NOTICE
ANSM - Updated on : 16/07/2021
IN THIS APPENDIX, THE TERMS "MARKETING AUTHORIZATION" AND "AUTHORIZATION" SHALL BE UNDERSTOOD AS "TRADITIONAL HERBAL MEDICINE REGISTRATION" AND "REGISTRATION" RESPECTIVELY.
Product name
CANEPHRON, film-coated tablet
Small centaury (powder of flowering aerial part), lovage (root powder), rosemary (leaf powder)
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 3 days.
What does this leaflet contain?
1. What is CANEPHRON, film-coated tablet and what is it used for?
2. What do I need to know before taking CANEPHRON, film-coated tablet?
3. How should I take CANEPHRON, film-coated tablet?
4. What are the possible side effects?
5. How should I store CANEPHRON, film-coated tablet?
6. Package contents and other information.
1. WHAT IS CANEPHRON, film-coated tablet AND WHAT IS IT USED FOR?
CANEPHRON, film-coated tablet is a traditional herbal medicine used as an adjuvant in conjunction with dietary and hygienic measures to increase the quantity of durine in order to improve urinary elimination:
- in the case of uncomplicated urinary disorders (such as frequent urinary incontinence, burning sensation when passing urine and increased urinary incontinence),
- to reduce renal microcalculus deposits.
Its use is reserved for the specified indication based exclusively on the length of time it has been used.
CANEPHRON, film-coated tablet is indicated for adults and adolescents aged 12 and over.
Consult a physician or qualified health care practitioner if symptoms persist while taking this drug or if adverse reactions not listed in the package insert occur.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING CANEPHRON, film-coated tablet?
Never take CANEPHRON :
- if you are allergic to the active substances, to other plants belonging to the Apiaceae family (Umbelliferae family, including anise and fennel), to anethole (a component of essential oils) or to any of the other ingredients of this medicine (listed in section 6).
- if you have a peptic ulcer.
- if you suffer from edema due to cardiac or renal malfunction and/or if your doctor has advised you to limit fluid intake.
Warnings and precautions
Consult your doctor immediately in the event of persistent fever, lower abdominal pain, spasms, blood in the urine, urine emission disorders or acute urinary retention.
Children and adolescents
There are insufficient data on the use of this drug in children under 12 years of age.
Urinary tract disorders in children require medical consultation (diagnosis, treatment and monitoring by a physician). Therefore, CANEPHRON, film-coated tablet should not be used in children under 12 years of age.
Before CANEPHRON, film-coated tablet can be used in adolescents under 18 years of age, a doctor must rule out the possibility of serious illness.
Other medicines and CANEPHRON, film-coated tablet
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or may take/use any other medicines.
There are no known interactions with other drugs. Clinical studies evaluating interactions have not been conducted.
CANEPHRON, film-coated tablet with food, beverages and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
CANEPHRON may be taken during pregnancy if the treating physician considers it necessary.
It is not known whether CANEPHRON or its active substances/metabolites are excreted in breast milk. CANEPHRON should not be used during lactation.
No data on effects on human fertility are available.
Driving and use of machinery
No studies on the ability to drive vehicles and use machines have been performed.
CANEPHRON, film-coated tablet contains sugars: glucose, sucrose and lactose.
If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
A film-coated tablet contains an average of 0.3 g of available carbohydrates. This should be taken into account for patients with diabetes mellitus.
3. HOW DO I TAKE CANEPHRON, film-coated tablet?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Adults and adolescents aged 12 and over:
The recommended dose is 1 film-coated tablet 3 times daily.
Insufficient data are available to recommend specific dosages in cases of impaired kidney/liver function.
Use in children and adolescents
There are insufficient data on the use of this drug in children under 12 years of age. Urinary tract disorders in children require medical consultation (they must be diagnosed, treated and monitored by a physician). Therefore, CANEPHRON, film-coated tablet should not be used in children under 12 years of age.
Before CANEPHRON, film-coated tablet can be used in adolescents under 18 years of age, a doctor must rule out the possibility of serious illness.
Method of administration
Take a single tablet of CANEPHRON 3 times a day (morning, noon and evening).
The tablet should be swallowed whole (not chewed) and preferably taken with a small amount of liquid, e.g. a glass of water.
It is essential to drink plenty of fluids during treatment.
Duration of treatment
If symptoms persist or worsen after 3 days of use, consult a physician or qualified health care practitioner.
Do not self-medicate for more than 2 weeks.
If you have taken more CANEPHRON, film-coated tablet than you should have
If you have taken more CANEPHRON, film-coated tablet than you should have, you should tell your doctor.
Your doctor will decide what action to take. Some of the side effects listed below may be more severe.
No cases of overdosage have been reported to date.
If you forget to take CANEPHRON, film-coated tablet
Do not take a double dose to make up for the tablet you forgot to take.
If you stop taking CANEPHRON, film-coated tablet
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Common side effects (which may affect up to 1 in 10 people):
Gastrointestinal disorders (nausea, vomiting, diarrhea).
Unknown frequency (cannot be estimated on the basis of available data):
Hypersensitivity reactions (rash, pruritus, facial swelling).
If adverse reactions occur, discontinue use and consult a physician immediately. The doctor can assess the severity of the adverse reaction and decide what further action may be necessary.
If any other side effects not mentioned above occur, consult a physician or qualified health care practitioner.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO STORE CANEPHRON, film-coated tablet?
Store at a temperature not exceeding 30°C.
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box and packaging (blister). The expiration date refers to the last day of that month.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What CANEPHRON, film-coated tablet contains
- The active ingredients are :
Little knapweed(Centaurium erythraea Rafn s.l.) (powder of flowering aerial part of)........ 36 mg
Lovage(Levisticum officinale Koch.) (root powder)................................................. 36 mg
Rosemary(Rosmarinus officinalis L.) (leaf powder) ................................................... 36 mg
For 1 film-coated tablet.
- Other components are :
Tablet core: lactose monohydrate, magnesium stearate (Ph. Eur.) [plants], corn starch, povidone K 25, colloidal anhydrous silica.
Film coating: calcium carbonate, virgin castor oil, iron(III) oxide (E172), dextrin (from corn starch), spray-dried glucose syrup, montanglycol wax, povidone K 30, sucrose (sucrose), shellac (no wax), talc, riboflavin (E101), titanium dioxide (E171).
What CANEPHRON film-coated tablets are and what they contain
Film-coated tablets are orange, round and biconvex, with a smooth surface and a diameter of between 10.2 mm and 10.6 mm.
Film-coated tablets are available in boxes of 30, 60 and 90 tablets.
Not all presentations may be marketed.
Marketing authorization holder
BIONORICA SE
KERSCHENSTEINERSTRASSE 11- 15
92318 NEUMARKT
GERMANY
Marketing authorization holder
BOIRON
2 AVENUE DE LOUEST LYONNAIS
69510 MESSIMY
Manufacturer
BIONORICA SE
KERSCHENSTEINERSTRASSE 11- 15
92318 NEUMARKT
GERMANY
Product names in member states of the European Economic Area
This medicinal product is authorized in the member states of the European Economic Area under the following names: In accordance with current regulations.
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The last date on which this leaflet was revised was :
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Other
Detailed information on this drug is available on the ANSM (France) website.