Oligosol Zinc Copper 28 Ampoules Menopause - PMS

Oligosol Zinc Copper – 28 Ampoules

Hormonal Balance – PMS – Puberty – Menopause

✔️ For Whom: Teenagers (12+), Adults
✔️ Pregnant Women: Not recommended
✔️ Breastfeeding: Not recommended
✔️ Form: Oral solution in ampoules

🌿 Purpose:

Oligosol Zinc Copper ampoules are designed to support physiological balance in individuals experiencing functional disorders associated with:

• Puberty
• Premenstrual Syndrome (PMS)
• Menopause

This medication helps regulate hormonal imbalances and is suitable for adolescents (12+) and adults.

💧 Active Ingredients (per 2 ml ampoule):

• Zinc Gluconate: 0.470 mg
  • (Equivalent Zinc: 0.0674 mg)
• Copper Gluconate: 0.518 mg
  • (Equivalent Copper: 0.0726 mg)
• Excipients: Glucose, Purified water

📋 Recommended Dosage:

• Route: Oral, sublingual (under the tongue)
• Dosage: 1 to 3 ampoules per day (average of 2 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:

• Break the ampoule at both ends for easy use.

⚠️ Precautions:

• Allergies: Avoid use if allergic to any of the ingredients.
• Children: Not suitable for children under 12 years old.
• Pregnancy & Breastfeeding: Use is not recommended during pregnancy or breastfeeding without prior medical consultation.
• This medication does not replace specific treatments prescribed by your doctor.

📦 Packaging:

• Box of 28 ampoules (2 ml each)

🔄 Support for Hormonal Balance:
Oligosol Zinc Copper offers gentle and effective support for managing hormonal imbalances linked to puberty, PMS, and menopause.

For any concerns or personalized advice, 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

ZINC-COPPER OLIGOSOL, oral solution in ampoule

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

• Zinc Gluconate: 0.470 mg
  • (Equivalent Zinc: 0.0674 mg)
• Copper Gluconate: 0.518 mg
  • (Equivalent Copper: 0.0726 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 functional disorders related to:

• Puberty (in children over 12 years old)
• Menopause
• Premenstrual Syndrome (PMS)

4.2 Posology and method of administration
Posology:

• Route of administration: Oral.
• Sublingual administration is recommended.
• For adults and children over 12 years old only.

Dosage:

• 1 to 3 ampoules per day (average dosage: 2 ampoules daily).

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 substances or any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

• Treatment with trace mineral elements does not replace specific treatments.
• This medicine contains glucose and is not recommended for patients with glucose-galactose malabsorption syndrome (a rare hereditary condition).

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 minerals.

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 not exceeding 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 307 525 7 9: 2 ml ampoule (colorless glass), box of 14.
• 34009 301 427 7 6: 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.