OMNILAX 10 G POWDER FOR ORAL SOLUTION IN SACHET

Introduction

Package Leaflet: Information for the User

Omnilax 10g powder for oral solution in sachet

macrogol 4000

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

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

Contents of the Package Leaflet

1. What is Omnilax and what is it used for
2. What you need to know before taking Omnilax
3. How to take Omnilax
4. Possible side effects
5. Storage of Omnilax
6. Package contents and additional information

1. What is Omnilax and what is it used for

Omnilax contains the active ingredient macrogol 4000 and belongs to a group of medications 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. Omnilax is not absorbed into the bloodstream or degraded in the body.

Omnilax is used to treat constipation in adults and children from 8 years of age. This medication is a powder that must be dissolved in a glass of water (at least 50 ml) and taken. It usually takes effect within 24 to 48 hours.

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

2. What you need to know before taking Omnilax

Do not take Omnilax:

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

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 fainting, collapse, or difficulty breathing and a feeling of general discomfort. If you experience any of these symptoms, you should stop taking Omnilax and see a doctor immediately.

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

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

Before taking Omnilax, talk to your doctor or pharmacist if you know you have a swallowing disorder. Avoid mixing Omnilax with food thickeners based on starch 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 medications and Omnilax

It is possible that the absorption of other medications taken may be temporarily reduced during treatment with Omnilax, particularly medications with a narrow therapeutic index or short half-life, such as digoxin, antiepileptics, coumarins, and immunosuppressants, leading to a decrease in efficacy.

Tell your doctor or pharmacist if you are taking or have recently taken any other medication, including medications purchased without a prescription.

If you have difficulty swallowing and need food thickeners to thicken liquids to swallow them safely, avoid mixing Omnilax with liquids thickened with starch-based food thickeners. Omnilax can counteract the effect of starch-based food thickeners, making preparations that should remain thick for people with swallowing difficulties become liquid.

Pregnancy and breastfeeding

Omnilax can be used during pregnancy and breastfeeding.

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

Driving and using machines

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

Omnilax contains sulfur dioxide, sorbitol, and sodium

Due to the presence of sulfur dioxide, it can cause severe hypersensitivity reactions and respiratory difficulties in exceptional cases.

This medication contains 0.7 mg of sorbitol in each sachet. However, Omnilax can be taken if you are diabetic or have a galactose-free diet.

This medication contains less than 1 mmol of sodium (23 mg) per sachet, i.e., it is essentially "sodium-free".

3. How to take Omnilax

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Adults and children from 8 years of age:

The recommended dose is 1 to 2 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:

• Omnimax usually takes effect within 24 to 48 hours.
• In children, the duration of treatment with Omnilax should not exceed 3 months.
• Improvement in bowel movement frequency after taking Omnilax can be maintained by adopting healthy lifestyle and diet measures.
• Consult your pharmacist or doctor if symptoms worsen or do not improve.

If you take more Omnilax than you should

Taking too much Omnilax can cause diarrhea, abdominal pain, and vomiting. Diarrhea disappears when treatment is interrupted or the dose is reduced.

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

If you forget to take Omnilax

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

4. Possible side effects

Like all medications, Omnilax can cause side effects, although not everyone experiences them.

Side effects are generally mild and transient, including:

In children

Frequent (may affect up to 1 in 10 people):

• Abdominal pain (stomach)
• Diarrhea, which can also cause pain around the rectum (perianal pain).

Uncommon (may affect up to 1 in 100 people):

• Nausea (feeling of discomfort) or vomiting
• Abdominal bloating (stomach)

Frequency not known (cannot be estimated from available data):

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

In adults

Frequent (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

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

Frequency not known (cannot be estimated from available data):

• Low potassium levels in the blood, which can cause muscle weakness, muscle contraction, or abnormal heart rhythm.
• Low sodium levels in the blood, which can cause fatigue and confusion, muscle contraction, convulsions, 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, difficulty breathing, weakness, or fainting.

Reporting side effects

If you experience side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Omnilax

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

Do not use this medication after the expiration date shown on the base of the box. The expiration date is the last day of the month indicated.

The reconstituted solution should be stored in the refrigerator (2°C to 8°C) and will be stable for 6 hours.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Omnilax

• The active ingredient is macrogol. Each sachet contains 10 g of macrogol.
• The other ingredients are sodium saccharin (E-954) and flavoring (orange and grapefruit flavor containing maltodextrin, sorbitol (E-420), sulfur dioxide (E-220), and gum arabic (E-414)).

Appearance of the product and package contents

White powder with orange-grapefruit flavor.

Omnilax is available in packages of 10, 20, 30, 50, or 100 sachets.

Only some package sizes may be marketed.

Marketing authorization holder

Pro Health Pharma Sweden AB

Genetor, Kungstorget 8

252 78 Helsingborg, Sweden

Manufacturer

Lamp San Prospero S.p.A

Via della Pace 25/A

41030 San Prospero (Modena), Italy

Local representative

NUTRICIÓN MÉDICA, S.L.

C/ Arequipa, 1 – 28043 Madrid, Spain

Date of the last revision of this package leaflet:September 2024

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