Ulgix Laxi

Package Leaflet: Information for the Patient

ULGIX LAXI

50 mg, Soft Capsules

Sodium Docusate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient, or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 7-10 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

• 1. What is ULGIX LAXI and what is it used for
• 2. Important information before using ULGIX LAXI
• 3. How to use ULGIX LAXI
• 4. Possible side effects
• 5. How to store ULGIX LAXI
• 6. Contents of the pack and other information

1. What is ULGIX LAXI and what is it used for

Sodium docusate is a surface-active agent. It acts as an emulsifier and reduces the surface tension at the interface of the intestinal mucosa and fecal mass. This facilitates the penetration of water and fats into the fecal mass in the large intestine, changing the consistency of the stool and making it easier to defecate. Sodium docusate does not stimulate intestinal peristalsis.

Indications

• prevention of constipation and treatment of chronic constipation,
• supportive treatment in patients with hemorrhoids and (or) anal fissures, as well as in patients for whom increased strain during defecation is not recommended due to their health condition,
• preparation for diagnostic and surgical procedures.

If after 7-10 days there is no improvement or you feel worse, contact your doctor.

2. Important information before using ULGIX LAXI

When not to use ULGIX LAXI

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• in case of nausea and vomiting,
• in case of appendicitis,

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• in case of intestinal obstruction and conditions threatening intestinal obstruction (accumulation of fecal mass, intestinal inflammation, intestinal narrowing, adhesions, hernias, polyps, tumors),
• in case of acute abdominal pain of unknown cause,
• in case of gastrointestinal bleeding of unknown cause,
• in case of dehydration.

Warnings and precautions

Before starting to use ULGIX LAXI, discuss it with your doctor, pharmacist, or nurse.
Long-term use of the medicine (more than 7 to 10 days) may lead to dependence on sodium docusate and lack of response to treatment.
In case of observed disorders of large intestine motility (manifested as changes in bowel habits, e.g., frequency of stool and its consistency), which persist for more than 2 weeks, laxatives should be used with caution and medical advice should be sought. This is especially important to avoid missing a bowel tumor, which may manifest as changes in bowel habits.
The occurrence of rectal bleeding or weakening of natural bowel movements (manifested as difficulty or inability to defecate) after using laxatives may indicate a serious disease. In such a case, the use of the medicine should be discontinued.

ULGIX LAXI and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
The medicine should not be used with:

• mineral oil (liquid paraffin), as their concurrent use may cause increased deposition of mineral oil in lymph nodes, intestinal mucosa, liver, and spleen; this may lead to chronic inflammation of these organs and additional liver cell infiltration,
• dantron, as the medicine increases dantron absorption, leading to increased toxicity, which may cause liver damage,
• droperidol, due to the risk of cardiotoxicity (heart muscle damage),
• levomethadone, as their concurrent use may lead to serious heart rhythm disorders,
• digitalis glycosides, due to the possibility of increased cardiotoxic effects, by reducing potassium levels in the blood serum,
• corticosteroids, as sodium docusate enhances their potassium-lowering effect; this interaction may occur only with long-term use of both medicines,
• acetylsalicylic acid, as their concurrent use may increase the adverse effects of acetylsalicylic acid on the gastrointestinal mucosa,
• tetracyclines, as sodium docusate reduces the bioavailability of antibiotics from this group,
• diuretics, as long-term concurrent use may cause increased potassium loss or weakened potassium-sparing effect of diuretics with such a mechanism of action.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
The medicine may be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
Sodium docusate passes into breast milk, and therefore, it is not recommended to use the medicine during breastfeeding.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines.
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The medicine contains sorbitol and propylene glycol

The medicine contains 3.5 mg of sorbitol in each capsule.
The medicine contains 15 mg of propylene glycol in each capsule.

3. How to use ULGIX LAXI

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor, pharmacist, or nurse. If you are unsure, ask your doctor, pharmacist, or nurse.
The medicine is taken orally.
The recommended dose is from 1 to 4 capsules per day (from 50 mg to 200 mg).

Use in children

Children from 6 to 12 years: from 1 to 2 capsules per day (from 50 mg to 100 mg).
The medicine is recommended for children over 6 years.
Each dose of the medicine should be taken with a full glass of water or fruit juice.
The effect of the medicine occurs within 1-3 days after taking the first dose.

Using a higher dose of ULGIX LAXI than recommended

Overdose of the medicine is rare and manifests as excessive water loss and electrolyte disturbances. In such a case, it is recommended to administer larger amounts of fluids orally and supplement electrolytes.

Missing a dose of ULGIX LAXI

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects during the use of sodium docusate in therapeutic doses are rare and include:

• gastrointestinal disorders - nausea, vomiting, bitter taste, abdominal pain, colic, diarrhea,
• skin allergic reactions - rashes.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.
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5. How to store ULGIX LAXI

Keep the medicine out of sight and reach of children.
Store in the original packaging, at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What ULGIX LAXI contains

• The active substance of the medicine is sodium docusate. One capsule contains 50 mg of sodium docusate.
• The other ingredients (excipients) are: macrogol 400, glycerol, propylene glycol, gelatin, sorbitol liquid non-crystallizing, purified water.

What ULGIX LAXI looks like and contents of the pack

Soft capsule of natural color, transparent, oval shape, and smooth shiny surface.
The medicine pack contains 15 or 30 capsules placed in a cardboard box.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

tel.: 22 742 00 22
e-mail: [email protected]

Date of the last update of the leaflet:

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