Macrogol Aurovitas 10 g powder for oral solution in sachet

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this 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 side 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 improve disorders 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 symptomatic treatment of constipation in adults and children over 8 years of age. This medicine is a powder that must be dissolved in a glass of water (at least 50 ml) and then drunk. It usually takes 24 to 48 hours to take effect.

Treatment of constipation with any medicine should only be considered alongside a healthy lifestyle and diet.

2. What you need to know before taking Macrogol Aurovitas

Do not take Macrogol Aurovitas

• If you are allergic to macrogol (polyethylene glycol) or to any of the other ingredients of this medicine (listed in section 6).

• If you have an existing medical 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.

• Abdominal pain syndromes of undetermined cause.

Do not take this medicine if any of the above situations apply. If you are unsure, consult your pharmacist or doctor before taking this medicine.

Warnings and precautions

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

Allergic reactions have been reported in adults after taking medicines containing macrogol (polyethylene glycol), including rash and swelling of the face or throat (angioedema). Isolated cases of severe allergic reactions have been reported, leading to fainting, collapse, difficulty breathing, and a general feeling of malaise. If you experience any of these symptoms, you must stop treatment with this medicine 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 medical attention immediately.

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

• You have impaired liver or kidney function.
• You are taking diuretics (medicines that promote fluid elimination) or if you are elderly, as these may lead to reduced 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] with 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 taking, have recently taken, or might need to take any other medicines.

The absorption of other medicines taken concomitantly 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 counteract the thickening effect.

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 become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and use of machines

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

Macrogol Aurovitas contains sorbitol

If your doctor has informed you that you have an intolerance to certain sugars, consult him 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 3.1 mg – 4.6 mg of sorbitol per sachet.

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

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

3. How to take Macrogol Aurovitas

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

Use in children and adolescents over 8 years of age

• The recommended dose is one or two sachets per day, preferably taken as a single dose in the morning.
• The daily dose can be adjusted according to the effect achieved and may range from one sachet every two days (especially in children) up 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 solution.

Please bear in mind the following:

• The effect of this medicine occurs within 24 to 48 hours after administration.
• In children, treatment with macrogol 4000 should not exceed 3 months in duration.
• Improvement in the frequency of bowel movements 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 diarrhoea, stomach pain, or vomiting. Diarrhoea usually resolves when treatment is stopped or the dose is reduced.

If you experience severe diarrhoea or vomiting, you should contact your doctor as soon as possible, as fluid loss may require treatment to prevent loss of salts (electrolytes).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 missed doses.

4. Possible adverse effects

Like all medicines, macrogol 4000 can cause adverse effects, although not everyone will experience them.

Adverse effects are usually mild and transient, and include:

In children:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

Frequency not known (cannot be estimated from available data)

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

In adults:

Common (may affect up to 1 in 10 people)

• Abdominal (stomach) pain.
• Abdominal distension (bloating).
• Nausea.
• Diarrhea.

Uncommon (may affect up to 1 in 100 people)

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

Frequency not known (cannot be estimated from available data)

• Low potassium levels which may cause muscle weakness, muscle cramps, or abnormal heart rhythm.
• Low sodium levels which may cause tiredness or confusion, muscle cramps, seizures, and coma.
• Dehydration caused by severe diarrhea, especially in elderly patients.
• Symptoms of an allergic reaction such as skin redness, rash, urticaria, swelling of the face or throat, breathing difficulty, weakness or fainting.

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 via 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 which is stated on the packaging and 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 visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and packaging should be returned to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to 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 10 g of macrogol 4000.
• The other ingredients are: sodium saccharin (E-954) and orange grapefruit flavour (containing orange oil, grapefruit oil, orange juice, lemonal, acetaldehyde, linalool, ethyl butyrate, alpha terpineol, octanol, beta and gamma hexenol, maltodextrin, arabic gum, sorbitol (E420) and butylated hydroxyanisole (E-320)).

Nature of the product and pack size

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 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 medicinal product is authorised 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 the most recent review of this leaflet: March 2023

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