Benlaxid

Package leaflet: Information for the patient

Benlaxid 6.9 g powder for oral solution

macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride
Please read this leaflet carefully before giving this medicine to your child
because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for your child only. Never give it to other
people, even if their symptoms are the same as your child's, because it could be
dangerous.
If your child experiences any side effects, including those not listed in this leaflet,
contact your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet

1. What Benlaxid is and what it is used for
2. What you need to know before giving Benlaxid
3. How to give Benlaxid
4. Possible side effects
5. How to store Benlaxid
6. Contents of the pack and other information

1. What Benlaxid is and what it is used for

This medicine is called Benlaxid powder for oral solution.
It is a laxative used for the treatment of chronic constipation in children aged between 1 and 11 years,
and for the treatment of severe constipation (called fecal impaction) in children aged between 5 and 11 years.
Benlaxid helps your child have a proper bowel movement, even if constipation has been ongoing for a long time.

2. What you need to know before giving Benlaxid

Do not give Benlaxid if your doctor has told you that your child has:

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

If your child has heart or kidney problems, an impaired pharyngeal reflex, or reflux esophagitis (burning caused by stomach contents flowing back into the esophagus), consult your doctor before giving Benlaxid.
Warnings and precautions
When taking Benlaxid, you must continue to drink plenty of fluids. The liquid solution of Benlaxid must not replace the regular intake of fluids.
Other medicines and Benlaxid
Inform your doctor if your child is taking, has recently taken, or might take any other medicines. It is recommended to wait at least 2 hours between taking Benlaxid and any other medicine.
The effectiveness of certain medicines, such as antiepileptics, may be reduced when taken concomitantly with Benlaxid. When your child is taking large volumes of Benlaxid (e.g. for faecal impaction), other medicines should not be taken within one hour after taking Benlaxid.
If a thickening agent is added to the solution to facilitate proper administration, Benlaxid may counteract the effect of the thickening agent.
Pregnancy and breastfeeding
Benlaxid may be taken during pregnancy and breastfeeding. Consult your pharmacist or doctor before giving Benlaxid.
Driving and using machines
Benlaxid does not affect the ability to drive or operate machinery.
Benlaxid contains sodium, aspartame and potassium
Benlaxid contains 93.4 mg of sodium (the main component of table salt) per sachet. This corresponds to 4.6% of the recommended maximum daily intake of sodium for an adult. Consult your doctor or pharmacist if your child needs four or more sachets per day for 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. This should be taken into account in individuals with reduced kidney function or those following a low-potassium diet.
This medicine contains 12.5 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder characterized by the accumulation of phenylalanine due to the body's inability to eliminate it properly.

3. How to administer Benlaxid

This medicine can be taken at any time, with or without food.
Dissolve the contents of each sachet in 62.5 ml (a quarter of a glass) of water, then
drink the solution.
Always follow exactly the instructions given by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Chronic constipation:
The dose of Benlaxid depends on the child's age and response to treatment.

• As an initial dose, children aged 1 to 6 years should be given one sachet (= 1 dose) daily.
• Children aged 7 to 11 years should be given two sachets daily. Your doctor may instruct you to increase the number of sachets until your child produces soft stools. If an increase in dose is needed, this should be done on alternate days. Children under 2 years of age should receive a maximum of 2 sachets per day. Children aged 2 to 11 years should normally receive no more than 4 sachets per day.

It is not necessary to drink the entire solution at once; if preferred, the child may drink half in the morning and the other half in the evening.

Faecal impaction:
A diagnosis of faecal impaction must be made before your child starts taking Benlaxid for the treatment of this condition.
A treatment cycle with Benlaxid is as follows:

The daily number of sachets must be taken divided into doses, all consumed within 12 hours (e.g. 8:00–20:00). Each sachet must be dissolved in 62.5 ml (a quarter of a glass) of water. The treatment regimen may be interrupted once the medicine has taken effect. This occurs when your child produces a large amount of stools and/or watery diarrhea.

Preparation instructions

• Open the sachet and pour the contents into a glass. Add about 62.5 ml (a quarter of a glass) of water to the glass. Stir well until the Benlaxid powder is completely dissolved, resulting in a clear or slightly cloudy solution, then give it to your child to drink.
• If desired, you may improve the taste of the drink by adding, for example, orange juice. If your child is taking Benlaxid for the treatment of fecal impaction, it may be easier to dissolve 12 sachets in 750 ml of water.

Duration of treatment
Chronic constipation:
Treatment should last for a prolonged period, at least 6–12 months.
Fecal impaction:
Treatment with Benlaxid may last up to 7 days.

If your child takes more Benlaxid than they should:
Your child may experience excessive diarrhea. In this case, administration of Benlaxid should be stopped and plenty of fluids should be drunk. In case of any doubt, consult your doctor or pharmacist.

If you forget to give Benlaxid:
Give the missed dose as soon as you remember.
Do not give a double dose to make up for the forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop treatment with Benlaxid and consult your doctor immediately if your child:

• Has a severe allergic reaction characterized by difficulty breathing, swelling of the face, lips, tongue or throat.

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

• Stomach ache
• Stomach rumbling

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

• Diarrhoea
• Vomiting (feeling sick)
• Nausea (feeling unwell)
• Anal irritation (discomfort around the anus). If your child is being treated for chronic constipation, diarrhoea usually improves by reducing the dose.

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

• Bloating
• Flatulence

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

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

Not known (frequency cannot be estimated from the available data)

• Skin rashes (wheals), itching, skin redness or urticaria
• Dyspnoea
• Angioedema
• Swelling of hands, feet or ankles
• Headache
• Indigestion
• High or low blood potassium levels
• Perianal inflammation

Reporting of side effects
If you or your child experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Benlaxid

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 on the
carton after “Exp.”. The expiry date refers to the last day of that month.
Intact sachet: no special storage conditions are required for intact sachets.
The reconstituted solution should be stored covered in the refrigerator (5 °C ± 3 °C) or at
room temperature (19 °C - 25 °C) and must be used within 24 hours.
Do not use this medicine if you notice that any of the sachets is damaged.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information
What Benlaxid contains
Each 6.9 g sachet of Benlaxid contains:
Macrogol 3350 6.563 g
Sodium chloride 0.1754 g
Sodium hydrogen carbonate 0.0893 g
Potassium chloride 0.0251 g

The other ingredients in this medicine are: orange flavour (corn maltodextrin,
arabic gum (E414), citric acid (E330), butylated hydroxyanisole (E320) and other flavouring substances), lemon flavour (corn maltodextrin, flavouring preparations, flavouring substances, natural flavouring substances, alpha-tocopherol (E307)), aspartame (E951) and
sucralose.

In the reconstituted solution prepared with one quarter glass (62.5 ml) of water, each sachet provides the equivalent of:
Sodium 65 millimoles/litre
Chloride 53 millimoles/litre
Potassium 5.0 millimoles/litre
Bicarbonate 17 millimoles/litre

Description of the appearance of Benlaxid and contents of the pack
Powder for oral solution.
Benlaxid is a white crystalline powder. Benlaxid is available in packs of 20 and 30 powder sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Italfarmaco S.p.A.
Viale F. Testi, 330
Milan
Italy

Manufacturer
Laboratoires Macors
22 Rue Des Caillottes,
Auxerre, 89000, France
or
Italfarmaco, S.A.
C/ San Rafael 3
28108 Alcobendas, Madrid
Spain

This medicine is authorised in the European Economic Area countries under the following names:
Netherlands: BENLAXID 13,7 g powder for drink
Spain: BIMOTIL 13,7 polvo para solución oral
Italy: BENLAXID 13,7g polvere per soluzione orale
Greece: BIMOTIL 13.7g Κόνις για πόσιμο διάλυμα

Package leaflet: Information for the patient

Benlaxid 13.7 g oral powder for oral solution

macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride
Please read this leaflet carefully before taking this medicine because
it contains important information for you.

• Keep this leaflet. 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. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Benlaxid is and what it is used for
2. What you need to know before taking Benlaxid
3. How to take Benlaxid
4. Possible side effects
5. How to store Benlaxid
6. Contents of the pack and other information

1. What Benlaxid is and what it is used for

This medicine is called Benlaxid powder for oral solution. It is a laxative used for the
treatment of constipation in adults, adolescents and the elderly. It is not recommended for children under
12 years of age.
Benlaxid helps to achieve adequate bowel movements, even if constipation has been present for a long
period. It is also effective in cases of severe constipation, known as fecal impaction.

2. What you need to know before taking Benlaxid

Do not take Benlaxid if your doctor has told you that you have:

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

Warnings and precautions
While taking Benlaxid, you should continue to drink plenty of fluids. The liquid solution of Benlaxid must not replace your regular fluid intake.
Heart conditions
If you are taking Benlaxid for the treatment of faecal impaction, follow the special instructions provided in section 3.
Other medicines and Benlaxid
Tell your doctor if you are taking, have recently taken, or might take any other medicines. It is recommended to wait at least 2 hours between taking Benlaxid and any other medicine.
The effectiveness of certain medicines, such as antiepileptic drugs, may be reduced when taken concomitantly with Benlaxid.
If a thickening agent is added to the solution to facilitate proper administration, Benlaxid may interfere with the effect of the thickening agent.
Pregnancy and breastfeeding
Benlaxid may be taken during pregnancy and breastfeeding. If you are pregnant, trying to become pregnant, or breastfeeding, consult your pharmacist or doctor before taking Benlaxid.
Driving and using machines
Benlaxid does not affect the ability to drive or operate machinery.
Benlaxid contains sodium, aspartame and potassium
Benlaxid contains 186.87 mg of sodium (the main component of table salt) per sachet. This corresponds to 9.3% of the maximum recommended daily intake of sodium for an adult.
Consult your doctor or pharmacist if you need to take four or more sachets per day for a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.
Benlaxid contains 5.0 mmol of potassium per sachet. This should be taken into account in individuals with impaired kidney function or those following a low-potassium diet.
Benlaxid contains 25 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take Benlaxid

This medicine can be taken at any time, with or without food.
Dissolve the contents of each sachet in 125 ml of water, then drink the solution.
Always take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Constipation:
One dose of Benlaxid consists of 1 sachet dissolved in 125 ml of water. Take 1 dose 1–3 times daily, depending on the severity of constipation.

Fecal impaction:
Fecal impaction must be diagnosed before you start taking Benlaxid for treatment of this condition.
The dose for treatment of fecal impaction is 8 sachets per day of Benlaxid.
Each sachet must be dissolved in 125 ml of water. The 8 sachets should be taken within 6 hours, for up to 3 days if necessary. If you have a heart condition, do not take more than 2 sachets within one hour.

Preparation instructions:
Open the sachet and pour the contents into a glass. Add approximately 125 ml of water to the glass.
Stir well until the Benlaxid powder is completely dissolved, resulting in a clear or slightly cloudy solution, then drink it. If you are taking Benlaxid for the treatment of fecal impaction, it may be easier to dissolve 8 sachets in 1 litre of water.

Duration of treatment:

Constipation:
Treatment with Benlaxid usually lasts about 2 weeks. If you need to take Benlaxid for a longer period, consult your doctor. If constipation is caused by a disease such as Parkinson’s disease or multiple sclerosis (MS), or if you are taking medicines that cause constipation, your doctor may recommend using Benlaxid for longer than 2 weeks. If you need to take Benlaxid for an extended period, consult your doctor.
Typically, during long-term treatment, the dose may be reduced to 1 or 2 sachets per day.

Fecal impaction:
Treatment with Benlaxid may last up to 3 days.

If you take more Benlaxid than you should:
You may experience excessive diarrhoea, which can lead to dehydration. In this case, stop taking Benlaxid and drink plenty of fluids. If you have any doubts, consult your doctor or pharmacist.

If you forget to take Benlaxid:
Take it as soon as you remember.
Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with Benlaxid and contact your doctor immediately if:

• You have a severe allergic reaction characterised by difficulty breathing, swelling of the face, lips, tongue or throat.

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

• Stomach ache
• Stomach rumbling

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

• Diarrhoea
• Vomiting (feeling sick)
• Nausea (feeling unwell)
• Anal irritation (discomfort around the anus). If you are being treated for chronic constipation, diarrhoea usually improves by reducing the dose.

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

• Bloating
• Flatulence

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

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

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

• Skin rashes (wheals), itching, redness of the skin or hives
• Dyspnoea
• Angioedema
• Swelling of the hands, feet or ankles
• Headache
• Indigestion
• High or low levels of potassium in the blood
• Perianal inflammation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Benlaxid

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 the carton after "Exp.". The expiry date refers to the last day of that month.
Intact sachet: no special storage precautions are required for intact sachets.
The reconstituted solution must be stored covered in a refrigerator (5 °C ± 3 °C) or at room temperature (19 °C - 25 °C) and must be used within 24 hours.
Do not use this medicine if you notice that any of the sachets is damaged.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Benlaxid contains
Each sachet of Benlaxid contains:
Macrogol 3350 13.125 g
Sodium chloride 0.3507 g
Sodium hydrogen carbonate 0.1785 g
Potassium chloride 0.0466 g
The other ingredients in this medicine are: orange flavour (maize maltodextrin,
arabic gum (E414), citric acid (E330), butylated hydroxyanisole (E320) and other flavouring substances), lemon flavour (maize maltodextrin, flavouring preparations, flavouring substances, natural flavouring substances, alpha-tocopherol (E307)), aspartame (E951) and sucralose.
In the reconstituted solution with 125 ml of water, each sachet provides the equivalent of:
Sodium 66 millimoles/litre
Chloride 53 millimoles/litre
Potassium 5.0 millimoles/litre
Hydrogen carbonate 17 millimoles/litre

Description of the appearance of Benlaxid and pack contents
Powder for oral solution.
Benlaxid is a white crystalline powder. Benlaxid is available in boxes containing 20 and 30 sachets of powder.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Italfarmaco S.p.A.
Viale F. Testi, 330
Milan
Italy

Manufacturer
Laboratoires Macors
22 Rue Des Caillottes,
Auxerre, 89000,
France
or
Italfarmaco, S.A.
C/ San Rafael 3
28108 Alcobendas, Madrid
Spain

This medicine is authorised in the European Economic Area countries under the following names:
Nederland: BENLAXID 6.9 g powder for drink
Spain: BIMOTIL 6.9 g powder for oral solution
Italy: BENLAXID 6.9 g powder for oral solution
Greece: BIMOTIL 6.9 g Κόνις για πόσιμο διάλυμα