Leaflet: information for the user

Kanova children2.25 grectal solution

Glycerol

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

Follow exactly the administration instructions for 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days of treatment.

1. What Kanova children is and for what it is used

2. What you need to know before starting to use Kanova children

3. How to use Kanova children

4. Possible side effects

5. Storage of Kanova children

6. Contents of the pack and additional information

The active ingredient, glycerol, is a laxative that is administered rectally. The laxative effect is achieved by the glycerol's ability to soften the 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 of treatment.

Do not use Kanova children

-If you are allergic (hypersensitive) to glycerol or to any of the other components of this medication (including those listed in section 6).

-If you have anorectal disease, hemorrhagic rectocolitis (a type of chronic intestinal inflammation) or 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 Kanova children.

• In case of the appearance of blood in stool, irritation, pain or you do not notice improvement, interrupt the treatment and consult the 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 severe diseases, especially cardiovascular (related to the heart or blood vessels).

Children

Kanova children is contraindicated in children under 2 years old.

Use of Kanova children with other medications

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

Use of Kanova children with food and drinks

Foods and drinks do not affect the efficacy of this medication.

Pregnancy, lactation and fertility

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

Driving and use of machines

The use of this medication does not affect the ability to drive or use machines.

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

The recommended dose is:

Children aged 2 to 12 years: 1 package per day, as needed, or as prescribed by your doctor.

This medication is for rectal use, do not ingest it.

Instructions for correct administration:

At the chosen time for defecation, and once the cap that closes the end of the package in the form of a cannula has been removed, place it in a vertical position with the tip pointing upwards and press lightly so that some drops of Kanova for children moisten the end of the cannula, in order to facilitate its introduction into the rectum. Once introduced into the rectum, press the package until it is completely empty and remove it gently without stopping pressing on its walls.

Suppress the evacuation, keeping the buttocks pressed, for as long as possible so that the medication can act perfectly.

Although there may be residues left in the package after administration, the specified dose is ensured. Each single-dose package can only be used once. It must be discarded after use.

In case of finding resistance during application, you must interrupt it, as it may be harmful and damaging, and consult your doctor.

If symptoms do not improve in 7 days, discontinue treatment and consult your doctor.

If you use more Kanova for children than you should

It is unlikely that cases of intoxication will occur due to its use.

Prolonged and abusive use of this medication may lead to a syndrome of irritable colon (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 will experience them.

During the period of use of glycerol in rectal solution as a laxative, the following adverse effects have been observed with unknown frequency (cannot be estimated from available data): itching, pain, and irritation of the anus.

Rare adverse reactions (may affect up to 1 in 10,000 patients)

Allergic reactions to chamomile (e.g., contact dermatitis). In patients allergic to plants of the same family, cross-reactions may occur. After internal use, these could be severe, and may include: swelling of the face, lips, mouth, tongue, or throat that cause difficulty swallowing or breathing.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: https://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.

No special storage conditions are required.

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.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Kanova Children Composition

-The active ingredient is glycerol. Each single-dose container contains 2.25 g of glycerol.

-The other components (excipients) are: liquid extract of Malva flower, liquid extract of Matricaria chamomilla, sodium caramel, and purified water.

Appearance of the product and contents of the packaging

It is a transparent and yellowish solution. It is presented in single-dose containers of 2.5 ml of polyethylene with a cannula-shaped end and a closure cap, which are packaged in cases containing 6 or 12 single-dose containers. A clinical container of 200 single-dose containers is also available.

Only some sizes of containers may be commercially available.

Other presentations

Kanova Adults 6.75 g rectal solution: It is presented in cases with 6 or 12 single-dose containers and clinical containers with 200 single-dose containers.

Marketing Authorization Holder and Responsible Manufacturer:

LAINCO, S.A. Avda. Bizet, 8-12 08191 Rubí (Barcelona)

Last review date of this leaflet:July 2010

Other sources of information

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