SUMMARY OF PRODUCT CHARACTERISTICS

ANSM – Last updated: August 1, 2023

1. NAME OF THE MEDICINAL PRODUCT

MANGANESE OLIGOSOL, oral solution in ampoules

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Manganese gluconate: 0.590 mg

Equivalent quantity of manganese: 0.0728 mg

Per 2 ml ampoule.

Excipient with a known effect: glucose (100 mg per 2 ml ampoule).

For the complete list of excipients, see Section 6.1.

3. PHARMACEUTICAL FORM

Oral solution in an ampoule.

4. CLINICAL PARTICULARS

4.1 Therapeutic Indications

Used as a terrain-modifying treatment, particularly during allergic conditions.

4.2 Dosage and Method of Administration

Dosage

Oral use.

Sublingual administration is recommended.

FOR ADULTS ONLY.

Take 1 to 2 ampoules daily.

The ampoules should preferably be taken:

• In the morning on an empty stomach
• Alternatively, 15 minutes before a meal or in the evening at bedtime

Hold the contents of the ampoule under the tongue for 1 to 2 minutes before swallowing.

Method of administration

Oral use.

4.3 Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in Section 6.1.

4.4 Special Warnings and Precautions for Use

This medicine contains glucose. Its use is not recommended for patients with glucose-galactose malabsorption syndrome.

Treatment with this trace mineral does not replace any specific treatment that may be required.

4.5 Interactions with Other Medicinal Products and Other Forms of Interaction

The data currently available do not suggest the existence of any clinically significant interactions.

4.6 Fertility, Pregnancy, and Breastfeeding

Due to the absence of experimental and clinical data, and as a precaution, use of this medicine should be avoided during pregnancy and breastfeeding.

4.7 Effects on the Ability to Drive and Operate Machinery

Not applicable.

4.8 Undesirable Effects

Reporting suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the medicine’s benefit-risk balance.

Healthcare professionals should report any suspected adverse reactions through the French national reporting system: the French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centers.

Website: www.signalement-sante.gouv.fr

4.9 Overdose

No cases of overdose have been reported.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic Properties

Pharmacotherapeutic class: OLIGOTHERAPY (V: Various).

Trace mineral element.

5.2 Pharmacokinetic Properties

No information available.

5.3 Preclinical Safety Data

No information available.

6. PHARMACEUTICAL PARTICULARS

6.1 List of Excipients

Anhydrous glucose, purified water.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

5 years.

6.4 Special Storage Precautions

Store below 25°C (77°F).

6.5 Nature and Contents of the Outer Packaging

A 2 ml, colorless Type I glass ampoule with two break-off tips.

Boxes of 14 or 28 ampoules.

6.6 Special Precautions for Disposal and Handling

No special requirements.

7. MARKETING AUTHORIZATION HOLDER

LABCATAL
1198 Avenue du Docteur Maurice Donat
ZAC du Font de l’Orme
06250 Mougins
France

8. MARKETING AUTHORIZATION NUMBER(S)

• 34009 307 517 4 9: 2 ml colorless glass ampoules, box of 14
• 34009 375 469 1 1: 2 ml colorless glass ampoules, box of 28

9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION

[To be completed at a later date by the marketing authorization holder.]

10. DATE OF REVISION OF THE TEXT

[To be completed at a later date by the marketing authorization holder.]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

PRESCRIPTION AND DISPENSING CONDITIONS

Medicinal product not subject to medical prescription.