VITAMIN C UPSA 1000 mg Orange - 20 Effervescent Tablets

ANSM - Updated on : 06/30/2020

1. DRUG NAME

VITAMIN C UPSA EFFERVESCENT 1000 mg, effervescent tablet

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Ascorbic acid................................................................................................................ 1000 mg

For one effervescent tablet.

Notable excipients: one tablet contains 50 mg sodium benzoate (E211), orange yellow S (E110), 628.375 mg sucrose, 283 mg sodium, 2.63 mg fructose and 2.63 mg glucose

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Effervescent tablet.

4. CLINICAL DATA

4.1. therapeutic indications

Transient states of fatigue.

This presentation is reserved for adults and children over 15 years of age

4.2. Dosage and administration

Dosage

1 effervescent tablet per day.

not exceed 1 g/day.

Due to the presence of vitamin C, avoid taking at the end of the day

Method of administration

Take by mouth.

Dissolve tablet in half a glass of water.

Duration of treatment

Treatment is limited to 1 month.

4.3. Contraindications

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

Oxalocalcic renal lithiasis (urinary tract calculi) for doses above 1 g/day

4.4 Special warnings and precautions for use

Special warn

symptoms persist beyond 1 month's treatment, or if they worsen, an etiological investigation should be carried out and the course of action reassessed

Precautions for use

its slightly stimulating effect, this drug should not be taken at the end of the day

This medicine contains an azoic coloring agent (E110, orange yellow S) and may cause allergic reactions.

This medicine contains 50 mg sodium benzoate (E211) per effervescent tablet.

This medicine contains 2.63 mg fructose per effervescent tablet. The additive effect of concomitantly administered products containing fructose (or sorbitol) and the dietary intake of fructose (or sorbitol) must be taken into account.

This medicine contains 2.63 mg of glucose per effervescent tablet. Patients with glucose-galactose malabsorption syndrome (a rare hereditary disease) should not take this medicine

This medicine contains 628.375 mg sucrose per effervescent tablet. Patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases) should

This medicine contains 283 mg sodium per effervescent tablet, equivalent to 14.15% of the WHO recommended maximum daily intake of 2 g sodium per adult

Vitamin C should be used with caution in patients suffering from iron metabolism disorders, predisposed to the formation of urinary or renal lithiasis, and in subjects deficient in Glucose-6 Phosphate Dehydrogenase

4.5. Interactions with other drugs and other forms of interaction

At doses exceeding 2 g/day of vitamin C, ascorbic acid may interfere with the following biological tests: blood and urine creatinine and glucose assays (glucose oxidase dipstick)

Combinations subject to precautions for use

Deferoxamine

With high-dose IV ascorbic acid: cardiac function abnormalities, even acute cardiac failure (usually reversible on discontinuation of vitamin C)

In cases of hemochromatosis, vitamin C should be given only after deferoxamine therapy has been initiated. Monitor cardiac function when combined.

4.6. Fertility, pregnancy and breast-feeding

Pregnancy

teratogenicity studies available in animals

Clinically, a large number of pregnancies exposed to vitamin C have not shown any malformative or ftotoxic effect

Consequently, this drug should be used during pregnancy only if necessary

Breast-feeding

In the absence of data on the passage of vitamin C into breast milk, this drug should not be used during breast-feeding

Fertility

Not applicable.

4.7. Effects on ability to drive and use machines

VITAMIN C UPSA EFFERVESCENTE 1000 mg, effervescent tablet has no effect on the ability to drive and use machines.

4.8. Undesirable effects

At vitamin C doses above 1 g/day, the following may occur: digestive disorders (heartburn, diarrhoea, abdominal pain), urinary disorders (oxalic, cystinic and/or uric lithiasis)

At doses exceeding 3 g/day vitamin C, risk of hemolysis in G6PD-deficient subjects.

Dizziness, hives, rashes and chromaturia have been reported

Reporting suspected adverse reactions

It is important to report suspected adverse reactions after the drug has been authorized. It enables ongoing monitoring of the drug's risk/benefit ratio. Healthcare professionals report any suspected adverse reaction via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.

4.9. Overdose

At doses exceeding 1 g/day of vitamin C, the following may occur: digestive disorders (gastric burning, diarrhea, abdominal pain), urinary disorders (oxalic, cystinic and/or uric lithiasis)

At vitamin C doses of over 2 g/day, ascorbic acid may interfere with the following biological tests: blood and urine creatinine and glucose assays (glucose oxidase dipstick)

At doses exceeding 3 g/day of vitamin C, risk of hemolysis in G6PD-deficient subjects

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic class: VITAMIN C, non associated, ATC code: A11GA01.

(A: digestive system and metabolism)

Mechanism of action

Vitamin C is a water-soluble vitamin.

Vitamin C is also involved in various cellular oxidation-reduction reactions

5.2. Pharmacokinetic properties

Digestive absorption of vitamin C is good.

intake exceeds requirements, excess is eliminated via the urinary tract

5.3. Preclinical safety data

Not applicable.

6. PHARMACEUTICAL DATA

6.1. List of excipients

Sodium bicarbonate, citric acid anhydrous, saccharose, saccharin sodium, macrogol 6000, sodium benzoate (E211), orange flavor (including fructose, glucose and saccharose), orange yellow S (E110).

6.2 Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special storage precautions

No special storage precautions.

6.5. Nature and contents of outer packaging

Tube (polypropylene) of 10 effervescent tablets closed with a polyethylene stopper containing a desiccant (molecular sieve)

6.6. Special precautions for disposal and handling

No special requirements.

7. MARKETING AUTHORIZATION HOLDER

UPSA SAS

3, RUE JOSEPH MONIER

92500 RUEIL-MALMAISON

[Tel, fax, e-Mail: to be completed later by the holder]

8. MARKETING AUTHORIZATION NUMBER(S)

324 290.4 or 34009 324 290 4 2 : 1 tube (polypropylene) of 10 tablets

324 291.0 or 34009 324 291 0 3 : 2 tubes (polypropylene) of 10 table

324 292.7 or 34009 324 292 7 1 : 10 tubes (polypropylene) of 10 table

9. DATE OF FIRST AUTHORIZATION/AUTHORIZATION RENEWAL

to be completed later by the holder] [to be completed later by the holder] [to be completed later by the holder] [to be completed later by the holder

Date of first authorization:{ DD months YYYY}

Date of last renewal:{ DD months YYYY}

10. TEXT UPDATE DATE

[to be completed later by the holder]

{ DD Month YYYY}

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

Not subject to medical prescription.