GLYCILAX ADULT SUPPOSITORIES

Introduction

Leaflet: information for the user

Glycilax adult suppositories

Glycerol

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

Follow the administration instructions of the medication 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 more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days

Contents of the leaflet

1. What Glycilax adults is and what it is used for
2. What you need to know before starting to use Glycilax adults
3. How to use Glycilax adults
4. Possible side effects
5. Storage of Glycilax adults
6. Package contents and additional information

1. What Glycilax adults is and what it is used for

The glycerol, active ingredient of this medication, is a laxative that is administered rectally. The laxative effect is achieved by the ability of glycerol to soften the stool, which, together with a mild local irritating action, stimulates the movements of the intestine.

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 it does not improve after 7 days of treatment.

2. What you need to know before starting to use Glycilax adults

Do not use Glycilax adults

• If you are allergic to glycerol or any of the other components of this medication (included in section 6).
• If you have anorectal conditions, hemorrhagic rectocolitis (a type of chronic inflammation of the intestine), and inflamed hemorrhoids.
• If you have cramps, colic, nausea, vomiting, or other signs of appendicitis, intestinal obstruction, acute inflammatory intestinal diseases, or, in general, any situation of abdominal pain, without knowing the cause that produces them.
• In children under 12 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Glycilax adults.

In case of the appearance of blood in stool, irritation, pain, or if it does not improve, you should interrupt the treatment and consult a doctor.

Do not use this medication for more than 7 consecutive days, unless your doctor indicates it.

This medication will be used only under strict medical control, in patients with serious diseases, especially cardiovascular (related to the heart or blood vessels).

Other medications and Glycilax adults

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

Due to the type of medication it is and its route of administration, it does not affect the use of other medications.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

The use of this medication does not affect the ability to drive and/or use machines.

3. How to use Glycilax adults

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is 1 suppository per day, when necessary, or as indicated by your doctor.

Once removed from the blister, moisten the suppository with cold water, placing it under the faucet for 30 seconds, or in a glass of water for at least 10 seconds before insertion.

The suppositories will be inserted deeply into the anus. You should restrain the evacuation as much as possible so that the medication can exert its action perfectly.

If you notice resistance at the time of administration, you should interrupt it, as it may be harmful and damaging, and consult your doctor.

Do not use the medication for more than 7 consecutive days. If the symptoms do not improve, you should suspend the treatment and consult a doctor.

If you use more Glycilax adults than you should

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

The abusive and prolonged use of this medication can lead to an irritable colon syndrome (symptoms or discomfort such as alternation of constipation and diarrhea, intestinal spasms, bloating, nausea, and gases).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, this medication can produce side effects, although not all people suffer from them.

During the period of use of glycerol by rectal route as a laxative, the following side effects have been observed, whose frequency has not been established with precision:

Anal irritation, itching, or burning.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Glycilax adults

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Glycilax adults

• The active ingredient is glycerol. Each suppository contains 3.31 g of glycerol.
• The other components (excipients) are: stearic acid and sodium hydroxide.

Appearance of the product and package contents

Colorless suppositories with a smooth and shiny surface.

They are presented in aluminum/polyethylene blisters in packages that contain 2 and 12 suppositories.

Only some package sizes may be marketed.

Marketing authorization 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 last revision of this leaflet:February 2021

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