Kanova Adultos 6.75 g rectal solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Kanova adults 6.75 g rectal solution
Glycerol
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for administering this medicine provided in this leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet, as you may need to refer to it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days of treatment.
Contents of this leaflet
- What Kanova adults is and what it is used for
- What you need to know before using Kanova adults
- How to use Kanova adults
- Possible side effects
- How to store Kanova adults
- Contents of the pack and other information
1. What Kanova adults is and what it is used for
Glycerol, the active substance in this medicine, is a laxative administered by rectal route. The laxative effect is achieved due to glycerol's ability to soften stools, which, together with a mild local irritant action, stimulates intestinal movements.
It is indicated for the local symptomatic relief of transient and occasional constipation in adults and adolescents aged 12 years and older.
You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.
2. What you need to know before using Kanova adults
Do not use Kanova adults
- If you are allergic (hypersensitive) to glycerol or to any of the other components of this medicine (listed in section 6).
- If you have any anorectal disease, hemorrhagic rectocolitis (a type of chronic intestinal inflammation), or inflamed hemorrhoids.
- If you have cramps, colic, nausea, vomiting, or other signs of appendicitis, intestinal obstruction, acute inflammatory bowel diseases, or, in general, any abdominal pain of unknown cause.
- In children under 12 years of age.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Kanova adults.
- If you notice blood in the stool, irritation, pain, or do not experience improvement, you must stop treatment and consult your doctor.
- Do not use this medicine for more than 7 consecutive days unless otherwise directed by your doctor.
- This medicine should be used only under strict medical supervision in patients with serious illnesses, especially cardiovascular diseases (related to the heart or blood vessels).
Children and adolescents
Kanova adults is contraindicated in children under 12 years of age.
Use of Kanova adults with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Use of Kanova adults with food and drink
Food and drink do not affect the effectiveness of this medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
The use of this medicine does not affect the ability to drive or operate machinery.
3. How to use Kanova adults
Follow exactly the instructions for administering the medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults and adolescents aged 12 years and older: 1 unit-dose container per day, as needed, or as prescribed by the physician.
This medicine is for rectal use only; do not swallow it.
Instructions for correct administration:
At the time chosen for administration, after removing the cap covering the end of the cannula-shaped container, place it vertically with the tip facing upwards and gently squeeze it so that a few drops of Kanova adults moisten the tip of the cannula, to facilitate its insertion into the rectum. Once inserted into the rectum, press the container until its entire contents have been emptied, then gently withdraw it while continuing to apply pressure on its walls.
Delay evacuation, keeping the buttocks tightly clenched, for as long as possible to allow the medicine to exert its full effect.
Even if some residue remains in the container after administration, the indicated dose has been properly delivered. Each single-dose container can only be used once. It must be discarded after use.
If resistance is encountered during administration, stop the procedure, as it could be harmful, and consult your doctor.
If symptoms do not improve within 7 days, discontinue 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
Cases of intoxication are unlikely due to the route of administration.
Abuse or prolonged use of this medicine may 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 immediately at 91 562 04 20, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone 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 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 causing difficulty in swallowing or breathing.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and their containers. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Kanova adults
- The active substance is glycerol. Each single-dose container 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 of the product and contents of the pack
It is a clear, yellowish solution. It is supplied in single-dose containers of 7.5 ml made of polyethylene, with a cannula-shaped tip and closure cap, packed in cartons containing 6 or 12 single-dose containers. A clinical pack containing 200 single-dose containers is also available.
Only certain pack sizes may be marketed.
Other presentations
Kanova children 2.25 g rectal solution: Supplied in cartons with 6 or 12 single-dose containers and clinical packs with 200 single-dose containers.
Marketing Authorization Holder and Manufacturer
LAINCO, S.A. Avda. Bizet, 8-12 08191 Rubí (Barcelona)
Date of the most recent review of this leaflet: June 2010
Other sources of information
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)