Leaflet: information for the user

Suppositories of Glycerin Rovi Children

Glycerol

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated 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 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 worsen or do not improve after 7 days.

The active ingredient, glycerol, is a laxative administered rectally. The laxative effect is achieved by glycerol's ability to soften stool, combined with a mild local irritating action, which stimulates intestinal movements.

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

Consult a doctor if symptoms worsen or do not improve after 7 days.

Do not use Rovi Glycerin Suppositories for Children

• 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 cramps, colics, nausea, vomiting or other signs of appendicitis, intestinal obstruction, acute inflammatory intestinal diseases or, in general, any abdominal pain situation without knowing the cause that produces it.
• In children under 2 years old.

Warnings and precautions

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

In case of blood in stool, irritation, pain or no improvement, you must interrupt the treatment and consult your doctor.

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

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

Children

This medication is contraindicated in children under 2 years old.

Other medications and Rovi Glycerin Suppositories for Children

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

Due to the type of medication involved and its administration route, it does not affect the use of other medications.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might 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 your ability to drive and/or operate machines.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is 1 suppository per day, as needed, or according to your doctor's prescription.

Administration Method

After removing the suppository from the blister, insert the suppository deeply into the rectum. Strain as much as possible to allow the medication to take effect.

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 Rovi Glycerin Suppositories for Children than you should

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

Prolonged and excessive 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).

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

During the period of use of glycerol rectally as a laxative, the following adverse effects have been observed, whose frequency has not been established with precision: irritation, pain, and itching or stinging sensation in the anus.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if

it is about possible adverse effects not listed in this prospectus. You can also

report them directly through the Spanish System of Pharmacovigilance of Medicines 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.

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.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection 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 Rovi Glycerin Suppositories for Children

• The active ingredient is1,375 gof glycerol per suppository.
• The other components (excipients) are: sodium stearate and sodium carbonate.

Appearance of the product and content of the packaging

Rovi Glycerin Suppositories for Children are presented in packaging containing 12 suppositories.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

JNTL Consumer Health (Spain), S.L.

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

28033-Madrid

Spain

Responsible for manufacturing:

FARMEA

10 rue Bouché Thomas

ZAC d’Orgemont

49000 Angers

France

Date of the last review of this leaflet:September 2023

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