PAIDOLAX NIÑOS, RECTAL SOLUTION

Introduction

Leaflet: information for the user

Paidolax children 4 g rectal solution

Glycerol

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, 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.

Contents of the leaflet

1. What Paidolax is and what it is used for
2. What you need to know before starting to use Paidolax
3. How to use Paidolax
4. Possible side effects
5. Storage of Paidolax
6. Package contents and additional information

1. What Paidolax is and what it is used for

This medication contains glycerol, which is a laxative and is administered rectally. The laxative effect is achieved by the ability of glycerol to soften the stool, which, along with a mild local irritant action, stimulates intestinal movements.

It is indicated for the local symptomatic relief of transient and occasional constipation in children from 2 to 12 years old.

You should consult a doctor if it worsens or does not improve after 7 days of treatment.

2. What you need to know before starting to use Paidolax

Do not use Paidolax:

• if you are allergic to glycerol or 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 colic, cramps, nausea, vomiting, or other signs of appendicitis, intestinal obstruction, acute inflammatory intestinal diseases, or, in general, any situation of abdominal pain, without knowing the cause that produces it.
• In children under 2 years of age.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Paidolax.

• In case of the appearance of blood in stool, irritation, pain, or if it does not improve, interrupt treatment and consult a doctor.
• Do not use this medication for more than 7 consecutive days, unless your doctor indicates it.
• This medication will be used only under strict medical control in patients with serious diseases, especially cardiovascular (related to the heart or blood vessels).

Children and adolescents

Do not administer in children under 2 years of age.

Use of Paidolax with other medications

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

Pregnancy, breastfeeding, and fertility

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

The use of this medication does not affect the ability to drive and/or use machines.

3. How to use Paidolax

Follow the administration instructions of this medication contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

In case of doubt, ask your doctor, pharmacist, or nurse.

The recommended dose is:

Children from 2 to 12 years old: administer 1 package per day, when necessary, or as prescribed by the doctor.

Use in children:

This medication is contraindicated in children under 2 years of age.

Method of administration:

The medication is administered rectally.

1. At the chosen time for administration, and once the cap that closes the end of the cannula is removed, place it in a vertical position and upwards, squeeze it lightly so that a few drops of the preparation moisten the end of it, in order to facilitate its introduction into the rectum. Introduce the cannula of the applicator into the rectum smoothly and slowly.
2. Introduce the contents of the applicator by pressing on the walls, and without stopping pressing, withdraw it smoothly once the application is finished.

In order to facilitate the application, the applicator is loaded with an excess of product that remains in it after use, so that the amount of solution released in the application is the complete dose.

Each applicator contains a single dose of the product, it must be discarded after use.

If you notice resistance during application, 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 the symptoms do not improve, suspend treatment and consult a doctor.

If you use more Paidolax than you should

It is unlikely that intoxication will occur due to its use.

The abusive and prolonged use of this medication can lead to an irritable colon syndrome (symptoms or discomfort such as alternation of constipation and diarrhea, intestinal spasms, bloating, nausea, and gases).

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91.562.04.20, indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. During the period of use of glycerol rectally as a laxative, the following side effects have been observed:

Frequency not known: anal itching, anal pain, anal irritation.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Paidolax

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

Store below 25°C.

Do not use this medication after the expiration date that appears on the package after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe damage or deterioration in the package.

Medications should not be thrown away in drains or trash. Deposit the packages and medications you no longer need in the SIGRE point of the pharmacy. 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 Paidolax

The active ingredient is glycerol. Each package contains 4 g of glycerol.

The other component (excipient) is purified water.

Appearance of the product and package contents

Paidolax is a rectal solution.

The medication is packaged in a low-density polyethylene applicator of 4 ml, provided with a cannula and capped with a hood.

The applicators are packaged in a cardboard box with 4 applicators each.

Marketing authorization holder and manufacturer

Casen Recordati, S.L.

Logroño Highway, km 13.300

50180 - Utebo (Zaragoza)

Spain.

Date of the last revision of this leaflet: November/2011.

Other sources of information

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