Leaflet: information for the user

VEROLAX CHILDREN Rectal solution

Glycerol

1.What VEROLAX is and for what it is used

2.Before using VEROLAX

3.How to use VEROLAX

4.Possible adverse effects

5.Storage of VEROLAX

6.Additional information

The active ingredient, glycerol, is a laxative that is administered rectally. The laxative effect is achieved by the glycerol's ability to soften the stool, along with a mild local irritating action, which stimulates intestinal movements.

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

• If you are allergic (hypersensitive) to glycerol or to any of the other components of this medication.
• 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 that produces it.
• Children under 2 years old.

Be especially careful with VEROLAX

In case of the appearance of blood in stools, irritation, pain or that does not improve, interrupt the treatment and consult the doctor.

Do not use this medication more than 7 consecutive days, unless your doctor indicates otherwise.

This medication will be used only under strict medical control, in patients with serious diseases, especially cardiovascular (relating to the heart or blood vessels).

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those acquired without a prescription.

Use in children

It should not be administered to children under 2 years old.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

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

Consult your doctor or pharmacist if you have any doubts.

The normal dose is:

Children aged 2 to 12 years: 1 single-dose package per day.

This medication is administered rectally.

Instructions for correct administration of the medication:

1. Open the applicator, holding it by the neck and turning the cap, making it easier to break the seal.

1. Gently press to allow a few drops of the medication to moisten the tip of the cannula, making it easier to introduce into the rectum.
2. Insert the cannula of the applicator into the rectum smoothly and slowly.
3. Insert the contents of the applicator by pressing against the walls of the balloon and without releasing the pressure, remove it gently once the application is complete.

Each applicator is loaded with an excess of product, which remains in the applicator after use, so that the amount released during application is the full dose and it is not necessary to empty it completely, making it easier to handle. It should be discarded after use.

If you experience resistance during administration, you must interrupt it, as it may be harmful and damaging.

This medication 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

It is unlikely that you will experience symptoms of overdose, due to its use.

Prolonged and abusive use of this medication may lead to a 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, phone 91.562.04.20, indicating the medication and the amount ingested.

Like all medications, VEROLAX may produce adverse effects, although not all people will experience them.

During the period of use of VEROLAX rectal solution as a laxative, the following adverse effects have been observed, whose frequency has not been established with precision:

Itching, pain, and irritation of the anus.

Very rarely in allergic patients, hypersensitivity reactions to chamomile (for example, contact dermatitis) have been produced. After internal use, these could be severe, and may include: facial swelling, lips, mouth, tongue, or throat that cause difficulty swallowing or breathing.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

No special storage conditions are required.

Do not use VEROLAX after the expiration date appearing on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need.By doing so, you will help protect the environment.

Composition of VEROLAX

-The active ingredient is glycerol. Each single-dose package 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

VEROLAXis presented in the form of a light brown rectal solution.

The medicine is packaged in a single-dose package in the form of a 2.5 ml collapsible container, provided with a plastic cannula and a closure cap. These are packaged in a box containing 6 single-dose packages.

Marketing Authorization Holder

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Edificio Australia

08840 Viladecans, Barcelona (Spain)

Responsible for Manufacturing

A.C.R.A.F. SpA

Via Vecchia del Pinocchio, 22

60131 Ancona (Italy)

This leaflet was approved in May 2011.