1. NAME OF THE MEDICINAL PRODUCT
LITHIUM OLIGOSOL, drinkable solution in ampoule or single-dose container
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Lithium gluconate .................................................. 8.14 mg (corresponding lithium quantity ...................... 0.2796 mg) For one ampoule or single-dose container of 2 ml. Notable excipient: glucose. For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution in ampoule or single-dose container.
4. CLINICAL DATA
4.1 Therapeutic indications Used as a ground modifier, particularly during minor psychological or psychosomatic manifestations in children over 6 years of age and adults (mild sleep disorders, irritability). 4.2. Dosage and method of administration Oral administration Sublingual administration is recommended. FOR ADULTS AND CHILDREN OVER 6 YEARS OF AGE. Adult: 2 to 4 ampoules or single-dose containers per day. Children: 1 to 2 ampoules or single-dose containers per day. Ampoules or single-dose containers should be taken: Preferably in the evening at bedtime, possibly 15 minutes before a meal or in the morning on an empty stomach. Keep the contents of the ampoule or single-dose container 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 Manic-depressive psychosis and certain psychiatric conditions warrant treatment with lithium at dosages to achieve lithium levels in the range of 0.5 to 0.8 mEq/l. Lithium in trace element form has no place in this treatment. The use of this medicinal product is not recommended during pregnancy (see section 4.6). This medicinal product 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 Pregnancy In clinical practice, the administration of lithium at doses used in psychiatry has caused a malformative effect mainly affecting the heart. Consequently, the use of Lithium Oligosol is not recommended in pregnant women. Breastfeeding The use of Lithium Oligosol should be avoided during breastfeeding. 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 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 Packaging in ampoule (glass): 5 years. Packaging in single-dose containers (polyethylene): 2 years. 6.4. Special precautions for storage Packaging in ampoule (glass): Store at a temperature not exceeding 25°C. Packaging in single-dose containers (polyethylene): Store at a temperature not exceeding 30°C. 6.5. Nature and contents of outer packaging Self-closing double-ended ampoule (colourless type I glass) of 2 ml. Box of 14 or 28 ampoules. Single-dose container (polyethylene) of 2 ml. Box of 30 single-dose containers. 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)
- 375 466-2 or 34009 375 466 2 1: 2 ml in ampoule (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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