CANEPHRON TBL N60 (URĪNCEĻU IEKAISUMU ĀRSTĒŠ.)

ATC code: G04BX01 

Active substances: Magnesium Hydroxide

Vendor, principal: Bionorica Gmbh. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

CANEPHRON 18MG/+18MG/+18MG N60

Package leaflet: Information for the user Canephron, coated tablets

Common centaury herb (Centaurium erythraea), levage root (Levisticum officinale), rosemary leaves
(Rosmarinus officinalis)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 7-14 days.

What is in this leaflet:

1.   What Canephron is and what it is used for
2.   What you need to know before you use Canephron
3.   How to use Canephron
4.   Possible side effects
5.   How to store Canephron
6.   Contents of the pack and other information

1. What Canephron is and what it is used for

Canephron is a traditional herbal medicinal product with indications based on long-standing application experience.
It is used for the supportive treatment of renal and urinary tract inflammatory diseases, and to prevent the formation of kidney stones.

2. What you need to know before you use Canephron Do not use Canephron:

-   if you are allergic to common centaury, levage root, rosemary leaves or other herbs belonging to the Apiaceae (Umbelliferae) family (e.g. anise, fennel), to anethole (constituent of essential oils of, for example, anise, fennel) or any other ingredients of this medicine (listed in section 6.1);
-   if you have acute peptic (upper part of the digestive tract) ulcer.

Warnings and precautions

Consult your doctor immediately if you have persistent fever, abdominal gas pain, blood in your urine and/or problems with urinating, and acute retention of urine.

Children

Not recommended for children under 12 years of age.

Other medicines and Canephron

There is no data on interactions with other medicines.
Tell your doctor if you are using, have recently used or might use any other medicines.

Canephron with food, drink and alcohol

No special precautions required.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy and breast-feeding
Due to lack of sufficient experience in use of this medicine during pregnancy and breast-feeding, it is not advisable to use it during pregnancy and breast-feeding.
Fertility
There are no data available about the effect on human fertility. Animal testing revealed no effects on the fertility of male and female animals.

Driving and using machines

No significant effect on ability to drive or use machines has been observed.

Canephron contains glucose, lactose and sucrose.

If you have been told by your doctor that you have an intolerance to some sugars, please consult your doctor before taking Canephron tablets.
Information for diabetics
One Canephron coated tablet contains approximately 0.020 BU (bread units).

3. How to use Canephron

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Recommended single dose for adolescents aged 12 and over and adults is 2 tablets. Daily dose is 6 tablets.
Take a single dose in the morning, lunchtime and evening.
Canephron tablets are swallowed whole, with some liquid (e.g. glass of water). An adequate amount of liquid should be drunk during the treatment.
Treatment duration is not limited, but please do read the information in Section 2 “Warnings and Precautions”.
If you feel that the effect of Canephron is too strong or too weak, consult your doctor or pharmacist.

If you take more Canephron than you should

No cases of overdose have been reported.
Symptomatic treatment should be used in case of an overdose.

If you forget to take Canephron

Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you stop taking Canephron

Discontinuation of Canephron treatment will not cause any problems.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Canephron can cause side effects, although not everybody gets them. In the evaluation of undesirable effects, the following frequency categories are used:

Very common: more than 1 patient in 10	Common: less than 1 patient in 10, but more than 1 patient in 100
Uncommon: less than 1 patient in 100, but more than in 1 patient in 1,000	Rare: less than 1 patient in 1000, but more than 1 patient in 10,000
Very rare: fewer than 1 patient in 10,000, including single cases not evaluable from the available data	Not known (frequency cannot be estimated from the available data)

Hypersensitivity/ allergic reactions and gastrointestinal problems (nausea, vomiting, diarrhoea) can occur. The frequency of these side effects is not known.
You should stop taking Canephron immediately when first signs of hypersensitivity/ allergic reaction occur.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Canephron

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
This medicinal product does not require any special storage conditions.

6. Contents of the pack and other information

What Canephron contains

Active substances:
1 coated tablet contains 18 mg common centaury powder, 18 mg lovage root powder and 18 mg rosemary leaf powder.
The excipients are:
Tablet core: lactose monohydrate, magnesium stearate (E470b), corn starch, Povidone K25, anhydrous colloidal silica.
Tablet coating: virgin castor oil, dextrin, montan glycol wax, Providone K30, sucrose (saccharose), shellac, talc (E553b), iron(III)oxide (E172), riboflavin (E101), titanium dioxide (E171), calcium carbonate, spray-dried glucose syrup, corn starch.

What Canephron looks like and contents of the pack

Orange-coloured coated tablets.
Blister pack (PVC/aluminium) contains 20 tablets.
Each pack contains 60 coated tablets or 120 coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bionorica SE
Kerschensteinerstrasse 11-15 92318 Neumarkt Germany
E-mail: [email protected]
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Miecys-Pharm OÜ Vitamiini 4 Tartu 51014 Phone +372 7380676
This leaflet was last revised in June 2015.