BIMOTIL INFANTIL 6.9 g ORAL SOLUTION POWDER

Introduction

Package Leaflet: Information for the Patient

Bimotil Infantil6.9 gpowder for oral solution

macrogol 3350/sodium chloride/sodium bicarbonate/potassium chloride

Read the entire package leaflet carefully before starting to give this medicine to your child, as it contains important information for you.

• Keep this package 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 to your child only, and you should not give it to others, even if they have the same symptoms as your child, as it may harm them.
• If your child experiences side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Bimotil Infantil and what is it used for
2. What you need to know before starting to give Bimotil Infantil
3. How to take Bimotil Infantil
4. Possible side effects
5. Storage of Bimotil Infantil
6. Contents of the pack and further information

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

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

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

Bimotil Infantil helps your child have a proper bowel movement, even if the constipation is long-lasting.

2. What you need to know before starting to give Bimotil Infantil

Do not give Bimotil Infantil to your child if their doctor has told them that they have:

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

If your child has a heart or kidney problem, a swallowing reflex disorder, or esophagitis due to reflux (heartburn caused by the backflow of stomach contents into the esophagus), they should consult their doctor before starting to take Bimotil Infantil.

Warnings and precautions

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

Other medicines and Bimotil Infantil

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

Some medicines, such as antiepileptics, may not be as effective when taken with this medicine. When taking large volumes of Bimotil Infantil (e.g., for fecal impaction), your child should not take other medicines for 1 hour after taking Bimotil Infantil.

If you need to thicken fluids to swallow them safely, Bimotil Infantil may neutralize the effect of the thickener.

Pregnancy and breastfeeding

This medicine can be taken during pregnancy and breastfeeding. Consult your doctor or pharmacist before giving this medicine.

Driving and using machines

Bimotil Infantil does not affect the ability to drive or use machines.

Bimotil Infantil contains sodium, potassium, and aspartame

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

Consult your doctor or pharmacist if your child needs four or more sachets per day for an extended period, especially if they have been advised to follow a low-salt diet (sodium).

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

This medicine contains 12.5 mg of aspartame per sachet. Aspartame is a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it properly.

3. How to take Bimotil Infantil

Follow the administration instructions for this medicine exactly as indicated by your doctor or pharmacist. If in doubt, 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 cup) of water and give it to your child.

Chronic constipation

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

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

Your doctor may indicate an increase in the number of sachets until your child has a proper bowel movement. If the dose is increased, this should be done every two days. Children under 2 years old should not take more than 2 sachets per day. In children from 2 to 11 years old, it is usually not necessary to take more than 4 sachets per day.

It is not necessary to take the entire drink at once. If your child prefers, they can take half of the drink in the morning and half in the afternoon.

Fecal impaction

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

Daily dosing schedule:

The daily number of sachets should be taken in divided doses, all consumed within 12 hours (e.g., from 8 am to 8 pm). Each sachet should be dissolved in 62.5 ml (1/4 cup) of water. The treatment can be interrupted when the medicine has taken effect, as indicated by the passage of large volumes of stool or watery diarrhea.

Preparation method

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

Duration of treatment

Chronic constipation

Treatment should be continued for at least 6-12 months.

Fecal impaction

Treatment with Bimotil Infantil may last up to 7 days.

If your child takes more Bimotil Infantil than they should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine 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 forgotten doses.

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

4. Possible side effects

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

Tell your doctor immediately and stop giving Bimotil Infantil if your child:

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

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

• stomach pain
• stomach noises.

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

• diarrhea
• vomiting
• nausea
• anal discomfort (uncomfortable feeling around the anus).

If your child is being treated for chronic constipation, diarrhea usually improves if the dose is reduced.

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

• stomach swelling
• gas.

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

• allergic reactions, which may include difficulty breathing.

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

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side 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 expiration date stated on the sachet and carton after EXP. The expiration date is 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 should be used within the next 24 hours.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further 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 ingredients are: orange flavor (corn maltodextrin, gum arabic (E414), citric acid (E330), butylhydroxyanisole (E320), and other flavorings), lemon flavor (corn maltodextrin, flavor preparations, flavorings, natural flavorings, and alpha-tocopherol (E307)), aspartame (E951), and sucralose.

When dissolved in 62.5 ml (1/4 cup) of water, each sachet is equivalent to:

Sodium 65 millimoles/liter

Chloride 53 millimoles/liter

Potassium 5.0 millimoles/liter

Bicarbonate 17 millimoles/liter

Appearance and packaging of the product

Powder for oral solution.

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

Not all pack sizes may be marketed.

Marketing authorization holder

Italfarmaco, S.A.

C/ San Rafael 3

28108 Alcobendas, Madrid

Spain

Manufacturer

Recipharm Höganäs

Sporthallsvägen 6

SE-263 35 Höganäs

Sweden

Italfarmaco, S.A.

C/ San Rafael 3

28108 Alcobendas, Madrid

Spain

This medicine is authorized 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 Πούδρα για πόσιμο διάλυμα

Italy Benlaxid 6.9 g powder for oral solution

Netherlands Benlaxid 6.9 g powder for drink

Date of the last revision of this package leaflet:August 2022

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