Package leaflet: Information for the user

ULGIX LAXI
50 mg, soft capsules
Sodium docusate
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

Keep this leaflet. You may need to read it again.
If you need advice or more information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 7–10 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

What ULGIX LAXI is and what it is used for
What you need to know before taking ULGIX LAXI
How to take ULGIX LAXI
Possible side effects
How to store ULGIX LAXI
Contents of the pack and other information

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

Sodium docusate is a surfactant compound. It acts as an emulsifier and reduces surface tension at the interface between the gastrointestinal mucosa and faecal masses. This facilitates penetration of water and fats into the faecal mass in the large intestine, thereby altering stool consistency and facilitating defecation. Docusate does not stimulate intestinal peristalsis.
Indications

Prevention and treatment of chronic constipation;
Supportive treatment in patients with haemorrhoids and/or anal fissures, as well as in patients for whom increased straining during defecation is contraindicated due to their medical condition;
Preparation for diagnostic and surgical procedures.

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

2. Important information before using ULGIX LAXI

When not to use ULGIX LAXI

if the patient is 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 masses, intestinal inflammation, intestinal stricture, adhesions, hernias, polyps, tumors),
in case of acute abdominal pain of unknown cause,
in case of gastrointestinal bleeding of unknown origin,
in case of dehydration.

Warnings and precautions
Before starting to use ULGIX LAXI, consult your doctor, pharmacist, or
nurse.
Prolonged use of the medicine (longer than 7 to 10 days) may lead to dependence on sodium picosulfate and lack of response to treatment.
If disturbances in the motility of the large intestine (manifested as changes in bowel habits, such as frequency and consistency of stools) persist for longer than 2 weeks, laxatives should be used with caution and medical advice should be sought. This is particularly important to avoid missing a bowel tumor, which may present with the aforementioned changes in bowel habits.
The occurrence of rectal bleeding or weakening of natural intestinal movements (manifested as difficulty or inability to pass stool) after using laxatives may indicate a serious disorder. In such a case, the use of the medicine should be discontinued.

ULGIX LAXI and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
This medicine should not be used with:

mineral oil (liquid paraffin), because their concomitant use may increase deposition of mineral oil in lymph nodes, intestinal mucosa, liver, and spleen; this may lead to chronic inflammation of these organs and additionally infiltration of liver cells,
danthron, because the medicine increases absorption of danthron, increasing its toxicity, which may lead to liver damage,
droperidol, due to the risk of cardiotoxicity (damage to the heart muscle),
levomethadone, because their concomitant use may lead to serious cardiac rhythm disturbances,
digitalis glycosides, due to the possibility of enhancing their cardiotoxic effects through reduction of serum potassium levels,
corticosteroids, because sodium picosulfate intensifies their potassium-lowering effect; this interaction may occur only after prolonged use of both medicines,
acetylsalicylic acid, because their concomitant use may intensify the adverse effects of acetylsalicylic acid on the gastrointestinal mucosa,
tetracyclines, because sodium picosulfate reduces the bioavailability of antibiotics in this group,
diuretics, because prolonged, concomitant use may intensify potassium loss or weaken the potassium-sparing effect of diuretics with such a mechanism of action.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.
Sodium picosulfate passes into breast milk and therefore the use of the medicine is not recommended in breastfeeding women.

Driving and operating machinery
No studies on the influence of the medicine on the ability to drive or operate machinery have been conducted.
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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 taken exactly as described in the patient information leaflet or as advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
This 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 aged 6 to 12 years: from 1 to 2 capsules per day (from 50 mg to 100 mg).
This medicine is recommended for children above 6 years of age.
Each dose should be taken with a full glass of water or fruit juice.
The effect of the medicine occurs 1–3 days after taking the first dose.
Taking more ULGIX LAXI than recommended
Overdose is rare and may manifest as excessive fluid loss and electrolyte imbalance. In such cases, increased oral fluid intake and electrolyte supplementation are recommended.
If you forget to take ULGIX LAXI
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions during the use of sodium docuzinate at therapeutic doses are rare and include:

gastrointestinal disturbances – nausea, vomiting, bitter taste, epigastric pain, colicky abdominal pain, diarrhoea,
skin allergic reactions – rashes.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.
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5. How to store ULGIX LAXI

Keep the medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What the medicine ULGIX LAXI contains

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

What ULGIX LAXI looks like and contents of the pack
Natural-colored, transparent soft oval capsule with a smooth, glossy surface.
The medicine pack contains 15 or 30 capsules placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine Information
tel.: 22 742 00 22
e-mail: [email protected]
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