GLYCILAX LACTANTES SUPPOSITORIES

Introduction

Package Leaflet: Information for the User

Glycilax Infant Suppositories

Glycerol

Read the 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 it worsens or does not improve after 7 days.

Contents of the Package Leaflet

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

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

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

It is indicated for the local symptomatic relief of transient and occasional constipation in children under 2 years of age.

You should consult a doctor if it does not improve after 7 days of treatment.

2. What you need to know before using Glycilax Infant

Do not use Glycilax Infant

• 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, cramps, nausea, vomiting, or other signs of appendicitis, intestinal obstruction, acute inflammatory bowel disease, or any situation of abdominal pain without knowing the cause.

Warnings and Precautions

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

In case of the appearance of blood in stools, 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 Infant

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 Infant

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 under 2 years: 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 pack, 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 infants, 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 Infant than you should

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

Prolonged and abusive use of this medication may lead to an irritable bowel syndrome (symptoms or discomfort such as alternating 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 as a laxative by rectal route, the following side effects have been observed, whose frequency has not been established with precision:

Anal irritation, itching, or burning.

Reporting of 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 Infant

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date stated 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 way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Glycilax Infant

The active ingredient is glycerol. Each suppository contains 0.672 g of glycerol.

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

Appearance of the Product and Package Contents

Glycilax Infant suppositories are colorless, smooth, and shiny.

They are presented in aluminum/polyethylene blister packs in packages containing 10 suppositories.

Marketing Authorization Holder and Manufacturer

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 Last Revision of this Package Leaflet:February 2021

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