PROSPECTO: INFORMATION FOR THE USER

Canephron Coated Tablets

Lesser Centaury, Levisticum and Rosemary

Traditional medication based on plants used as an adjunct in the relief of symptoms associated with minor lower urinary tract infections and to increase urine elimination and facilitate the elimination of sand, based exclusively on its traditional use.

Consult a doctor if it worsens or does not improve after 4 days.

Do not take Canephron

• If you are allergic to centaury, lemongrass, rosemary, or any of the other components of this medication (listed in section 6).
• If you have been advised to reduce your fluid intake (such as in the case of heart or kidney disease).
• If you have an active peptic ulcer.
• If you have nephritis or any other disease that reduces kidney function.
• In case of edema due to reduced kidney or cardiac function.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Canephron

• If urinary tract discomfort worsens or during use of the product symptoms such as fever, dysuria, spasms, or hematuria appear, you should consult your doctor immediately.

Children and adolescents

Children and adolescents under 18 years should not use this medication.

Warning for diabetic patients

One tablet of this medication contains approximately 0.020 units of carbohydrate exchange units (CEU).

Other medications and Canephron

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications.

Taking Canephron with food and drinks

Foods and drinks have no influence on the effect of the medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

No adequate and well-controlled studies have been conducted in pregnant women or in breastfeeding women with this medication, so its administration is not recommended in these cases.

Driving and operating machines

No effects have been registered on the ability to drive and operate machines.

Canephron contains lactose monohydrate, glucose syrup, and saccharose

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults: Take 2 coated tablets, three times a day.

This medication is administered orally.

The recommended treatment period is 2 weeks, however, if symptoms do not improve after 4 days of treatment, consult your doctor if you should continue with the same.

It is recommended to take the tablets whole, without chewing, with a glass of water or other liquid. (See section “Possible adverse effects”).

Drinking more than 1 liter of water favors treatment.

Use in children and adolescents

Do not use in children and adolescents under 18 years old.

Consult your doctor or pharmacist if you consider that the effects of Canephron are too strong or too weak.

If you take more Canephron than you should

No cases of overdose with Canephron have been reported.

In case of overdose or accidental ingestion, consult your pharmacist or doctor immediately or call the Toxicological Information Service, phone 91.562.04.20, indicating the product and the amount ingested.

If you forgot to take Canephron

Do not take a double dose to compensate for the missed doses.

Like all medications, Canephron may produce adverse effects, although not all people will experience them.

Very rare cases of gastrointestinal discomfort such as nausea, vomiting, and diarrhea (may affect up to 1 in 10,000 people) have been reported.

In very rare cases (may affect up to 1 in 10,000 people), some allergic reactions (for example, itching, rash, and urticaria) have been described.

If you experience the first signs of an allergic reaction, do not continue taking Canephron.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Do not store at a temperature above 86°F (30°C).

Expiration Date

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Canephron:

The active principles are: 18 mg of dried aerial parts of Lesser Centaury (Centaurium erythraeaRafn); 18 mg of dried rhizomes of Lovage (Levisticum officinaleKoch); 18 mg of dried leaves of Rosemary (Rosmarinus officinalisL.).

The other components (excipients) are: lactose monohydrate (45 mg), glucose syrup (1,086 mg), sucrose (60,431 mg), calcium carbonate, magnesium stearate, cornstarch, dextrin, glycomontan wax, virgin castor oil, povidone (25, 30), shellac lacquer, silicon dioxide, talc, iron(III) oxide (E 172), riboflavin (E 101), titanium dioxide (E 171).

Appearance of the product and contents of the packaging

Orange-colored tablets. Packaging with 60, 120, and 200 coated tablets.

Holder of the marketing authorization and Responsible for manufacturing

BIONORICA SE

Kerschensteinerstrasse 11-15

92318 Neumarkt

Germany

Phone +49 / 9181 / 231-90

Fax +49 / 9181 / 231-265

This leaflet was approved in: October 2011

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/