Ovules for the treatment of cervical lesions, CERVIRON, 10 pcs

INSTRUCTIONS FOR USE Qualitative and Quantitative Composition One ovule contains: bismuth subgallate – 100 mg, plant collagen – 15 mg, thyme extract (Thymus vulgaris) – 10 mg, goldenseal extract (Hydrastis canadensis) – 10 mg, calendula extract (Calendula officinalis) – 10 mg, turmeric extract (Curcuma longa) – 10 mg, hexylresorcinol – 2 mg, semi-synthetic glycerides, anhydrous lanolin, colloidal silicon dioxide. Description of the Medical Device Vaginal ovules, yellow to dark yellow in color, without undissolved particles or air bubbles. Each box contains 2 blister packs with 5 ovules each. One ovule weighs 2 g. Intended Users Cerviron is intended for women (including women of menopausal age). Intended Use Cerviron is used for the treatment of: • acute and chronic atrophic, aerobic, traumatic, and infectious vulvovaginitis, • cervical erosions, • traumatic vaginal bleeding, • disturbances of vaginal pH and normal vaginal flora. Cerviron may also be used to support postoperative healing after gynecological surgery and as an adjunct during antibiotic or antifungal therapy. Indications Cerviron is a medical device intended for the treatment of acute and chronic vulvovaginitis of atrophic, aerobic, traumatic, or infectious origin; traumatic or infectious cervical erosions and associated bleeding; postoperative healing after gynecological procedures; restoration of vaginal pH and normal vaginal flora; and as an adjunct to antibiotic or antifungal therapy. Cerviron is intended to treat the following symptoms: • leukorrhea, • vaginal itching, • burning sensation in the vaginal area, • rash, • foul-smelling vaginal discharge, • dysuria, • dyspareunia, • bleeding caused by cervical erosions. Cerviron may be used as monotherapy or in combination with medicinal products intended for gynecological conditions. Contraindications Do not use Cerviron if you are hypersensitive to any of its components. Pregnancy and Breastfeeding Due to insufficient clinical data, the use of Cerviron is not recommended during pregnancy. Consultation with a specialist is advised. No special precautions are required during breastfeeding. Effects on the Ability to Drive and Use Machines None of the components affect the ability to drive or operate machinery. Interactions With Other Products No known interactions. Consult your doctor before using Cerviron together with other vaginal medical devices or medicinal products. Dosage and Method of Administration Insert one ovule into the vagina, preferably in the evening before bedtime or as recommended by your doctor. Separate one ovule by tearing along the perforated line. Gently pull apart the two layers where they are not sealed. Push from the opposite end to remove the ovule. Insert the ovule preferably while lying down. Insert deeply into the vagina. Begin using the ovules on the first day after menstruation. The duration of use is 10 or 15 days per month or as directed by your doctor. Effects may appear after the first month of treatment. Treatment may be repeated for several months until the condition is resolved, or to reinforce and maintain the achieved improvement. Special Warnings and Precautions • No specific precautions are generally required due to the composition. • Wash hands and the intimate area thoroughly before insertion. • Do not use if the blister pack is damaged or if any parts protrude. • Do not use ovules that show uniform or clustered residue on the surface. • Do not split the ovules. • Keep out of the sight and reach of children. • For vaginal use only. Do not swallow. • Avoid contact with eyes. • Do not use after the expiry date indicated on the packaging and blister pack. • Vaginal ovules may reduce the effectiveness of condoms and latex diaphragms. • Inform your doctor if you are planning a pregnancy. • Report any serious incident related to the use of Cerviron to the manufacturer or the competent authorities. Side Effects Prolonged use of local products may cause irritation or sensitivity. If any side effects occur, discontinue use and consult your doctor or pharmacist. Any serious incident related to the device should be reported to the manufacturer and the competent authority of the country in which the user is located. Overdose No overdose cases have been reported. The components are not systemically absorbed and are naturally eliminated within 24 hours. Shelf Life, Storage, and Disposal Store at 2–25 °C in the original packaging, protected from direct sunlight. The expiry date indicated on the package applies when stored according to the manufacturer’s instructions. The medical device should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medical devices you no longer use. Revision 02, Review 06 Issued: 21.01.2024