Patient Information Leaflet

Dr. Torrents Adult Glycerin Suppositories Blister 3.27 g Suppository

Glycerol

Read this leaflet carefully before you start using this medicine. It contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given 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 doctor or 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 you get worse or do not improve after 7 days.

Contents of the Leaflet

1. What Supositorios de glicerina Dr. Torrents adultos blíster is and for what it is used

2. What you need to know before starting to use Supositorios de glicerina Dr. Torrents adultos blíster

3. How to use Supositorios de glicerina Dr. Torrents adultos blíster

4. Possible side effects

5. Storage of Supositorios de glicerina Dr. Torrents adultos blíster

6. Contents of the package and additional information

The active ingredient, glycerol, is a laxative administered rectally. The laxative effect is achieved by the glycerol's ability to soften stools, 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 over 12 years old.

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

Do not use Glycerin Suppositories Dr. Torrents Adult Blister

- If you are allergic to glycerol or to any of the other components (excipients) of this medication included in section 6.

- If you have any anorectal disease, hemorrhagic rectocolitis (a type of chronic intestinal inflammation) and inflamed hemorrhoids.

- If you have cramps, colics, nausea, vomiting or other signs of appendicitis, intestinal obstruction, acute inflammatory intestinal diseases or, in general, any abdominal pain without knowing the cause that produces it.

- In children under 12 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Glycerin Suppositories Dr. Torrents Adult Blister.

- In case of the appearance of blood in stools, irritation, pain or that does not improve, interrupt the treatment and consult the doctor.

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

- This medication will be used only under strict medical control in patients with severe pathological conditions, especially cardiovascular (relating to the heart or blood vessels).

Children and adolescents

Do not use Glycerin Suppositories Dr. Torrents Adult Blister in children under 12 years old.

Other medications and Glycerin Suppositories Dr. Torrents Adult Blister

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

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 the ability to drive and/or operate machines.

Follow exactly the administration instructions of this medication 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:

Adults or adolescents over 12 years old:1 suppository per day, as needed, or according to your doctor's prescription.

Administration form:

• The suppository is administered rectally
• After removing the suppository from the blister, to facilitate handling, keep the suppository in cold water for about half a minute before inserting it into the rectum.
• Insert the suppository deeply into the rectum.
• Suppress evacuation as much as possible in order for the medication to take effect.
• If you experience resistance during administration, interrupt it immediately, as it may be harmful and damaging.
• Do not use the medication for more than 7 consecutive days. If symptoms do not improve, discontinue treatment and consult your doctor.

If you use more Glycerin Suppositories Dr. Torrents Adult Blister than you should

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

Prolonged and abusive use of this medication may lead to an "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, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

During the period of use of Glycerol rectal solution as a laxative, the following adverse effects have been observed, whose frequency has not been established with precision: itching, anal pain and irritation.

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 theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: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.

No special storage conditions are required.

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 in the trash. Dispose of the packaging and medications you no longer need at the Sigre Point of the 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 Dr. Torrents Adult Glycerin Suppositories Blister

• The active ingredient is glycerol. Each suppository contains 3.27 grams of glycerol
• The other components (excipients) are: stearic acid, sodium hydroxide, and purified water.

Appearance of the product and content of the packaging

Dr. Torrents Adult Glycerin Suppositories Blister are colorless suppositories with a smooth and shiny surface, and are presented in a blister pack containing 12 suppositories.

Holder of the marketing authorization

Fleer Española S.L.

Rambla Catalunya n.º 53 Ático

08007, Barcelona

Spain

Responsible for manufacturing

Fleer Española, S.L.

Avda. Hospital s/n

08795 Olesa de Bonesvalls (Barcelona) Spain

Telephone: 93 898 40 11 Fax: 93 898 41 76

Full revision date of this leaflet:December 2020

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