GLYCILAX NIÑOS SUPPOSITORIES

Introduction

Package Leaflet: Information for the User

Glycilax Children Suppositories

Glycerol

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

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

Contents of the Package Leaflet

1. What Glycilax Children is and what it is used for
2. What you need to know before starting to use Glycilax Children
3. How to use Glycilax Children
4. Possible side effects
5. Storage of Glycilax Children
6. Package Contents and Additional Information

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

The active ingredient of this medication, glycerol, is a laxative that is administered rectally. The laxative effect is achieved by glycerol's ability to soften the stool, which, along with a mild local irritating action, stimulates intestinal movements.

It is indicated for the local symptomatic relief of transient and occasional constipation in children from 2 to 12 years old.

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

2. What you need to know before starting to use Glycilax Children

Do not use Glycilax Children

• If you are allergic to glycerol or any of the other components of this medication (listed in section 6).
• If you have anorectal conditions, hemorrhagic rectocolitis (a type of chronic intestinal inflammation), and inflamed hemorrhoids.
• If you have colic, nausea, vomiting, or other signs of appendicitis, intestinal obstruction, acute inflammatory intestinal diseases, or any situation of abdominal pain without knowing the cause.
• In children under 2 years old.

Warnings and Precautions

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

In case of the appearance of blood in stool, irritation, pain, or if it does not improve, you should interrupt treatment and consult a doctor.

Do not use this medication for more than 7 consecutive days, unless your doctor indicates otherwise.

This medication will only be used under strict medical control in patients with severe illnesses, especially cardiovascular ones (related to the heart or blood vessels).

Other Medications and Glycilax Children

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This medication is not indicated for adults.

Driving and Using Machines

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

3. How to use Glycilax Children

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Children from 2 to 12 years old: 1 suppository per day, as needed, or as indicated by the doctor.

Method of Administration:

The medication is administered rectally.

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

Insert the suppository deeply into the rectum.

Repress evacuation as much as possible so that the preparation can exert its action perfectly; therefore, in children, it is recommended to keep the thighs together for a brief period.

It can be applied at room temperature.

If you notice resistance during administration, you should interrupt it, as it may be harmful and damaging, and consult your doctor.

Do not use the medication for more than 7 consecutive days. If symptoms do not improve, you should suspend treatment and consult a doctor.

If you use more Glycilax Children than you should

It is unlikely that intoxication will occur due to its use.

The abusive and prolonged use of this medication can lead to an irritable colon syndrome (symptoms or discomfort such as alternation of constipation and diarrhea, intestinal spasms, bloating, nausea, and gases).

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

During the period of use of glycerol rectally as a laxative, the following side effects have been observed, whose frequency cannot be established with precision:

Anal irritation, itching, or burning.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Glycilax Children

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Glycilax Children

The active ingredient 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 Package Contents

Glycilax Children suppositories are colorless with a smooth and shiny surface.

They are presented in aluminum/polyethylene blisters in packages containing 15 suppositories.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 Last Revision of this Package Leaflet: February 2021

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob/