Omnilax 10 g powder for oral solution in sachet
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Omnilax 10g powder for oral solution in sachet
macrogol 4000
Read the entire 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 should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Omnilax is and what it is used for
- What you need to know before taking Omnilax
- How to take Omnilax
- Possible side effects
- How to store Omnilax
- Contents of the pack and other information
1. What Omnilax is and what it is used for
Omnilax 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 relieve disorders caused by very slow intestinal movements. Omnilax is not absorbed into the bloodstream and is not broken down in the body.
Omnilax is used for the treatment of constipation in adults and children aged 8 years and older. 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 starting to take Omnilax
Do not take Omnilax:
-
if you are allergic (hypersensitive) 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 intestinal dilation)
- 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 occur. If you are unsure, consult your pharmacist or doctor before taking this medicine.
Warnings and precautions
Allergic reactions, including rash and swelling of the face or throat (angioedema), have been reported in adults after taking medications containing macrogol (polyethylene glycol). Isolated cases of severe allergic reactions have been reported, leading to fainting, collapse, breathing difficulties, and a general feeling of malaise. If you experience any of these symptoms, you must stop taking Omnilax immediately and seek medical attention without delay.
Since this medicine may cause diarrhea in some cases, consult your doctor or pharmacist before taking Omnilax if:
- you have impaired liver or kidney function
- you are taking diuretics (medications that promote fluid elimination) or are elderly, as these may reduce blood levels of sodium (salt) or potassium.
Before taking Omnilax, speak with your doctor or pharmacist if you know you have a swallowing disorder. Avoid mixing Omnilax with starch-based food thickeners if you have difficulty swallowing. This may result in a watery liquid that could enter your lungs and cause pneumonia if you are unable to swallow properly.
Other medicines and Omnilax
The absorption of other medications taken concurrently may be temporarily reduced during treatment with Omnilax, particularly drugs with a narrow therapeutic index or short half-life such as digoxin, antiepileptics, coumarins, and immunosuppressive agents, potentially leading to reduced efficacy.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
If you have difficulty swallowing and require food thickeners to safely consume liquids, avoid mixing Omnilax with liquids thickened with starch-based food thickeners. Omnilax may counteract the effect of starch-based food thickeners, causing preparations that should remain thick for individuals with swallowing difficulties to liquefy.
Pregnancy and breastfeeding
Omnilax may 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 medicine.
Driving and using machines
No studies have been conducted on the effects on the ability to drive and/or operate machinery.
Omnilax contains sulfur dioxide, sorbitol, and sodium
Due to the presence of sulfur dioxide, it may exceptionally cause severe hypersensitivity reactions and breathing difficulties.
This medicine contains 0.7 mg of sorbitol per sachet. However, Omnilax can be taken if you are diabetic or on a galactose-free diet.
This medicine contains less than 1 mmol of sodium (23 mg) per sachet; therefore, it is essentially “sodium-free”.
3. How to take Omnilax
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, 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 as a single dose in the morning. The daily dose may be adjusted according to the effect obtained 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 liquid.
Please consider the following:
- Omnilax generally takes 24 to 48 hours to take effect.
- In children, treatment with Omnilax should not last longer than 3 months.
- Improvement in the frequency of intestinal movements after taking Omnilax can be maintained by adopting measures related to a healthy lifestyle and diet.
- Consult your pharmacist or doctor if symptoms worsen or do not improve.
If you take more Omnilax than you should
Taking too much Omnilax may cause diarrhea, abdominal pain, and vomiting. Diarrhea resolves when treatment is stopped or the dose is reduced.
If you experience severe diarrhea or vomiting, you should contact your doctor as soon as possible, as fluid loss may require treatment to prevent electrolyte depletion.
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 missed dose.
4. Possible adverse effects
Like all medicines, Omnilax may cause adverse effects, although not everyone will experience them.
Adverse effects are generally mild and transient, and include:
In children
Common (may affect up to 1 in 10 people):
- Abdominal pain (stomach pain)
- Diarrhea, which may also cause pain around the rectum (perianal pain)
Uncommon (may affect up to 1 in 100 people):
- Nausea (feeling unwell) 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, difficulty breathing, weakness or fainting).
In adults
Common (may affect up to 1 in 10 people):
- Abdominal pain (stomach pain)
- Abdominal bloating (stomach bloating)
- Nausea
- Diarrhea
Uncommon (may affect up to 1 in 100 people):
- Urgent need to go to the toilet
- Fecal incontinence
Frequency not known (cannot be estimated from available data):
- Low blood potassium levels, which may cause muscle weakness, muscle cramps, or abnormal heart rhythm.
- Low blood sodium levels, which may cause tiredness and 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, difficulty breathing, weakness or fainting.
Reporting of adverse effects
If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products (www.notificaRAM.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Omnilax
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottom of the carton. The expiry date refers to the last day of the month indicated.
The reconstituted solution must be kept tightly closed and stored in the refrigerator (2°C to 8°C) and will remain stable for 6 hours.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Omnilax
- The active substance is macrogol. Each sachet contains 10 g of macrogol.
- The other components are sodium saccharin (E-954) and flavouring (orange and grapefruit flavour containing maltodextrin, sorbitol (E-420), butylhydroxyanisole (E-320) and arabic gum (E-414)).
Appearance of the product and contents of the pack
Whiteish powder with an orange-grapefruit flavour.
Omnilax is available in packs of 10, 20, 30, 50 or 100 sachets.
Only certain pack 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 most recent revision of this leaflet: November 2025
Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).