Suppositories Glycerine Vilardell Infants 15 units

Glycerol, the active ingredient in this medicine, is a laxative that is administered rectally. The laxative effect is achieved by the ability of glycerol to soften the stool which, together with a slight local irritant action, stimulates bowel movements.

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

Do not use Vilardell Lactantes Glycerine Suppositories:

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

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

- If you suffer from anorectal disease, haemorrhagic rectocolitis (a type of chronic inflammation of the bowel) and inflamed haemorrhoids.

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

- In case of the appearance of blood in stools, irritation, pain or if it does not improve, you should stop treatment and consult your doctor.

- Do not use this medicine for more than 7 days in a row, unless your doctor tells you to.

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

Use of Vilardell Glycerine Suppositories for Infants with other medicines:

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

Pregnancy and breast-feeding:

If you are pregnant or breast-feeding, think you may be pregnant or intend 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 use machines.

Follow exactly the instructions for use given in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Infants and children under 2 years of age: 1 suppository a day, when needed, or as prescribed by the doctor.

Method of administration:

The medicine is administered rectally.

After removing the suppository from the container, insert it deeply into the rectum through the flat end (see picture). Hold the evacuation as long as possible to allow the medicine to work.

If at the time of administration you feel resistance, you should stop the administration, as it may be harmful and harmful, and consult your doctor.

The medicine should not be used for more than 7 days in a row. If symptoms do not improve, you should stop treatment and consult your doctor.

If you use more Vilardell Glycerine Suppositories for Infants than you should:

- Intoxication is not likely to occur, due to its use.

- Abusive and prolonged use of this medicine may lead to irritable bowel syndrome (symptoms or discomfort such as alternating constipation and diarrhoea, intestinal spasms, bloating, nausea and gas).

- In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Servicio de Información Toxicológica, telephone 91 562 04 20, indicating the medicine and the quantity administered.

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

Like all medicines, this medicine may cause side effects, although not everybody gets them.

During the period of use of glycerol as a rectal laxative, the following side effects have been observed, the frequency of which could not be established with certainty: itching, pain and irritation of the anus.

Reporting of side effects

If you experience any side effects, please contact your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly to the Spanish Pharmacovigilance System for Medicinal Products for Human Use: https:// www.notificaram.es . By reporting adverse effects you can help to provide more information on the safety of this medicine.

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date is the last day of the month indicated.

Medicines should not be flushed down the drain or thrown away. Please dispose of unneeded medicines and containers at the SIGRE Point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unneeded medicine containers and medicines. In this way, you will help to protect the environment.

Composition of Vilardell Infant Glycerine Suppositories

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

- The other component (excipient) is sodium stearate.

Product appearance and package contents

Vilardell Lactantes Glycerine Suppositories are colourless translucent suppositories or suppositories with a slight yellow tinge. They come in jars containing 6 and 15 suppositories and in blister packs containing 6 suppositories.

Marketing authorisation holder and responsible for manufacture

Laboratorios Vilardell, S.A.

Constitución, 66-68

08980 Sant Feliu de Llobregat (Barcelona)

Spain

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

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Health Products (AEMPS) (http://www.aemps.gob.es/).