GLYCERIN SUPPOSITORIES VILARDELL FOR LACTATING WOMEN

Introduction

Package Leaflet: Information for the User

Glycerine Vilardell Suppositories for Infants

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 or pharmacist.

• 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 or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Package Leaflet

1. What Glycerine Vilardell Suppositories for Infants are and what they are used for
2. What you need to know before using Glycerine Vilardell Suppositories for Infants
3. How to use Glycerine Vilardell Suppositories for Infants
4. Possible side effects
5. Storage of Glycerine Vilardell Suppositories for Infants
6. Package Contents and Additional Information

1. What Glycerine Vilardell Suppositories for Infants are and what they are used for

Glycerol, the active ingredient of this medication, is a laxative 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 symptomatic relief of transient and occasional constipation in infants and children under 2 years of age.

2. What you need to know before using Glycerine Vilardell Suppositories for Infants

Do not use Glycerine Vilardell Suppositories for Infants:

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

Warnings and Precautions:Consult your doctor or pharmacist before starting to use Glycerine Vilardell Suppositories for Infants.

• In case of blood in stools, irritation, pain, or no improvement, you should discontinue treatment and consult your doctor.
• Do not use this medication for more than 7 consecutive days, unless your doctor instructs you to do so.
• This medication will only be used under strict medical supervision in patients with severe illnesses, especially cardiovascular diseases (related to the heart or blood vessels).

Using Glycerine Vilardell Suppositories for Infants with other medications:

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

Pregnancy and Breastfeeding:

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

Driving and Using Machines:

Using this medication does not affect your ability to drive or use machines.

3. How to use Glycerine Vilardell Suppositories for Infants

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

The recommended dose is:

Infants and children under 2 years: 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 to allow the medication to take effect.

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

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

If you use more Glycerine Vilardell Suppositories for Infants 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 gas).
• 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 further questions about using this medication, ask your doctor or pharmacist.

4. Possible Side Effects

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

During the period of using glycerol as a laxative rectally, the following side effects have been observed, whose frequency could not be 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 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 Glycerine Vilardell Suppositories for Infants

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date stated on the package 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 packages and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Glycerine Vilardell Suppositories for Infants

• The active ingredient is glycerol. Each suppository contains 920 mg of glycerol.
• The other component (excipient) is sodium stearate.

Appearance of the Product and Package Contents

Glycerine Vilardell Suppositories for Infants are colorless or slightly yellowish translucent suppositories, presented in jars with 6 and 15 suppositories and in blisters with 6 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 Package 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/)