Package Leaflet

Deltavagin

(Betamethasone/Tyrotrocin/Alpha-amino valerianic acid)
COMPOSITION
Each suppository contains:
Active substances:
Betamethasone 2 mg
Tyrotrocin 10 mg
Alpha-aminopentanoic acid (Norvaline) 100 mg
Excipients:
Semi-synthetic glycerides
PHARMACEUTICAL FORM AND PRESENTATION
Vaginal suppositories. Package containing 6 suppositories.
THERAPEUTIC CATEGORY
Antibiotics and corticosteroids
MARKETING AUTHORISATION HOLDER
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome
MANUFACTURING AND QUALITY CONTROL
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)
Control also performed at:
Biolab S.p.A.
Via B. Buozzi, 2 Vimodrone - Milan
THERAPEUTIC INDICATIONS
Non-specific vaginal inflammations.
CONTRAINDICATIONS
Known hypersensitivity to the components; local viral, fungal or tubercular infections.
SUITABLE PRECAUTIONS FOR USE
The product is intended for vaginal use only.
Locally applied corticosteroids may reduce skin resistance to bacteria, viruses and fungi, and may mask hypersensitivity reactions. If concomitant antibacterial treatment is inappropriate, the anti-inflammatory effect of steroids may lead to an apparent improvement in the clinical condition only. Therefore, if conditions do not promptly and effectively respond to combined treatment, therapy should be discontinued and the infection adequately treated with alternative measures.
In any case, treatment should not exceed one week, after which only the necessary component should be continued. Excessive use of the product, as in prolonged treatment of extensive areas beyond the recommended limit, may result in systemic effects due to systemic absorption (Cushing's syndrome, inhibition of the hypothalamic-pituitary-adrenal axis).
SPECIAL WARNINGS
Prolonged or repeated use of topical products may lead to sensitization or the development of bacterial or fungal infections that are not sensitive to treatment.
Pregnancy and Lactation:
During pregnancy and breastfeeding, the product should be administered only when clearly necessary and under direct medical supervision.
Effects on ability to drive and use machines
No interference is known.
INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTION
No drug interactions are known.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
One suppository every evening before bedtime, inserted deeply into the vagina. Begin treatment immediately after menstruation, repeating, if necessary, one cycle after the next menstrual period.
OVERDOSE
Use at high doses and for prolonged periods may cause symptoms of iatrogenic pseudoaldosteronism due to systemic absorption; in such cases, administration of the product should be discontinued and antialdosterone agents administered if necessary.
UNDESIRABLE EFFECTS
Local signs of hypersensitivity such as hyperaemia, oedema, pruritus and desquamation; with prolonged treatment beyond the recommended duration, skin atrophy, hypertrichosis, acneiform eruptions, capillary fragility and purpura may occur.
Excess corticosteroid effects may include asthenia, adynamia, arterial hypertension, cardiac rhythm disturbances, hypokalaemia and metabolic alkalosis.
Patients are advised to inform their physician or pharmacist of any adverse effects not described in this leaflet.
WARNING: Do not use the medicinal product after the expiry date stated on the packaging.
STORAGE CONDITIONS
Store at a temperature not exceeding 25°C.
KEEP OUT OF REACH OF CHILDREN