Casesnjunior

Package leaflet: Information for the patient

Casenjunior 4 g powder for oral solution in sachet

Macrogol 4000
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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Casenjunior is and what it is used for

The name of this medicine is Casenjunior 4 g powder for oral solution in sachet.
Casenjunior belongs to a group of medicines called osmotic laxatives. Osmotic laxatives are medicines that increase the amount of water in the stool, making its passage easier.
Casenjunior is indicated for the symptomatic treatment of constipation in children aged between 6 months and 8 years. It should be used in conjunction with appropriate lifestyle changes and a suitable diet (see section 2).
Consult your doctor if you do not feel better or if you feel worse.
This medicine contains Macrogol (P.E.G. = polyethylene glycol).
In case of constipation, the maximum treatment duration in children is 3 months.

2. What you need to know before taking Casenjunior

Treatment of constipation with a laxative should be supportive to a healthy lifestyle and an appropriate diet.
Do not take Casenjunior

• If your child is allergic to macrogol (P.E.G. = polyethylene glycol) or to any of the other ingredients of this medicine (listed in section 6).
• If your child has any intestinal or colon disease (such as ulcerative colitis, Crohn's disease).
• If your child has abdominal pain of unknown cause.
• If your child has, suspects having, or is at risk of gastrointestinal perforation.
• If your child has or suspects having intestinal obstruction.

Warnings and precautions
Talk to your doctor or pharmacist before taking Casenjunior.
If diarrhea develops during treatment with Casenjunior, you may be at risk of developing electrolyte imbalances (a decrease in certain salts in the blood). This risk is higher if you are elderly, have liver or kidney problems, or are taking diuretics (medicines to increase urine production). If you belong to any of these groups and develop diarrhea, you should see a doctor to have your electrolyte levels checked through a blood test.
Children
Consult your doctor before administering this treatment to your child in order to rule out any organic cause of constipation. After 3 months of treatment, your child's clinical condition should be evaluated by the doctor.
Other medicines and Casenjunior
Casenjunior may delay the absorption of other medicines, making them less effective or ineffective, especially those with a narrow therapeutic index (e.g., antiepileptics, digoxin, and immunosuppressive agents). Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Casenjunior may be used during pregnancy.
Breastfeeding
Casenjunior may be used during breastfeeding.
Driving and using machines
Casenjunior does not affect the ability to drive or operate machinery.
Casenjunior contains sulfur dioxide.
This medicine may rarely cause severe hypersensitivity reactions and bronchospasm (difficulty breathing) because it contains sulfur dioxide.
Casenjunior contains a negligible amount of sugars or polyols and can therefore be prescribed to diabetic patients or patients on a galactose-free diet.

3. How to take Casenjunior

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For oral use.
The recommended dose is:
From 6 months to 1 year: 1 sachet per day.
Between 1 and 4 years: 1 to 2 sachets per day.
From 4 to 8 years: 2 to 4 sachets per day.
The treatment should be administered in the morning at a dose of one sachet per day, or divided between morning and evening for higher doses. It is recommended to drink an additional 125 ml of liquid (for example, water) after each administration of the product.
The daily dosage should be adjusted according to the clinical effects achieved.
The effect of Casenjunior appears within 24–48 hours after administration.
Dissolve the contents of the sachet in a glass of water (at least 50 ml) immediately before use and drink the solution. The resulting solution will be clear and transparent like water.
Improvement in bowel movement frequency after taking Casenjunior can be maintained through a healthy lifestyle and an appropriate diet.

Use in children and adolescents
In children, treatment should not exceed 3 months due to lack of clinical data for treatment periods longer than 3 months.
Treatment should be gradually discontinued and restarted if constipation recurs.

If you take more Casenjunior than you should
You may develop diarrhea, abdominal pain, and vomiting, which resolve when treatment is temporarily stopped or the dose is reduced.
In case of severe diarrhea or vomiting, contact a doctor as soon as possible, as you may require treatment to prevent loss of minerals (electrolytes) due to fluid loss.

If you forget to take Casenjunior
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.
The most serious side effects are allergic reactions (hypersensitivity) which include itching (pruritic rash), skin rash, facial oedema (swelling of the face), Quincke's oedema (rapid swelling of the deep layers of the skin), urticaria (hives) and anaphylactic shock. Their frequency has been reported as very rare (may affect up to 1 in 10,000) in the adult population and as not known (frequency cannot be estimated from the available data) in the paediatric population. If you notice any of the reactions listed above, stop taking the medicine immediately and consult a doctor urgently.

Adults:
In general, adverse reactions have been mild and transient and mainly involved the gastrointestinal system. These side effects include:

Common (may affect up to 1 in 10)

• Abdominal pain
• Abdominal distension
• Diarrhoea
• Nausea

Uncommon (may affect up to 1 in 100)

• Vomiting
• Urgency to defecate
• Faecal incontinence

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

• Electrolyte disturbances (low blood levels of sodium and potassium: hyponatraemia, hypokalaemia)
• Dehydration caused by severe diarrhoea, especially in elderly patients
• Erythema

Children:
Adverse reactions have generally been mild and transient and mainly involved the gastrointestinal system. These side effects include:

Common (may affect up to 1 in 10)

• Abdominal pain
• Diarrhoea (may cause perianal pain)

Uncommon (may affect up to 1 in 100)

• Vomiting
• Bloating sensation
• Nausea

Overdosage may cause diarrhoea, abdominal pain and vomiting, which usually resolve when the dose is reduced or treatment is temporarily discontinued.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Casenjunior

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp."
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Casenjunior contains
The active substance is: Macrogol 4000.
Each sachet contains 4 g of macrogol 4000.
The other ingredients (excipients) are: Sodium saccharin (E954) and strawberry flavour (maltodextrins,
triethyl citrate E1505, acacia gum E414, benzyl alcohol, sulphur dioxide E220 and alpha tocopherol
E307). See section 2 “Casenjunior contains sulphur dioxide”.
Description of the appearance of Casenjunior and package contents
Casenjunior is a nearly white powder with a strawberry odour contained in a sachet for preparing an oral solution.
It is available in packs of 10, 20, 30 or 50 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Casen Recordati, S.L.
Autovía de Logroño, Km 13,300
50180 UTEBO. Zaragoza (Spain)
Marketing Authorisation Holder in Italy
RECORDATI Industria Chimica e Farmaceutica S.p.A.
Via M. Civitali, 1 – 20148 Milano
This medicinal product is authorised in the European Economic Area countries under the
following names:
Denmark: Casenlax 4g pulver til oral opløsning
Finland: Casenlax 4g jauhe oraaliliuosta varten
Germany: Laxbene junior 4 g Pulver zur Herstellung einer Lösung zum Einnehmen, in Einzeldosis-Beuteln, für Kinder von 6 Monaten bis 8 Jahre
Italy: Casenjunior 4g polvere per soluzione orale
Netherlands: Casenlax 4g poeder voor drank
Norway: Casenlax 4g pulver til mikstur, oppløsning
Portugal: Casenlax 4g pó para solução oral
Spain: Casenlax 4g polvo para solución oral
Sweden: Casenlax 4g pulver till oral lösning
Further sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA):
http://www.agenziafarmaco.gov.it

Package leaflet: Information for the patient

Casenjunior 500 mg/ml oral solution

Macrogol 4000
Please read this entire 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. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Casenjunior is and what it is used for

The name of this medicine is Casenjunior 500 mg/ml oral solution.
Casenjunior belongs to a group of medicines called osmotic laxatives.
Osmotic laxatives are medicines that help increase the amount of water in the stool, making it easier to pass.
Casenjunior is indicated for the symptomatic treatment of constipation in children aged between 6 months and 8 years. It should be used in combination with appropriate lifestyle changes and a suitable diet (see section 2).
Consult your doctor if you do not feel better or if you feel worse.
This medicine contains Macrogol (P.E.G. = polyethylene glycol).
In cases of constipation, the maximum treatment duration in children is 3 months.

2. What you need to know before taking Casenjunior

Treatment of constipation with a laxative should be supportive to a healthy lifestyle and an appropriate diet.
Do not take Casenjunior

• If you are allergic to macrogol (P.E.G. = polyethylene glycol) or to any of the other ingredients of this medicine (listed in section 6).
• If you have any intestinal or colon disease (such as ulcerative colitis, Crohn's disease).
• If you have abdominal pain of unknown cause.
• If you have or suspect you may have a gastrointestinal perforation or are at risk of intestinal perforation.
• If you have or suspect you may have intestinal obstruction.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Casenjunior.
If you develop diarrhoea during treatment with Casenjunior, you may be at risk of developing electrolyte imbalances (a decrease in certain salts in the blood). This risk is higher if you are elderly or have liver or kidney problems, or if you are taking diuretics. If you belong to any of these groups and develop diarrhoea, you should see a doctor to have your electrolyte levels checked through a blood test.
Children
Consult your doctor before giving this treatment to your child, in order to rule out any organic cause of constipation. After 3 months of treatment, your doctor should reassess your child's clinical condition.
Other medicines and Casenjunior
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Casenjunior may be used during pregnancy.
Breastfeeding
Casenjunior may be used during breastfeeding.
Driving and using machines
Casenjunior does not affect the ability to drive vehicles or operate machinery.
Casenjunior contains a negligible amount of sugars or polyols and therefore can be prescribed to diabetic patients or patients on a galactose-free diet.

3. How to take Casenjunior

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For oral use.
The recommended dose is:
From 6 months to 1 year: 8 ml per day.
Between 1 and 4 years: from 8 ml to 16 ml per day.
From 4 to 8 years: from 16 ml to 32 ml per day.
The treatment should be administered in the morning at a dose of 8 ml per day, or divided between morning and evening for higher doses.
The daily dosage should be adjusted according to the clinical response obtained.
The effect of Casenjunior appears within 24–48 hours after administration.
It is recommended to measure the oral solution using the syringe provided in the package.
Improved bowel movement frequency after taking Casenjunior can be maintained through a healthy lifestyle and an appropriate diet.

Use in children and adolescents
In children, treatment should not exceed 3 months due to lack of clinical data for treatment periods longer than 3 months.
Treatment should be discontinued gradually and restarted only if constipation recurs.

If you take more Casenjunior than you should
You may develop diarrhoea, which resolves when treatment is temporarily stopped or the dose is reduced.
If you experience severe diarrhoea or vomiting, contact a doctor as soon as possible, as you may require treatment to prevent loss of mineral salts (electrolytes) due to fluid loss.

If you forget to take Casenjunior
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 everyone experiences them.
The most serious side effects are allergic reactions (hypersensitivity) which
include itching (pruritic rash), skin rash, facial oedema (swelling
of the face), Quincke's oedema (rapid swelling of the deep layers of the skin),
urticaria (hives) and anaphylactic shock. The frequency of these reactions has been reported
as very rare (may affect up to 1 in 10,000 people) in the adult population
and as not known (frequency cannot be estimated from the available data)
in the paediatric population. If you notice any of the reactions listed above,
stop taking the medicine immediately and consult a doctor urgently.
Adults:
In general, adverse reactions have been mild and transient and have mainly
involved the gastrointestinal system. These side effects include:
Common (may affect up to 1 in 10 people)

• Abdominal pain
• Abdominal distension
• Diarrhoea
• Nausea

Uncommon (may affect up to 1 in 100 people)

• Urgency to defecate
• Faecal incontinence

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

• Electrolyte disturbances (low blood levels of sodium and potassium: hyponatraemia, hypokalaemia)
• Dehydration caused by diarrhoea, especially in elderly patients

In children, adverse reactions have generally been mild and transient and have
mainly involved the gastrointestinal system. These side effects include:
Common (may affect up to 1 in 10 people)

• Abdominal pain
• Diarrhoea (may cause perianal pain)

Uncommon (may affect up to 1 in 100 people)

• Vomiting
• Bloating sensation
• Nausea

Excessive doses may cause diarrhoea, which usually resolves when the dose
is reduced or treatment is discontinued.
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 www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Casenjunior

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after
Exp.
The expiry date refers to the last day of that month.
Once the bottle has been opened, the medicine can be used for 2 months.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
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. Package contents and other information

What Casenjunior contains
The active substance is: Macrogol 4000.
Each ml contains 500 mg of macrogol 4000.
The other components (excipients) are: Sodium benzoate (E-211), potassium sorbate, citric acid, sodium citrate and sucralose.
Description of the appearance of Casenjunior and package contents
Casenjunior is a clear, colourless, odourless and tasteless solution.
It is available in a 200 ml amber glass bottle and an oral dosing syringe is provided to facilitate administration.
Marketing Authorization Holder and Manufacturer
Casen Recordati, S.L.
Autovía de Logroño, Km 13,300
50180 UTEBO. Zaragoza (Spain)
Marketing Authorization Holder in Italy
RECORDATI Industria Chimica e Farmaceutica S.p.A.
Via M. Civitali, 1 – 20148 Milano
This medicinal product is authorized in the Member States of the European Economic Area
under the following names:

Other sources of information
More detailed information about this medicine is available on the website of the AIFA
http://www.agenziafarmaco.gov.it