Pharmafit Provence
A 313 200 000 IU/100 g Pom T/50g

Pharma Développement

A 313 200 000 IU/100 g Pom T/50g

CIP / EAN code: 3400930001479

Product information from VIDAL.

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Product information

Find indications, dosage and precautions in the sections below.

Automatic English translation of the French VIDAL document. Original numerical values and units are retained, including decimal commas.

VIDAL
Medicines
Update of the 06/10/2014

*A 313® ointment
retinol


Forms and presentations

Ointment:  Tube of 50 g.


Composition

  p 100 g
Retinol (DCI) or synthetic vitamin A, oily concentrate 
200 000 IU
Excipients: macrogol 400, macrogol 4000, polysorbate 80.

Indications

Adjunctive treatment of irritative dermatitis.

Dosage and administration

Apply locally 1 to 2 times per day.

Contraindications

  • History of hypersensitivity to one of the components.
  • Infected dermatoses.
  • Weeping dermatoses.

Warnings and precautions

The risk of hypervitaminosis A is not to be excluded in the case of prolonged application.
The systemic effects (risk of hypervitaminosis) are all the more to be feared as the topical is applied repeatedly, over a large surface, under occlusion or in a thick layer, on damaged skin (notably burned), on a mucosa, the skin of a premature infant and in the infant and young child due to the surface/weight ratio and the effect of spontaneous occlusion due to folds and diapers at the seat level.

Fertility, pregnancy and breastfeeding

Pregnancy:
  • Oral route: At high dose, the absence of epidemiological study prevents concluding on the reality of the teratogenic risk. It is therefore not recommended to exceed 5000 IU per day (recommended daily intakes).
  • Cutaneous route: The systemic passage of vitamin A from this topical form is negligible.
    There are currently not a sufficient number of exposed pregnancies to assess a possible effect of vitamin A administered by cutaneous route.

Consequently, the use of this medicine should be considered during pregnancy only if necessary, avoiding simultaneous intake of another medicine containing vitamin A.


Breastfeeding:

Do not apply on the breasts during breastfeeding due to the risk of ingestion of the product by the newborn.


Adverse effects

Possibility of local allergic reaction to one of the components.
Reporting of suspected adverse effects:

The reporting of suspected adverse effects after authorization of the medicine is important. It allows continuous monitoring of the benefit/risk ratio of the medicine. Healthcare professionals must report any suspected adverse effect via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and network of Regional Pharmacovigilance Centers. Website: www.ansm.sante.fr.


Overdose

The systemic passage has not been studied under the abnormal conditions of use described in the section Warnings and precautions.
The appearance of signs of hypervitaminosis A (nausea, headache, dizziness, dry skin, fatigue) must lead to discontinuation of treatment.

Pharmacodynamics

Cutaneous protectant (D: dermatology).


Pharmacokinetics

The systemic passage of retinol under normal conditions of use is considered negligible.


Storage conditions

Shelf life
30 months.

Store at a temperature not exceeding 25 °C.


HANDLING/ELIMINATION MODALITIES

No particular requirements.


Prescription, supply and reimbursement

MA 3400930001479 (1948/98, SmPC rev 17.08.2009).
Not reimbursed by Social Security.


PHARMA DEVELOPPEMENT SA
Chemin de Marcy. 58800 Corbigny
Tel: 03 86 20 21 64
Website:  http://www.pharmadeveloppement.com

Source: VIDAL · Updated on 10/11/2026. This information does not replace advice from a healthcare professional.