CANEPHRON

CANEPHRON N Coated Tablets

Important notes (mandatory information)

Canephron N Dragees, coated tablets. Areas of application: for supportive treatment and to supplement specific measures for minor ailments in the context of inflammatory diseases of the urinary tract; for flushing the urinary tract to reduce the deposition of kidney gravel.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Canephron N Dragees, coated tablets for use in adolescents aged 12 years and over and adults
Active ingredients: centaury powder, lovage root powder, rosemary leaf powder
Traditional herbal medicinal product

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Canephron N Dragees must be used as directed in order to be effective.

• Keep the package leaflet. You may want to read it again later.
• Ask your doctor or pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after about 7 days, you must see a doctor.
• If any of the side effects listed here affect you severely or if you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.

The package leaflet contains

1. WHAT ARE CANEPHRON N DRAGEES AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CANEPHRON N DRAGEES?
3. HOW TO TAKE CANEPHRON N DRAGEES?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD CANEPHRON N DRAGEES BE STORED?
6. FURTHER INFORMATION

1. WHAT ARE CANEPHRON N DRAGEES AND WHAT ARE THEY USED FOR?

Canephron N Dragees is a traditional herbal medicinal product. Traditionally used for supportive treatment and to supplement specific measures for minor ailments in the context of inflammatory diseases of the urinary tract; for flushing the urinary tract to reduce the deposition of kidney gravel. Note: Canephron N Dragees is a traditional herbal medicinal product that is registered for the area of application exclusively on the basis of long-standing use.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CANEPHRON N DRAGEES?

Canephron N Dragees must not be taken:

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

Warnings and precautions

Please talk to your doctor or pharmacist before taking Canephron N Dragees. In case of persistent fever, cramps, blood in the urine, discomfort when urinating and acute urinary retention, a doctor must be consulted immediately.

Children

Canephron N Dragees should not be used in children under 12 years of age.

When taking Canephron N Dragees with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. Interactions with other medicines are not known to date.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Canephron N Dragees can be considered during pregnancy if the doctor deems it necessary. It is not known whether Canephron N Dragees or its active ingredients/metabolites pass into breast milk. Canephron N Dragees should not be used during breast-feeding. There are no data on the effect on fertility in humans.

Driving and using machines

No special precautions are required.

Canephron N Dragees contains the sugars glucose, sucrose and lactose

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

3. HOW TO TAKE CANEPHRON N DRAGEES?

Always take Canephron N Dragees exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: Single dose: 2 coated tablets. Total daily dose: Adolescents aged 12 years and over and adults take 2 coated tablets 3 times a day.

Method of administration

Canephron N Dragees should preferably be taken whole with some liquid. Drinking plenty of fluids supports the therapy.

Duration of use

The duration of use is in principle not limited, but please observe the information under "Special care must be taken when taking Canephron N Dragees".

Please talk to your doctor or pharmacist if you have the impression that the effect of Canephron N Dragees is too strong or too weak.

If you have taken more Canephron N Dragees than you should

If you have taken more Canephron N Dragees than you should, please inform a doctor. He/she 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 N Dragees

If you have taken too little Canephron N Dragees or have forgotten to take it, do not take twice the amount the next time, but continue taking it as prescribed by your doctor or as described in the dosage instructions.

If you stop taking Canephron N Dragees

Discontinuing Canephron N Dragees 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, Canephron N Dragees can have side effects, although not everybody gets them.

The following frequency information is used to assess side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Significant side effects or signs to watch out for, and measures to be taken if affected

Gastrointestinal complaints (nausea, vomiting, diarrhoea) can often occur. Allergic reactions may occur. The frequency is not known. If side effects occur, the preparation should be discontinued immediately and a doctor consulted. He/she can decide on the severity and any further measures that may be necessary.

Reporting of side effects

If you get 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 to 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 provide more information on the safety of this medicine.

5. HOW SHOULD CANEPHRON N DRAGEES BE STORED?

Keep out of the reach of children! Do not use the medicine after the expiry date which is stated on the container (blister pack) and the folding box with month/year. The expiry date refers to the last day of the month. Storage conditions: Do not store above 30°C.

6. FURTHER INFORMATION

What Canephron N Dragees contain

The active ingredients are: 1 coated tablet contains: centaury powder 18 mg, lovage root powder 18 mg, rosemary leaf powder 18 mg. The other ingredients are: calcium carbonate, dextrin, spray-dried glucose syrup, lactose monohydrate, magnesium stearate (vegetable), maize starch, montan glycol wax, povidone (25, 30), native castor oil, sucrose (saccharose), shellac (wax-free), highly dispersed silicon dioxide, talcum, colourings: iron(III) oxide (E172), riboflavin (E101), titanium dioxide (E171).

Diabetic note

One Canephron N Dragee contains an average of 0.2 g of available carbohydrates.

What Canephron N Dragees look like and contents of the pack

orange-coloured coated tablets in packs of 60 (N1), 120 (N2) and 200 (N3) coated tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

BIONORICA SE
Kerschensteinerstraße 11-15
92318 Neumarkt
Phone 09181 / 231-90
Fax 09181 / 231-265
Internet: www.bionorica.de
E-mail: info@bionorica.de

Co-distributor

PLANTAMED Arzneimittel GmbH
Kerschensteinerstraße 11-15
92318 Neumarkt
Phone: 09181 / 231-0
Fax: 09181 / 21850

This package leaflet was last revised in January 2017.

Source: Information from the package leaflet
Status: 01/2018
Areas of application: for supportive treatment and to supplement specific measures for minor ailments in the context of inflammatory diseases of the urinary tract; for flushing the urinary tract to reduce the deposition of kidney gravel.