Package Insert: Information for the Patient

Bimotil Infantil6,9 gpowder for oral solution

macrogol 3350/sodium chloride/sodium bicarbonate/potassium chloride

Read this package insert carefully before giving this medication to your child, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for the child, and should not be given to others who may have the same symptoms, as it may harm them.
• If the child experiences any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

The name of this medication isBimotil6,9 g 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 (designated fecal impaction) in children aged 5 to 11 years.

BimotilInfantil helps the child to have adequate intestinal movement evenif constipation is of long duration.

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

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

If the child has a heart or kidney problem, a swallowing reflex alteration or gastroesophageal reflux (stomach burning caused by the return flow of stomach contents into the esophagus), consult your doctor before starting to give Bimotil Infantil.

Warnings and precautions

When administering Bimotil Infantil, plenty of liquids should be ingested. The liquid content of Bimotil Infantil does not replace the child's usual liquid intake.

Other medications and Bimotil Infantil

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

Some medications, such as antiepileptics, may not be as effective when taken with this medication. When large volumes of Bimotil Infantil are taken (for example, for fecal impaction), the child should not take other medications for 1 hour after taking Bimotil Infantil.

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

Pregnancy and breastfeeding

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

Driving and operating machines

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

Bimotil Infantil contains sodium, potassium and aspartame

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

Consult your doctor or pharmacist if you need four or more sachets per day for a prolonged period, especially if you have been recommended a low-sodium diet.

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

This medication contains 12.5 mg of aspartame in each sachet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

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

Chronic Constipation

The dosage ofBimotilInfantil depends on the child's age and their 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 has a proper bowel movement. If the dose is increased, this should be done every two days.Children under 2 years should not take more than 2 sachets per day.. In children aged 2 to 11 years, 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 the child prefers, they can take half of the drink in the morning and half in the afternoon.

Fecal Impaction

Before the child takes this medication for fecal impaction, it must be medically confirmed that the child actually suffers from this disease.

Daily dosage schedule:

The daily number of sachets should be taken in divided doses, all consumed within 12 hours (for example, from 8 am to 8 pm). Each sachet should be dissolved in 62.5 ml (1/4 of a glass) of water. Treatment can be interrupted when the medication has taken effect. This is evident by the deposition of large volumes of feces or watery diarrhea.

Preparation Method

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

Treatment Duration

Chronic Constipation

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

Fecal Impaction

Treatment withBimotilInfantil 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, interrupt 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to give Bimotil Infantil

Give the dose as soon as you remember that you have to take it.Do not give a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

• experiences a severe allergic reaction that causes 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)

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

If the child is being treated forchronic constipation, diarrhea usually improves if the dose is reduced.

Uncommon Adverse Effects(may affect up to 1 in 100 people)

• stomach bloating
• gas.

Rare Adverse Effects(may affect up to 1 in 1,000 people)

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

Adverse Effects of Unknown Frequency(frequency cannot be estimated from available data)

• skin rash (urticaria), itching, skin redness, or urticaria
• shortness of breath
• angioedema
• inflammation of hands, feet, or ankles
• headaches
• indigestion
• high or low potassium levels in the blood
• perianal inflammation.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and the box after CAD. The expiration date is the last day of the month indicated.

Unopened packets: this medication does not require special storage conditions.

Once prepared, the solution must be stored in a refrigerator (between 2°C and 8°C) or at room temperature (between 19°C and 25°C) and must be used within the next 24 hours.

Do not use this medication if you observe that any of the packets is damaged.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bimotil Infantil

Each sachet of6.9 gcontains:

Macrogol 33506.563 g

Sodium chloride0.1754 g

Sodium bicarbonate0.0893 g

Potassium chloride0.0233 g

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

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

Sodium65 millimoles/litre

Chloride53 millimoles/litre

Potassium5.0 millimoles/litre

Bicarbonate17 millimoles/litre

Appearance of the product and contents of the package

Oral solution powder.

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Italfarmaco, S.A.

C/ San Rafael 3

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

Recipharm Höganäs

Sporthallsvägen 6

SE-263 35 Höganäs

Sweden

This medicinal product is authorized in the member states of the European Economic Area with the following names:

SpainBimotil Infantil 6.9 g oral solution powder

GreeceBimotil 6.9 g Κ?νις για π?σιμο δι?λυμα

ItalyBenlaxid 6.9 g polvere para soluzione orale

NetherlandsBenlaxid 6.9 g poeder voor drank

Last review date of this leaflet:August 2022

Further information on this medicinal product is available onthe website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).