VEROLAX NIÑOS RECTAL SOLUTION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

VEROLAX NIÑOS Rectal Solution

Glycerol

Read the entire leaflet carefully because it contains important information for you.

This medicine can be purchased without a prescription. However, to achieve the best results, it must be used correctly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If symptoms worsen or persist beyond 7 days, you should consult a doctor.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

1. What VEROLAX is and what it is used for
2. Before you use VEROLAX
3. How to use VEROLAX
4. Possible side effects
5. How to store VEROLAX
6. Further information

1. What VEROLAX is and what it is used for

Glycerol, the active substance in this medicine, is a laxative administered by rectal route. The laxative effect is achieved due to glycerol's ability to soften the 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 between 2 and 12 years of age.

2. Before using VEROLAX

• If you are allergic (hypersensitive) to glycerol or any of the other ingredients of this medicine.
• If you suffer from any anorectal disease, ulcerative colitis (a type of chronic intestinal inflammation), or inflamed haemorrhoids.
• If you have cramps, colic, nausea, vomiting, or other signs of appendicitis, intestinal obstruction, acute inflammatory bowel diseases, or in general, any abdominal pain of unknown cause.
• Children under 2 years of age.

Take special care with VEROLAX

If blood appears in the stool, or if irritation, pain, or lack of improvement occurs, discontinue 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).

Use of other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Use in children

This medicine must not be administered to children under 2 years of age.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

The use of this medicine does not affect the ability to drive and/or operate machinery.

3. How to use VEROLAX

Follow exactly the administration instructions for VEROLAX as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

The usual dose is:

Children from 2 to 12 years: 1 single-dose unit per day.

This medicine is administered rectally.

Instructions for correct administration of the medicine:

1. Open the applicator by holding it by the neck and twisting the cap to break the seal.

2. Gently squeeze so that a few drops of the medicine moisten the tip of the cannula, to facilitate its insertion into the rectum.
3. Insert the applicator's cannula gently and slowly into the rectum.
4. Administer the contents of the applicator by pressing the sides of the bulb, and without releasing pressure, gently withdraw the applicator once administration is complete.

Each applicator is filled with a slight excess of product, which remains inside the applicator after use. This ensures that the amount released during administration corresponds to the complete dose, and it is not necessary to empty it completely, facilitating handling. The applicator must be discarded after use.

If you feel resistance during administration, you should stop the procedure, as it could be harmful.

This medicine should not be used for more than 7 consecutive days. If symptoms do not improve, discontinue treatment and consult your doctor.

If you use more VEROLAX than you should

Cases of intoxication are unlikely due to the route of administration.

Abuse or prolonged use of this medicine may lead to a laxative-induced 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 91.562.04.20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, VEROLAX may cause adverse effects, although not everybody experiences them.

During the period of use of VEROLAX rectal solution as a laxative, the following adverse effects have been observed, although their frequency could not be established with certainty:

itching, pain, and irritation of the anus.

Very rarely, hypersensitivity reactions to chamomile have occurred in allergic patients (e.g. contact dermatitis). After internal use, these reactions could be severe and might include swelling of the face, lips, mouth, tongue, or throat causing difficulty in swallowing or breathing.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of VEROLAX

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use VEROLAX after the expiry date stated on the container, after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of VEROLAX

• The active substance is glycerol. Each single-dose container with 2.5 ml of rectal solution contains 1.8 ml of glycerol.
• The other components (excipients) are: fluid extract of Malva sylvestris, fluid extract of Matricaria chamomilla, wheat starch, and purified water.

Appearance of the product and contents of the package

VEROLAX is a light brown rectal solution.

The medicine is packaged in a single-dose squeeze container of 2.5 ml, provided with a plastic cannula and a closure cap. These are packed in a box containing 6 single-dose containers.

Marketing Authorization Holder

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Building Australia

08840 Viladecans, Barcelona (Spain)

Manufacturer

A.C.R.A.F. SpA

Via Vecchia del Pinocchio, 22

60131 Ancona (Italy)

This leaflet was approved in May 2011.