CAMPHRICE DU CANADA - Stick 25 G

ANSM - Updated on : 06/22/2017

1. DRUG NAME

CAMPHRICE DU CANADA 4 PER CENT, stick for topical application.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Racemic camphor ..............................................................................................................4.0 g

Per 100 g.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Stick for local application.

4. CLINICAL DATA

4.1. therapeutic indications

Adjunctive treatment of irritant dermatitis.

4.2. Dosage and administration

Apply twice a day to cleansed skin.

4.3. Contraindications

- Children under 30 months.

- Oozing dermatitis.

- Superinfected skin.

- Do not use on mucous membranes.

Linked to the presence of terpene derivatives:

- infants under 30 months,

- children with a history of convulsions (febrile or otherwise).

4.4 Special warnings and precautions for use

Due to the presence of camphor and the risk of convulsions in children, this product should be used with caution before the age of 12. In particular, do not use over a large surface area, on mucous membranes, especially the nose, or on the lips.

Special warnings

This product contains terpene derivatives which, in excessive doses, can cause neurological accidents such as convulsions in infants and children.

Follow the dosage and use recommendations, in particular:

- do not apply to large areas of the body,

- do not apply to breasts if breast-feeding.

Precautions for use

If you have a history of epilepsy, be aware of the presence of terpene derivatives.

4.5. Interactions with other drugs and other forms of interaction

Not applicable.

4.6. Fertility, pregnancy and lactation

Breast-feeding

If you are breast-feeding, it is preferable not to use this product because of :

- no kinetic data on the passage of terpene derivatives into milk,

- their potential neurological toxicity in infants.

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

Local allergic reactions may occur.

Due to the presence of terpene derivatives and in the event of non-compliance with recommended doses:

- risk of convulsions in infants and children,

- possibility of agitation and confusion in the elderly.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after a drug has been authorized is important. It enables ongoing monitoring of the drug's risk/benefit ratio. Healthcare professionals report all suspected adverse reactions via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers - Website : www.ansm.sante.fr .

4.9. Overdose

In case of overdose, risk of neurological accident such as convulsions.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic class: CUTANEOUS PROTECTIVE, (D. Dermatology), ATC code: D02AX.

This drug contains terpene derivatives which may lower the epileptogenic threshold.

5.2. Pharmacokinetic properties

Not applicable.

5.3. Preclinical safety data

Not applicable.

6. PHARMACEUTICAL DATA

6.1. List of excipients

Thyme essential oil, terpinol, solid kerosene, petroleum jelly.

6.2 Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special storage precautions

Store at temperatures below 25°C.

6.5. Nature and contents of packaging

30 g polystyrene tube applicator, closed by a polystyrene cap with a polyethylene inner cup inner polyethylene cup.

6.6. Special precautions for disposal and handling

Any unused medication or waste must be disposed of in accordance with current regulations.

7. MARKETING AUTHORIZATION HOLDER

PHARMACIE ET LABORATOIRE DE L'HOMME DE FER

2, PLACE DE L'HOMME DE FER

67000 STRASBOURG

8. MARKETING AUTHORIZATION NUMBER(S)

- 316 103-4 : 30 g stick for local application in tube (polystyrene).

9. DATE OF FIRST AUTHORIZATION/AUTHORIZATION RENEWAL

Date of first authorization: April 22, 1996

Date of last renewal april 22, 2006.

10. TEXT UPDATE DATE

may 22, 2017

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

CONDITIONS OF PRESCRIPTION AND DELIVERY

Not subject to medical prescription.