Package insert: information for the

patient
Canephron
coated tablets
Active ingredients: centaury powder; lovage root powder; rosemary leaf powder
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
Consult your pharmacist if you want further information or advice.
If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement, or if your symptoms worsen after 3 days.

Contents of this 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
How to store Canephron
Package contents and other information

1. What Canephron is and what it is used for

Canephron is a traditional herbal medicinal product.

for supportive treatment and as an adjunct to specific measures in the case of mild symptoms (such as frequent urination, burning sensation during urination, and increased urinary urgency) caused by inflammatory diseases of the urinary tract;
for flushing the urinary tract to help reduce the deposition of renal sand (so-called renal gravel). The use of this traditional herbal medicinal product for the indicated therapeutic indications is based exclusively on long-standing experience of use.

Consult a doctor or qualified healthcare professional if symptoms persist during use of the medicine or if adverse effects not mentioned in the package leaflet occur.

2. What you need to know before taking Canephron

Do not take Canephron

if you are allergic to the active substances, to other plants of the Apiaceae family (Umbelliferae, for example anise, fennel), to anethole (a component of essential oils), or to any of the other ingredients of this medicine (listed in section 6);
if you suffer from peptic ulcer;
in case of edema due to impaired cardiac or renal function and/or if your doctor has recommended reducing fluid intake.

Warnings and precautions
Consult your doctor immediately if you have persistent fever, lower abdominal pain, spasms, blood in the urine, urinary disorders, or acute urinary retention.

Children and adolescents
There are insufficient data on the use of this medicine in children under 12 years of age.
Urinary tract disorders in children require medical intervention (they must be diagnosed, treated, and monitored by a physician). Therefore, Canephron must not be used in children under 12 years of age.
Canephron should be used in adolescents under 18 years of age only after a physician has ruled out serious underlying conditions.

Other medicines and Canephron
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
To date, no interactions with other medicines are known. No clinical interaction studies have been conducted.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
The use of Canephron may be considered during pregnancy if deemed necessary by your treating physician.
It is not known whether Canephron or its active substances/metabolites are excreted in breast milk. Canephron must not be used during breastfeeding.
There are no data available regarding effects on human fertility.

Driving and using machines
No studies have been performed with Canephron regarding the effects on the ability to drive vehicles or operate machinery.

Canephron contains the sugars glucose, sucrose, and lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Note for diabetics:
One coated tablet contains on average 0.3 g of available carbohydrates.

3. How to take Canephron

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults and adolescents aged 12 years and older: 1 coated tablet 3 times daily.
Use in children and adolescents
There are insufficient data on the use of this medicine in children under 12 years of age. Urinary tract disorders in children require medical intervention (they must be diagnosed, treated, and monitored by a doctor).
Canephron should therefore not be used in children under 12 years of age. Canephron should be used in adolescents under 18 years of age only after a doctor has ruled out serious conditions.
There are insufficient data to provide specific dosage recommendations in cases of impaired renal or hepatic function.
Method of administration:
Take a single dose of Canephron 3 times a day (morning, midday, evening). Canephron tablets must be swallowed whole (not chewed) and it is best to take them with some liquid, for example a glass of water.
Drinking plenty of fluids during treatment supports the therapy.
If symptoms worsen or do not improve within 3 days, consult a doctor or qualified healthcare professional. This medicine should not be used for more than 2 weeks for self-medication.
If you take more Canephron than you should
If you have taken a dose of Canephron higher than you should have taken, inform your doctor.
Your doctor will decide on the necessary measures. It is possible that the side effects listed below may be more intense.
To date, cases of overdose have not been reported.
If you forget to take Canephron
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people):
Gastrointestinal disorders (nausea, vomiting, diarrhoea).
Not known (frequency cannot be estimated from the available data):
Hypersensitivity reactions (rash, pruritus, facial oedema).
If you experience any side effects, stop treatment and consult a doctor immediately. The doctor will assess the severity and decide on any necessary further steps.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Canephron

Do not store above 30 °C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and container (blister). The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Canephron contains
The active substances are:
1 coated tablet contains:
Centaurium erythraea Rafn s.l., herba (lesser centaury powder) 36 mg; Levisticum officinale
Koch., radix (lovage root powder) 36 mg; Rosmarinus officinalis L., folium (rosemary leaf powder) 36 mg.
The other components are:
Tablet core: lactose monohydrate; magnesium stearate (Ph.Eur.) [of vegetable origin]; maize starch; povidone K 25; colloidal anhydrous silica
Coating: calcium carbonate; virgin castor oil; iron(III) oxide (E172); dextrin (from maize starch); atomized glucose syrup; montan glycol wax; povidone K 30; sugar (sucrose); shellac (without wax); talc; riboflavin (E101); titanium dioxide (E171).

Description of the appearance of Canephron and package contents
The coated tablets are orange-coloured, round, biconvex, with a smooth surface. One coated tablet has a diameter of 10.2–10.6 mm, available in packs of 30, 60 and 90 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
BIONORICA SE
Kerschensteinerstraße 11-15
92318 Neumarkt
Germany
Telephone: +49(0)9181 / 231-90
Fax: +49(0)9181 / 231-265
E-mail: [email protected]

This medicinal product is authorized in the European Economic Area countries under the following names:
France Canephron
Germany Canephron Uno
Italy Canephron