KANOVA NIÑOS 2.25g RECTAL SOLUTION

Introduction

Package Leaflet: Information for the User

Kanova Children2.25 gRectal Solution

Glycerol

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

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, 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 not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days of treatment.

Contents of the Package Leaflet

1. What is Kanova Children and what is it used for
2. What you need to know before you start using Kanova Children
3. How to use Kanova Children
4. Possible side effects
5. Storage of Kanova Children
6. Contents of the pack and further information

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

Glycerol, the active substance of this medicine, is a laxative that is administered rectally. The laxative effect is achieved by the ability of glycerol to soften the stool, which, together with a mild local irritant action, stimulates the movements of the intestine.

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

You should consult a doctor if it worsens or does not improve after 7 days of treatment.

2. What you need to know before you start using Kanova Children

Do not use Kanova Children

• If you are allergic (hypersensitive) to glycerol or any of the other components of this medicine (listed in section 6).
• If you have any anorectal disease, rectocolitis, or inflamed hemorrhoids.
• If you have colic, nausea, vomiting, or other signs of appendicitis, intestinal obstruction, acute inflammatory bowel disease, or any situation of abdominal pain without knowing the cause.
• In children under 2 years old.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Kanova Children.

• In case of appearance of blood in stool, irritation, pain, or no improvement, you should interrupt treatment and consult your doctor.
• Do not use this medicine for more than 7 consecutive days, unless your doctor indicates it.
• This medicine will only be used 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.

Using Kanova Children with other medicines

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

Using Kanova Children with food and drinks

Food and drinks do not affect the efficacy of this medicine.

Pregnancy, Breastfeeding, and Fertility

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

Driving and Using Machines

The use of this medicine does not affect your ability to drive or use machines.

3. How to use Kanova Children

Follow the instructions for administration of the medicine 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:

Children from 2 to 12 years old: 1 unit dose per day, when necessary, or as prescribed by the doctor.

This medicine is for rectal use only, do not ingest it.

Instructions for correct administration:

At the chosen time for bowel movement, and once the cap that closes the end of the unit dose is removed, place it in a vertical position with the tip upwards and press lightly so that a few drops of Kanova Children moisten the end of the unit dose, in order to facilitate its introduction into the rectum. Once introduced into the rectum, press the unit dose until it is completely empty and remove it gently without stopping pressure on its walls.

Repress the evacuation, keeping the buttocks tight, for as long as possible so that the medicine can exert its action perfectly.

Although there may be remains in the unit dose after administration, the supply of the indicated dose is ensured. Each unit dose can only be used once. It must be discarded after use.

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

If symptoms do not improve within 7 days, you should stop treatment and consult your doctor.

If you use more Kanova Children than you should

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

The abusive and prolonged use of this medicine can lead to an irritable bowel syndrome (symptoms 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 medicine and the amount ingested.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Very 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 serious and may include: swelling of the face, lips, mouth, tongue, or throat that cause difficulty swallowing or breathing.

Reporting of Side Effects:

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

5. Storage of Kanova Children

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the unit dose after CAD. The expiry date is the last day of the month indicated.

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

6. Contents of the Pack and Further Information

Composition of Kanova Children

• The active substance is glycerol. Each unit dose contains 2.25 g of glycerol.
• The other components (excipients) are: fluid extract of Malva flower, fluid extract of Matricaria chamomilla, sodium carmellose, and purified water.

Appearance of the Product and Contents of the Pack

It is a transparent and yellowish solution. It is presented in unit doses of 2.5 ml of polyethylene with a cannula-shaped end and a closing cap, which are packaged in boxes containing 6 or 12 unit doses. A clinical pack of 200 unit doses is also available.

Only some pack sizes may be marketed.

Other Presentations

Kanova Adults 6.75 g rectal solution: It is presented in boxes with 6 or 12 unit doses and clinical packs with 200 unit doses.

Marketing Authorization Holder and Manufacturer:

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

Date of the Last Revision of this Package Leaflet:July 2010

Other Sources of Information

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