Glycerol, the active ingredient in this medicine, is a laxative, which is administered rectally. The laxative effect is achieved by the ability of glycerol to soften the stool which, together with a slight local irritant action, manages to stimulate bowel movements.

It is indicated for the symptomatic relief of temporary and occasional constipation for children between 2 and 12 years of age.

Do not use Rovi Children's Glycerin Suppositories:

• If you are allergic (hypersensitive) to glycerol or any of the other ingredients of this medicine.
• If you suffer from anorectal conditions, hemorrhagic rectocolitis (a type of chronic inflammation of the intestine) and inflamed hemorrhoids.
• If you have cramps, colic, nausea, vomiting or other signs of appendicitis, intestinal obstruction, acute inflammatory bowel diseases or, in general, any situation of abdominal pain, without knowing the cause that produces them
• In children under 2 years of age.

Take special care with Rovi Children's Glycerin Suppositories:

In case of the appearance of blood in the stool, irritation, pain or that does not improve, you should interrupt the treatment and consult a doctor.

Do not use this medicine for more than 7 days in a row, unless your doctor tells you to.

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

Use of other medications

Please inform your doctor or pharmacist if you are using or have recently used any other medicines, even those obtained without a prescription.

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

Pregnancy and breastfeeding

Check with your doctor or pharmacist before using any medicine.

Driving and using machines

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

Follow the administration instructions exactly unless your doctor has given you different instructions.

Ask your doctor or pharmacist if you have doubts.

The normal dose is:

Administer 1 suppository a day, when necessary, or according to the doctor's prescription.

Form of administration

After removing the suppository from the blister pack, insert the suppository deep into the rectum. Suppress the evacuation as much as possible so that the medicine can exert its action, so in young children it is recommended to keep the thighs together for a short time.

The medicine should not be used for more than 7 days in a row. If symptoms do not improve, you should stop treatment and consult a doctor.

If you use more Rovi Kids Glycerin Suppositories than you should:

Poisoning is not likely due to its use.

Abusive and prolonged use of this medicine can lead to 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. Telephone: 91 562 04 20 (Indicating the medicine and the amount ingested).

Like all medicines, Rovi Children Glycerin Suppositories can have side effects, although not everyone gets them.

During the period of use of Glycerol rectally as a laxative, the following adverse effects have been observed, the frequency of which has not been established with precision:

Anal irritation, stinging or itching.

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

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton, after EXP.

The expiration date is 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. Deposit the containers and medicines you do not need at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.

Composition of Rovi Children's Glycerin Suppositories

• Each suppository contains 1,140 g of glycerol as the active ingredient.
• The other ingredients (excipients) are: Stearic acid and sodium hydroxide.

What the product looks like and contents of the pack

Rovi Kids Glycerin Suppositories are presented in packs containing 15 suppositories.

Marketing authorization holder:

Johnson & Johnson SA

Walk of the Twelve Stars 5-7

28042 Madrid

Spain

Responsible for manufacturing:

ROVI PHARMA INDUSTRIAL SERVICES SA Julián Camarillo, 35

28037 Madrid

Spain

This leaflet was approved in February 2011.

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