MACROGOL AUROVITAS 4 G ORAL SOLUTION POWDER IN SACHET

Introduction

Package Leaflet: Information for the User

Macrogol Aurovitas 4 g Powder for Oral Solution in Sachet

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

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

1. What is Macrogol Aurovitas and what is it 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 water in the stools, which helps to relieve the disorders caused by very slow intestinal movements. Macrogol 4000 is not absorbed in 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. This medicine is a powder that must be dissolved in a glass of water and given to your child to drink. It usually takes effect within 24 to 48 hours.

Treatment of constipation with medicines should only be used as a complement to healthy lifestyle and dietary habits.

2. What you need to know before you take Macrogol Aurovitas

Do not take Macrogol Aurovitas

• if your child is allergic to macrogol (polyethylene glycol) or any of the other ingredients of this medicine (listed in section 6).
• if your child has an existing disease, such as severe 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
• abdominal pain of uncertain cause.

Do not give this medicineif any of the above situations apply to your child. If you are not sure, talk to your pharmacist or doctor before giving the medicine.

Warnings and Precautions

Talk to your doctor or pharmacist before starting to take macrogol 4000.

There have been reports of allergic reactions with skin rash and swelling of the face or throat (angioedema) in adults after taking products containing macrogol (polyethylene glycol). There have been reports of serious, isolated cases of severe allergic reactions that caused fainting, collapse, or difficulty breathing and general discomfort.

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

If you experience sudden abdominal pain or rectal bleeding while taking Macrogol Aurovitas for intestinal preparation, contact your doctor or go to a doctor immediately.

An organic disorder should be ruled out before starting treatment. Talk to your pharmacist or doctor before giving the medicine.

As this medicine may sometimes cause diarrhea, talk to a doctor or pharmacist before giving this medicine if your child:

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

Before taking Macrogol Aurovitas, talk to your doctor or pharmacist if you know you have a swallowing disorder. Avoid mixing [Macrogol Aurovitas-PEG laxative] and starch-based thickeners if you have difficulty swallowing. This can result in a watery liquid that could enter your lungs and cause pneumonia if you cannot swallow properly.

Other Medicines and Macrogol Aurovitas

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

The absorption of other medicines taken may be temporarily reduced during treatment with macrogol 4000, in particular medicines with a narrow therapeutic index or short half-life such as digoxin, antiepileptics, coumarins, and immunosuppressants, leading to a decrease in 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Macrogol 4000 can be taken during pregnancy and breastfeeding.

Driving and Using Machines

No studies have been performed on the effects on the ability to drive and/or use machines.

Macrogol Aurovitas Contains Sorbitol

If your doctor has told you that you have an intolerance to some 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 if you follow a galactose-free diet.

Macrogol Aurovitas contains 1.2 mg - 1.8 mg of sorbitol in each sachet.

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

3. How to Take Macrogol Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose depends on the age of your child:

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 you only need one sachet, give it to your child in the morning. If you need more than one sachet, give this medicine to your child in the morning and at night.

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

Note:

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

If You Take More Macrogol Aurovitas Than You Should

Administering too much macrogol 4000 can cause diarrhea, stomach pain, or vomiting. Diarrhea usually disappears when treatment is stopped or the dose is reduced.

If your child suffers from severe diarrhea or vomiting, they should contact their doctor as soon as possible, as they may need treatment 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, phone 91 562 04 20, indicating the medicine and the amount taken.

If You Forget to Take Macrogol Aurovitas

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 pain (stomachache).
• Diarrhea that can also cause pain around the rectum (perianal pain).

Uncommon (may affect up to 1 in 100 people)

• Nausea (feeling sick) or vomiting.
• Abdominal swelling (bloating).

Frequency Not Known (cannot be estimated from the available data)

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

In Adults:

Side effects have been generally mild and transient and are mainly related to the gastrointestinal system. These side effects include:

Uncommon (may affect up to 1 in 100 people)

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

Frequency Not Known (cannot be estimated from the available data)

• Low potassium levels in the blood that can cause muscle weakness, spasms, or abnormal heart rhythm.
• Low sodium levels in the blood that can cause fatigue and confusion.
• Muscle spasms, convulsions, and coma.
• Dehydration caused by severe diarrhea, especially in the elderly.
• Redness of the skin.

Reporting of Side Effects

If you experience 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 Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the packaging and on the sachet after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 orange grapefruit flavor (contains 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)).

Appearance of the Product and Pack Size

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicine 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

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

Italy: Macrogol Aurobindo

Netherlands: Macrogol Aurobindo 4 g, powder for oral solution in sachet

Portugal: Macrogol Generis

Date of Last Revision of this Leaflet: March 2023

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