Oligosol Cobalt 28 Ampoules Migraine - Adult

Oligosol Cobalt – 28 Ampoules

Migraine Support – For Adults and Adolescents (15+)

✔️ For Whom: Adults, Adolescents (15+)
✔️ Pregnant Women: Not recommended
✔️ Breastfeeding: Not recommended
✔️ Form: Oral solution in ampoules

🌿 Purpose:

Oligosol Cobalt ampoules are used in oligotherapy as a terrain modifier, particularly to support individuals suffering from migraine conditions.

This product is suitable for adults and adolescents over 15 years old and is designed to complement overall migraine management.

💧 Active Ingredients (per 2 ml ampoule):

• Cobalt Gluconate: 0.450 mg
  • (Equivalent Cobalt: 0.059 mg)
• Excipients: Glucose, Purified water

📋 Recommended Dosage:

• Route: Oral, sublingual (under the tongue)
• Dosage: 1 to 3 ampoules per day

Administration Instructions:

• Preferably in the morning on an empty stomach
• Alternatively, 15 minutes before a meal or at bedtime
• Hold the contents under the tongue for 1 to 2 minutes before swallowing

Ampoule Opening Tip:

• The ampoules are self-breaking. Break them at the colored rings on each tip for easy opening.

⚠️ Precautions for Use:

• Allergies: Do not use if allergic to any of the ingredients.
• Consultation: Speak with your doctor or pharmacist if you are taking or planning to take other medications.
• Pregnancy & Breastfeeding: Use is not recommended during pregnancy or breastfeeding.
• This medication does not replace specific treatments prescribed by your healthcare professional.

📦 Packaging:

• Box of 28 ampoules (2 ml each)

🔄 Gentle Support for Migraine Relief:
Oligosol Cobalt offers a targeted, natural approach to migraine management as part of a holistic care plan.

For personalized advice, please consult your healthcare professional.

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

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM – Updated on: 01/08/2023

1. NAME OF THE MEDICINAL PRODUCT

COBALT OLIGOSOL, oral solution in ampoule

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

• Cobalt Gluconate: 0.450 mg
  • (Equivalent Cobalt: 0.059 mg)
• Per 2 ml ampoule

Notable excipient: Glucose (100 mg per 2 ml ampoule).

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral solution in ampoule.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications
Used as a terrain modifier, particularly in migraine conditions.

4.2 Posology and method of administration
Posology:

• Route of administration: Oral.
• Sublingual administration is recommended.
• For adults only.

Dosage:

• 1 to 3 ampoules per day.

Administration instructions:

• Preferably in the morning on an empty stomach.
• Alternatively, 15 minutes before a meal or at bedtime.
• Hold the contents under the tongue for 1 to 2 minutes before swallowing.

Method of administration: Oral route.

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 medicine contains glucose and is not recommended for patients with glucose-galactose malabsorption syndrome (a rare hereditary condition).
• Treatment with this trace mineral element does not replace specific treatments prescribed by your doctor.

4.5 Interaction with other medicinal products and other forms of interaction

• No clinically significant interactions have been reported.

4.6 Fertility, pregnancy, and lactation

• In the absence of experimental and clinical data, the use of this medicine is not recommended during pregnancy and breastfeeding.

4.7 Effects on the ability to drive and use machines

• Not applicable.

4.8 Undesirable effects

• Reporting of suspected adverse reactions:
  Reporting suspected adverse reactions after authorization is important. It allows continuous monitoring of the benefit-risk balance of the medicine.
  Healthcare professionals are encouraged to report any suspected adverse reactions via the national reporting system:
  National Agency for the Safety of Medicines and Health Products (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 provided.

5.3 Preclinical safety data

• Not provided.

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 precautions for storage

• Store at a temperature below 25°C.

6.5 Nature and contents of container

• 2 ml ampoule with two breakable tips made of colorless glass (Type I)
• Box of 14 or 28 ampoules

6.6 Special precautions for disposal and handling

• No special requirements.

7. MARKETING AUTHORISATION HOLDER

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

8. MARKETING AUTHORISATION NUMBERS

• 34009 307 513 9 8: 2 ml ampoule (colorless glass), box of 14.
• 34009 301 459 7 5: 2 ml ampoule (colorless glass), box of 28.

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

[To be completed by the Marketing Authorization Holder]

10. DATE OF REVISION OF THE TEXT

[To be completed by the Marketing Authorization Holder]

11. DOSIMETRY

• Not applicable.

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

• Not applicable.

PRESCRIPTION AND DISPENSING CONDITIONS:

• This medicine is not subject to medical prescription.

For any concerns or personalized advice, please consult your healthcare professional.