Leaflet

Qualitative and quantitative composition:

An ovule contains: Semi-synthetic glycerides– 1587 mg; lanolin – 50 mg; Aloe vera oil – 60 mg; Calendula extract – 60 mg; Silicon dioxide – 25 mg; vitamin E – 10 mg; sodium hyaluronate – 5 mg; xylitol – 3 mg

Aspect of the device:

Homogeneous, white or slightly yellowish ovules, without undissolved particles or air bubbles. Each box contains 2 blisters with 5 ovules; the weight of an ovule is 1,8g.

What it is and what it is used for:

Halova is intended for adult women (including those in menopause) who suffer from:

Vaginal dryness
Disruption of vaginal pH and normal vaginal flora.
Dyspareunia
Dysuria
Changes in the thickness of the endometrium

Indications:

HALOVA is a medical device intended for intravaginal administration in order to promote and / or accelerate the hydration, healing, reepithelialization and/ or soothing of injured, atrophic or irritated vaginal mucosa. The ovules melt evenly on the vaginal mucosa forming a cream that contributes to restoring the normal lubrication of the vaginal mucosa and helps to maintain a normal pH and vaginal flora.

Halova is a medical device intended for use in the:

treatment of vaginal dryness caused by age or various pathologies
treatment of vaginal dryness caused by other drug treatments
relief of pain and discomfort during sexual intercourse
balancing of the vaginal flora
treatment of vaginal pH disturbances

Contraindications:

Do not use HALOVA ovules in case of hypersensitivity to any of the components of the product.

Pregnancy and breast-feeding

It is recommended to use during pregnancy under the supervision of a specialist. No precautions need to be taken when used during breast-feeding.

Effects on ability to drive and use machines

None of the components of the product affect the ability to drive or use machines.

Interactions with other products:

Interactions with other products are not known, therefore it is recommended to consult a doctor before using Halova together with other medical devices or medicines for vaginal use.

Dosage and administration:

The recommended dose is 1 ovule administered vaginally, preferably in the evening. Treatment begins on the first day after menstruation.

to prevent the occurrence of vaginal infections due to excessive hygiene or various environmental factors – 10 consecutive days, twice a year.
premenopause and menopause – one ovule a day, in the evening for the first 10 days. The action may take 1-2 months after which, depending on the individual estrogen profile, it may be necessary to repeat the therapy.
to reduce pain and discomfort during intercourse, associated with vaginal dryness, 1 ovule a day, 10 consecutive days, preferably in the evening.
to restore the vaginal pH and balance the vaginal flora, 1 ovule a day, 10 consecutive days, preferably in the evening.

Improvement may occur in the first month of treatment. It can be repeated for several months, until the healing or to consolidate and maintain the favourable effects obtained.

Special warnings and precautions for use:

Due to the composition of the product, no precautions are generally required. Sanitize your hands and intimate area well before administering the ovule.

Do not use ovules with damaged alveoli or traces of substance on the outside of the alveolus.

Do not use ovules that are uneven in appearance or that show traces of agglomerated particles.

Do not divide the ovules.

Notify the manufacturer or the competent authorities of any serious incident caused by the use of the medical device Halova.

Side effects:

Using topical products for a long time may cause local irritation and sensitization. If side effects occur, stop treatment and contact your doctor or pharmacist.

Any serious incident that occurred in relation to the medical device must be reported to the manufacturer and the competent authority of the Member State where the user and/or patient is established.

Overdose:

No cases of overdose are known. The substances contained are not systemically absorbed, the natural ones are eliminated in maximum 24 hours from the administration.

Expiration, storage and disposal:

Store at 2 – 25 ° C in the original package in order to protect from direct sunlight. The term of validity inscribed on the package refers to the product stored under the conditions provided by the manufacturer. The medical device should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medical devices that you no longer use.