Leaflet: information for the patient

Bimotil 13.7 g powder for oral solution

macrogol 3350/sodium chloride/sodium bicarbonate/potassium chloride

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

The name of this medication isBimotilpowder 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 old.

Bimotilhelps with proper intestinal movement even when constipation is of long duration.Bimotilis also effective in the treatment of severe constipation, also known as fecal impaction.

Do not take Bimotil if your doctor has diagnosed you with:

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

Warnings and precautions

When takingBimotilyou should continue to drink plenty of liquids. The liquid content ofBimotildoes not replace your usual liquid intake.

Cardiac conditions

Follow the special instructions in section 3 if you are takingBimotilfor fecal impaction.

Other medications and Bimotil

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.It is recommended to wait at least 2 hours between takingBimotiland other medications.

Some medications, such as antiepileptic drugs, may not be as effective when taken with this medication.

If you need to thicken liquids to safely swallow them,Bimotilmay neutralize the thickening effect.

Pregnancy and breastfeeding

This medication can be taken during pregnancy and breastfeeding.If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

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

Bimotil contains sodium, potassium and aspartame

This medication contains 186.87 mg of sodium (main component of table salt/for cooking) in each sachet. This is equivalent to 9.3% 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 5.0 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 25 mg of aspartame in each sachet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

Dissolve the contents of each sachet in 125 ml of water and take it.

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

Constipation

The dose ofBimotilis 1 sachet dissolved in 125 ml(half a glass)of water. Take 1 sachet 1 - 3 times a day according to the severity of constipation.

Fecal impaction

Before takingBimotilfor fecal impaction, it must be confirmed that you actually suffer from this disease.

To treat fecal impaction, it is necessary to take 8 sachets a day. Each sachet must be dissolved in 125 ml(half a glass)of water. The 8 sachets must be taken in 6 hours over 3 days, if necessary. If you have any heart condition, do not take more than 2 sachets every hour.

Preparation method

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 the powder has dissolved and the Bimotil solution is clear or slightly turbid, then drink the solution. If you are taking this medication for fecal impaction, it may be easier to dissolve the 8 sachets in1 literof water.

Treatment duration

Constipation

The treatment withBimotilusually lasts about 2 weeks. If you need to take this medication for a longer period, please consult your doctor. If constipation is caused by a disease such as Parkinson's or multiple sclerosis, or you are taking other medications that cause constipation, your doctor may advise you to take this medication for more than 2 weeks. If you need to take this medication for more than 2 weeks, please consult your doctor.

Normally, during long-term treatment, the dose can be reduced to 1 or 2 sachets a day.

Fecal impaction

The treatment withBimotilmay last up to 3 days.

If you take more Bimotil than you should

You may develop excessive diarrhea, which may cause dehydration. If this occurs, interrupt the treatment withBimotiland drink plenty of liquid. 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 take Bimotil

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

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

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

Inform your doctor immediately and stop taking Bimotil if:

• You experience 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)

• Abdominal pain
• Gastrointestinal noises.

Common Adverse Effects(may affect up to 1 in 10 people)

• Diarrhea
• Vomiting
• Nausea
• Anal discomfort (uncomfortable sensation around the anus).

If you are being treated forChronic Constipation, diarrhea usually improves if the dose is reduced.

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

• Abdominal distension
• Gas.

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

• Allergic reactions, which may include dyspnea or difficulty breathing.

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

• Skin rash (urticaria), itching, skin redness, or urticaria
• Dyspnea
• Angioedema
• Swelling 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 for Pharmacovigilance of Medicinal Products 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 usethis medicationafter the expiration date that appears onthe package and the boxafter CAD. The expiration date is the last day of the month indicated.

Unopened packages: This medication does not require special storage conditions.

Once prepared, the solution must 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 the next 24 hours.

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

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

Bimotil Composition

Each sachet contains:

Macrogol 335013,125 g

Sodium chloride0,3507 g

Sodium bicarbonate0,1785 g

Potassium chloride0,0466 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, flavoring substances, natural flavoring substances and alpha-tocopherol (E307)), aspartame (E951) and sucralose.

When dissolved in 125 ml (half a glass) of water, each sachet is equivalent to:

Sodium65 millimoles/liter

Chloride53 millimoles/liter

Potassium5,0 millimoles/liter

Bicarbonate17 millimoles/liter

Product Appearance and Packaging Content

Oral solution powder.

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

Only some packaging 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 13,7 g oral solution powder

GreeceBimotil 13,7 g Κ?νις για π?σιμο δι?λυμα

ItalyBenlaxid 13,7 g polvere para soluzione orale

NetherlandsBenlaxid 13,7 g poeder voor drank

Last review date of this leaflet:August 2022

More detailed information about this medicinal productis available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).