Macrogol Aurobindo

Package leaflet: Information for the user

Macrogol Aurobindo 4 g powder for oral solution in sachets

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, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 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

1. What Macrogol Aurobindo is 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 help 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 must be used in association with appropriate lifestyle changes and dietary measures (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 Macrogol Aurobindo

Treatment of constipation with a laxative should be supportive of a healthy lifestyle and dietary measures.
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 having, or is at risk of gastrointestinal perforation.
• If your child has or suspects having intestinal obstruction.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Macrogol Aurobindo.
If diarrhoea occurs during treatment with Macrogol Aurobindo, 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. If you belong to any of these groups and develop diarrhoea, you should see a doctor for blood tests to check your electrolyte levels.
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 child's clinical condition should be evaluated by the doctor.
Other medicines and Macrogol Aurobindo
Inform 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 use of Macrogol Aurobindo. The therapeutic effect of medicines with a narrow therapeutic index may be particularly affected (e.g. antiepileptics, digoxin, and immunosuppressive agents).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Macrogol Aurobindo can be used during pregnancy.
Breastfeeding
Macrogol Aurobindo can be used during breastfeeding.
Driving and using machines
Macrogol Aurobindo does not affect the ability to drive vehicles or operate machinery.
Macrogol Aurobindo contains sorbitol
If your doctor has told you that you have an intolerance to certain sugars, consult 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 on 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 exactly as directed by your doctor. If in doubt, 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.
The daily dosage should be adjusted according to the clinical effects achieved.
The effect of Macrogol Aurobindo occurs within 24–48 hours after administration.
Dissolve the contents of one sachet in 50 ml of water immediately before use and drink the solution. The reconstituted solution is colourless and ranges from cloudy to transparent.
The improvement in 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 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 Macrogol Aurobindo than you should
You may develop diarrhoea, abdominal pain, and vomiting, which resolve when treatment is temporarily stopped or the dose is reduced.
In case of severe diarrhoea or vomiting, you should 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 Macrogol Aurobindo
Do not take 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 everybody will get them.
The most serious side effects are allergic reactions (hypersensitivity), which include itching (pruritic rash), skin rash, facial swelling (facial oedema), 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 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, mainly affecting 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 the 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 generally been mild and transient, mainly affecting 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 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 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 stated on the carton and sachet after Exp.
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 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 Macrogol Aurobindo contains

• The active substance is macrogol 4000. Each sachet contains 4 g of macrogol 4000.
• The other components are: Sodium saccharin (E-954) and grapefruit-orange flavour (containing orange oil, grapefruit oil, orange juice, citral, acetaldehyde, linalool, ethyl butyrate, alpha-terpineol, octanal, beta and gamma hexenol, maltodextrin, arabic gum, 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 waxy or paraffin-like appearance, with an orange odour. It is available 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)
Italy

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 names:
Belgium: Macrogol AB 4 g powder for oral solution in sachet
Italy: Macrogol Aurobindo
Netherlands: Macrogol Aurobindo 4 gram, powder for oral solution in sachet
Portugal: Macrogol Generis
Spain: Macrogol Aurovitas 4 g Powder for oral solution in sachet

Package leaflet: information for the user

Macrogol Aurobindo 10 g powder for oral solution in sachets

Macrogol 4000
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement 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 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

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

Macrogol Aurobindo contains the active substance macrogol 4000 and belongs to a group of medicines called osmotic laxatives. It adds water to the stools, softening them and increasing their volume, which helps overcome problems caused by very slow intestinal movements. It is not absorbed into the bloodstream or metabolized in the body.
Macrogol Aurobindo is used for the treatment of constipation in adults and children aged 8 years and older.
This medicine is a powder to be dissolved in 50 ml of water and then drunk. It works gradually within 24–48 hours.
Treatment of constipation with any medicinal product should be considered as an 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 severe pre-existing intestinal disease, such as:
  • inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease) or abnormal dilation of the intestine;
  • intestinal perforation or risk of intestinal perforation;
  • ileus or suspected intestinal obstruction;
  • abdominal pain of undetermined cause.

Do not use this medicine if you have any of the conditions listed above. If you are unsure, consult your
pharmacist or doctor before taking this medicine.
Warnings and precautions
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, breathing difficulties, and general malaise have also been reported. If you experience any of these symptoms, stop taking Macrogol Aurobindo and seek immediate medical assistance.
Since this medicine may sometimes cause diarrhoea, consult your doctor or pharmacist before taking the medicine if:

• you have impaired liver or kidney function;
• you are taking diuretics ("water tablets") or are elderly, as there is a risk of reduced sodium or potassium levels in the blood.

Other medicines and Macrogol Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Macrogol Aurobindo may be used during pregnancy and breastfeeding.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Macrogol Aurobindo does not affect the ability to drive or operate machinery.
Macrogol Aurobindo contains sorbitol
If your doctor has informed you that you have an intolerance to certain sugars, consult 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 on 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 on a galactose-free diet.

3. How to take Macrogol Aurobindo

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

Adults and children above 8 years of age

• The recommended dose is 1 or 2 sachets per day, preferably taken as a single dose in the morning.
• Start with one sachet per day and, if necessary, increase to two sachets per day.
• The daily dose may be adjusted according to the clinical response achieved and may vary from 1 sachet every other day (especially in children) up to a maximum of 2 sachets per day.
• Dissolve the contents of the sachet in 50 ml of water immediately before use and drink the solution.

It is important to note that:

• Macrogol Aurobindo generally takes 24–48 hours to work.
• In the management of children with constipation, the duration of treatment with macrogol should not exceed 3 months.
• The improvement in bowel movement frequency achieved with Macrogol Aurobindo can be maintained through a healthy lifestyle and dietary measures.
• Consult 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 may cause diarrhoea, stomach pain, and vomiting. Diarrhoea usually resolves when treatment is stopped or the dose is reduced.
In case of 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 Macrogol Aurobindo
Take the next dose 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 everyone experiences 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 may cause rectal cramps (anus)

Uncommon (may affect up to 1 in 100 people)

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

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

• Low blood potassium levels which may cause muscle weakness, tremors and irregular heartbeat
• Low sodium levels which may cause tiredness and confusion, muscle spasms, seizures and coma
• Dehydration caused by severe diarrhoea, particularly in the elderly
• Symptoms of an allergic reaction, such as skin redness, skin rash (urticaria), swelling of the face and throat, difficulty breathing, weakness and collapse.

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 the following website: 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 stated on the carton and sachet after "Exp.".
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 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 Macrogol Aurobindo contains

• The active substance is macrogol 4000. Each sachet contains 10 g of macrogol 4000.
• The other components are: Sodium saccharin (E-954) and grapefruit-orange flavour (containing orange oil, grapefruit oil, orange juice, citral, acetaldehyde, linalool, ethyl butyrate, alpha-terpineol, octanal, 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 waxy or paraffin-like appearance and an orange odour, for oral solution. It is available 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)
Italy

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 names:
Belgium: Macrogol AB 10 g powder for oral solution in sachet
Italy: Macrogol Aurobindo
Netherlands: Macrogol Aurobindo 10 gram, powder for oral solution in sachet
Portugal: Macrogol Generis
Poland: Macrogol Aurovitas
Czech Republic: Macrogol Aurovitas
Spain: Macrogol Aurovitas 10 g Powder for oral solution in sachet