Manganese-Cobalt - Oligosol Mn Co - OLIGOSOL - 28 Drinking Ampoules

1. NAME OF THE MEDICINAL PRODUCT

MANGANESE-COBALT OLIGOSOL, drinkable solution in ampoule

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Manganese gluconate ............................................................................................................... 0,590 mg (Corresponding amount of manganese ...................................................................................... 0,0728 mg) Cobalt gluconate ....................................................................................................................... 0,553 mg (Corresponding amount of cobalt .............................................................................................. 0,0726 mg) For one 2 ml ampoule. For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral solution in ampoule.

4. CLINICAL DATA

4.1 Therapeutic indications Used as a soil modifier, particularly during states of neurovegetative dystonia. 4.2. Dosage and method of administration Oral. Sublingual administration is recommended. FOR ADULTS ONLY 1 to 2 ampoules per day. The ampoules should be taken: - preferably in the morning on an empty stomach, - possibly 15 minutes before a meal or in the evening at bedtime. Keep the contents of the ampoule under the tongue for 1 to 2 minutes before swallowing. 4.3. Contraindications This medicine is contraindicated in case of hypersensitivity to any of the components of the solution. 4.4. Special warnings and precautions for use This medicine contains glucose. Its use is not recommended in patients with glucose and galactose malabsorption syndrome. 4.5. Interactions with other medicinal products and other forms of interaction The data available to date do not suggest the existence of clinically significant interactions. 4.6. Pregnancy and lactation In the absence of experimental and clinical data and as a precautionary measure, the use of this medicinal product should be avoided during pregnancy and lactation. 4.7. Effects on ability to drive and use machines Not applicable. 4.8. Undesirable effects Not applicable. 4.9. Overdose No cases of overdose have been reported.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties Pharmacotherapeutic class: OLIGOTHERAPY (V: Miscellaneous) Trace minerals. 5.2. Pharmacokinetic properties Not known. 5.3. Preclinical safety data Not stated.

6. PHARMACEUTICAL DATA

6.1. List of excipients Anhydrous glucose, purified water. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 5 years. 6.4. Special precautions for storage Store at a temperature below 25°C. 6.5. Nature and contents of outer packaging 2 ml colourless type I glass ampoule with two self-closing tips. Box of 14 or 28 ampoules. 6.6. Special precautions for disposal and handling No special requirements.

7. MARKETING AUTHORISATION HOLDER

LABCATAL 7, RUE ROGER SALENGRO BP 305 92541 MONTROUGE CEDEX

8. MARKETING AUTHORISATION NUMBER(S)

- 329 575-7: 2 ml in ampoule (colourless glass). Box of 14. - 375 473-9: 2 ml in ampoule (colourless glass). Box of 28.

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

[To be completed by the holder]

10. DATE OF UPDATE OF THE TEXT

[to be completed by the holder] 11.

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

CONDITIONS OF PRESCRIPTION AND SUPPLY

Not subject to medical prescription.