Leaflet: information for the user

Glycilax suppositories for infants

Glycerol

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 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 it worsens or does not improve after 7 days.

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

It is indicated for local symptomatic relief of transient and occasional constipation in children under 2 years of age.

Consult a doctor if symptoms do not improve after 7 days of treatment.

Do not use Glycilax lactantes

• If you are allergic to glycerol or any of the other components of this medication (listed in section 6).
• If you have anal or rectal problems, 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to useGlycilax lactantes.

In case of blood in stool, irritation, pain or no improvement, interrupt treatment and consult your doctor.

Do not use this medication for more than 7 consecutive days, unless your doctor tells you to.

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

Other medications and Glycilax lactantes

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 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 under 2 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, 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, and in infants, it is recommended to hold 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, 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 Infants 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 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 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 medication may produce adverse effects, although not all people may experience them.

During the period of use of glycerol rectally 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 a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines 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 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.

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 point at 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 lactantes

The active ingredient is glycerol. Each suppository contains 0.672 g of glycerol.

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

Appearance of the product and contents of the packaging

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

They are presented in aluminium/polyethylene blisters in packs containing 10 suppositories.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer responsible

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/