KANOVA ADULTOS 6.75g RECTAL SOLUTION

Introduction

Package Leaflet: Information for the User

Kanova Adults 6.75 g Rectal 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 your symptoms worsen or do not improve after 7 days of treatment.

Contents of the Package Leaflet

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

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

Glycerol, the active ingredient 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 slight local irritating action, stimulates the movements of the intestine.

It is indicated for the local symptomatic relief of transient and occasional constipation in adults and adolescents from 12 years of age.

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

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

Do not use Kanova Adults

• 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 12 years of age.

Warnings and Precautions

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

• In case of appearance of blood in stool, irritation, pain, or if you do not notice 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 and Adolescents

Kanova Adults is contraindicated in children under 12 years of age.

Using Kanova Adults with Other Medicines

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

Using Kanova Adults 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 Adults

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:

Adults and adolescents from 12 years of age: 1 unit dose per day, when necessary, or as prescribed by your 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 Adults moisten the end of the nozzle, 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 pressing 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 single 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 damaging, and consult your doctor.

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

Use in Children

Do not administer to children under 12 years of age.

If You Use More Kanova Adults Than You Should

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

The abusive and prolonged use of this medicine may lead to an irritable bowel syndrome (symptoms or discomfort 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, allergic reactions could be severe, including: 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 contribute to providing more information on the safety of this medicine.

5. Storage of Kanova Adults

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 that appears on the packaging after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

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6. Contents of the Pack and Further Information

Composition of Kanova Adults

• The active ingredient is glycerol. Each single unit dose contains 6.75 g of glycerol.
• The other components (excipients) are: fluid extract of Malva flower, fluid extract of Matricaria chamomilla, sodium carmellose, and purified water.

Appearance and Packaging of the Product

It is a transparent and yellowish solution. It is presented in single unit doses of 7.5 ml of polyethylene with a nozzle-shaped end and a closing cap, which are packaged in boxes containing 6 or 12 single unit doses. A clinical pack of 200 single unit doses is also available.

Not all pack sizes may be marketed.

Other Presentations

Kanova Children 2.25 g Rectal Solution: Presented in boxes with 6 or 12 single unit doses and clinical packs with 200 single 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:June 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/)