MACROGOL AUROVITAS 10 G ORAL SOLUTION POWDER IN SACHET

Introduction

Package Leaflet: Information for the User

Macrogol Aurovitas 10 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 amount of water in the stool, which helps to improve 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 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 effect within 24 to 48 hours.

Treatment of constipation with any medication should only be considered along with a healthy lifestyle and diet.

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

Do not take Macrogol Aurovitas

• If you are allergic to macrogol (polyethylene glycol) or any of the other ingredients of this medicine (listed in section 6).
• If you have 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.
• Intestinal obstruction or suspected intestinal obstruction.
• Abdominal pain of unknown cause.

Do not take this medicineif you are in any of the above situations. If you are not sure, consult your pharmacist or doctor before taking this medicine.

Warnings and Precautions

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

After taking medicines 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 fainting, collapse, or difficulty breathing and a feeling of general malaise. If you experience any of these symptoms, you should stop treatment with this medicine and consult your doctor 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.

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

• You have impaired liver or kidney function.
• You are taking diuretics (medicines that facilitate the elimination of fluids) or if you are an elderly person, as sodium or potassium levels in the blood may decrease.

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 food 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, have recently used, or might use any other medicines.

The absorption of other medicines taken may be temporarily reduced during treatment with macrogol 4000, particularly 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 counteract the effect of the thickener.

Pregnancy and Breastfeeding

Macrogol Aurovitas can be used during 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.

Driving and Using Machines

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

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 3.1 mg - 4.6 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".

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

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.

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 according to 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 medicine occurs 24 to 48 hours after 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 can cause diarrhea, stomach pain, or vomiting. Diarrhea usually disappears when treatment is discontinued or when the dose is reduced.

If you suffer from intense diarrhea or vomiting, you should contact your doctor as soon as possible, as you 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 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 Side Effects

Like all medicines, macrogol 4000 can cause side effects, although not everybody gets them.

Side effects are generally mild and temporary, including:

In Children:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Nausea or vomiting.
• Abdominal bloating (stomach swelling).

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

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

In Adults:

Common (may affect up to 1 in 10 people)

• Abdominal pain (stomach ache).
• Abdominal distension (stomach swelling).
• Nausea.
• Diarrhea.

Uncommon (may affect up to 1 in 100 people)

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

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

• Low potassium levels that can cause muscle weakness, muscle contraction, or abnormal heart rhythm.
• Low sodium levels that can cause fatigue or confusion, muscle contraction, convulsions, and coma.
• Dehydration caused by intense diarrhea, especially in elderly patients.
• Symptoms of an allergic reaction such as skin redness, rash, urticaria, swelling of the face or throat, difficulty breathing, weakness, or fainting.

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 carton and sachet after EXP. The expiry date is the last day of the month stated.

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 10 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 Contents of the Pack

Macrogol Aurovitas is a white or almost white fluid powder with a waxy or paraffin-like appearance and 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 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: 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

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)