Crohn's disease, or toxic megacolon.

If the child has a heart or kidney condition, a swallowing reflex disorder, or reflux esophagitis (heartburn caused by stomach contents flowing back into the esophagus), you must consult with your doctor before starting Bimotil Infantil.

Warnings and precautions

When administering Bimotil Infantil, the child should continue to drink plenty of fluids. The liquid content of Bimotil Infantil does not replace the usual fluid intake.

Other medicines and Bimotil Infantil

Inform your doctor if the child is taking, has recently taken, or might need to take any other medicines. It is recommended to wait at least 2 hours between taking Bimotil Infantil and other medicines.

Some medicines, such as antiepileptic drugs, may become less effective when taken together with this medicine. When large amounts of Bimotil Infantil are taken (e.g., for fecal impaction), the child should not take other medicines within one hour after taking Bimotil Infantil.

If you need to thicken liquids for safe swallowing, Bimotil Infantil may neutralize the thickening agent's effect.

Pregnancy and breastfeeding

This medicine may be used during pregnancy and breastfeeding. Consult your doctor or pharmacist before administering this medicine.

Driving and using machines

Bimotil Infantil does not affect the ability to drive or operate machinery.

Bimotil Infantil contains sodium, potassium, and aspartame

This medicine contains 93.4 mg of sodium (a main component of table/cooking salt) per sachet. This corresponds to 4.6% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you require four or more sachets daily over a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.

This medicine contains 5 mmol of potassium per sachet, which should be considered in patients with renal insufficiency or those on potassium-restricted diets.

This medicine contains 12.5 mg of aspartame per sachet. Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take Bimotil Infantil

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, please consult your doctor or pharmacist again.

This medicine can be taken at any time, with or without food.

Dissolve the contents of each sachet in 62.5 ml (1/4 glass) of water and take it.

Chronic constipation

The dose of Bimotil Infantil depends on the child's age and response to treatment.

• As an initial dose, children aged 1 to 6 years should take 1 sachet (= 1 dose) per day.
• Children aged 7 to 11 years should take 2 sachets per day.

Your doctor may instruct you to increase the number of sachets until the child achieves adequate bowel movement. If the dose is increased, this should be done every two days. Children under 2 years of age should not take more than 2 sachets per day. In children aged 2 to 11 years, more than 4 sachets per day is usually not necessary.

It is not necessary to drink the entire solution at once. If preferred, the child may take half of the drink in the morning and half in the afternoon.

Faecal impaction

Before the child takes this medicine for faecal impaction, it must be medically confirmed that the child actually has this condition.

Daily dosing regimen:

The daily number of sachets should be taken in divided doses, all consumed within 12 hours (for example, from 8 a.m. to 8 p.m.). Each sachet must be dissolved in 62.5 ml (1/4 glass) of water. The treatment may be interrupted when the medicine has taken effect. This is evidenced by the passage of large volumes of stools or watery diarrhea.

Preparation instructions

• Open the sachet and pour the contents into a glass. Add approximately 1/4 glass (about 62.5 ml) of water. Stir well until the powder is completely dissolved and the solution becomes clear or slightly cloudy, then give it to the child to drink.
• If desired, orange juice may be added to the drink to improve the taste. If the child is taking Bimotil Infantil for fecal impaction, it may be easier to dissolve 12 sachets in 750 ml of water.

Duration of treatment

Chronic constipation

The treatment should last for at least 6–12 months.

Fecal impaction

Treatment with Bimotil Infantil may last up to 7 days.

If the child takes more Bimotil Infantil than they should

The child may develop excessive diarrhea. If this occurs, stop treatment with Bimotil Infantil and provide plenty of fluids. If you are concerned, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to give Bimotil Infantil

Give the dose as soon as you remember. Do not give a double dose to make up for missed doses.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Tell your doctor immediately and stop administering Bimotil Infantil if the child:

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

Very common adverse effects (may affect more than 1 in 10 people)

• stomach pain
• stomach noises.

Common adverse effects (may affect up to 1 in 10 people)

• diarrhoea
• vomiting
• nausea
• anal discomfort (uncomfortable sensation around the anus).

If the child is being treated for chronic constipation, diarrhoea usually improves when the dose is reduced.

Uncommon adverse effects (may affect up to 1 in 100 people)

• stomach swelling
• flatulence.

Rare adverse effects (may affect up to 1 in 1,000 people)

• allergic reactions, possibly including dyspnoea or difficulty breathing.

Adverse effects with unknown frequency (frequency cannot be estimated from available data)

• skin rash (urticaria), itching, redness of the skin, or hives
• dyspnoea
• angioedema
• swelling of hands, feet, or ankles
• headache
• indigestion
• high or low blood potassium levels
• perianal inflammation.

Reporting of adverse effects

If you notice any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bimotil Infantil

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

Do not use this medicine after the expiry date stated on the sachet and carton after EXP. The expiry date refers to the last day of the month indicated.

Unopened sachets: this medicine does not require special storage conditions.

The solution once prepared should be stored in the refrigerator (between 2°C and 8°C) or at room temperature (between 19°C and 25°C) and must be used within 24 hours.

Do not use this medicine if you notice that any of the sachets are damaged.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bimotil Infantil

Each 6.9 g sachet contains:

Macrogol 3350 6.563 g

Sodium chloride 0.1754 g

Sodium bicarbonate 0.0893 g

Potassium chloride 0.0233 g

The other components are: orange flavour (corn maltodextrin, gum arabic (E414), citric acid (E330), butylated hydroxyanisole (E320) and other flavouring substances), lemon flavour (corn maltodextrin, flavouring preparations, flavouring substances, natural flavouring substances and alpha-tocopherol (E307)), aspartame (E951) and sucralose.

When dissolved in 62.5 ml (a quarter of a glass) of water, each sachet provides:

Sodium 65 millimoles/litre

Chloride 53 millimoles/litre

Potassium 5.0 millimoles/litre

Bicarbonate 17 millimoles/litre

Nature of the product and contents of the pack

Powder for oral solution.

Bimotil Infantil is a white crystalline powder. Bimotil Infantil is available in packs of 20 or 30 sachets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Italfarmaco, S.A.

C/ San Rafael 3

28108 Alcobendas, Madrid

Spain

Manufacturer

Laboratoires Macors

22 Rue Des Caillottes,

Auxerre, 89000, France

Italfarmaco, S.A.

C/ San Rafael 3

28108 Alcobendas, Madrid

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Spain Bimotil Infantil 6.9 g powder for oral solution

Greece Bimotil 6.9 g Κ?νις για π?σιμο δι?λυμα

Italy Benlaxid 6.9 g powder for oral solution

Netherlands Benlaxid 6.9 g powder for oral solution

Date of the most recent review of this leaflet: August 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).