Leaflet: information for the user

Glycilax children suppositories

Glycerol

Read this leaflet carefully before you start using 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.

The glycerol, active ingredient of this medication, is a laxative, 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 aged 2 to 12 years.

Consult a doctor if there is no improvement after 7 days of treatment.

Do not use Glycilax children

Warnings and precautions

Consult your doctor or pharmacist before starting to use Glycilax children .

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.

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

Other medications and Glycilax children

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

Due to the type of medication involved and its administration route, it does not affect the use of other medications.

Pregnancy and breastfeeding

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.

This medication is not indicated for adults.

Driving and operating machines

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

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

The recommended dose is:

Children aged 2 to 12 years: 1 suppository per day, as needed, or as directed by your doctor.

Administration method:

The medication is administered rectally.

Once removed from the blister pack, moisten the suppository with cold water, placing it under the faucet for 30 seconds or in a glass of water for at least 10 seconds before insertion.

Insert the suppository deeply into the rectum.

Suppress evacuation as much as possible in order for the preparation to exert its action perfectly. In children, it is recommended to keep the thighs together for a brief period of time.

The medication can be applied at room temperature.

If you experience resistance during administration, discontinue use immediately, 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, discontinue treatment and consult your doctor.

If you use more Glycilax 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 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 or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, this medicationmay cause adverse effects, although not all people will experience them.

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

Anal irritation, itching, or prickling.

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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://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.

This medication does not require special conditions for conservation.

Do not usethis medicationafter 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 packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Glycilax children

The active ingredient is glycerol. Each suppository contains 1.44 g of glycerol.

The other components (excipients) are: stearic acid and sodium hydroxide.

Appearance of the product and content of the packaging

Glycilax children suppositories are colourless with a smooth and shiny surface.

They are presented in aluminium/polyethylene blisters in packs containing 15 suppositories.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

Huarte (Navarra) – Spain

31620

Responsible for manufacturing:

Laboratorios Vilardell, S.A.

C/ Constitución, 66-68,

08980 Sant Feliu de Llobregat (Barcelona) – Spain

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: February 2021

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