GLYCERIN SUPPOSITORIES ROVI FOR LACTATING MOTHERS

Introduction

Package Leaflet: Information for the User

Glycerin Rovi Suppositories for Infants

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 Suppositories for Infants are and what they are used for.
2. What you need to know before starting to use Glycerin Rovi Suppositories for Infants.
3. How to use Glycerin Rovi Suppositories for Infants.
4. Possible side effects.
5. Storage of Glycerin Rovi Suppositories for Infants.
6. Package contents and additional information.

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

Glycerol, the active ingredient of this medication, is a laxative administered rectally. The laxative effect is achieved by glycerol's ability to soften the stool, which, along with a mild local irritant action, stimulates intestinal movements.

It is indicated for the local symptomatic relief of transient and occasional constipation in infants and children under 2 years of age.

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 Suppositories for Infants

Do not use Glycerin Rovi Suppositories for Infants

• 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, cramps, 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 them.
• In children.

Warnings and Precautions

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

In the event of the appearance of blood in stool, irritation, pain, or no improvement, you should interrupt treatment and consult a doctor.

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

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

Other Medications and Glycerin Rovi Suppositories for Infants

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 Suppositories for Infants

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, you should discontinue treatment and consult a doctor.

If You Use More Glycerin Rovi Suppositories for Infants 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 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 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 rectally as a laxative, the following side effects have been observed, whose frequency has not been established with precision: irritation, pain, burning, or itching in the anal area.

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 Medication Surveillance System for Human Use: 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 Suppositories for Infants

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 unused medications at the SIGRE collection point in the pharmacy. In case of 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 Suppositories for Infants

• The active ingredient is 900 mg of glycerol per suppository.
• The other components (excipients) are: sodium stearate and sodium carbonate.

Appearance of the Product and Package Contents

Glycerin Rovi Suppositories for Infants 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/.