Glycerol suppositories Cuve Niños

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Supositorios de glicerina Cuve niños 1.9 g suppositories

glycerol

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

Follow exactly the instructions for use of this medicine as described in this leaflet or as 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 adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 7 days.

Contents of this leaflet

1. What Supositorios de glicerina Cuve niños is and what it is used for
2. What you need to know before using Supositorios de glicerina Cuve niños
3. How to use Supositorios de glicerina Cuve niños
4. Possible side effects
5. How to store Supositorios de glicerina Cuve niños
6. Contents of the pack and other information

1. What Supositorios de glicerina Cuve niños 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 stools, which, together with a mild local irritant action, stimulates intestinal movements.

It is indicated for local symptomatic relief of transient and occasional constipation in children aged 6 to 12 years.

You should consult a doctor if symptoms worsen or do not improve after 7 days.

2. What you need to know before using Glycerin Suppositories Cuve children

Do not use Glycerin Suppositories Cuve children

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

• If you suffer from any anorectal disease, hemorrhagic rectocolitis (a type of chronic intestinal inflammation), or inflamed hemorrhoids.

• If you have cramps, colic, nausea, vomiting, or other signs of appendicitis, intestinal obstruction, acute inflammatory bowel diseases, or, in general, any condition of abdominal pain of unknown cause.

• In children under 6 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Glycerin Suppositories Cuve children.

If you notice blood in the stool, irritation, pain, or if there is no improvement, 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 illnesses, especially cardiovascular diseases (related to the heart or blood vessels).

Children

This medicine is contraindicated in children under 6 years of age.

Other medicines and Glycerin Suppositories Cuve children

Tell 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 plan 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 Cuve Children's Glycerin Suppositories

Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Children aged 6 to 12 years:

1 suppository per day, when necessary, or as prescribed by the doctor.

Method of administration:

Open the container and remove the suppository. Insert it deeply into the anus and keep the buttocks held together for a period of time.

Delay bowel movement as long as possible to allow the medicine to take effect.

If you feel resistance during administration, stop the procedure, as continuing may be harmful.

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

If you use more Cuve Children's Glycerin Suppositories than you should

Cases of intoxication are unlikely due to the nature of its use.

Abusive and prolonged 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, or call the Toxicology Information Service at telephone number 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to use Cuve Children's Glycerin Suppositories

Do not take a double dose to make up for a missed dose.

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 experiences them.

During the period of use of Glycerin Suppositories Cuve niños as a laxative, the following adverse effects have been observed, although their frequency cannot be precisely determined:

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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Glycerin Suppositories Cuve Children

Keep this medicine out of the sight and reach of children.

Store below 25 °C.

Keep the container in the outer carton to protect it from light.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Glycerin Suppositories Cuve Children

• The active substance is glycerol. Each suppository contains 1.9 grams of glycerol.
• The other components (excipients) are: sodium carbonate and stearic acid.

Appearance of the product and contents of the pack

Glycerin Suppositories Cuve Children are transparent, colorless, slightly opaque suppositories with uniform texture and oval shape, available in packs of 4 and 12 suppositories.

Marketing Authorization Holder

Pharmex Pharma S.L.U.
C/ Anabel Segura, 16, Building 1, 1st Floor, right side
28108 Alcobendas – Madrid
Spain

Manufacturer

Pharmex Advanced Laboratories, S.L.
Road A-431, Km. 19
14720 Almodóvar del Río (Córdoba) Spain

Date of the most recent review of this leaflet: February 2011

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