GLYCILAX ADULTOS SUPPOSITORIES

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Glycilax adults suppositories

Glycerol

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 7 days.

Contents of the leaflet

1. What Glycilax adults is and what it is used for
2. What you need to know before using Glycilax adults
3. How to use Glycilax adults
4. Possible adverse effects
5. How to store Glycilax adults
6. Contents of the pack and other information

1. What Glycilax Adults is and what it is used for

Glycerol, the active substance in this medicine, is a laxative administered rectally. The laxative effect is achieved due to glycerol's ability to soften the stools, which, together with a mild local irritant action, stimulates intestinal movements.

It is indicated for the local symptomatic relief of transient and occasional constipation in adults and adolescents aged 12 years and older.

You should consult a doctor if you do not improve after 7 days of treatment.

2. What you need to know before using Glycilax adults

Do not use Glycilax adults

• If you are allergic to glycerol or to any of the other components of this medicine (listed in section 6).
• If you have anorectal conditions, hemorrhagic rectocolitis (a type of chronic intestinal inflammation), or inflamed hemorrhoids.
• If you have cramps, colic, nausea, vomiting, or other signs of appendicitis, intestinal obstruction, acute inflammatory intestinal diseases, or, in general, any abdominal pain of unknown cause.
• In children under 12 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Glycilax adults.

If blood in the stool, irritation, pain, or lack of improvement occurs, discontinue treatment and consult your doctor.

Do not use this medicine for more than 7 consecutive days, unless otherwise directed by your doctor.

This medicine should be used only under strict medical supervision in patients with serious illnesses, especially cardiovascular diseases (related to the heart or blood vessels).

Other medicines and Glycilax adults

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Due to the type of medicine and its route of administration, it does not affect the use of other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

The use of this medicine does not affect the ability to drive and/or operate machinery.

3. How to use Glycilax adults

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is 1 suppository per day, when needed, or as directed by your physician.

Once removed from the blister pack, moisten the suppository with cold water by placing it under running tap water for 30 seconds, or in a glass of water for at least 10 seconds before insertion.

The suppositories should be inserted deeply into the rectum. Delay bowel movement as much as possible to allow the medication to act effectively.

If you feel resistance during administration, stop immediately, as it may be harmful, and consult your doctor.

Do not use this medicine for more than 7 consecutive days. If symptoms do not improve, discontinue treatment and consult your doctor.

If you use more Glycilax adults than you should

Cases of poisoning are unlikely due to the nature of its use.

Abuse or prolonged use of this medicine may lead to a laxative-dependent irritable colon syndrome (symptoms or discomfort such as alternating constipation and diarrhea, intestinal spasms, bloating, nausea, and gas).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone will experience them.

The following adverse effects have been observed during the period of use of glycerol administered rectally as a laxative. Their frequency cannot be precisely determined:

Anal irritation, burning, or itching.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Glycilax adults

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the package and other information

Composition of Glycilax adults

• The active substance is glycerol. Each suppository contains 3.31 g of glycerol.
• The other components (excipients) are: stearic acid and sodium hydroxide.

Appearance of the product and contents of the package

Colourless suppositories with a smooth and shiny surface.

They are presented in aluminium/polyethylene blisters within packs containing 2 and 12 suppositories.

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer:

Laboratorios Vilardell, S.A.

C/ Constitución, 66-68,

08980 Sant Feliu de Llobregat (Barcelona) - Spain

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent revision of this package leaflet: February 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.