Canephron Tablet Boiron Homeopathy Uncomplicated Urinary Disorders

Canephron is a traditional medicine from the Boiron laboratory that was made from three plants. Each tablet consists of 36 mg of centaury flowered aerial powder ( Centaurium erythraea  Rafn sI), 36 mg of lovage root powder ( Levisticum officinale  Koch.) and 36 mg of rosemary leaf powder ( Rosmarinus officinalis  L.). The excipients are glucose, sucrose (sugar) and lactose.

This medicine is intended to promote urinary drainage and is particularly indicated in the case of uncomplicated urinary disorders such as a burning sensation when urinating, or a significant change in the urge to urinate . It can also be prescribed to reduce the deposit of kidney microstones .
 

Canephron Dosage

It is taken exclusively orally and is suitable for both adults and children aged at least 12 years.
The Boiron laboratory recommends taking 1 tablet, 3 times a day.
 

Precautions for use

It is not permitted to take Canephron Boiron under 12 years of age or in case of doubt as to a possible allergy to one of the components.
The same applies in the event of a gastroduodenal ulcer or edema linked to poor cardiac or renal function.

Concerning pregnancy and breastfeeding, women concerned are invited to consult a doctor's advice beforehand.

The Boiron laboratory is best known for its homeopathic medicines.

Packaging: Box of 30 film-coated tablets

Please Read the following full disclosure before purchasing or taking these tablets:

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM - Updated on: 16/07/2021

IN THIS ANNEX, THE TERMS "MARKETING AUTHORIZATION" SHALL BE UNDERSTOOD AS "TRADITIONAL HERBAL MEDICINE REGISTRATION," AND THE TERM "AUTHORIZATION" AS "REGISTRATION."

1. NAME OF THE MEDICINAL PRODUCT

CANEPHRON, film-coated tablet

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Centaury (Centaurium erythraea Rafn s.l.) (powder of the flowering aerial part) ………..36 mg

Lovage (Levisticum officinale Koch.) (root powder) ……………………………………………36 mg

Rosemary (Rosmarinus officinalis L.) (leaf powder) …………………………………………..36 mg

Per 1 film-coated tablet.

Notable excipients:

Glucose syrup 2.17 mg

Lactose monohydrate 90.00 mg

Sucrose (saccharose) 120.86 mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablet.

The film-coated tablet is orange, round, biconvex, with a smooth surface, and a diameter between 10.2 and 10.6 mm.

4. CLINICAL DATA

4.1. Therapeutic Indications

Traditional herbal medicine used as an adjunct to dietary and hygienic measures to promote diuresis:

• In cases of uncomplicated urinary disorders (such as frequent urination, burning sensation during urination, and increased urgency to urinate),
• To reduce the deposition of kidney microcalculi.

Its use is reserved for the specified indication based exclusively on long-standing use.

CANEPHRON, film-coated tablet is indicated for adults and adolescents aged 12 years and older.

4.2. Posology and Method of Administration

Dosage

Adults and adolescents aged 12 years and older:

1 film-coated tablet 3 times a day.

The available data are insufficient to recommend specific dosages in cases of renal/hepatic insufficiency.

Pediatric Population

There is insufficient data on the use of this medicine in children under 12 years of age. Urinary tract disorders in children require medical consultation (they must be diagnosed, treated, and monitored by a doctor). Therefore, CANEPHRON, film-coated tablet should not be used in children under 12 years of age.

Before using CANEPHRON, film-coated tablet in adolescents under 18 years of age, it is necessary for a doctor to rule out the possibility of a serious disease.

Method of Administration

Oral use.

One tablet 3 times a day (morning, noon, and evening).

The film-coated tablet should be swallowed whole (without chewing) and preferably taken with some liquid, such as a glass of water.

A significant amount of liquid intake is necessary during treatment.

Duration of Treatment

If symptoms persist or worsen beyond 3 days of use, a doctor should be consulted.

Patients are advised not to take this medicine for more than 2 weeks for self-medication.

The duration of use depends on the response to treatment.

4.3. Contraindications

• Hypersensitivity to the active substances, other plants of the Apiaceae family (Umbelliferae, including anise and fennel), anethole (a component of essential oils), or any of the excipients mentioned in section 6.1.
• Gastro-duodenal ulcer.
• Irrigation therapy should not be used in cases of edema due to heart or renal insufficiency and/or if a doctor has recommended reducing fluid intake.

4.4. Special Warnings and Precautions for Use

In cases of persistent fever, lower abdominal pain, spasms, blood in the urine, urinary tract disorder, or acute urinary retention, a doctor should be consulted immediately.

This medicine contains lactose monohydrate, glucose, and sucrose. Patients with fructose or galactose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomaltase deficiency, or total lactase deficiency (rare hereditary diseases) should not take this medicine.

One film-coated tablet contains approximately 0.3 g of available carbohydrates. This should be considered for people with diabetes.

Pediatric Population

There is insufficient data on the use of this medicine in children under 12 years of age. Urinary tract disorders in children require medical consultation (they must be diagnosed, treated, and monitored by a doctor). Therefore, CANEPHRON, film-coated tablet should not be used in children under 12 years of age.

A doctor must rule out the possibility of a serious disease before using CANEPHRON, film-coated tablet in adolescents under 18 years of age.

4.5. Interactions with Other Medicinal Products and Other Forms of Interaction

No known interactions with other medicines to date. No interaction studies have been conducted.

4.6. Fertility, Pregnancy, and Lactation

Pregnancy

A moderate amount of data in pregnant women (between 300 and 1000 pregnancies) has not shown any malformative or toxic effects on the fetus or newborn from CANEPHRON, film-coated tablet.

Animal studies have not shown reproductive toxicity (see section 5.3).

The prescription of CANEPHRON, film-coated tablet can be considered during pregnancy if necessary.

Lactation

It is unknown whether CANEPHRON, film-coated tablet or its active substances/metabolites are excreted in human milk. A risk to the newborn/infant cannot be excluded. CANEPHRON, film-coated tablet should not be used during breastfeeding.

Fertility

No data is available regarding the effects on human fertility. In available animal studies, no effects on male or female fertility were observed (see section 5.3).

4.7. Effects on Ability to Drive and Use Machines

The effects on the ability to drive and use machines have not been studied.

4.8. Undesirable Effects

Gastrointestinal Disorders

Common (≥ 1/100 to < 1/10): gastrointestinal disorders (e.g., nausea, vomiting, diarrhea).

Immune System Disorders

Frequency unknown: hypersensitivity reactions (rash, pruritus, facial edema).

The leaflet advises the patient to stop taking the preparation and consult a doctor immediately if these or any other side effects occur.

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after the medication is authorized is important. It allows continuous monitoring of the benefit/risk ratio of the drug. Healthcare professionals report any suspected adverse reactions via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.

4.9. Overdose

No cases of overdose have been reported.

In case of overdose, symptomatic treatment should be initiated.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Not applicable.

5.2. Pharmacokinetic Properties

No pharmacokinetic studies have been conducted.

5.3. Preclinical Safety Data

Non-clinical data from conventional safety pharmacology and repeated-dose toxicity studies have not revealed any particular risk for humans.

Genotoxicity studies in vitro (Ames test) and in vivo (micronucleus test in rats) conducted with the medicinal preparation have not revealed significant mutagenic potential.

No data is available regarding the carcinogenic potential of CANEPHRON, film-coated tablet.

In rats given a dose of up to 1400 mg/kg body weight/day, no negative effects on male or female fertility were observed. In the available embryo-fetal and pre- and post-natal development studies, no indication of teratogenic potential was observed in rats up to a dose of 1400 mg/kg body weight or in rabbits up to a dose of 1000 mg/kg body weight.

6. PHARMACEUTICAL DATA

6.1. List of Excipients

Tablet Core:

Lactose monohydrate

Magnesium stearate (Ph. Eur.) [vegetable]

Corn starch

Povidone K 25

Colloidal anhydrous silica.

Film Coating:

Calcium carbonate

Virgin castor oil

Iron oxide (III) (E172)

Dextrin (from corn starch)

Spray-dried glucose syrup

Montanglycol wax

Povidone K 30

Sucrose (saccharose)

Shellac (wax-free)

Talc

Riboflavin (E101)

Titanium dioxide (E171).

6.2. Incompatibilities

Not applicable.

6.3. Shelf Life

3 years.

6.4. Special Precautions for Storage

Store at a temperature not exceeding 30°C.

6.5. Nature and Contents of the Outer Packaging

Blister (PVC/PVDC/Aluminium).

Boxes containing 30 film-coated tablets.

Boxes containing 60 film-coated tablets.

Boxes containing 90 film-coated tablets.

Not all pack sizes may be marketed.

6.6. Special Precautions for Disposal and Handling

No special disposal requirements.

7. MARKETING AUTHORIZATION HOLDER

BIONORICA SE

Kerschensteinerstraße 11-15

92318 Neumarkt

Germany

8. MARKETING AUTHORIZATION NUMBER(S)

• 34009 302 141 3 8: 30 tablets in blisters (PVC/PVDC/Aluminium).
• 34009 302 141 4 5: 60 tablets in blisters (PVC/PVDC/Aluminium).
• 34009 302 141 5 2: 90 tablets in blisters (PVC/PVDC/Aluminium).

9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION

[to be completed later by the holder]

10. DATE OF REVISION OF THE TEXT

[to be completed later by the holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

PRESCRIPTION AND DISPENSING CONDITIONS

Medicinal product not subject to medical prescription.