NADIXA Cream 25 g

QUALITATIVE AND QUANTITATIVE COMPOSITION
 
 
 
What is the active ingredient?
 
1e cream contains 10mg Nadifloxacin.
 
Help ingredients - white soft Paraphs, light liquid paraffin, stearyl alcohol, cetyl alcohol, polyoxyethylene (5) cetyl ether, polyoxyethylene (20) cetyl ether, sodium hydroxide, glycerol, diethanolamine, disodium edetate, benzalkonium chloride, purified water.
 
 
 
 
 
PHARMACEUTICAL FORM AND Pharmacotherapeutic group

What Nadixa cream?
 
Nadifloxacin is a synthetic bactericidal quinolone with a broad spectrum of activity.
 
Nadixa Cream 1% Cream is for external use only. The tube contains 25e Cream

INDICATION

For the topical treatment of mild to moderate acne vulgaris when papules and pustules I-II degree.

CONTRAINDICATIONS

When should you not use Nadiksa cream?

Nadixa Cream should not be used in patients with hypersensitivity to nadifloxacin or any of the excipients.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

The safety and effectiveness of Nadixa cream has not been adequately studied in children under 14 years of age. So Nadixa Cream should not be used in patients in this age grupa.Tryabva to avoid contact with eyes and other mucous membranes. If Nadixa cream gets on these areas, they should be immediately flushed with water. After applying the cream to affected areas is advisable to wash your hands to avoid accidentally spreading to other areas.

In systemic use of fluoroquinolones is possible photosensitivity reaction. In research done by nadifloxacin animals and humans has not been established phototoxic and photoallergic potential active substance nadifloxacin, but using the ointment vehicle can enhance the effect of photosensitivity. There is insufficient data on the safety in use of Nadixa cream in a prolonged exposure to sunlight or artificial UV light. Therefore, patients using Nadixa cream should, avoid exposure to artificial UV light (UV lamps, couches, sunroom) and where possible to avoid exposure to direct sunlight svetlina.Ako develop a hypersensitivity reaction to general or local irritation, use of drug should be discontinued.

Nadixa Cream should not be applied to broken skin (cuts and scrapes). Insufficient data on the safety of concomitant treatment with other medicines for acne (eg, benzoyl peroxide), so Nadixa Cream should not be used alone ( monotherapy).

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Which drugs can affect the action of Nadiksa cream?

Nadifloxacin absorption through the skin is very slow and therefore less likely to interact with other systemically administered drugs. There is no evidence that the efficacy of systemically administered drugs affected by topical administration of Nadixa cream. 

Nadixa cream can cause skin irritation and therefore not desirable concomitant use of products with exfoliating effect.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES.

Neither pharmacodynamic profile or clinical experience suggests an effect on the ability to drive or operate machinery.

Intake during pregnancy and lactation

What should I keep in mind during pregnancy and lactation?

There is no experience on the use of nadifloksatsin pregnant. In experimental studies in animals have shown no adverse effects. Nevertheless Nadixa cream should be used carefully consider the doctor that the benefit is greater than the risk. Because nadifloksatsin passes into breast milk, Nadixa Cream should not be used during breastfeeding. Therefore, breast-feeding women should not take Nadixa cream on breasts and chest.

DOSAGE AND ADMINISTRATION

When and how to use Nadiksa cream?

Nadixa cream is applied to the acne area twice a day - morning and evening, in a thin layer, then carefully clean and dry the affected area. Avoid eyes and lips. To avoid infection, Nadixa cream should be applied with a cotton swab. Nadixa should not be used with occlusive dressings.

How long should apply Nadiksa cream?

The usual duration of therapy Nadixa cream is 8 weeks, but for medical reasons, this period can be extended to a maximum of 12 weeks.

Nadixa Cream should not be used in patients under 14 years.

OVERDOSE

What should you do if you used a higher dose Nadiksa cream?

Nadixa cream on the skin only, not for oral use. Excessive use will lead to more rapid or better results, but may be redness and discomfort. However Accidental ingestion should perform gastric lavage.

SIDE EFFECTS

What side effects can cause Nadiksa cream?

In some cases, can be caused skin reactions such as itching, redness, heat, or contact dermatitis. If you notice any side effects not listed in this leaflet please ask your doctor or pharmacist.

What should I take for side effects?

Depending on the local side effects Nadiksa application of cream should be discontinued until the symptoms disappear. If hypersensitivity or severe skin irritation, treatment should be stopped.

Storage Instructions

Do not use after the expiration date.

Shelf life:

See label on the packaging and the tube.

Keep out of reach of children.

How should I store Nadiksa cream?

Store at or below 25 ° C.