Leaflet: information for the user

Paidolax children 4 g rectal solution

Glycerol

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

Follow exactly the administration instructions contained in this leaflet or those given 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 any 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 your symptoms worsen or do not improve after 7 days.

This medication contains glycerol, which is a laxativeand is administered via the rectal route. The laxative effect is achieved by the ability of glycerol to soften the stool, which, together with a mild local irritating action, stimulates intestinal movements.

It is indicated for local symptomatic relief of transient and occasional constipation in children aged2 to12 years.

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

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 anorectal disease, chronic rectocolitis (a type of chronic intestinal inflammation) and inflamed hemorrhoids.
• If you have cramps, colic, 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 2 years old.

Warnings and precautions

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

• In case of blood in stool, irritation, pain or no improvement, 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 and adolescents

Do not administer in children under 2 years old.

Use of Paidolax with other medications

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

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

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

If in doubt, ask your doctor, pharmacist, or nurse.

The recommended dose is:

Children from 2 to 12 years: administer 1 package per day, as needed, or as prescribed by your doctor.

Use in children:

This medication is contraindicated in children under 2 years.

Administration form:

The medication is administered rectally.

1. At the chosen time for administration, and once the cap that closes the end of the cannula has been removed, place this in a vertical position and upwards, press lightly so that some drops of the preparation moisten the end of the same, in order to facilitate its introduction into the rectum. Introduce the cannula of the applicator into the rectum smoothly and slowly.
2. Introduce the content of the applicator by pressing on the walls and, without stopping pressing, remove 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 its use, so that the amount of solution released during the application is the complete dose.

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

If you feel resistance during the 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 symptoms do not improve, suspend treatment and consult your doctor.

If you use more Paidolax than you should

It is unlikely that you will experience intoxication due to its use.

Prolonged and abusive use of this medication may lead to a syndrome of irritable colon (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, phone: 91.562.04.20 indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people may experience them. During the period of use of glycerol by rectal route as a laxative, the following adverse effects have been observed:

Unknown Frequency: anal itching, anal pain, anal irritation.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicinal Products 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 below25°C.

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.

Do not use this medication if you observe damage or deterioration on the packaging.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

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 contents of the packaging

Paidolax is a rectal solution.

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

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

Holder of the marketing authorization and responsible for manufacturing

Casen Recordati, S.L.

Autovia de Logroño, km. 13,300

50180 - Utebo (Zaragoza)

Spain.

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

Other sources of information

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