ADULAX 7.5 G RECTAL SOLUTION

Introduction

Package Leaflet: Information for the User

Adulax 7.5 g Rectal Solution

Glycerol

Read the entire package leaflet carefully before starting to use this medicine, as it contains important information for you.

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Package Leaflet

1. What Adulax is and what it is used for

2. What you need to know before using Adulax

3. How to use Adulax

4. Possible side effects

5. Storage of Adulax

6. Contents of the pack and further information

1. What Adulax is and what it is used for

This medicine contains glycerol, which is a laxative administered rectally. The laxative effect is achieved by glycerol's ability to soften stools, which, along 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 from 12 years of age.

You should consult a doctor if your symptoms worsen or do 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 any of the other components of this medicine (listed in section 6).
• if you have any anorectal disease, rectocolitis hemorrhagica (a type of chronic intestinal inflammation), or inflamed hemorrhoids.
• if you have colic, nausea, vomiting, or other signs of appendicitis, intestinal obstruction, acute inflammatory intestinal diseases, or any situation of abdominal pain without knowing the cause.
• In children under 12 years of age.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Adulax.

• In case of blood in stools, irritation, pain, or no improvement, interrupt treatment and consult your doctor.
• Do not use this medicine for more than 7 consecutive days, unless your doctor indicates otherwise.
• This medicine will be used only under strict medical control in patients with severe diseases, especially cardiovascular (related to the heart or blood vessels).

Children and adolescents

Do not administer to children under 12 years of age.

Other medicines and Adulax

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 use machines.

3. How to use Adulax

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

In case of doubt, ask your doctor, pharmacist, or nurse.

The recommended dose is:

Adults and adolescents from 12 years of age: administer 1 unit per day, as needed, or as prescribed by your doctor.

Use in children

This medicine is contraindicated in children under 12 years of age.

Method of administration:

The medicine is administered rectally.

1. At the chosen time for administration, and once the cap that closes the end of the cannula is removed, place it in a vertical position and upwards, squeeze it slightly so that a few drops of the preparation moisten the end of the cannula, in order to facilitate its introduction into the rectum. Introduce the cannula of the applicator into the rectum smoothly and slowly.
2. Introduce the contents of the applicator by pressing on the walls, and without stopping pressing, withdraw it smoothly once the application is finished.

In order to facilitate the application, the applicator is loaded with an excess of product that remains in it after use, so that the amount of solution released in the application is the complete dose.

Each applicator contains a single dose of the product; it should be discarded after use.

If you notice resistance during application, interrupt it, as it may be harmful and damaging, and consult your doctor.

Do not use the medicine for more than 7 consecutive days. If symptoms do not improve, suspend treatment and consult your doctor.

If you use more Adulax than you should

It is unlikely that intoxication will occur due to its use.

Prolonged and abusive use of this medicine may lead to an irritable colon syndrome (symptoms or discomfort such as alternating constipation and diarrhea, intestinal spasms, bloating, nausea, and gases).

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91.562.04.20, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. During the period of use of glycerol rectally as a laxative, the following side effects have been observed:

Frequency not known: anal itching, anal pain, anal irritation.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing 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 25°C.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medicine if you notice damage or deterioration of the packaging.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Adulax

The active ingredient is glycerol. Each unit contains 7.5 g of glycerol.

The other component (excipient) is purified water.

Appearance of the 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 capped with a hood.

The applicators are packaged in a cardboard box with 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 last revision of this package leaflet: November 2011

Other sources of information

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/