Paidolax Niños rectal solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Paidolax niños 4 g rectal solution
Glycerol
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.
Always follow exactly the instructions for use 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 side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 7 days.
Contents of the leaflet
- What Paidolax is and what it is used for
- What you need to know before using Paidolax
- How to use Paidolax
- Possible side effects
- How to store Paidolax
- Contents of the pack and other information
1. What Paidolax is and what it is used for
This medicine contains glycerol, which is a laxative administered by rectal route. 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 children aged 2 to 12 years.
You should consult a doctor if symptoms worsen or do not improve after 7 days of treatment.
2. What you need to know before using Paidolax
Do not use Paidolax:
- if you are allergic to glycerol or to any of the other components of this medicine (listed in section 6).
- if you have any anorectal disease, ulcerative proctocolitis (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 intestinal diseases, or, in general, any condition of abdominal pain of unknown cause.
- in children under 2 years of age.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Paidolax.
- If you notice blood in the stool, irritation, pain, or no 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 conditions, especially cardiovascular diseases (related to the heart or blood vessels).
Children and adolescents
Do not administer to children under 2 years of age.
Use of Paidolax with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
This medicine does not affect the ability to drive and/or operate machinery.
3. How to use Paidolax
Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor, pharmacist, or nurse.
If in doubt, consult your doctor, pharmacist, or nurse.
The recommended dose is:
Children aged 2 to 12 years: administer 1 applicator per day, when necessary, or as prescribed by the doctor.
Use in children:
This medicine is contraindicated in children under 2 years of age.
Method of administration:
The medicine is administered rectally.
- At the time of administration, after removing the cap covering the tip of the cannula, hold the cannula vertically with the tip pointing upwards. Gently squeeze until a few drops of the preparation moisten the tip to facilitate its insertion into the rectum. Gently and slowly insert the cannula of the applicator into the rectum.
- Empty the contents of the applicator by squeezing the sides, and without stopping the pressure, gently withdraw the applicator once the administration is complete.
To facilitate administration, the applicator is filled with a slight excess of product, which remains inside after use, ensuring that the amount of solution released during administration corresponds to the full dose.
Each applicator contains a single dose of the product. It must be discarded after use.
If you feel resistance during administration, stop the procedure, as it may be harmful, and consult your doctor.
This medicine must not be used for more than 7 consecutive days. If symptoms do not improve, discontinue treatment and consult your doctor.
If you use more Paidolax than you should
Intoxication is unlikely following 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, immediately contact your doctor, pharmacist, 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 may produce adverse effects, although not everyone will experience them. The following adverse effects have been observed during the period of rectal use of glycerol as a laxative:
Frequency not known: anal itching, anal pain, anal irritation.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Paidolax
Keep this medicine out of sight and reach of children.
Store below 25°C.
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.
Do not use this medicine if you notice any damage or deterioration in the packaging.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at a SIGRE Point located at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the package and other information
Composition of Paidolax
The active substance is glycerol. Each container contains 4 g of glycerol.
The other component (excipient) is purified water.
Appearance of the product and contents of the package
Paidolax is a rectal solution.
The medicine is packaged in a low-density polyethylene applicator of 4 ml, equipped with a cannula and sealed with a cap.
The applicators are packed in a cardboard box containing 4 applicators each.
Marketing Authorization Holder and Manufacturer
Casen Recordati, S.L.
Autovía de Logroño, km. 13,300
50180 - Utebo (Zaragoza)
Spain
Date of the most recent revision of this leaflet: November 2011
Other sources of information
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.es/