Leaflet: information for the user

Enema Glycerin Vilardell for Infants

Glycerol

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

Follow exactly the administration instructions contained in this leaflet or those 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

1. What are Enema Glycerin Vilardell for Infants and what are they used for

2. What you need to know before starting to use Enema Glycerin Vilardell for Infants

3. How to use Enema Glycerin Vilardell for Infants

4. Possible adverse effects

5. Storage of Enema Glycerin Vilardell for Infants

6. Contents of the pack and additional information

The active ingredient, glycerol, is a laxative administered rectally. The laxative effect is achieved by glycerol's ability to soften stool, combined with a mild local irritating action, which stimulates intestinal movements.

It is indicated for symptomatic relief of transient and occasional constipation in infants and children under 2 years old.

Do not use Vilardell Lactantes Glycerin Suppositories:

- If you are allergic to glycerol or to any of the other components of this medication (listed in section 6).

- If you have abdominal cramps, colic, nausea, vomiting, or other symptoms of appendicitis, intestinal obstruction, other acute inflammatory intestinal diseases, or, in general, any abdominal pain without knowing the cause.

- If you have any anorectal disease, hemorrhagic rectocolitis (a type of chronic intestinal inflammation) and inflamed hemorrhoids.

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

- In case of blood in stool, irritation, pain, or if it does not improve, discontinue treatment and consult your doctor.

- Do not use this medication for more than 7 consecutive days, unless your doctor advises otherwise.

- This medication will be used only under strict medical supervision in patients with severe diseases, especially cardiovascular (relating to the heart or blood vessels).

Use of Vilardell Lactantes Glycerin Suppositories with other medications:

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

Pregnancy and breastfeeding:

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

Driving and operating machinery:

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

Follow exactly the medication administration instructions contained in this leaflet or those 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 according to your doctor's prescription.

Administration method:

The medication is administered rectally.

After removing the suppository from the packaging, insert it deeply into the rectum through the flat end (see image). Press down as much as possible to allow the medication to take effect.

If you experience resistance during administration, stop immediately, as this may be harmful and consult your doctor.

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

If you use more Vilardell Lactantes Glycerin Suppositories than you should:

- It is unlikely that you will experience symptoms of intoxication due to its use.

- Prolonged and excessive use of this medication may lead to 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 Toxicological Information Service at 91 562 04 20, indicating the medication and the amount administered.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

During the period of use of glycerol as a rectal laxative, the following adverse effects have been observed, whose frequency has not been established with precision: itching, anal pain and irritation.

Reporting Adverse Effects

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

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 packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Vilardell Lactantes Glycerin Suppositories

- The active ingredient is glycerol. Each suppository contains 920 mg of glycerol.

- The other component (excipient) is sodium stearate.

Appearance of the product and contents of the packaging

Vilardell Lactantes Glycerin Suppositories are transparent, colorless or slightly yellowish suppositories, presented in a jar with 6 and 15 suppositories and in a blister pack with 6 suppositories.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Vilardell, S.A.

Constitución, 66-68

08980 Sant Feliu de Llobregat (Barcelona)

Spain

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

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)