Glycilax Lactantes suppositories
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Glycilax lactantes suppositories
Glycerol
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for administering this medicine provided 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days.
Contents of this leaflet
- What Glycilax lactantes is and what it is used for
- What you need to know before using Glycilax lactantes
- How to use Glycilax lactantes
- Possible adverse effects
- How to store Glycilax lactantes
- Contents of the pack and other information
1. What Glycilax Paediatric is and what it is used for
Glycerol, the active ingredient 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, helps stimulate intestinal movements.
It is indicated for the local symptomatic relief of transient and occasional constipation in children under 2 years of age.
You should consult a doctor if there is no improvement after 7 days of treatment.
2. What you need to know before using Glycilax infants
Do not use Glycilax infants
- If you are allergic to glycerol or to any of the other components of this medicine (listed in section 6).
- If you have anorectal conditions, haemorrhagic rectocolitis (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 condition of abdominal pain of unknown cause.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Glycilax infants.
If you notice blood in the stool, irritation, pain, or no improvement, 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, particularly cardiovascular diseases (related to the heart or blood vessels).
Other medicines and Glycilax infants
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Due to the type of medicine and its route of administration, it does not affect the use of other medicines.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. This medicine is not indicated for adults.
Driving and using machines
The use of this medicine does not affect the ability to drive and/or operate machinery.
3. How to use Glycilax infants
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Children under 2 years: 1 suppository per day, when necessary, or as directed by the physician.
Method of administration:
The medicine is administered rectally.
Once removed from the blister pack, moisten the suppository with cold water by placing it under a tap for 30 seconds or in a glass of water for at least 10 seconds before insertion.
Insert the suppository well into the rectum.
Delay bowel movement as long as possible so that the preparation can exert its effect properly; therefore, in infants, it is recommended to keep the thighs together for a short period of time after administration.
It can be used at room temperature.
If you feel resistance during administration, stop the procedure, as it could be harmful; consult your doctor.
Do not use this medicine for more than 7 consecutive days. If symptoms do not improve, discontinue treatment and consult your doctor.
If you use more Glycilax infants than you should
Intoxication is unlikely due to its use.
Abusive and prolonged use of this medicine may lead to 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
During the period of rectal use of glycerol as a laxative, the following adverse effects have been observed, whose frequency cannot be precisely determined:
Anal irritation, burning, or itching.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Glycilax infant
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Glycilax Lactantes
The active substance 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 pack
Glycilax Lactantes suppositories are colourless with a smooth, shiny surface.
They are supplied in aluminium/polyethylene blisters, packed in containers containing 10 suppositories.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Manufacturer
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
Date of the most recent revision of this leaflet: February 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob/