Macrogol Aurovitas 4 g powder for oral solution in sachet

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Macrogol Aurovitas 4 g powder for oral solution in sachet

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Macrogol Aurovitas contains the active substance macrogol 4000 and belongs to a group of medicines called osmotic laxatives. It works by increasing the amount of water in the stools, which helps relieve problems caused by very slow intestinal movements. Macrogol 4000 is not absorbed into the bloodstream and is not broken down in the body.

Macrogol 4000 is used for the treatment of constipation in children from 6 months to 8 years of age. This medicine is a powder that must be dissolved in a glass of water and taken orally by your child. It usually takes 24 to 48 hours to take effect.

Treatment of constipation with medicines should only be used as an addition to healthy lifestyle habits and diet.

2. What you need to know before starting Macrogol Aurovitas

Do not take Macrogol Aurovitas

• if your child is allergic to macrogol (polyethylene glycol) or to any of the other ingredients of this medicine (listed in section 6).

• if your child has an existing condition such as a serious intestinal disease

• inflammatory bowel disease (such as ulcerative colitis, Crohn's disease, abnormal dilation of the intestine).

• intestinal perforation or risk of intestinal perforation

• ileus or suspected intestinal obstruction

• painful abdominal syndromes of uncertain cause.

Do not administer this medicine if any of the above situations apply to your child. If you are unsure, speak with your pharmacist or doctor before giving the medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting macrogol 4000.

Cases of allergic reactions with 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 causing fainting, collapse, breathing difficulties, and general malaise have also been reported.

If your child experiences any of these symptoms, seek medical help immediately.

If sudden abdominal pain or rectal bleeding occurs while taking Macrogol Aurovitas for bowel preparation, contact your doctor or seek immediate medical attention.

An organic disorder should be ruled out before starting treatment. Consult your pharmacist or doctor before administering the medicine.

Since this medicine may sometimes cause diarrhea, consult a doctor or pharmacist before administering this medicine if your child:

• has impaired liver or kidney function, or
• is taking diuretics (water tablets), as your child may be at risk of low levels of sodium (salt) or potassium in the blood.

Before taking Macrogol Aurovitas, speak with your doctor or pharmacist if you know you have a swallowing disorder. Avoid mixing [Macrogol Aurovitas-PEG laxative] and starch-based food thickeners if you have difficulty swallowing. This may result in an aqueous liquid that could enter your lungs and cause pneumonia if you are unable to swallow properly.

Other medicines and Macrogol Aurovitas

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

The absorption of other concomitantly administered medicines may be temporarily reduced during treatment with macrogol 4000, particularly drugs with a narrow therapeutic index or short half-life such as digoxin, antiepileptics, coumarins, and immunosuppressants, potentially leading to reduced efficacy.

If you need to thicken liquids to swallow them safely, macrogol 4000 may neutralize the effect of the thickener.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Macrogol 4000 may be taken during pregnancy and breastfeeding.

Driving and use of machinery

No studies on the effects on the ability to drive and/or operate machinery have been conducted.

Macrogol Aurovitas contains sorbitol

If your doctor has informed you of an intolerance to certain sugars, contact them before taking this medicine. This medicine contains a small amount of a sugar called sorbitol. It can be used if you are diabetic or following a galactose-free diet.

Macrogol Aurovitas contains 1.2 mg – 1.8 mg of sorbitol per sachet.

This medicine contains less than 1 mmol of sodium (23 mg) per oral solution; essentially "sodium-free".

3. How to take Macrogol Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose depends on your child's age:

Children from 6 months to 1 year: one sachet per day,
Children from 1 to 4 years: one to two sachets per day,
Children from 4 to 8 years: two to four sachets per day.

Dissolve the contents of the sachets in a glass of water (at least 50 ml) immediately before administration and give it to your child to drink. If only one sachet is required, give it to your child in the morning. If more than one sachet is needed, give this medicine to your child in the morning and in the evening.

In children over one year of age, the daily dose may be adjusted according to the effect achieved.

Please note:

• Macrogol 4000 usually takes between 24 and 48 hours to take effect.
• The duration of treatment with macrogol 4000 should not exceed 3 months in children.
• Improvement in your child's bowel movement frequency after taking macrogol 4000 can be maintained by adopting a healthy lifestyle and diet.
• Talk to your pharmacist or doctor if symptoms worsen or do not improve.

If you take more Macrogol Aurovitas than you should

Taking too much macrogol 4000 may cause diarrhea, stomach pain, or vomiting. Diarrhea usually resolves when treatment is stopped or the dose is reduced.

If your child experiences severe diarrhea or vomiting, you should contact your doctor as soon as possible, as treatment may be needed to prevent loss of salts (electrolytes) due to fluid loss.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Macrogol Aurovitas

Take the next dose as soon as you remember, but do not take a double dose to make up for forgotten doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The side effects that are usually mild and do not last long include:

In children:

Common (may affect up to 1 in 10 people)

• Abdominal (stomach) pain.
• Diarrhea, which may also cause pain around the rectum (perianal pain).

Uncommon (may affect up to 1 in 100 people)

• Nausea (feeling sick) or vomiting.
• Abdominal bloating (of the stomach).

Frequency not known (cannot be estimated from the available data)

Allergic reactions (hypersensitivity) (rash, hives (urticaria), swelling of the face or throat, difficulty breathing, fainting or collapse).

In adults:

Adverse effects have generally been minor, transient, and primarily related to the gastrointestinal system. These adverse effects include:

Uncommon (may affect up to 1 in 100 people)

• Urgent need to go to the toilet.
• Fecal incontinence.

Frequency not known (cannot be estimated from the available data)

• Low levels of potassium in the blood, which may cause muscle weakness, spasms, or abnormal heart rhythm.
• Low levels of sodium in the blood, which may cause tiredness and confusion.
• Muscle spasms, seizures, and coma.
• Dehydration caused by severe diarrhea, especially in the elderly.
• Skin redness.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Macrogol Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the sachet after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any signs of visible deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Macrogol Aurovitas

• The active substance is macrogol 4000. Each sachet contains 4 g of macrogol 4000.
• The other excipients are: sodium saccharin (E-954) and grapefruit-orange flavour (containing orange oil, grapefruit oil, orange juice, lemonal, acetaldehyde, linalool, ethyl butyrate, alpha terpineol, octanol, beta and gamma hexenol, maltodextrin, gum arabic, sorbitol (E420) and butylhydroxyanisole (E-320)).

Nature of the product and contents of the pack

Macrogol Aurovitas is a white or almost white, free-flowing powder with a waxy or paraffin-like appearance and an orange odour. It is supplied in sachets, with pack sizes of 10, 20, 30, 50, 60 and 100 sachets for the preparation of an oral solution.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicinal product is authorised in the European Economic Area member states under the following names:

Belgium: Macrogol AB 4 g poeder voor drank in sachet

Spain: Macrogol Aurovitas 4 g powder for oral solution in sachet

Italy: Macrogol Aurobindo

Netherlands: Macrogol Aurobindo 4 g, poeder voor drank in sachet

Portugal: Macrogol Generis

Date of the most recent review of this leaflet: March 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)