Canephron coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Canephron® Film-coated Tablets
Lesser Centaury, Lovage and Rosemary
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
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Package leaflet:
- What Canephron is and what it is used for
- What you need to know before taking Canephron
- How to take Canephron
- Possible side effects
- Storage of Canephron
- Contents of the pack and other information
1. What Canephron is and what it is used for
A traditional herbal medicinal product used as an adjunct in the relief of symptoms associated with mild disorders of the lower urinary tract and to increase urine output and facilitate the elimination of urinary sand, based exclusively on its traditional use.
You should consult a doctor if symptoms worsen or do not improve after 4 days.
2. Before taking Canephron
Do not take Canephron
- If you are allergic to centaury, lovage, rosemary, or any of the other components of this medicine (listed in section 6).
- If you have been advised to reduce your fluid intake (as in the case of heart or kidney disease).
- If you suffer from active peptic ulcer.
- If you have nephritis or any other condition that reduces kidney function.
- In case of edema due to impaired renal or cardiac function.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Canephron
- If urinary tract discomfort worsens or symptoms such as fever, dysuria, spasms, or hematuria appear during treatment, you should consult your doctor immediately.
Children and adolescents
Children and adolescents under 18 years of age must not use this medicine.
Warning for diabetic patients
One tablet of this medicine contains approximately 0.020 carbohydrate exchange units (CEU).
Other medicines and Canephron
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Taking Canephron with food and drinks
Food and drinks do not affect the medicine's action.
Pregnancy and breastfeeding
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.
There are no adequate and well-controlled studies in pregnant or breastfeeding women with this medicine; therefore, its use is not recommended in these cases.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported.
Canephron contains lactose monohydrate, glucose syrup, and sucrose
If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Canephron
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is:
Adults: Take 2 coated tablets three times daily.
This medicine is administered orally.
The recommended treatment period is 2 weeks; however, if symptoms do not improve after 4 days of treatment, consult your doctor whether to continue treatment.
It is recommended to take the tablets whole, without chewing, with a glass of water or other liquid. (See section "Possible adverse effects".)
Drinking more than 1 liter of water supports the treatment.
Use in children and adolescents
Do not use in children and adolescents under 18 years of age.
Consult your doctor or pharmacist if you think the effects of Canephron are too strong or too weak.
If you take more Canephron than you should
Cases of overdose with Canephron have not been reported.
In case of overdose or accidental ingestion, contact your pharmacist or doctor immediately or call the Toxicology Information Service at telephone number 91.562.04.20, indicating the product and the amount ingested.
If you forget to take Canephron
Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, Canephron may cause adverse effects, although not everyone will experience them.
Gastrointestinal discomfort such as nausea, vomiting and diarrhoea are very rare (may affect up to 1 in 10,000 people).
In very rare cases (may affect up to 1 in 10,000 people), some allergic reactions have been reported (e.g. itching, rash and urticaria).
If the first signs of an allergic reaction occur, do not continue taking Canephron.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor.
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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Canephron
Keep out of the sight and reach of children.
Do not store above 30°C.
Expiry date
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 should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Canephron:
The active substances are: 18 mg of dried aerial parts of Centaury (Centaurium erythraea Rafn); 18 mg of dried rhizomes of Lovage (Levisticum officinale Koch); 18 mg of dried leaves of Rosemary (Rosmarinus officinalis L.).
The other components (excipients) are: monohydrate lactose (45 mg), glucose syrup (1.086 mg), sucrose (60.431 mg), calcium carbonate, magnesium stearate, corn starch, dextrin, glycomontanate wax, virgin castor oil, povidone (25, 30), shellac lacquer, silicon dioxide, talc, iron (III) oxide (E 172), riboflavin (E 101), titanium dioxide (E 171).
Appearance of the product and pack contents
Orange-colored tablets. Pack sizes of 60, 120 and 200 film-coated tablets.
Marketing Authorization Holder and Manufacturer
BIONORICA SE
Kerschensteinerstrasse 11-15
92318 Neumarkt
Germany
Tel +49 / 9181 / 231-90
Fax +49 / 9181 / 231-265
This leaflet was last approved in: October 2011
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/