1. NAME OF THE MEDICINAL PRODUCT
MAGNESIUM OLIGOSOL, drinkable solution in ampoule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Magnesium gluconate ............................................................................................................... 1.781 mg (corresponding quantity of magnesium ...................................................................................... 0.1044 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 ground modifier, particularly in neuro-vegetative dystonia and conditions grouped under the term spasmophilia. 4.2. Dosage and method of administration Oral administration Sublingual administration is recommended. RESERVED FOR ADULTS. 1 to 3 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 No adverse effects are expected with these doses of magnesium during pregnancy and lactation. 4.7. Effects on ability to drive and use machines Not applicable. 4.8. Adverse reactions 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 mineral element. 5.2. Pharmacokinetic properties Not available. 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)
- 307 516-8: 2 ml in ampoule (colourless glass). Box of 14. - 375 468-5: 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.
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