GLYCERIN SUPPOSITORIES VILARDELL NIÑOS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Supositorios de Glicerina Vilardell Niños

Glycerol

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you. Follow exactly the instructions for use provided in this leaflet or those given 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 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 you worsen or do not improve after 7 days.

Contents of the leaflet

1. What Supositorios de Glicerina Vilardell Niños is and what it is used for
2. What you need to know before using Supositorios de Glicerina Vilardell Niños
3. How to use Supositorios de Glicerina Vilardell Niños
4. Possible side effects
5. How to store Supositorios de Glicerina Vilardell Niños
6. Contents of the pack and other information

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

Glycerol, the active substance of this medicine, is a laxative administered by rectal route. The laxative effect is achieved due to glycerol's ability to soften stools, which, together with a mild local irritant action, helps stimulate intestinal movements.

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

2. What you need to know before using Vilardell Glycerin Suppositories for Children

Do not use Vilardell Glycerin Suppositories for Children:

• 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 an anorectal disease, hemorrhagic rectocolitis (a type of chronic intestinal inflammation), or inflamed hemorrhoids.
• In children under 2 years of age.

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

• If blood appears in the stool, or if irritation, pain occurs, or symptoms do not improve, treatment must be stopped and a doctor should be consulted.
• Do not use this medicine for more than 7 consecutive days unless otherwise 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).

Children:

For children under 2 years of age, another dose of Vilardell Glycerin Suppositories more suitable for infants is available.

Use of Vilardell Glycerin Suppositories for Children 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 using machines:

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

3. How to use Vilardell Glycerin Suppositories for Children

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Recommended dosage:

Children aged 2 to 12 years: 1 suppository per day, as needed, 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 Glycerin Suppositories for Children 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 a condition resembling 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

During the period of use of glycerol as a rectal laxative, the following adverse effects have been observed, whose frequency could not be established with accuracy: 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 through 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 Children

Keep out of sight and reach of children.

No special storage conditions required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is 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 Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the package and other information

Composition of Glycerin Suppositories Vilardell Children

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

Appearance of the product and contents of the pack

Glycerin Suppositories Vilardell Children are colorless translucent suppositories or with a slight yellowish tint, available in jars containing 12 and 18 suppositories, and in blisters containing 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 most recent review 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/)