1. NAME OF THE MEDICINE
OSTEOCYNESINE, orodispersible tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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Calcarea carbonica ostrearum 3 DH ..................................................... 0.625 mg
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Calcarea fluorica 3 DH .......................................................................... 0.625 mg
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Calcarea phosphorica 3 DH ................................................................. 0.625 mg
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Sulfur iodatum 4 CH .............................................................................. 0.625 mg
For one 250 mg orodispersible tablet.
Notable excipient: lactose. One tablet contains 246.25 mg of lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Orodispersible tablet.
4. CLINICAL DATA
4.1. Therapeutic Indications
A homeopathic medicine traditionally used for growth disorders, recovery from fractures, and calcium metabolism disorders.
4.2. Posology and Method of Administration
Posology
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Dosage: 2 tablets per day.
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Adults : Let the tablets dissolve under the tongue.
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Maximum treatment duration: 1 month.
Treatment may be renewed upon medical advice.
Method of administration
Sublingual route.
4.3. Contraindications
Hypersensitivity to active ingredients or any of the excipients listed in section 6.1.
4.4. Special Warnings and Precautions for Use
- Patients with galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption (rare hereditary diseases) should not take this medication.
- Due to the presence of Sulfur iodatum in the formula, this medication should not be used for dermatosis without medical advice.
4.5. Interactions with Other Medicines and Other Forms of Interaction
Not applicable.
4.6. Fertility, Pregnancy, and Lactation
Given the high dilutions of the strains in the Osteocynesine composition, this medicine can be used during pregnancy or breastfeeding.
4.7. Effects on Driving and Using Machines
Not applicable.
4.8. Undesirable Effects
Reporting suspected adverse reactions
Reporting suspected adverse reactions after medication authorization is important. It allows for continuous monitoring of the benefit-risk ratio of the medication. Healthcare professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the Regional Pharmacovigilance Centers network - Website: www.signalement-sante.gouv.fr.
4.9. Overdose
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Pharmacotherapeutic class: Homeopathic medicine.
In the absence of scientific data, the indication of this medicine is based on the traditional homeopathic use of its components.
5.2. Pharmacokinetic Properties
Not applicable.
5.3. Preclinical Safety Data
Not applicable.
6. PHARMACEUTICAL DATA
6.1. List of Excipients
Lactose, sodium croscarmellose, magnesium stearate.
6.2. Incompatibilities
Not applicable.
6.3. Shelf Life
5 years.
6.4. Special Precautions for Storage
Store at a temperature not exceeding 30°C.
6.5. Nature and Contents of the Outer Packaging
Orodispersible tablets in blister packs (PVC/Aluminum).
Box of 60 tablets.
6.6. Special Precautions for Disposal and Handling
No special requirements.
7. MARKETING AUTHORIZATION HOLDER
BOIRON
2 AVENUE DE L’OUEST LYONNAIS
69510 MESSIMY
FRANCE
8. MARKETING AUTHORIZATION NUMBER(S)
- 34009 301 958 1 9: blister pack (PVC/Aluminum). Box of 60 tablets. 3 blister packs of 20 tablets.
9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION
[To be completed later by the holder]
10. DATE OF TEXT REVISION
[To be completed later by the holder]
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
CONDITIONS OF PRESCRIPTION AND DISPENSING
Medicine not subject to a medical prescription.
