MACROGOL 4 G Proszek do sporządzania roztworu doustnego

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1. Macrogol Aurobindo 4 g powder for oral solution in sachets, 4000
   1. What is Macrogol Aurobindo and what it is used for
   2. What you need to know before taking Macrogol Aurobindo
   3. How to take Macrogol Aurobindo
   4. Possible side effects
   5. How to store Macrogol Aurobindo
   6. Contents of the pack and other information
2. Macrogol Aurobindo 10 g powder for oral solution in sachets
   1. What is Macrogol Aurobindo and what is it used for
   2. What you need to know before taking Macrogol Aurobindo
   3. How to take Macrogol Aurobindo
   4. Possible side effects
   5. How to store Macrogol Aurobindo
   6. Contents of the pack and other information

Macrogol Aurobindo 4 g powder for oral solution in sachets, 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 they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Macrogol Aurobindo and what it is used for

The name of this medicine is Macrogol Aurobindo 4 g powder for oral solution.
Macrogol Aurobindo 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 its passage easier.
Macrogol Aurobindo is indicated for the symptomatic treatment of constipation in children aged
between 6 months and 8 years. It should be used in association with adequate changes to lifestyle and dietary
measures (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 Macrogol Aurobindo

Treatment of constipation with a laxative should support a healthy lifestyle and a
dietary regimen.

Do not take Macrogol Aurobindo:

• 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 have, or is at risk of having a gastrointestinal perforation.
• If your child has or suspects they have an intestinal obstruction.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Macrogol Aurobindo.
If diarrhea occurs during treatment with Macrogol Aurobindo, 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 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, the doctor will need to evaluate your child’s clinical
condition.

Other medicines and Macrogol Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
There is a possibility that the absorption of other medicines may be temporarily reduced during
the use of Macrogol Aurobindo. The therapeutic effect of medicines with a narrow therapeutic index may
be particularly affected (e.g. antiepileptics, digoxin and immunosuppressants).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Macrogol Aurobindo can be used during pregnancy.
Breastfeeding
Macrogol Aurobindo can be used during breastfeeding.

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

Macrogol Aurobindocontains sorbitol
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking
this medicine. This medicine contains a small amount of a sugar called sorbitol and
can be used if you are diabetic or follow a galactose-free diet.
Macrogol Aurobindo contains 1.2-1.8 mg of sorbitol per sachet.
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially ‘sodium-free’.

3. How to take Macrogol Aurobindo

Use this medicine following the instructions of your doctor exactly. 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 year and 4 years: 1 to 2 sachets per day.
From 4 years to 8 years: 2 to 4 sachets per day.
Treatment should be administered in the morning at a dose of one sachet per day or divided between morning
and evening for higher dosages.
The daily dosage should be adjusted based on the clinical effects obtained.
The effect of Macrogol Aurobindo manifests within 24-48 hours after administration.
Dissolve the contents of the sachet in 50 ml of water immediately before use and drink the liquid. The
reconstituted solution is colorless and from cloudy to transparent.
The improvement of bowel movement frequency after taking Macrogol Aurobindo 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 Macrogol Aurobindo 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 Macrogol Aurobindo
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 (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 from 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 (frequency cannot be estimated from available data)

• Electrolyte disturbances (low blood levels of sodium and potassium: hyponatraemia, hypokalaemia)
• Dehydration, caused by 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
• Swelling
• 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 possible side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system at
http://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 Macrogol Aurobindo

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 and on the sachet after Exp.
The expiry date refers to the last day of that month.
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 the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Macrogol Aurobindo contains

• The active ingredient is macrogol 4000. Each sachet contains 4 g of macrogol 4000.
• The other ingredients are: Sodium saccharin (E-954) and grapefruit orange flavour (contains orange oil, grapefruit oil, orange juice, citral, acetaldehyde, linalool, ethyl butyrate, alpha-terpineol, octonal, beta and gamma hexenol, maltodextrin, gum arabic, sorbitol (E420), butylated hydroxyanisole (E320)).

Description of the appearance of Macrogol Aurobindo and contents of the pack
Macrogol Aurobindo is a white or almost white, free-flowing powder with a wax-like or paraffin-like appearance
with an orange odour, in packs containing 10, 20, 30, 50, 60 and 100 sachets for the preparation of an
oral solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102

• 21047 – Saronno (VA)

Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Belgium: Macrogol AB 4 g powder for drink in sachet
Italy: Macrogol Aurobindo
Netherlands: Macrogol Aurobindo 4 gram, powder for drink in sachet
Portugal: Macrogol Generis
Spain: Macrogol Aurovitas 4 g Powder for oral solution in sachet

Macrogol Aurobindo 10 g powder for oral solution in sachets

Macrogol 4000
Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 14 days.

Contents of this leaflet:

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

1. What is Macrogol Aurobindo and what is it used for

Macrogol Aurobindo contains the active ingredient macrogol 4000 and belongs to a group of medicines
called osmotic laxatives. It adds water to the stool, softening it and increasing its volume, which
helps to overcome problems caused by very slow bowel movements. It is not absorbed into the
circulatory system or metabolized in the body.
Macrogol Aurobindo is used for the treatment of constipation in adults and children aged 8 years and
over.
This medicine consists of a powder to be dissolved in 50 ml of water and then drunk. It acts
gradually within 24-48 hours.
The treatment of constipation with any medicinal product should be considered in addition to a
healthy lifestyle and dietary measures.

2. What you need to know before taking Macrogol Aurobindo

Do not take Macrogol Aurobindo:

• If you are allergic to macrogol (polyethylene glycol) or to any of the other ingredients of this medicine (listed in section 6).
• If you have a serious existing intestinal disease, such as:
• inflammatory bowel disease (such as ulcerative colitis, Crohn's disease) or abnormal dilation of the intestine;
• perforation or risk of intestinal perforation;
• ileus or suspected intestinal obstruction;
• abdominal pain from undetermined causes.

Do not use this medicine if you suffer from any of the conditions listed above. If you are not sure, ask your
pharmacist or doctor before taking the medicine.

Warnings and precautions
Cases of allergic reactions such as skin rash and swelling of the face or throat
(angioedema) have been reported in adults after taking products containing macrogol (polyethylene glycol). Isolated cases of severe allergic reactions characterized by weakness, collapse or difficulty breathing and
general malaise have been reported. If you experience any of these symptoms, stop taking Macrogol Aurobindo and
seek immediate medical assistance.
Because this medicine can sometimes cause diarrhea, check with your doctor or pharmacist before
taking the medicine if:

• you suffer from impaired liver or kidney function;
• you are taking diuretics (water tablets) or are elderly because there is a risk of a reduction in sodium (salt) or potassium in the blood.

Other medicines and Macrogol Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Pregnancy and breastfeeding
Macrogol Aurobindo can be used during pregnancy and breastfeeding.
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Macrogol Aurobindo does not impair the ability to drive vehicles or use machines.

Macrogol Aurobindocontains sorbitol
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking
this medicine. This medicine contains a small amount of a sugar called sorbitol and
can be used if you are diabetic or follow a galactose-free diet.
Macrogol Aurobindo contains 3.1-4.6 mg of sorbitol per sachet.
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially ‘sodium-free’.
Macrogol Aurobindo can be used if you are diabetic or follow a galactose-free diet.

3. How to take Macrogol Aurobindo

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults and children over 8 years of age

• The recommended dose is 1 or 2 sachets daily, preferably taken in a single administration in the morning.
• Start by taking one sachet daily and if necessary increase to two sachets daily.
• The daily dose may be adjusted based on the clinical effect obtained and may vary from 1 sachet every other day (especially in children) up to a maximum of 2 sachets daily.
• Dissolve the contents of the sachet in 50 ml of water immediately before use and drink the liquid.

It is important to note that:

• Macrogol Aurobindo generally takes 24-48 hours to take effect.
• In the management of children with constipation, the duration of treatment with macrogol should not exceed 3 months.
• The improvement in the frequency of your bowel movements obtained with the use of Macrogol Aurobindo can be maintained through a healthy lifestyle and dietary measures.
• Contact your doctor or pharmacist if your symptoms worsen or do not improve.

If you take more Macrogol Aurobindo than you should
Taking too much macrogol can cause diarrhea, stomach pain and vomiting. Diarrhea generally
disappears when treatment is stopped or 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 Macrogol Aurobindo
Take the next dose as soon as you remember.
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.
Side effects are generally mild and temporary and include:

In children:
Common(may affect up to 1 in 10 people)

• Abdominal pain (stomach ache)
• Diarrhoea which can cause cramps in the rectum (anus)

Uncommon(may affect up to 1 in 100 people)

• Nausea (feeling unwell) or vomiting
• Abdominal bloating (stomach bloating)

Not known(frequency cannot be estimated from available data)

• Allergic reactions (hypersensitivity) (skin rash (urticaria), swelling of the face and throat, difficulty breathing, weakness or collapse)

In adults:
Common(may affect up to 1 in 10 people)

• Abdominal pain (stomach ache)
• Abdominal bloating (stomach bloating)
• Nausea (feeling unwell)
• Diarrhoea

Uncommon(may affect up to 1 in 100 people)

• Vomiting
• Urgent need to go to the toilet
• Faecal incontinence

Not known(frequency cannot be estimated from available data)

• Low levels of potassium in the blood which can cause muscle weakness, tremors and altered heart rhythm
• Low levels of sodium which can induce fatigue and confusion, muscle spasms, convulsions and coma
• Dehydration caused by severe diarrhoea, especially in the elderly
• Symptoms of an allergic reaction, such as redness of the skin, skin rash (urticaria), swelling of the face and throat, difficulty breathing, weakness and collapse.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at http://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 Macrogol Aurobindo

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 package and on the sachet after Exp.
The expiry date refers to the last day of that month.
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 the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Macrogol Aurobindo contains

• The active ingredient is macrogol 4000. Each sachet contains 10 g of macrogol 4000.
• The other ingredients are: Sodium saccharin (E-954) and grapefruit orange flavour (contains orange oil, grapefruit oil, orange juice, citral, acetaldehyde, linalool, ethyl butyrate, alpha-terpeniol, octonal, beta and gamma hexenol, maltodextrin, gum arabic, sorbitol (E420), butylated hydroxyanisole (E320)).

Description of the appearance of Macrogol Aurobindo and contents of the pack
Macrogol Aurobindo is a white or almost white, free-flowing powder with a wax- or paraffin-like appearance
with an orange odour, in packs containing 10, 20, 30, 50, 60 and 100 sachets for the preparation of a
oral solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102

• 21047 – Saronno (VA)

Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Belgium: Macrogol AB 10 g powder for drink in sachet
Italy: Macrogol Aurobindo
Netherlands: Macrogol Aurobindo 10 gram, powder for drink in sachet
Portugal: Macrogol Generis
Poland: Macrogol Aurovitas
Czech Republic: Macrogol Aurovitas
Spain: Macrogol Aurovitas 10 g Powder for oral solution in sachet