Oligosol Zinc – 28 Oral Ampoules (2 ml each)

Skin Conditions – Acne – Adults & Teens (15+)

For: Adults and adolescents (15 years and older)
Pregnancy: Not recommended
Breastfeeding: Not recommended
Form: Oral ampoules for sublingual use

Description

In oligotherapy, Oligosol Zinc ampoules are used as a terrain modulator, particularly in the management of skin disorders such as acne and other cutaneous conditions.
Each ampoule contains zinc gluconate (0.470 mg) as the active ingredient, along with glucose and purified water.

Zinc plays a vital role in maintaining healthy skin and supports immune and enzymatic functions. Oligosol Zinc provides a bioavailable form designed for optimal absorption through the sublingual route.

Directions for Use

• For oral sublingual use only.

• Recommended for adults and adolescents over 15 years old.

• Take 1 to 3 ampoules per day, preferably in the morning on an empty stomach.

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

• It can also be taken at bedtime or 15 minutes before a meal.

Precautions & Warnings

• Do not use during pregnancy or while breastfeeding.

• Consult your doctor or pharmacist before using any medication, especially if you have known allergies or underlying conditions.

• Do not use if allergic to any of the ingredients.

Storage

• Shelf life: 5 years

• Store below 25°C (77°F) and away from direct light.

Packaging

Box of 28 ampoules (2 ml each).

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

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM – Updated on: 01/08/2023

1. NAME OF THE MEDICINAL PRODUCT

ZINC OLIGOSOL, oral solution in ampoules

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Zinc gluconate .............................................................................................................. 0.470 mg
(Corresponding quantity of zinc ..................................................................................... 0.0674 mg)
Per 2 ml ampoule.

Excipient with known effect: glucose.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral solution in ampoules.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Used as a terrain modulator, particularly in the management of skin disorders.

4.2 Posology and method of administration

Posology

Oral route.
Sublingual administration is recommended.

For adults only.

1 to 3 ampoules per day.

Ampoules should be taken:

• Preferably in the morning on an empty stomach,

• Or 15 minutes before a meal, or 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 substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Treatment with this trace element does not replace any specific therapy that may be required.

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

4.5 Interaction with other medicinal products and other forms of interaction

Available data to date do not suggest any clinically significant interactions.

4.6 Fertility, pregnancy and lactation

In the absence of experimental and clinical data, and as a precautionary measure, the use of this medicine should be avoided during pregnancy and breastfeeding.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after marketing authorization is important. It allows continued monitoring of the benefit-risk balance of the medicinal product.
Healthcare professionals should report any suspected adverse reactions via the national reporting system:
Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centres – 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

Two-tip breakable ampoules made of type I colorless glass, 2 ml each.
Box of 14 or 28 ampoules.

6.6 Special precautions for disposal and other 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 307 524 0 1: 2 ml ampoule (colorless glass), box of 14.

• 34009 375 477 4 1: 2 ml ampoule (colorless glass), box of 28.

9. DATE OF FIRST AUTHORIZATION / RENEWAL OF THE AUTHORIZATION

[To be completed later by the marketing authorization holder]

10. DATE OF REVISION OF THE TEXT

[To be completed later by the marketing authorization holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

PRESCRIPTION AND DISPENSING CONDITIONS

Medicinal product not subject to medical prescription.