GLYCERIN SUPPOSITORIES DR. TORRENTS FOR LACTATING WOMEN

Introduction

Package Leaflet: Information for the User

GLYCERIN SUPPOSITORIES DR. TORRENTS INFANTS

GLYCEROL

Read the package leaflet carefully because it contains important information for you.

This medication can be purchased without a prescription. Nevertheless, to obtain the best results, it should be used properly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after 7 days, you should consult your doctor.
• If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the package leaflet:

1. What Glycerin Suppositories Dr. Torrents Infants are and what they are used for
2. Before using Glycerin Suppositories Dr. Torrents Infants
3. How to use Glycerin Suppositories Dr. Torrents Infants
4. Possible side effects
5. Storage of Glycerin Suppositories Dr. Torrents Infants
6. Additional information

1. What Glycerin Suppositories Dr. Torrents Infants are and what they are used for

Glycerol, the active ingredient of this medication, is a laxative that is administered rectally.

The laxative effect is achieved by glycerol's ability 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 infants and children under 2 years of age.

2. Before using Glycerin Suppositories Dr. Torrents Infants

Do not use Glycerin Suppositories Dr. Torrents Infants:

• If you are allergic (hypersensitive) to glycerol or any of the other components (excipients) of the medication.
• If you have any anorectal disease, rectocolitis (a type of chronic inflammation of the intestine), 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.

Be careful with Glycerin Suppositories Dr. Torrents Infants:

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

Use of other medications

Tell your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

3. How to use Glycerin Suppositories Dr. Torrents Infants

Follow the administration instructions of Glycerin Suppositories Dr. Torrents Infants exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The normal dose is:

Infants under 2 years of age

Administer 1 suppository per day, as needed, or as prescribed by the doctor.

Method of administration:

The suppository is administered rectally.

After removing the suppository from the container, insert it deeply into the rectum. Delay evacuation as long as possible so that the medication can take effect.

If you notice resistance during administration, you should interrupt it, as it may be harmful and damaging.

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

If you think the effect of Glycerin Suppositories Dr. Torrents Infants is too strong or too weak, inform your doctor or pharmacist.

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

If you use more Glycerin Suppositories Dr. Torrents Infants 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 gas)

In case of overdose or accidental ingestion, consult your doctor, pharmacist, 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, Glycerin Suppositories Dr. Torrents Infants can cause side effects, although not everyone experiences them.

During the period of use of Glycerol rectal solution 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.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of Glycerin Suppositories Dr. Torrents Infants

Keep out of the reach and sight of children.

No special storage conditions are required.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of Glycerin Suppositories Dr. Torrents Infants

Each suppository contains 1.25 g of Glycerol as the active ingredient

The other components (excipients) are: stearic acid and sodium hydroxide

Appearance of the product and packaging content

Glycerin Suppositories Dr. Torrents Infants are suppositories

They are presented in containers containing 12 suppositories

Marketing authorization holder and manufacturer

Marketing authorization holder:

FLEER ESPAÑOLA S.L.

Rambla Catalunya nº 53 atico

08007, Barcelona-Spain

Manufacturer:

FLEER ESPAÑOLA S.L.

Avda. Hospital s/n

08795 Olesa de Bonesvalls (Barcelona) Spain

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

This package leaflet was approved in April 2011.

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