Bimotil 13.7 g powder for oral solution
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Bimotil 13.7 g powder for oral solution
macrogol 3350/sodium chloride/sodium bicarbonate/potassium chloride
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience 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
- What Bimotil is and what it is used for
- What you need to know before taking Bimotil
- How to take Bimotil
- Possible side effects
- How to store Bimotil
- Contents of the pack and other information
1. What Bimotil is and what it is used for
The name of this medicine is Bimotil powder for oral solution. It is a laxative used for the treatment of constipation in adults, adolescents, and elderly individuals. It is not recommended for children under 12 years of age.
Bimotil helps restore proper intestinal movement, even when constipation is long-standing. Bimotil is also effective in the treatment of severe constipation, also known as fecal impaction.
2. What you need to know before taking Bimotil
Do not take Bimotil if your doctor has diagnosed you with:
- an allergy to the active substances or to any of the other components of this medicine (listed in section 6).
- intestinal obstruction (blockage of the intestine, intestinal paralysis (ileus)),
- perforation of the intestinal wall,
- a severe inflammatory bowel disease such as ulcerative colitis, Crohn's disease, or toxic megacolon.
Warnings and precautions
When taking Bimotil, you must continue to drink plenty of fluids. The liquid content of Bimotil does not replace your normal fluid intake.
Heart conditions
Follow the special instructions in section 3 if you are taking Bimotil for faecal impaction.
Other medicines and Bimotil
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. It is recommended to wait at least 2 hours between taking Bimotil and other medicines.
Some medicines, such as antiepileptic drugs, may be less effective when taken together with this medicine.
If you need to thicken liquids to swallow them safely, Bimotil may neutralize the thickening effect.
Pregnancy and breastfeeding
This medicine may be taken during pregnancy and breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 operate machinery.
Bimotil contains sodium, potassium, and aspartame
This medicine contains 186.87 mg of sodium (the main component of table/cooking salt) per sachet. This corresponds to 9.3% of the maximum recommended daily sodium intake for an adult.
Consult your doctor or pharmacist if you need to take 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 5.0 mmol of potassium per sachet, which should be taken into account in patients with renal impairment or those on potassium-restricted diets.
This medicine contains 25 mg of aspartame per sachet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
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.
Always follow exactly the instructions for use provided 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 condition.
For the treatment of fecal impaction, it is necessary to take 8 sachets per day. Each sachet must be dissolved in 125 ml (half a glass) of water. The 8 sachets should be taken within 6 hours, over 3 days if necessary. If you have any heart 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 (half a glass). Stir well until the powder has dissolved and the Bimotil solution becomes 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 normally 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 disease or multiple sclerosis, or if 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 longer than 2 weeks, please consult your doctor.
During long-term treatment, the dose can usually 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 could 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Bimotil
Take the missed dose as soon as you remember. Do not take a double dose to make up for forgotten doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Tell your doctor immediately and stop taking Bimotil if:
- you experience 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)
- diarrhea
- vomiting
- nausea
- anal discomfort (uncomfortable sensation around the anus).
If you are being treated for chronic constipation, diarrhea usually improves if the dose is reduced.
Uncommon adverse effects (may affect up to 1 in 100 people)
- stomach swelling
- gas.
Rare adverse effects (may affect up to 1 in 1,000 people)
- allergic reactions, possibly including dyspnea 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
- dyspnea
- angioedema
- swelling of hands, feet, or ankles
- headache
- indigestion
- high or low blood potassium levels
- perianal inflammation.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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
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 any special storage conditions.
The prepared 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 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. Please return unused medicines and their packaging to the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other 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 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 125 ml (half 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 container
Powder for oral solution.
Bimotil is a white crystalline powder. Bimotil is available in packs of 20 or 30 sachets.
Only certain pack sizes may be marketed.
Marketing Authorization 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 authorized in the European Economic Area (EEA) member states 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 polvere per soluzione orale
Netherlands Benlaxid 13.7 g poeder voor drank
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/).