Glycerol suppositories Vilardell adults

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Suppositories Glycerine Vilardell Adults

Glycerol

Read the entire 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 as directed 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 your condition worsens or does not improve after 7 days.

Contents of the leaflet

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

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

Glycerol, the active substance in this medicine, is a laxative administered rectally. The laxative effect is achieved due to 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 adults and adolescents over 12 years of age.

2. What you need to know before using Supositorios de Glicerina Vilardell Adultos

Do not use Supositorios de Glicerina Vilardell Adultos:

• 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 when the cause is unknown.
• If you suffer from an 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 starting to use Supositorios de Glicerina Vilardell Adultos.

• If blood appears in the stool, or if irritation, pain occurs, or symptoms do not improve, you must stop treatment and consult your doctor.
• 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 diseases, especially cardiovascular diseases (related to the heart or blood vessels).

Children:

For children under 12 years of age, other doses of Supositorios de Glicerina Vilardell more suitable for children and infants are available.

Use of Supositorios de Glicerina Vilardell Adultos 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 Adults

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

Recommended dose:

Adults: 1 suppository per day, as needed, or as prescribed by the physician.

Adolescents over 12 years of age: 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 (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, you must stop the procedure, as it could be harmful, and consult your doctor.

This medicine should not be used 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:

• Cases of intoxication are unlikely due to the nature of its use.
• Prolonged and excessive use of this medicine 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 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 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, although their 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 can 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 Adults

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 must 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 have any doubts, 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 Vilardell Glycerin Suppositories for Adults

• The active substance is glycerol. Each suppository contains 3,000 mg of glycerol.
• The other component (excipient) is sodium stearate.

Appearance of the product and contents of the pack

Vilardell Glycerin Suppositories for Adults are colorless translucent suppositories, or with a slight yellowish tint, available in jars containing 12 and 18 suppositories, and in blister packs 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 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 Medical Devices (AEMPS) (http://www.aemps.gob.es/)