Laxol

Leaflet attached to the packaging: patient information

Laxol

100 mg, suppositories
Sodium docusate

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

This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Laxol and what is it used for
• 2. Important information before using Laxol
• 3. How to use Laxol
• 4. Possible side effects
• 5. How to store Laxol
• 6. Package contents and other information

1. What is Laxol and what is it used for

Laxol contains sodium docusate - a surface-active agent (anionic detergent) that reduces surface tension and facilitates the penetration of water and fats into the fecal mass in the large intestine. It does not stimulate peristalsis, but only facilitates defecation by increasing the volume and changing the consistency of the stool. The medicine is administered to facilitate defecation and reduce pain during stool passage.

Indications for use

Laxol is indicated for short-term use in constipation in adults and adolescents over 12 years of age.
If there is no improvement after 7 days or the patient feels worse, they should consult a doctor.

2. Important information before using Laxol

When not to use Laxol

• If the patient is allergic to the active substance or any other component of this medicine (listed in section 6).
• In the case of inflammatory bowel diseases, hemorrhoids, anal fissure, intestinal obstruction, abdominal pain of unknown etiology.

Warnings and precautions

Before starting to use Laxol, the patient should discuss it with their doctor or pharmacist.
Laxol should not be taken for a long time. Long-term use may cause colon atony and hypokalemia.

Laxol and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Laxol should not be used with liquid paraffin, as the active substance increases the absorption of mineral oils and other medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using the medicine.
Pregnancy
Due to the lack of data on the safety of using the preparation during pregnancy, it is not recommended to use Laxol suppositories during this period.
Breastfeeding
The active substance passes into breast milk and may have a laxative effect on breastfed infants.
The effect on fertility is unknown.

Driving and using machines

Laxol does not affect the ability to drive or use machines.

3. How to use Laxol

This medicine should always be used as described in the patient leaflet or according to the doctor's or pharmacist's instructions. If in doubt, the patient should consult their doctor or pharmacist.
Before use, the patient should tear off the triangular end of the foil, remove the suppository from the blister, and insert it into the rectum.
Adults and adolescents over 12 years of age - 1 suppository twice a day.

Using a higher dose of Laxol than recommended

Side effects may occur. If worrying symptoms occur, the patient should stop using the medicine and consult their doctor.

Missing a dose of Laxol

The patient should not use a double dose to make up for a missed dose.

Stopping the use of Laxol

If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Laxol can cause side effects, although not everybody gets them.
Side effects are presented according to the classification of organs and systems according to MedDRA and frequency of occurrence: very common (≥1/10); common (≥1/100 to <1>During the use of Laxol, the following may occur:
Frequency not known: gastrointestinal disorders (pain and burning of the anus or rectum, diarrhea, swelling of the rectal mucosa, rectal bleeding.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. 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, Al. Jerozolimskie 181 C, 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Laxol

Store in a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton after EXP. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Laxol contains

• The active substance of the medicine is sodium docusate - 100 mg.
• The excipient is: solid fat.

What Laxol looks like and what the package contains

Laxol is white suppositories in PVC/PE foil blisters.
The package contains 12 suppositories.

Marketing authorization holder and manufacturer

Wrocławskie Zakłady Zielarskie „Herbapol” SA
50-951 Wrocław, ul. św. Mikołaja 65/68
Phone: +48 71 33 57 225
Fax: +48 71 372 47 40
Email: [email protected]
To obtain more detailed information about the medicine, the patient should contact the marketing authorization holder at +48 71 321 86 04, ext. 123

Date of the last update of the leaflet: