Glycerol suppositories Vilardell Lactantes

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vilardell Glycerin Suppositories for Infants

Glycerol

Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

Always follow exactly the instructions for administration provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if there is no improvement after 7 days.

Contents of this leaflet

1. What Vilardell Glycerin Suppositories for Infants are and what they are used for
2. What you need to know before using Vilardell Glycerin Suppositories for Infants
3. How to use Vilardell Glycerin Suppositories for Infants
4. Possible adverse effects
5. How to store Vilardell Glycerin Suppositories for Infants
6. Contents of the pack and other information

1. What Supositorios de Glicerina Vilardell Lactantes is and what it is used for

Glycerol, the active substance in this medicine, is a laxative administered rectally. The laxative effect is achieved through glycerol's ability to soften the stools, which, together 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 starting to use Vilardell Lactantes Glycerin Suppositories

Do not use Vilardell Lactantes Glycerin Suppositories:

• If you are allergic to glycerol or to any of the other components of this medicine (listed in section 6).
• If you have cramps, colic, nausea, vomiting, or other symptoms of appendicitis, intestinal obstruction, other acute inflammatory intestinal diseases, or, in general, any condition of abdominal pain of unknown cause.
• If you suffer from anorectal disorders, hemorrhagic rectocolitis (a type of chronic intestinal inflammation), or inflamed hemorrhoids.

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

• If blood appears in the stool, or if 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 directed by your doctor.
• This medicine should be used only under strict medical supervision in patients with serious illnesses, especially cardiovascular diseases (related to the heart or blood vessels).

Using Vilardell Lactantes Glycerin Suppositories with other medicines:

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any 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.

Driving and operating machinery:

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

3. How to use Vilardell Lactant Glycerin Suppositories

Follow exactly the administration instructions contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Recommended dose:

Infants and children under 2 years of age: 1 suppository per day, when necessary, or as prescribed by the physician.

Method of administration:

The medicine is administered rectally.

After removing the suppository from its packaging, insert it deeply into the rectum with the flat end first (see image). Try to retain the bowel movement as long as possible so that the medicine can exert its effect.

If you feel resistance during administration, stop the procedure, as it could 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 Vilardell Lactant Glycerin Suppositories than you should:

• Cases of intoxication are unlikely due to the nature of its use.
• Prolonged and excessive use of this medicine may lead to 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 administered.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

During the period of use of glycerol as a rectal laxative, the following adverse effects have been observed, although their frequency could not be accurately determined: itching, pain, and irritation of the anus.

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 may also report them directly via 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 Vilardell Glycerin Suppositories for Infants

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to 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 are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Glycerin Suppositories Vilardell Infant

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

Appearance of the product and contents of the pack

Glycerin Suppositories Vilardell Infant are colorless translucent or slightly yellowish suppositories, supplied in a jar containing 6 or 15 suppositories, and in blister packs containing 6 suppositories.

Marketing Authorization Holder and Manufacturer

Laboratorios Vilardell, S.A.

Constitución, 66-68

08980 Sant Feliu de Llobregat (Barcelona)

Spain

Date of the most recent revision of this leaflet: April 2012.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)