Glycilax Adultos 6.75 g rectal solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Glycilax adults 6.75 g rectal solution
Glycerol
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
You should consult a doctor if you worsen or do not improve after 7 days of treatment.
Contents of the leaflet
- What Glycilax adults is and what it is used for
- What you need to know before using Glycilax adults
- How to use Glycilax adults
- Possible side effects
- Storage of Glycilax adults
- Contents of the pack and other information
1. What Glycilax adults is and what it is used for
This medicine contains glycerol, a laxative administered rectally. The laxative effect is achieved due to glycerol's ability to soften stools, which, together with a mild local irritant action, stimulates intestinal movements.
It is indicated for the local symptomatic relief of transient and occasional constipation in adults and adolescents aged 12 years and older.
You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.
2. What you need to know before using Glycilax adults
Do not use Glycilax adults
- If you are allergic to glycerol or to any of the other components of this medicine (listed in section 6).
- If you suffer from any anorectal disease, hemorrhagic rectocolitis (a type of chronic intestinal inflammation), or inflamed hemorrhoids.
- If you have cramps, colic, nausea, vomiting, or other signs of appendicitis, intestinal obstruction, acute inflammatory bowel diseases, or, in general, any condition causing abdominal pain of unknown origin.
- In children under 12 years of age.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Glycilax adults.
- If you notice blood in your stool, irritation, pain, or do not experience improvement, you must stop 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).
Children and adolescents
This medicine is contraindicated in children under 12 years of age.
Other medicines and Glycilax adults
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, this medicine does not affect the use of other medicines.
Use of Glycilax adults with food and drink
Taking food and drink does not affect the effectiveness of this medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
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 adults
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults and adolescents aged 12 years and older: 1 unit-dose container per day, as needed, or as prescribed by the doctor.
This medicine is for rectal use only; do not swallow it.
Method of administration:
This medicine is administered rectally.
At the chosen time for administration, after removing the cap sealing the tip of the container shaped like a cannula, place it vertically with the tip pointing upwards and gently squeeze so that a few drops of the medicine moisten the cannula-shaped tip, to facilitate its insertion into the rectum. Once inserted into the rectum, press the container until all its contents are completely emptied, and then gently withdraw it without stopping to apply pressure on its walls.
Delay defecation by keeping the buttocks tightly clenched for as long as possible, so that the medicine can fully exert its effect.
Even if some residue remains in the container after administration, the prescribed dose has been delivered. Each container holds a single dose. The container must be discarded after use.
If you feel resistance during administration, stop the procedure, as it could be harmful, and 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.
Use in children
Do not administer to children under 12 years of age.
If you use more Glycilax adults than you should
Cases of poisoning are unlikely due to its use.
Abuse or 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, pharmacist, or call the Toxicology Information Service immediately at telephone number 91.562.04.20, indicating the medicine and the amount ingested.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.
During the period of rectal use of glycerol as a laxative, the following adverse effects have been observed, although their frequency could not be established accurately:
-
Itching, pain, and irritation of the anus.
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Very rarely, hypersensitivity reactions to chamomile have occurred in allergic patients (for example, 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.
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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Glycilax adults
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
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 drains or in household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Glycilax adults
- The active substance is glycerol. Each single-dose container contains 6.75 g of glycerol.
- The other components (excipients) are: fluid extract of Malva flower, fluid extract of Matricaria chamomilla, sodium carmellose, and purified water.
Appearance of the product and contents of the pack
Glycilax adults is a transparent, yellowish rectal solution.
The medicine is supplied in single-dose containers of 7.5 ml made of polyethylene, with a cannula-shaped tip and a closure cap, packed in cartons containing either 4 or 12 single-dose containers.
Only certain pack sizes may be commercially available.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Manufacturer:
LAINCO, S.A.
Avda. Bizet, 8-12
08191 Rubí (Barcelona)
Spain
Date of the most recent revision of this leaflet: February 2025
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)
You can access detailed and up-to-date information about this medicine by scanning the QR code included in the package leaflet and outer packaging with your mobile phone (smartphone). You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80818/P_80818.html
QR code link: https://cima.aemps.es/cima/dochtml/p/80818/P_80818.html
https://cima.aemps.es/cima/dochtml/p/80818/P_80818.html