Adulax 7.5 g rectal solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Adulax 7.5 g rectal solution
Glycerol
Read this 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, 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 the leaflet
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What Adulax is and what it is used for
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What you need to know before using Adulax
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How to use Adulax
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Possible side effects
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How to store Adulax
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Contents of the pack and other information
1. What Adulax 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 the stools, and together with a mild local irritant action, it 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 Adulax
Do not use Adulax:
- 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 unexplained abdominal pain.
- in children under 12 years of age.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Adulax.
- If blood appears in the stool, or if irritation, pain, or lack of improvement occurs, 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 diseases, especially cardiovascular conditions (related to the heart or blood vessels).
Children and adolescents
Do not administer to children under 12 years of age.
Other medicines and Adulax
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
The use of this medicine does not affect the ability to drive or operate machinery.
3. How to use Adulax
Follow exactly the instructions for administering this medicine as described 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:
Adults and adolescents aged 12 years and older: administer 1 container per day, when necessary, or as prescribed by the doctor.
Use in children
This medicine is contraindicated in children under 12 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, place the cannula in an upright, vertical position. 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 pressing on the sides, and without releasing pressure, gently withdraw it 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 complete dose.
Each applicator contains a single dose of the product and must be discarded after use.
If you feel resistance during administration, stop the procedure, as continuing may 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.
If you use more Adulax than you should
Intoxication is unlikely to occur 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, pharmacist, or call the Toxicology Information Service immediately at: 91.562.04.20, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may cause 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 pruritus, 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 Adulax
Keep this medicine out of the sight and reach of children.
Store below 25ºC.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is 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 or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Adulax
The active substance is glycerol. Each container contains 7.5 g of glycerol.
The other component (excipient) is purified water.
Appearance of the medicinal product and contents of the pack
Adulax is a rectal solution.
The medicine is packaged in a low-density polyethylene applicator of 7.5 ml, provided 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/