Leaflet: information for the user

Glycerin Suppositories Vilardell Adults

Glycerol

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

Follow exactly the administration instructions of the medicine 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 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 you get worse or do not improve after 7 days.

1. What are Glycerin Suppositories Vilardell Adults and what are they used for

2. What you need to know before starting to use Glycerin Suppositories Vilardell Adults

3. How to use Glycerin Suppositories Vilardell Adults

4. Possible side effects

5. Storage of Glycerin Suppositories Vilardell Adults

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 adults and adolescents 12 years of age and older.

Do not use Vilardell Adult Glycerin Suppositories:

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

- If you experience 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, chronic rectocolitis (a type of chronic intestinal inflammation) and inflamed hemorrhoids.

- In children under 12 years old.

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

- In case of blood in stool, irritation, pain, or no improvement, you must interrupt 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 be used only under strict medical supervision in patients with severe diseases, especially cardiovascular (relating to the heart or blood vessels).

Children:

For children under 12 years old, other suitable doses of Vilardell Glycerin Suppositories are available (Children and Infants).

Use of Vilardell Adult 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines:

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

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:

Adults: 1 suppository per day, as needed, or as prescribed by your doctor.

Older adolescents (12 years and above): 1 suppository per day, as needed, or as prescribed by your doctor.

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).

Strain 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 Glycerin Suppositories for Adults than you should:

- It is unlikely that you will experience symptoms of overdose, 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, phone 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 will 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 possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines 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 unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Vilardell Adult Glycerin Suppositories

- The active ingredient is glycerol. Each suppository contains 3,000 mg of glycerol.

- The other component (excipient) is sodium stearate.

Appearance of the product and content of the packaging

Vilardell Adult Glycerin Suppositories are transparent, colorless or slightly yellowish suppositories, presented in a jar with 12 and 18 suppositories and in a blister pack with 6 and 12 suppositories.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Vilardell, S.A.

Constitución, 66-68

08980 Sant Feliu de Llobregat (Barcelona)

Spain

Last review date 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/)