1. NAME OF THE MEDICINAL
Granions ZINC 15 mg / 2 ml oral solution in ampoule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Zinc gluconate
Corresponding amount of zinc .............................................. ................................. 15.00 mg
For a bulb
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution.
4. CLINICAL DATA
4.1. Indications
Inflammatory acne macrocystic and / or nodular.
4.2. Dosage and method of administration
The daily dose is 2 ampoules per day - equivalent to 30 mg of zinc metal - in one take, the morning before breakfast with a glass of water. This dose of 2 ampoules per day is maintained for 3 months and then reduced to one bulb per day.
4.3. Cons-indications
This drug is cons-indicated in patients who
Hypersensitivity to any component of the solution.
4.4. Special warnings and precautions for use
Precautions:
To achieve maximum absorption, the medication will be between meals.
4.5. Interaction with other medicinal products and other forms of interaction
Do not use the association with tetracyclines because of the risk of chelation in the gut with reduced gastrointestinal absorption.
For the same reasons, we will avoid the association with the following medications:
Alkaline gastric dressings
Drugs based on calcium or iron
Due to interference in the intestinal absorption, foods high phytic acid content of the meals will be excluded following a decision (eg wholemeal bread, bean sprouts, corn kernels).
4.6. Pregnancy and lactation
Pregnancy
In acne, in Q1, given the available data, it is preferable as a precaution to avoid using Granions Zinc.
The 2nd and 3rd quarters, the use of Zinc Granions is possible, but the dosage will consider other potential zinc intake (supplements "multivitamins and trace elements" in particular).
Feeding
In acne, Zinc Granions use in nursing women is possible, but the dosage will consider other possible contributions of Zinc (supplements "multivitamins and trace elements" in particular).
To date, there have been no reports of adverse reactions in children whose mothers received doses less than or equal to 30 mg zinc element during breastfeeding.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Adverse reactions
Gastrointestinal manifestations can be observed, mainly gastric, they are mild and transient.
4.9. Overdose
The probability of acute poisoning is zero, as potential treatments salts of calcium EDTA or phytic are reported as a reminder acid.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
.The Zinc gluconate acts on the inflammatory component of acne.
5.2. Pharmacokinetic properties
Zinc gluconate is absorbed through the intestine.
Peak serum obtained between the 2nd and the 3rd hour.
Absorption is influenced by taking the drug with meals. Clinical pharmacology studies have shown that zinc is found in the skin.
Mainly fecal elimination.
5.3. Preclinical safety data
Not specified.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Amyloidosis, glycerol, glycine, purified water.
6.2. Incompatibilities
Not applicable.
6.3. Retention period
2 years
6.4. Special precautions for storage
No special storage conditions.
6.5. Nature and contents of container
Bulb (glass) 2 ml, 30 box.
6.6. Special precautions for disposal and handling
No special requirements.
7. HOLDER OF MARKETING AUTHORISATION
LABORATORY Granions
THE MERCATOR
7 RUE DE L'INDUSTRIE
98000 MONACO
MONACO
8. NUMBER (S) MARKETING AUTHORIZATION
335 247-8: 2 ml ampoule (glass), 30 box.
9. DATE OF FIRST AUTHORIZATION / RENEWAL OF AUTHORIZATION
21 July 1992 / July 21, 2007
10. DATE OF REVISION OF THE TEXT
November 15, 2010
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
Réf. : 023629