GLYCERIN SUPPOSITORIES VILARDELL FOR CHILDREN

Introduction

Leaflet: information for the user

Glycerin Vilardell Children's Suppositories

Glycerol

Read the entire 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 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the leaflet

1. What Glycerin Vilardell Children's Suppositories are and what they are used for
2. What you need to know before starting to use Glycerin Vilardell Children's Suppositories
3. How to use Glycerin Vilardell Children's Suppositories
4. Possible side effects
5. Storage of Glycerin Vilardell Children's Suppositories
6. Package contents and additional information

1. What Glycerin Vilardell Children's Suppositories are and what they are used for

The glycerol, the active ingredient of this medication, is a laxative that is administered rectally. The laxative effect is achieved by the ability of glycerol to soften the stools, which, together with a mild local irritating action, stimulates the movements of the intestine.

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

2. What you need to know before starting to use Glycerin Vilardell Children's Suppositories

Do not use Glycerin Vilardell Children's Suppositories:

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

Warnings and precautions:Consult your doctor or pharmacist before starting to use Glycerin Vilardell Children's Suppositories.

• In case of the appearance of blood in stools, irritation, pain, or if it does not improve, you should interrupt treatment and consult your doctor.
• Do not use this medication for more than 7 consecutive days, unless your doctor indicates it.
• This medication will be used only under strict medical control in patients with serious diseases, especially cardiovascular (related to the heart or blood vessels).

Children:

For children under 2 years of age, another dose of Glycerin Vilardell Suppositories is available (Infants).

Use of Glycerin Vilardell Children's Suppositories with other medications:

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

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.

Driving and using machines:

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

3. How to use Glycerin Vilardell Children's Suppositories

Follow the administration instructions for the medication contained in this 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 prescribed by the doctor.

Method of administration:

The medication is administered rectally.

After removing the suppository from the package, insert it deeply into the rectum by the flat end (see image). Delay evacuation as long as possible so that the medication can take effect.

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 the symptoms do not improve, you should suspend treatment and consult your doctor.

If you use more Glycerin Vilardell Children's Suppositories 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 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 administered.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences 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: itching, pain, and irritation of the anus.

Reporting side effects

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

5. Storage of Glycerin Vilardell Children's Suppositories

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Glycerin Vilardell Children's Suppositories

• The active ingredient is glycerol. Each suppository contains 1,500 mg of glycerol.
• The other component (excipient) is sodium stearate.

Appearance of the product and package contents

Glycerin Vilardell Children's Suppositories are translucent, colorless, or slightly yellowish suppositories, which come in a jar with 12 and 18 suppositories and in a blister pack with 6 and 12 suppositories.

Marketing authorization holder and manufacturer

Laboratorios Vilardell, S.A.

Constitución, 66-68

08980 Sant Feliu de Llobregat (Barcelona)

Spain

Date of the last revision of this leaflet:April 2012.

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.es/)