Leaflet: information for the user

Glycilax suppositories for adults

Glycerol

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days

The active ingredient, glycerol, is a laxative that is administered rectally. The laxative effect is achieved by the glycerol's ability to soften the stool, combined with a mild local irritating action, which stimulates intestinal movements.

It is indicated for local symptomatic relief of transient and occasional constipation in adults and adolescents 12 years of age and older.

Consult a doctor if symptoms do not improve after 7 days of treatment.

Do not use Glycilax adults

• If you are allergic to glycerol or any of the other components of this medication (listed in section 6).
• If you have anal or rectal problems, chronic rectocolitis (a type of chronic intestinal inflammation) 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 abdominal pain without knowing the cause.
• In children under 12 years old.

Warnings and precautions

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

Stop treatment and consult your doctor if you experience blood in stool, irritation, pain or if it does not improve.

Do not use this medication for more than 7 consecutive days, unless your doctor tells you to.

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

Other medications and Glycilax adults

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

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

Pregnancy and breastfeeding

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

Driving and operating machines

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

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

The recommended dose is 1 suppository per day, as needed, or as directed by your doctor.

Once removed from the blister pack, 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 must repress the evacuation as much as possible in order for the medication to act perfectly.

If you experience resistance during administration, you must interrupt it, as it may be harmful and damaging, and consult with your doctor.

The medication should not be used for more than 7 consecutive days. If symptoms do not improve, discontinue treatment and consult with your doctor.

If you use more Glycilax adults than you should

It is unlikely that you will experience symptoms of intoxication due to its use.

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

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

Like all medications, this medicationmay cause adverse effects, although not all people will experience them.

During the period of use of glycerol rectally as a laxative, the following adverse effects have been observed, whose frequency has not been established with precision:

Anal irritation, itching, or stinging.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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 disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Glycilax for 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 contents of the packaging

Colourless suppositories with a smooth and shiny surface.

They are presented in aluminium/polyethylene blisters in packs containing 2 and 12 suppositories.

Only some pack sizes may be marketed.

Marketing Authorization Holder:

Cinfa Laboratories, S.A

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Responsible for manufacturing:

Villardell Laboratories, S.A.

Constitution Street, 66-68,

08980 Sant Feliu de Llobregat (Barcelona) - Spain

or

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:February 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.