Package Insert: Information for the User

Macrogol Aurovitas 4 g Powder for Oral Solution in a Sachet

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Macrogol Aurovitas contains the active ingredient macrogol 4000 and belongs to a group of medicines called osmotic laxatives. It works by increasing water in the faeces, which helps to relieve the disturbances caused by very slow intestinal movements. Macrogol 4000 is not absorbed into the bloodstream nor is it broken down in the body.

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

The treatment of constipation with medication should only be used as a complement to healthy lifestyle habits and a healthy diet.

Do not take Macrogol Aurovitas

• if your child is allergic to macrogol (polyethylene glycol) or any of the other components of this medication (listed in section 6).
• if your child has an existing disease, such as a severe intestinal disease

• inflammatory bowel disease (such as ulcerative colitis, Crohn's disease, abnormal intestinal dilation).
• intestine perforation or risk of intestine perforation
• ileus or suspected intestinal obstruction
• abdominal pain syndromes of uncertain cause.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 severe cases of severe allergic reactions have been reported, which caused fainting, collapse, or difficulty breathing and general discomfort.

If your child experiences any of these symptoms, seek immediate medical attention.

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

Organic disorder should be ruled out before starting treatment, consult your pharmacist or doctor before administering the medication.

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

• has altered liver or kidney function or
• is taking diuretics (urine pills), as your child may be at risk of having low sodium (salt) or potassium levels 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 thickening agents if you have difficulty swallowing. This may result in a watery liquid that could enter your lungs and cause pneumonia if you cannot swallow properly.

Other medications andMacrogol Aurovitas

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

The absorption of other medications taken may be temporarily reduced during treatment with macrogol 4000, particularly medications 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 safely swallow them, macrogol 4000 may neutralize the effect of the thickener.

Pregnancy and lactation

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

Macrogol 4000 can be taken during pregnancy and lactation.

Driving and operating machines

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

Macrogol Aurovitascontains sorbitol

If your doctor has told you that you have intolerance to some sugars, contact him before taking this medication. This medication contains a small amount of a sugar called sorbitol, it can be used if you are diabetic or follow a galactose-free diet.

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

This medication contains less than 1 mmol of sodium (23 mg) per oral solution; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated 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 only one sachet is needed, give it to your child in the morning. If more than one sachet is needed, give this medication to your child in the morning and at night.

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

Remember:

• Macrogol 4000 usually takes between 24 and 48 hours to take effect.
• The duration of treatment with macrogol 4000 should not exceed three months in children.
• The improvement in the frequency of bowel movements in your child after taking macrogol 4000 may be maintained by following 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

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

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

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

If you forgot to take Macrogol Aurovitas

Administer the next dose as soon as you remember, but do not take a double dose to compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

In children:

Frequent (may affect up to 1 in 10 people)

• Abdominal pain (stomach ache).
• Diarrhea that may also cause pain around the rectum (perianal pain).

Rare (may affect up to 1 in 100 people)

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

Unknown frequency (cannot be estimated from available data)

Allergic reactions (hypersensitivity) (rash, hives (urticaria), facial or throat swelling, difficulty breathing, dizziness, or collapse).

In adults:

The adverse effects have generally been milder and of a transient nature, and are primarily related to the gastrointestinal system. These adverse effects include:

Rare (may affect up to 1 in 100 people)

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

Unknown frequency (cannot be estimated from available data)

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and on the overwrap after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Do not use this medication if you detect any visible signs of deterioration.

Medications should not be thrown down the drain or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need if you are unsure. By doing so, you will help protect the environment.

Composition ofMacrogol Aurovitas

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

Appearance of the product and contents of the packaging

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

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Bélgica: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

Last review date of this leaflet: March 2023

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