CANEPHRON

CANEPHRON Uno coated tablets

Important notes (mandatory information)

Canephron Uno coated tablets. Areas of application: for supportive treatment and to supplement specific measures for minor ailments (such as frequent urination, burning during urination and increased urge to urinate) in the context of inflammatory diseases of the urinary tract; for flushing the urinary tract to reduce the build-up of kidney gravel.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Canephron Uno coated tablets, for use in adults and adolescents aged 12 and over
Active ingredients: centaury powder, lovage root powder, rosemary leaf powder

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 3 days, contact your doctor.

What this package leaflet contains

1. WHAT IS CANEPHRON UNO AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CANEPHRON UNO?
3. HOW TO TAKE CANEPHRON UNO?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE CANEPHRON UNO?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS CANEPHRON UNO AND WHAT IS IT USED FOR?

Canephron Uno is a traditional herbal medicine for the supportive treatment and to supplement specific measures for minor ailments (such as frequent urination, burning during urination and increased urge to urinate) in the context of inflammatory diseases of the urinary tract; for flushing the urinary tract to reduce the build-up of kidney gravel. The medicine is a traditional herbal medicine that is registered exclusively on the basis of long-term use for the area of application. The user should consult a doctor or other qualified person in the healthcare profession if symptoms of the illness persist or if side effects other than those mentioned in the package leaflet occur.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CANEPHRON UNO?

Canephron Uno must not be taken:

• if you are allergic to the active ingredients, to other Apiaceae (Umbelliferae, e.g. anise, fennel), to anethole (a component of essential oils) or to any of the other ingredients of this medicine listed in section 6.
• in the case of stomach ulcers.
• in the case of oedema due to impaired heart or kidney function and/or if the doctor has recommended reduced fluid intake.

Warnings and precautions

In the case of persistent fever, pain in the lower abdomen, cramps, blood in the urine, discomfort during urination and acute urinary retention, a doctor should be consulted immediately.

Children

There are no sufficient studies on the use of this medicine in children under 12 years of age. It should therefore not be used in children under 12 years of age.

Taking Canephron Uno together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Interactions with other medicines are not known to date. Clinical studies on interactions with other medicines have not been conducted.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Use of Canephron Uno during pregnancy may be considered if deemed necessary by the doctor. It is not known whether Canephron Uno or its active ingredients/metabolites pass into breast milk. Canephron Uno should not be used during breast-feeding. There are no data on the effects on fertility in humans.

Driving and using machines

Studies on the effects of Canephron Uno on the ability to drive and use machines have not been conducted.

Canephron Uno contains the sugars glucose, sucrose and lactose

Therefore, please only take Canephron Uno after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

Diabetic note

One coated tablet contains an average of 0.3 g of available carbohydrates.

3. HOW TO TAKE CANEPHRON UNO?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

• Adults and adolescents aged 12 and over take 1 coated tablet 3 times a day.

• Children

  Canephron Uno should not be used in children under 12 years of age.
• There are no sufficient data for specific dosage recommendations in the case of impaired kidney/liver function.

Method of administration

Please take a single dose of Canephron Uno 3 times a day (morning, midday, evening). It is best to take Canephron Uno whole with a little liquid, e.g. a glass of water. Drinking plenty of fluids during the treatment phase supports the therapy.

Duration of use

If symptoms worsen or do not improve after 3 days, contact your doctor. The medicine should not be used for self-medication for longer than 2 weeks.

If you have taken more Canephron Uno than you should

If you have taken more Canephron Uno than you should, please inform a doctor. They can decide on any necessary measures. The side effects listed below may occur more frequently. No cases of overdose have been reported to date.

If you forget to take Canephron Uno

Do not take double the amount if you have forgotten to take the previous dose.

If you stop taking Canephron Uno

Stopping Canephron Uno is generally harmless.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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 complaints (nausea, vomiting, diarrhoea).

Not known (frequency cannot be estimated from the available data)

Allergic reactions.

If side effects occur, the preparation should be discontinued immediately and a doctor should be consulted. They can decide on the severity and any further measures that may be necessary.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly via the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW TO STORE CANEPHRON UNO?

Do not store above 30°C. Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the container (blister pack). The expiry date refers to the last day of the month indicated. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you have finished using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Canephron Uno contains

The active ingredients are: 1 coated tablet contains: centaury powder (Centaurium erythraea Rafin s.l., herba) 36 mg, lovage root powder (Levisticum officinale Koch, radix ) 36 mg, rosemary leaf powder (Rosmarinus officinalis L., folium) 36 mg. The other ingredients are: Tablet core: lactose monohydrate, magnesium stearate (Ph.Eur.)[vegetable], maize starch, povidone K 25, silicon dioxide (highly dispersed). Coating: calcium carbonate, native castor oil, iron(III) oxide (E12), dextrin (from maize starch), spray-dried glucose syrup, montan glycol wax, povidone K30, sucrose (saccharose), shellac (wax-free), riboflavin (E101), talc, titanium dioxide (E171).

What Canephron Uno looks like and contents of the pack

The coated tablets are orange, round, biconvex with a smooth surface. The coated tablet has a diameter of 10.2 to 10.6 mm in packs of 30, 60 and 90 coated tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

BIONORICA SE
Kerschensteinerstraße 11 - 15
92318 Neumarkt
Telephone: 09181/231-90
Telefax: 09181/231-265
E-mail: info@bionorica.de

Co-distributor

PLANTAMED Arzneimittel GmbH
Kerschensteinerstraße 11 - 15
92318 Neumarkt
Telephone: 09181/231-0
Telefax: 09181/21850

This package leaflet was last revised in April 2018.

Source: Information from the package leaflet
Status: 10/2019
Areas of application: for supportive treatment and to supplement specific measures for minor ailments (such as frequent urination, burning during urination and increased urge to urinate) in the context of inflammatory diseases of the urinary tract; for flushing the urinary tract to reduce the build-up of kidney gravel.