GLYCILAX NIÑOS SUPPOSITORIES

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Glycilax niños suppositories

Glycerol

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

Follow exactly the instructions for taking this medicine contained in this leaflet or those provided by your doctor, pharmacist or nurse.

• 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, pharmacist or nurse, even if they are adverse 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 niños is and what it is used for
2. What you need to know before using Glycilax niños
3. How to use Glycilax niños
4. Possible adverse effects
5. How to store Glycilax niños
6. Contents of the pack and other information

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

Glycerol, the active substance in this medicine, is a laxative administered by rectal route. The laxative effect is achieved due to glycerol's ability to soften 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 children aged 2 to 12 years.

You should consult a doctor if there is no improvement after 7 days of treatment.

2. What you need to know before using Glycilax niños

Do not use Glycilax niños

• 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, ulcerative colitis (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 bowel diseases, or, in general, any condition of abdominal pain of unknown cause.
• In children under 2 years of age.

Warnings and precautions

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

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 your doctor instructs otherwise.

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

Other medicines and Glycilax niños

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 may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine is not indicated for use in adults.

Driving and using machines

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

3. How to use Glycilax children

Follow exactly the instructions for administering this medicine as stated in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Recommended dose:

Children aged 2 to 12 years: 1 suppository per day, as needed, or as prescribed by the physician.

Method of administration:

The medicine is administered rectally.

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.

Insert the suppository well into the rectum.

Delay bowel evacuation as long as possible so that the preparation can exert its effect properly; in children, it is recommended to keep the thighs together for a short period of time after administration.

The medicine may be administered at room temperature.

If you feel resistance during administration, stop the procedure, 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 children than you should

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

Abusive and 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 medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

During the period of rectal use of glycerol as a laxative, the following adverse effects have been observed, although their frequency could not be established accurately:

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 can also report them directly through the Spanish Pharmacovigilance System for 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 niños

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Glycilax niños

The active substance is glycerol. Each suppository contains 1.44 g of glycerol.

The other components (excipients) are: stearic acid and sodium hydroxide.

Appearance of the product and contents of the pack

Glycilax niños suppositories are colourless with a smooth, shiny surface.

They are presented in aluminium/polyethylene blisters, in packs containing 15 suppositories.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
Huarte (Navarra) – Spain
31620

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 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/