Leaflet: information for the user

Omnilax 10g powder for oral solution in sachet

macrogol 4000

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.

1. What Omnilax is and what it is used for

2. What you need to know before you start taking Omnilax

3. How to take Omnilax

4. Possible side effects

5. Storage of Omnilax

6. Contents of the pack and additional information

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 disturbances caused by very slow intestinal movements. Omnilax is not absorbed into the bloodstream nor degraded in the body.

Omnilax is used for the treatment of constipation in adults and in children aged 8 years and above. This medication is a powder that must be dissolved in a glass of water (at least 50 ml) and consumed. It generally 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 Omnilax:

-if you are allergic (hypersensitive) to macrogol (polyethylene glycol) or to 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 intestinal dilation)
• intestinal perforation or risk of intestinal perforation
• ileus or suspected intestinal obstruction
• unexplained abdominal pain syndromes.

Do not take this medicationin case of the above situations. 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 that caused dizziness, collapse, or difficulty breathing and general feeling of discomfort. If you experience any of these symptoms, stop taking Omnilax and seek medical attention immediately.

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 (salt) or potassium levels in the blood.

Before taking Omnilax, speak with your doctor or pharmacist if you know you have a swallowing disorder. Avoid mixing Omnilax with 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 and Omnilax

It is possible that the absorption of other medications taken may be reduced temporarily 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.

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

If you have difficulty swallowing, and need food thickeners to thicken liquids and be able to swallow them safely, avoid mixing Omnilax with liquids thickened with starch-based thickeners. Omnilax may counteract the effect of starch-based thickeners, making preparations that must remain thick for people with difficulty swallowing liquefy.

Pregnancy and lactation

Omnilax may 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 on the ability to drive and/or operate machines.

Omnilax contains sulfur dioxide, sorbitol, and sodium

Due to the presence of sulfur dioxide, it may cause severe hypersensitivity reactions and breathing difficulties exceptionally.

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

This medication contains less than 1 mmol of sodium (23 mg) per sachet, which is; essentially “sodium-free”.

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

Adults and children 8 years and older:

The recommended dose is 1 to 2 packets 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 packet every two days (especially in children) to a maximum of two packets per day.

Dissolve the contents of the packets in a glass of water (at least 50 ml) just before administration and drink the liquid.

Consider the following:

• Omnilax usually takes 24 to 48 hours to take effect.
• In children, the duration of Omnilax treatment should not exceed 3 months.
• The improvement in bowel movement frequency after taking Omnilax may be maintained by adopting healthy lifestyle and dietary 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 may cause diarrhea, abdominal pain, and vomiting. Diarrhea will resolve when treatment is stopped or the dose is reduced.

If you experience severe diarrhea or vomiting, contact your doctor as soon as possible, as you may need treatment to prevent electrolyte loss 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 compensate for the missed dose.

Like all medications, Omnilax may cause side effects, although not everyone will experience them.

Side effects are generally mild and transient and may include:

In children

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

• Abdominal pain
• Diarrhea that may also 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, difficulty breathing, 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
• Urgent need to use the bathroom
• Fecal incontinence

Unknown frequency (cannot be estimated from available data):

• Low levels of potassium in the blood that may cause muscle weakness, muscle cramps, or abnormal heart rhythm.
• Low levels of sodium in the blood that may cause fatigue and confusion, muscle cramps, seizures, and coma
• Severe dehydration caused by severe diarrhea, especially in elderly patients
• Symptoms of an allergic reaction such as skin redness, rash, urticaria, facial or throat inflammation, 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 that do not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use (www.notificaRAM.es). By reporting side 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 bottom of the box. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Omnilax

• The active ingredient is macrogol. Each sachet contains 10g of macrogol.
• The other components 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 content of the packaging

White powdery product with orange-grapefruit flavor.

Omnilax is presented in packaging of 10, 20, 30, 50 or 100 sachets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization

Pro Health Pharma Sweden AB

Genetor, Kungstorget 8

252 78Helsingborg, Sweden

Responsible for manufacturing

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 review of this leaflet:September 2024

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