Oligosol Magnesium Ampoules – 28 Ampoules

Oligosol Magnesium is a targeted solution for adults and adolescents experiencing neurovegetative dystonia and spasmophilia, conditions often characterized by involuntary muscle contractions and nervous tension. This medication is designed to act as a terrain modifier, helping to regulate and balance the body's systems.

Key Features of Oligosol Magnesium

• Relieves Muscle Spasms: Addresses involuntary muscle contractions and nervous system imbalances.
• Sublingual Absorption: Efficiently absorbed under the tongue for faster results.
• Convenient Format: Comes in easy-to-use ampoules for precise dosing.

Active Ingredients

Each 2 ml ampoule contains:

• Magnesium Gluconate: 17.781 mg
• Supplemented with anhydrous glucose and purified water.

Dosage and Administration

• Recommended Dosage: 1 to 3 ampoules per day, as needed.
• Sublingual Use: Hold the liquid under your tongue for 1 to 2 minutes before swallowing.
• Timing: Best taken in the morning on an empty stomach, 15 minutes before a meal, or at bedtime.

Who Can Use This Product?

• For Adults and Adolescents: Suitable for individuals aged 15 years and older.
• Pregnant and Breastfeeding Women: Use only under medical advice.

Warnings and Precautions

• Do not use if you have galactosemia or glucose malabsorption syndrome.
• Avoid if allergic to any of the components.
• Consult a healthcare professional before use during pregnancy or breastfeeding.
• Keep out of reach of children.

Storage Instructions

• Store below 25°C.
• Protect from light and moisture.

Packaging

• Each box contains 28 ampoules of 2 ml.

Alternative Recommendation

For more severe involuntary muscle contractions, Oligosol Manganese Cobalt Ampoules may be a better option.

Oligosol Magnesium Ampoules provide a convenient and effective way to manage muscle spasms and neurovegetative imbalances, helping you feel more relaxed and in control.

Please read the following full disclosure before purchasing or using this product.

PRODUCT CHARACTERISTICS SUMMARY

ANSM - Updated on: 08/01/2023

1. NAME OF THE MEDICINAL PRODUCT

MAGNESIUM OLIGOSOL, oral solution in ampoules

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Magnesium gluconate ........................................................................................................... 1.781 mg
(Corresponding amount of magnesium ............................................................................... 0.1044 mg)

Per 2 ml ampoule.

Excipient with known effect: Glucose.

For the complete list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral solution in ampoules.

4. CLINICAL DATA

4.1. Therapeutic Indications

Used as a terrain modifier, particularly in cases of neurovegetative dystonia and conditions grouped under the term spasmophilia.

4.2. Posology and Method of Administration

Posology
FOR ADULTS ONLY.
1 to 3 ampoules per day.

Ampoules should be taken:

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

Method of Administration
Oral route.
Sublingual administration is recommended: hold the content of the ampoule under the tongue for 1 to 2 minutes before swallowing.

4.3. Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1.

4.4. Special Warnings and Precautions for Use

This medication contains glucose. Patients with glucose-galactose malabsorption syndrome (a rare hereditary condition) should not take this medication.

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

Available data does not suggest the presence of clinically significant interactions.

4.6. Fertility, Pregnancy, and Lactation

No adverse effects are expected at these doses of magnesium during pregnancy and breastfeeding.

4.7. Effects on Ability to Drive and Use Machines

MAGNESIUM OLIGOSOL, oral solution in ampoules, has no effect on the ability to drive or operate machinery.

4.8. Undesirable Effects

Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after the medication is authorized is important. It ensures continuous monitoring of the benefit-risk ratio of the drug. Healthcare professionals should report any suspected adverse reactions through the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and Regional Pharmacovigilance Centers Network - 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

Not applicable.

5.3. Preclinical Safety Data

Not provided.

6. PHARMACEUTICAL DATA

6.1. List of Excipients

Glucose monohydrate and purified water.

6.2. Incompatibilities

Not applicable.

6.3. Shelf Life

5 years.

6.4. Special Precautions for Storage

Store below 25°C.

6.5. Nature and Content of the Outer Packaging

2 ml ampoule with two self-breaking tips made of colorless glass (Type I). Pack sizes: 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 307 516 8 8: 2 ml ampoule (colorless glass), box of 14.
• 34009 375 468 5 0: 2 ml ampoule (colorless glass), box of 28.

9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION

[To be completed by the authorization holder]

10. DATE OF TEXT REVISION

[To be completed by the authorization holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

CONDITIONS FOR PRESCRIPTION AND DISPENSING

Medication not subject to medical prescription.