CASENJUNIOR 4 Г Оральный порошок для раствора

Содержание инструкции

1. Casenjunior 4 g powder for oral solution in sachet
   1. What is Casenjunior and what is it 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
2. Casenjunior 500 mg/ml oral solution
   1. What is Casenjunior and what is it used for
   2. What you need to know before taking Casenjunior
3. Casenjunior contains an insignificant amount of sugars or polyols and therefore
   1. How to take Casenjunior
   2. Possible side effects
   3. How to store Casenjunior
   4. Contents of the pack and other information

Casenjunior 4 g powder for oral solution in sachet

Macrogol 4000
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 you take 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 is Casenjunior and what is it used for

The name of this medicine is Casenjunior 4 g powder for oral solution in sachets.
Casenjunior belongs to a group of medicines called osmotic laxatives. Osmotic
laxatives are medicines that allow to increase the amount of water in the stool,
making 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 association with appropriate changes
to lifestyle and an appropriate 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 period in children is 3 months.

2. What you need to know before taking Casenjunior

Treatment of constipation with a laxative should support 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 they may have, or is at risk of having a gastrointestinal perforation.
• If your child has or suspects they may have an intestinal obstruction.

Warnings and precautions
Talk to your doctor or pharmacist before taking Casenjunior.
If you develop diarrhoea during treatment with Casenjunior you may be at risk of
developing electrolyte imbalances (a decrease in some salts in the blood). You are more likely to
be exposed to this risk if you are elderly or have liver or kidney problems or are taking diuretics
(water tablets). If you are one of these people and develop diarrhoea you should see a
doctor for a check of your electrolyte levels through a blood test.

Children
Ask your doctor for advice before giving this treatment to your child, to
exclude any organic cause of constipation. After 3 months of treatment, the
doctor will need to evaluate your child's clinical condition.

Other medicines and Casenjunior
Casenjunior may delay the absorption of other medicines making them less effective or
ineffective, particularly those with a narrow therapeutic index (e.g. antiepileptics,
digoxin and immunosuppressants). Tell 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 or are planning a pregnancy, or if you are
breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.

Pregnancy
Casenjunior can be used during pregnancy.

Breastfeeding
Casenjunior can be used during breastfeeding.

Driving and operating machinery
Casenjunior does not alter the ability to drive vehicles or operate machinery.

Casenjunior contains sulphur dioxide.
This medicine rarely can cause serious hypersensitivity reactions and bronchospasm
(difficulty breathing) because it contains sulphur dioxide.
Casenjunior contains a non-significant amount of sugars or polyols and therefore can be
prescribed to diabetic patients or patients following a galactose-free diet.

3. How to take Casenjunior

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
For oral use.
The recommended dose is:
From 6 months to 1 year: 1 sachet per day.
Between 1 year and 4 years: 1 to 2 sachets per day.
From 4 years 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 dosages. It is recommended to drink 125 ml of additional fluids (for example water) after each administration of the product.
The daily dosage should be adjusted based on the clinical effects obtained.
The effect of Casenjunior manifests 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 liquid. The resulting solution will be clear and transparent like water.
The improvement in the frequency of bowel movements 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 the lack of clinical data for
periods longer than 3 months of treatment.
Treatment should be discontinued gradually and resumed if constipation recurs.

If you take more Casenjunior than you should
You may develop diarrhea, abdominal pain and vomiting that disappear when the treatment
is temporarily interrupted or when the dose is reduced.
In case of severe diarrhea or vomiting, you should contact a doctor as soon as possible as you may
need treatment to prevent the 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 a 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 (itchy rash), skin rash, facial edema (swelling of the face), angioedema (rapid
swelling of the deep layers of the skin), urticaria (urticarial rash) and anaphylactic shock. Their
frequency has been reported as very rare (may affect up to 1 in 10,000 people) in the adult
population and as not known (the 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 urgently consult a doctor.

Adults:
In general, adverse reactions have been mild and transient and have mainly affected 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)

• Vomiting
• Urgency to defecate
• Faecal incontinence

Not known (the 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 been generally mild and transient and have mainly affected 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
• Feeling of bloating
• Nausea

Overdoses can cause diarrhoea, abdominal pain and vomiting which usually
disappear when the dose is reduced or the treatment is temporarily suspended.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through 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 which is stated on the pack after Scad.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Casenjunior contains
The active ingredient is: Macrogol 4000.
Each sachet contains 4 g of macrogol 4000.
The other ingredients (excipients) are: Sodium saccharin (E954) and strawberry aroma (maltodextrin,
triethyl citrate E1505, gum arabic E414, benzyl alcohol, sulfur dioxide E220 and alpha tocopherol
E307). See section 2 “Casenjunior contains sulfur dioxide”.

Description of the appearance of Casenjunior and contents of the pack
Casenjunior is an almost white powder with a strawberry odour in a sachet for preparing a
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
RECORDATI Industria Chimica e Farmaceutica S.p.A.
Via M. Civitali, 1 – 20148 Milan

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Denmark: Casenlax 4g powder for oral solution
Finland: Casenlax 4g powder for oral solution
Germany: Laxbene junior 4 g Powder for the preparation of a solution for ingestion, in
single-dose sachets, for children from 6 months to 8 years
Italy: Casenjunior 4g powder for oral solution
Netherlands: Casenlax 4g powder for drink
Norway: Casenlax 4g powder for mixture, solution
Portugal: Casenlax 4g powder for oral solution
Spain: Casenlax 4g powder for oral solution
Sweden: Casenlax 4g powder for oral solution

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

Casenjunior 500 mg/ml oral solution

Macrogol 4000
Read this leaflet carefully before taking this medicine as
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 other people, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, ask 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 you take 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 is Casenjunior and what is it 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 allow to increase the amount of water
in the stool, making passage easier.
Casenjunior is indicated for the symptomatic treatment of constipation in children of
ages between 6 months and 8 years. It should be used in association with
appropriate lifestyle changes and an appropriate dietary regimen (see
paragraph 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 period in children is 3 months.

2. What you need to know before taking Casenjunior

Treatment of constipation with a laxative should be supportive of a healthy lifestyle and an appropriate diet.

Do not take Casenjunior

• If you are allergic to macrogol (P.E.G. = polyethylene glycol) or 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 have a gastrointestinal perforation or are at risk of having an intestinal perforation.
• If you have or suspect you have an intestinal obstruction.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Casenjunior.
If you develop diarrhea during treatment with Casenjunior, you may be at risk of developing electrolyte imbalances (a decrease in some salts in the blood). You are more likely to be exposed to this risk if you are elderly or have liver or kidney problems or are taking diuretics. If you are one of these people and develop diarrhea, you should see a doctor for a check of your electrolyte levels through a blood test.

Children
Ask your doctor for advice before giving this treatment to your child, in order to exclude any organic cause of constipation. After 3 months of treatment, your doctor will need to assess your child's clinical condition.

Other medicines and Casenjunior
Tell 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 are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Casenjunior can be used during pregnancy.

Breastfeeding
Casenjunior can be used during breastfeeding.

Driving and operating machinery
Casenjunior does not impair the ability to drive vehicles or operate machinery.

Casenjunior contains an insignificant amount of sugars or polyols and therefore

can be prescribed to diabetic patients or to patients following a diet free of
galactose.

3. How to take Casenjunior

Take this medicine following strictly the instructions of the doctor or
pharmacist. If you have 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 year and 4 years: from 8 ml to 16 ml per day.
From 4 years to 8 years: from 16 ml to 32 ml per day.
The treatment must be administered in the morning at a dose of 8 ml per day or
divided between morning and evening for higher dosages.
The daily dosage must be adjusted according to the clinical effects obtained.
The effect of Casenjunior manifests within 24-48 hours after administration.
It is recommended to dose the oral solution using the syringe provided inside the
package.
The improvement of the frequency of bowel movements 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 the lack of clinical data
for periods longer than 3 months of treatment.
Treatment should be discontinued gradually and resumed if constipation
recurs.

If you take more Casenjunior than you should
You may develop diarrhea, which disappears when the treatment is temporarily
interrupted or when the dose is reduced.
In case of severe diarrhea or vomiting, contact a doctor as soon as possible as
you may need treatment to prevent the 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 a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most serious side effects are allergic reactions (hypersensitivity) which
include itching (itchy rash), skin rash, facial edema (swelling of the face), angioedema (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 people) in the adult population
and as not known (frequency cannot be estimated based on available data)
in the pediatric population. If you notice any of the reactions listed above,
immediately stop taking the medicine and urgently consult a
doctor.

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

Common (may affect up to 1 in 10 people)

• Abdominal pain
• Abdominal distension
• Diarrhea
• Nausea

Uncommon (may affect up to 1 in 100 people)

• Urgency to defecate
• Fecal incontinence

Not known (frequency cannot be estimated based on available data)

• Electrolyte disturbances (low blood levels of sodium and potassium: hyponatremia, hypokalemia)
• Dehydration caused by diarrhea, especially in elderly patients

In children, adverse reactions have been generally mild and transient and have
mainly affected the gastrointestinal system. These side effects
include:

Common (may affect up to 1 in 10 people)

• Abdominal pain
• Diarrhea (may cause perianal pain)

Uncommon (may affect up to 1 in 100 people)

• Vomiting
• Feeling of fullness
• Nausea

Overdoses can cause diarrhea, which usually resolves when the dose
is reduced or the treatment is discontinued.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through 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 pack 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 particular storage conditions.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Contents of the pack and other information

What Casenjunior contains
The active ingredient is: Macrogol 4000.
Each ml contains 500 mg of macrogol 4000.
The other ingredients (excipients) are: Sodium benzoate (E-211), potassium sorbate, citric acid,
sodium citrate and sucralose.

Description of the appearance of Casenjunior and contents of the pack
Casenjunior is a transparent, colorless, odorless and tasteless solution.
It is available in an amber bottle of 200 ml and a syringe is provided to facilitate the
dosage of the oral solution.

Marketing Authorization Holder and Manufacturer
Casen Recordati, S.L.
Autovía de Logroño, Km 13,300
50180 UTEBO. Zaragoza (Spain)

Sales Representative
RECORDATI Industria Chimica e Farmaceutica S.p.A.
Via M. Civitali, 1 – 20148 Milano

This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations:
Other sources of information
More detailed information on this medicine is available on the AIFA website
http://www.agenziafarmaco.gov.it