Leaflet: information for the user

Macrogol Aurovitas 10 g powder for oral solution in sachet

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. 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 the amount of water in the faeces, which helps to improve 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 symptomatic treatment of constipation in adults and children over 8 years old.This medicine is a powder that must be dissolved in a glass of water (at least 50 ml) and drunk. It usually takes 24 to 48 hours to take effect.

The treatment of constipation with any medication should only be considered in conjunction with a healthy lifestyle and diet.

Do not take Macrogol Aurovitas

• If you are allergic to macrogol (polyethylene glycol) or any of the other components of this medication (listed in section 6).
• If you have an existing illness, such as a severe intestinal disease:

• Inflammatory bowel disease (such as ulcerative colitis, Crohn's disease, abnormal intestinal dilation).
• Intestinal perforation or risk of intestinal perforation.
• Intestinal obstruction or suspected intestinal obstruction.
• Abdominal pain syndromes of unknown cause.

Do not take this medicationif any of the above situations occur. If you are unsure, consult your pharmacist or doctor before taking this medication.

Warnings and precautions

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

After taking medications containing macrogol (polyethylene glycol), cases of allergic reactions have been reported in adults, including rash and swelling of the face or throat (angioedema). Isolated cases of severe allergic reactions have been reported, which caused dizziness, collapse, or difficulty breathing and a general feeling of discomfort. If you experience any of these symptoms, discontinue treatment with this medication and seek medical attention immediately.

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

Since this medication may cause diarrhea in some cases, consult your doctor or pharmacist before taking this medication if:

• You have liver or kidney function impairment.
• You are taking diuretics (medications that facilitate the elimination of liquids) or are an elderly person, as they may decrease sodium 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, have used recently, 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 drink safely, macrogol 4000 may counteract the effect of the thickening agent.

Pregnancy and lactation

Macrogol Aurovitas can be used during pregnancy and lactation.

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

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 3.1 mg – 4.6 mg of sorbitol in each sachet.

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

Macrogol 4000 can be used if you are diabetic or follow a galactose-free diet.

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.

Use in children and adolescents over 8 years old

• The recommended dose is one or two sachets per day, preferably taken in a single dose in the morning.
• The daily dose can be adjusted based on the effect obtained and may range from one sachet every two days (especially in children) to a maximum of two sachets per day.
• Dissolve the contents of the sachets in a glass of water (at least 50 ml) just before administration and drink the liquid.

Consider the following:

• The effect of this medication occurs within 24 to 48 hours of administration.
• In children, the duration of treatment with macrogol 4000 should not exceed 3 months.
• Improvement in bowel movement frequency after taking macrogol 4000 will be maintained by adopting lifestyle and dietary measures.
• Consult your pharmacist or doctor if symptoms worsen or do not improve.

If you take more Macrogol Aurovitas than you should

Excessive intake of macrogol may cause diarrhea, stomach pain, or vomiting. Diarrhea usually subsides when treatment is stopped or the dose is reduced.

If you experience intense diarrhea or vomiting, contact your doctor as soon as possible, as you may need treatment to prevent electrolyte loss due to fluid loss.

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

If you forgot to take Macrogol Aurovitas

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

Like all medications, macrogol 4000 may cause adverse effects, although not everyone will experience them.

Adverse effects are generally mild and transient, and include:

In children:

Frequent (may affect up to 1 in 10 people)

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

Less frequent (may affect up to 1 in 100 people)

• Nausea or vomiting.
• Abdominal distension.

Unknown frequency (cannot be estimated from available data)

• Allergic reactions (hypersensitivity) (rash, urticaria, facial or throat inflammation, respiratory difficulty, weakness or fainting).

In adults:

Frequent (may affect up to 1 in 10 people)

• Abdominal pain.
• Abdominal distension.
• Nausea.
• Diarrhea.

Less frequent (may affect up to 1 in 100 people)

• Vomiting.
• Urgency to defecate.
• Fecal incontinence.

Unknown frequency (cannot be estimated from available data)

• Low levels of potassium that may cause muscle weakness, muscle cramps, or abnormal heart rhythm.
• Low levels of sodium that may cause dizziness or confusion, muscle cramps, seizures, and coma.
• Dehydration, caused by intense diarrhea, especially in elderly patients.
• Symptoms of an allergic reaction such as skin redness, rash, urticaria, facial or throat inflammation, respiratory difficulty, weakness or fainting).

Reporting 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 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 disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the packaging 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 10 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 fluid 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 10 g powder for oral solution in sachet

Spain:Macrogol Aurovitas 10 g powder for oral solution in sachet

Italy:Macrogol Aurobindo

Netherlands:Macrogol Sanias 10 g, powder for oral solution in sachet

Poland:Macrogol Aurovitas

Portugal:Macrogol Generis

Last review date of this leaflet: March 2023

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