Leaflet: information for the user

Rectal suppositories with glycerin Cuve children 1.9 g suppositories

glycerol

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

Follow exactly the administration instructions for this medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keepthis leaflet, as you may need to read it again.
• Ifyou 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 it worsens or does not improve after 7 days.

1. What Supositorios de glicerina Cuve niños are and for what they are used

2. What you need to know before starting to use Supositorios de glicerina Cuve niños

3. How to use Supositorios de glicerina Cuve niños

4. Possible side effects

5. Storage of Supositorios de glicerina Cuve niños

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

Consult a doctor if symptoms worsen or do not improve after 7 days.

Do not useGlycerin Suppositories Cuve for children

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

- If you have any anorectal disease, hemorrhagic rectocolitis (a type of chronic intestinal inflammation) and inflamed hemorrhoids.

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

- In children under 6 years old.

Warnings and precautions

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

In case of blood in stool, irritation, pain, or if it does not improve, discontinue 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

This medication is contraindicated in children under 6 years old.

Other medications andGlycerin Suppositories Cuve for children

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 medicationdoes not affect your ability to drive and/or operate machines.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Children aged 6 to 12 years:

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

Administration method:

Open the container, and remove the suppository. Insert it deeply into the anus, keeping the buttocks together for a while.

Suppress defecation as much as possible to allow the medication to take effect.

If you experience resistance during administration, stop immediately, as it may be harmful and damaging.

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 Glycerin Suppositories Cuve for Children than you should

It is unlikely that you will experience symptoms of intoxication 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, pharmacist, or call the Toxicological Information Service at 91.562.04.20, indicating the medication and the amount ingested.

If you forgot to use Glycerin Suppositories Cuve for Children

Do not take a double dose to compensate for missed doses.

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 may experience them.

During the period of use of Supositorios de glicerina Cuve niños as a laxative, the following adverse effects have been observed, whose frequency has not been established with precision:

pruritus, anal pain and irritation.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Store below 25 °C.

Keep the bottle in the case to protect it from light.

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.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Glycerin Suppositories for Children Cuve

• The active ingredient 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 content of the packaging

Glycerin Suppositories for Children Cuve are transparent, colorless, slightly opaque, uniform texture, oval-shaped suppositories that are presented in packs of 4 and 12 suppositories.

Holder of the marketing authorization

Pharmex Pharma S.L.U.

C/ Anabel Segura, 16, Edif. 1 Planta 1 dcha.

28108 Alcobendas – Madrid

Spain

Responsible for manufacturing

Pharmex Advanced Laboratories,S.L.

Ctra.A-431 Km.19

14720 Almodóvar del Río (Córdoba) Spain

Last review date of this leaflet:February 2011

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