Package leaflet: Information for the patient

Laxol
100 mg, suppositories
Sodium docusate
Please read carefully the entire leaflet 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 instructions
provided by the doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.

Table of contents of the leaflet:

What Laxol is and what it is used for
Important information before using Laxol
How to use Laxol
Possible side effects
How to store Laxol
Contents of the pack and other information

1. What Laxol is and what it is used for

Laxol contains sodium docusate – this is a surfactant (anionic detergent) which reduces surface tension and facilitates penetration of water and fats into the fecal mass in the large intestine. It does not stimulate peristalsis, but facilitates defecation by increasing stool volume and altering stool consistency. The medicine is administered to ease defecation and reduce pain during bowel movements.
Indications
Laxol is indicated for short-term use in constipation in adults and adolescents aged 12 years and older.
If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.

2. Important information before using Laxol

When not to use Laxol

If the patient is allergic to the active substance or to any of the other components of this medicine (listed in section 6).
In inflammatory diseases of the large intestine, haemorrhoids, anal fissure, intestinal obstruction, abdominal pain of unknown origin.

Warnings and precautions
Before starting to use Laxol, consult a doctor or pharmacist.
Do not take Laxol for prolonged periods. Long-term use may lead to colonic atony and hypokalaemia.
Laxol and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
Laxol should not be used with liquid paraffin, as the active substance increases the absorption of mineral oils and other drugs.
Pregnancy, breastfeeding and fertility
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.
Pregnancy
Due to lack of data on safety during pregnancy, the use of Laxol suppositories is not recommended in this period.
Breastfeeding
The active substance passes into breast milk and may have a laxative effect in breastfed infants.
Effect on fertility is unknown.
Driving and operating machinery
Laxol does not affect the ability to drive or operate machinery.

3. How to use Laxol

This medicine should always be used as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Before use, tear open 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 daily.
Use of a higher than recommended dose of Laxol
Adverse effects may occur. If any disturbing symptoms appear, discontinue use and consult your doctor.
Missed dose of Laxol
Do not use a double dose to make up for a missed dose.
Stopping Laxol
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The adverse reactions of the medicine are presented according to MedDRA organ system and frequency categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000), including single cases; frequency not known (cannot be estimated from available data).

When using Laxol medicine, the following may occur:
Frequency not known: gastrointestinal disorders (abdominal pain and burning sensation in the anus or rectum, diarrhoea, swelling of the rectal mucosa, rectal bleeding).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +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 the medicine.

5. How to store Laxol

Store below 25ºC.
Keep the medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Laxol contains

The active substance is sodium docosanolate - 100 mg.
The excipient is: hard fat.

What Laxol looks like and contents of the pack
Laxol is white suppositories in PVC/PE foil blisters.
The pack contains 12 suppositories.
Marketing Authorisation Holder and Manufacturer
Wrocławskie Zakłady Zielarskie „Herbapol” SA
50-951 Wrocław, ul. św. Mikołaja 65/68
Tel: + 48 71 33 57 225
Fax: + 48 71 372 47 40
E-mail: [email protected]
For further information about the medicinal product, please contact the Marketing Authorisation Holder at tel. 71 321 86 04 ext. 123