Glycerol suppositories Rovi children

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Supositorios de Glicerina Rovi Niños

glycerol

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

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed 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 adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 7 days.

Contents of the leaflet

1. What Supositorios de Glicerina Rovi Niños is and what it is used for.
2. What you need to know before using Supositorios de Glicerina Rovi Niños.
3. How to use Supositorios de Glicerina Rovi Niños.
4. Possible side effects.
5. How to store Supositorios de Glicerina Rovi Niños.
6. Contents of the pack and other information.

1. What Supositorios de Glicerina Rovi Niños is and what it is used for

Glycerol, the active substance in this medicine, is a laxative administered rectally. The laxative effect is achieved due to glycerol's ability to soften stools, which, together with a mild local irritant action, stimulates intestinal movements.

It is indicated for the local symptomatic relief of transient and occasional constipation in children aged 2 to 12 years.

You should consult a doctor if symptoms worsen or do not improve after 7 days.

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

Do not use Glycerin Suppositories Rovi Children

• If you are allergic to glycerol or to any of the other ingredients of this medicine (listed in section 6).
• If you suffer from any anorectal disease, hemorrhagic rectocolitis (a type of chronic intestinal inflammation), or inflamed hemorrhoids. If you have cramps, colic, nausea, vomiting, or other signs of appendicitis, intestinal obstruction, acute inflammatory bowel diseases, or in general, any condition of abdominal pain of unknown cause.
• In children under 2 years of age.

Warnings and precautions

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

If you notice blood in the stool, irritation, pain, or symptoms do not improve, you must stop treatment and consult your doctor.

Do not use this medicine for more than 7 consecutive days unless otherwise directed by your doctor.

This medicine should be used only under strict medical supervision in patients with serious illnesses, especially cardiovascular diseases (related to the heart or blood vessels).

Children

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

Other medicines and Glycerin Suppositories Rovi Children

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Pregnancy and breastfeeding

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

Driving and using machines

The use of this medicine does not affect the ability to drive and/or operate machinery.

3. How to use Glycerin Suppositories Rovi Children

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is 1 suppository per day, when needed, or as prescribed by the physician.

Method of administration

After removing the suppository from the blister, insert the suppository deeply into the rectum. Delay defecation as long as possible in order for the medication to exert its effect.

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

If you use more Glycerin Suppositories Rovi Children than you should

Poisoning is unlikely to occur as a result of using this medicine.

Abuse or prolonged use of this medicine may lead to a condition resembling 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 contact the Toxicology Information Service at telephone number: 91 562 04 20 (indicating the medicine and the amount ingested).

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

During the period of rectal use of glycerol as a laxative, the following adverse effects have been observed, whose frequency cannot be established precisely: anal irritation, pain, and anal burning or itching.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if
they are possible adverse effects not listed in this leaflet. You may also
report them directly through the Spanish Pharmacovigilance System for
Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Glycerin Suppositories Rovi Children

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

Do not use this medicine after the expiry date stated on the container, following “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Glycerin Suppositories Rovi Children

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

Appearance of the product and contents of the pack

Glycerin Suppositories Rovi Children are presented in packs 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 most recent review of this leaflet: September 2023

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