GLYCERIN SUPPOSITORIES ROVI FOR CHILDREN

Introduction

Package Leaflet: Information for the User

Glycerin Rovi Children Suppositories

glycerol

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What Glycerin Rovi Children Suppositories are and what they are used for.
2. What you need to know before starting to use Glycerin Rovi Children Suppositories.
3. How to use Glycerin Rovi Children Suppositories.
4. Possible side effects.
5. Storage of Glycerin Rovi Children Suppositories.
6. Package Contents and Additional Information.

1. What Glycerin Rovi Children Suppositories 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 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 children from 2 to 12 years old.

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

2. What you need to know before starting to use Glycerin Rovi Children Suppositories

Do not use Glycerin Rovi Children Suppositories

• If you are allergic to glycerol or any of the other components of this medication (listed in section 6).
• If you have any type of anorectal disease, hemorrhagic rectocolitis (a type of chronic intestinal inflammation), and inflamed hemorrhoids. If you have 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 it.
• In children under 2 years of age.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medication.

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

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

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

Children

This medication is contraindicated in children under 2 years of age.

Other Medications and Glycerin Rovi Children Suppositories

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 and its route of administration, it does not affect the use of other medications.

Pregnancy and Breastfeeding

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 Glycerin Rovi Children Suppositories

Follow the administration instructions for the medication contained in this package 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, as needed, or as prescribed by the doctor.

Method of Administration

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

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

If you use more Glycerin Rovi Children Suppositories than you should

It is unlikely that intoxication will occur 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 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 cause side effects, although not everyone will experience 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: irritation, pain, and anal itching or burning.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.

Reporting Side Effects

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

5. Storage of Glycerin Rovi Children Suppositories

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

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.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. 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. Package Contents and Additional Information

Composition of Glycerin Rovi Children Suppositories

• The active ingredient is 1.375 g of glycerol per suppository.
• The other components (excipients) are: sodium stearate and sodium carbonate.

Appearance of the Product and Package Contents

Glycerin Rovi Children Suppositories are presented in packages containing 12 suppositories.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

JNTL Consumer Health (Spain), S.L.

C/ Vía de los Poblados 1, Edificio E, planta 3

28033-Madrid

Spain

Manufacturer:

FARMEA

10 rue Bouché Thomas

ZAC d’Orgemont

49000 Angers

France

Date of the Last Revision of this Package Leaflet:September 2023

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