BIMOTIL 13.7 g POWDER FOR ORAL SOLUTION

Introduction

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

Contents of the leaflet

1. What is Bimotil and what is it used for
2. What you need to know before taking Bimotil
3. How to take Bimotil
4. Possible side effects
5. Storage of Bimotil
6. Package contents and additional information

1. What is Bimotil and what is it used for

The name of this medicine is Bimotil powder 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 of age.

Bimotil helps with proper intestinal movement even when constipation is long-lasting. Bimotil is also effective in the treatment of severe constipation, also called fecal impaction.

2. What you need to know before taking Bimotil

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

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

Warnings and precautions

When taking Bimotil, you should continue to drink plenty of fluids. The liquid content of Bimotil does not replace your usual fluid intake.

Cardiac conditions

Follow the special instructions in section 3 if you are taking Bimotil for fecal impaction.

Other medicines and Bimotil

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

Some medicines, such as antiepileptics, may not be as effective when administered with this medicine.

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

Pregnancy and breastfeeding

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

Driving and using machines

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

Bimotil contains sodium, potassium, and aspartame

This medicine contains 186.87 mg of sodium (main component of table salt/kitchen salt) per 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 to take four or more sachets daily for a prolonged period, especially if you have been advised to follow a low-salt diet (sodium).

This medicine 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 medicine contains 25 mg of aspartame per sachet. Aspartame is 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 properly.

3. How to take Bimotil

This medicine 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 the administration instructions of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Constipation

The dose of Bimotil is 1 sachet dissolved in 125 ml (half a glass) of water. Take 1 sachet 1-3 times a day, depending on the severity of constipation.

Fecal impaction

Before taking Bimotil for fecal impaction, it must be confirmed that you actually have this disease.

For the treatment of fecal impaction, it is necessary to take 8 sachets per day. Each sachet should be dissolved in 125 ml (half a glass) of water. The 8 sachets should be taken over 6 hours for 3 days, if necessary. If you have a cardiac condition, do not take more than 2 sachets per 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). Shake well until the powder is dissolved and the Bimotil solution is clear or slightly cloudy, then drink the solution. If you are taking this medicine for fecal impaction, it may be easier to dissolve the 8 sachets in 1 liter of water.

Duration of treatment

Constipation

Treatment with Bimotil usually lasts about 2 weeks. If you need to take this medicine 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 medicines that cause constipation, your doctor may advise you to take this medicine for more than 2 weeks. If you need to take this medicine for more than 2 weeks, please consult your doctor.

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

Fecal impaction

Treatment with Bimotil may last up to 3 days.

If you take more Bimotil than you should

You may develop excessive diarrhea, which can lead to dehydration. If this occurs, stop treatment with Bimotil and drink 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 take Bimotil

Take the dose as soon as you remember you need to take it. Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

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

Tell 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 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 you are 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 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 not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bimotil

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. Place 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. Package contents and additional information

Composition of Bimotil

Each sachet contains:

Macrogol 3350 13.125 g

Sodium chloride 0.3507 g

Sodium bicarbonate 0.1785 g

Potassium chloride 0.0466 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 125 ml (half a glass) 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 of the product and package contents

Powder for oral solution.

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

Only some 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 13.7 g powder for oral solution

Greece Bimotil 13.7 g Κ?νις για π?σιμο δι?λυμα

Italy Benlaxid 13.7 g powder for oral solution

Netherlands Benlaxid 13.7 g powder for drink

Date of the last revision of this 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/).