GLYCILAX ADULTS 6.75 g RECTAL SOLUTION

Introduction

Leaflet:information for the user

Glycilax adults 6.75 g rectal solution

glycerol

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

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist exactly.

• 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 not listed in this leaflet. See section 4.

You should consult a doctor if it worsens or does not improve after 7 days of treatment.

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 Conservation of Glycilax adults

1. Contents of the package and additional information

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

This medicine contains glycerol, a laxative that is administered rectally. The laxative effect is achieved by the ability of glycerol to soften the stool, which, together with a slight 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 worsens or does not improve after 7 days of treatment.

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

Do not useGlycilax adults

• 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 inflammation of the intestine), and 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 that produces it.
• 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 you do not notice improvement, you should interrupt treatment and consult a doctor.
• Do not use this medicine for more than 7 consecutive days, unless your doctor indicates it. This medicine will only be used under strict medical control in patients with severe diseases, especially cardiovascular (related to the heart or blood vessels).

Children and adolescents

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

Other medicines andGlycilax adults

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

Due to the type of medicine it is, its route of administration, this medicine does not affect the use of other medicines.

Use of Glycilax adultswith food and drinks

The intake of food and drinks does not affect the efficacy of this 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/or use machines.

3. How to use Glycilax adults

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

The recommended dose is:

Adults and adolescents from 12 years of age: 1 package per day, when necessary, or as prescribed by the doctor.

This medicine is for rectal use only, do not ingest it.

Form of administration:

This medicine is administered rectally.

At the chosen time for administration, and once the cap that closes the end of the package in the form of a cannula is removed, place it in a vertical position with the tip upwards and press lightly so that a few drops of the medicine moisten the end in the form of a cannula, in order to facilitate its introduction into the rectum. Once introduced into the rectum, squeeze the package until it is completely empty and remove it gently without stopping pressing on its walls.

Repress the evacuation, keeping the buttocks tight, for as long as possible so that the medicine can exert its action perfectly.

Although there may be remains in the package after administration, the supply of the indicated dose is guaranteed. Each package contains a single dose of the product. It should be discarded after use.

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

Do not use the medicine for more than 7 consecutive days. If the symptoms do not improve, you should suspend treatment and go to the doctor.

Use in children

Do not administer to children under 12 years of age.

If you use more Glycilax adultsthan you should

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

The abusive and prolonged use of this medicine 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, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount ingested.

If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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:

• Itching, pain, and irritation of the anus.

• Very rarely in allergic patients, hypersensitivity reactions to chamomile have occurred (for example, contact dermatitis). After internal use, these could be serious and could be: swelling of the face, lips, mouth, tongue, or throat that cause difficulty swallowing or breathing.

Reporting of 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 Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Glycilax adults

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

It does not require special storage conditions.

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

Medicines should not be thrown away through the sewers or in the trash. Deposit the packages and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines that you no longer need. This way, you will help protect the environment.

6. Contents of the package and additional information

Composition ofGlycilax adults

• The active principle is glycerol. Each single-dose package contains 6.75 g of glycerol.
• The other components (excipients) are: Malva flower fluid extract, Matricaria chamomilla fluid extract, sodium carmellose, and purified water.

Appearance of the product and contents of the package

Glycilax adults is a transparent and yellowish rectal solution.

The medicine is presented in single-dose packages of 7.5 ml of polyethylene with a cannula-shaped end and a closing plug, which are packaged in boxes containing 4 or 12 single-dose packages.

Only some package sizes may be marketed.

Marketing authorization holderand 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 last revision of this leaflet:February 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80818/P_80818.html

QR code to: https://cima.aemps.es/cima/dochtml/p/80818/P_80818.html

https://cima.aemps.es/cima/dochtml/p/80818/P_80818.html