GLYCERIN SUPPOSITORIES VILARDELL ADULTS

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

Do not use Glycerine Vilardell Adult Suppositories:

• If you are allergic to glycerol or any other component of this medication (listed in section 6).
• If you have cramps, colic, nausea, vomiting, or other symptoms of appendicitis, intestinal obstruction, other acute inflammatory bowel 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.
• In children under 12 years of age.

Warnings and Precautions:Consult your doctor or pharmacist before using Glycerine Vilardell Adult Suppositories.

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

Children:

For children under 12 years of age, other doses of Glycerine Vilardell Suppositories are available (Children and Infants).

Using Glycerine Vilardell Adult Suppositories with other medications:

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

Pregnancy and Breastfeeding:

If you are pregnant or breastfeeding, think you may 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 and/or use machines.

3. How to use Glycerine Vilardell Adult Suppositories

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:

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

Adolescents over 12 years of age: 1 suppository per day, as needed, or as prescribed by your doctor.

Method of administration:

The medication is administered rectally.

After removing the suppository from the package, insert it deeply into the rectum through the flat end (see image).

Delay evacuation as long as possible so that the medication can take effect.

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

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

If you use more Glycerine Vilardell Adult Suppositories 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 other 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 Adult Suppositories

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 the packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Glycerine Vilardell Adult 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 Package Contents

Glycerine Vilardell Adult Suppositories are translucent, colorless, or slightly yellowish suppositories, presented in a jar with 12 and 18 suppositories and in a blister pack with 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 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/)