Vioplex-t skin spray

The distribution of this drug over the Internet is strictly prohibited and regulated by the laws of the Republic of Serbia, while its presentation on the Internet is allowed, solely for the purpose of informing the general and professional public about its purpose and better familiarization with the basic characteristics of the drug itself.

YOU CAN VIEW THE REGULATION ON THE METHOD OF ADVERTISING MEDICINE, REGARDING MEDICINE ("Sl. Gl. RS", no. 79/2010) HERE.

Read this instruction carefully before you start using this medicine, because it contains information that is important for you.

Always use this medicine exactly as stated in this leaflet or as explained to you by your doctor or pharmacist.

- Save the instructions. You may need to read it again.

- If you have additional questions or need advice, contact your pharmacist.

- If you experience any side effects, contact your doctor or pharmacist. This includes any side effects not listed in this guide. See section 4.

- If you do not feel better or feel worse after 7 days, you must contact your doctor.

In this guide you will read:

1. What is VIOPLEX-T and what is it for?

2. What you need to know before using VIOPLEX-T

3. How to administer VIOPLEX-T

4. Possible side effects

5. How to store VIOPLEX-T

6. Contents of the package and other information

1. What is VIOPLEX-T and what is it for?

The drug VIOPLEX-T, skin spray, powder, is an antibacterial drug for local application. It contains two antibiotics (neomycin and bacitracin) and is used in the prevention of infections in superficial skin injuries such as: minor cuts, abrasions and opectoids. VIOPLEX-T is intended for adults and children over 12 years of age.

2. What you need to know before using VIOPLEX-T

The drug VIOPLEX-T, a powder in a spray, is applied locally, exclusively for external use on the skin. Warn your doctor if you are taking other medicines, have a chronic disease, a metabolic disorder, are hypersensitive to medicines or have allergic reactions to some of them.

You must not use VIOPLEX-T

If you are allergic (hypersensitive) to the active substances or any of the auxiliary substances of this medicine (listed in section 6). If you are hypersensitive to other aminoglycoside antibiotics. Due to the possible systemic resorption and consequent toxic effects of both antibiotics, the use of VIOPLEX-T on large areas of damaged skin is contraindicated.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using VIOPLEX-T. For topical, dermal use only. It is necessary to avoid applying the drug if there is a risk of increased resorption: large surfaces and/or damaged skin, on larger wounds and ulcerations, because signs of systemic toxicity (nephrotoxicity, ototoxicity) may appear (see the section "Vioplex-T should not be used apply"). Due to the possibility of resorption through the skin, the drug should be used with particular caution in patients with impaired kidney function, as there is a possibility of nephrotoxic and ototoxic effects. VIOPLEX-T should be used with caution in people prone to allergies. Application of the drug should be stopped immediately if any signs of skin irritation or signs of hypersensitivity reaction occur. Patients suffering from myasthenia gravis (an autoimmune disease characterized by muscle fatigue and weakness) and patients taking neuromuscular blocking agents should not apply this medicine to large areas of damaged skin. Excessive use of the drug VIOPLEX-T can cause the appearance of fungi. VIOPLEX-T should not be used for longer than 7 days. Do not use more than the recommended dose.

Other drugs and the drug VIOPLEX-T

Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, including medicines that can be obtained without a prescription. Due to potential nephrotoxicity and ototoxicity, the drug should be used with caution in circumstances of simultaneous administration of other nephrotoxic or ototoxic drugs such as: furosemide, vancomycin or other aminoglycosides. The drug VIOPLEX-T must not be applied to larger areas of affected skin in patients who are simultaneously taking drugs from the group of narcotics, anesthetics and/or muscle relaxants due to possible systemic absorption that can lead to worsening of neuromuscular blockade. The simultaneous use of other local preparations with VIOPLEX-T is not recommended.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. The drug VIOPLEX-T can be used during pregnancy/breastfeeding only after an individual consideration of the ratio of benefits for the mother and risks for the fetus, by the doctor.

Driving vehicles and operating machines

There are no data on the effect of VIOPLEX-T on the ability to drive and use machines.

3. How to administer VIOPLEX-T

Always use this medicine exactly as stated in this leaflet or as explained to you by your doctor or pharmacist. If you are not sure, check with your doctor or pharmacist.

The drug VIOPLEX-T is intended for adults and children over 12 years old.

The drug VIOPLEX-T is intended exclusively for external skin application.

Do not use for the treatment of large areas of the skin.

Duration of treatment depends on clinical manifestations.

Spray the affected area on the skin two to three times a day from a distance of 20-25 cm. Three consecutive sprays of three seconds each with breaks in spraying of 30 seconds are recommended. Use this medicine for a maximum of 7 days.

If there is no improvement after 7 days, the treatment should be reconsidered.

Whenever applicable, microbiological tests and an antibiogram should be performed.

Shake the spray bottle well before use. Always keep the bottle upright.

In order to remove active substances from the outlet opening on the valve, it is necessary to turn the bottle upside down after use and press the valve until clean gas starts to flow out.

After use, it is necessary to cover the valve with a protective transparent cap.

Applications in children - In small children, newborns and infants, due to the immaturity of the skin, there is a possibility of increased resorption of the drug. Also, due to the immaturity of the kidney function, it is possible to have a prolonged excretion time of the drug absorbed through the skin.

If you have used more VIOPLEX-T than you should. There are no data on side effects in case of excessive use.

If you forget to use VIOPLEX-T. Do not take a double dose to make up for a missed dose. In case you forgot to apply the medicine, immediately continue with the application as in the previous period.

If you suddenly stop using VIOPLEX-T. Continue using according to the therapy prescribed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Common side effects (may occur in up to 1 in 10 patients taking the drug):

- hypersensitivity to neomycin (can be manifested as an allergic reaction in the form of rash, swelling, itching and non-healing of the wound).

Rare side effects (may occur in up to 1 in 1000 patients taking the drug):

- muscle weakness caused by neuromuscular blockade.

Frequency not known (cannot be estimated based on available data):

- severe hypersensitivity reactions (anaphylactic and anaphylactoid reactions);

- hearing loss, deafness, damage to the vestibular system (ototoxicity);

- nephrotoxicity (proteinuria, cylindruria, azotemia);

- local irritation, swelling, itching, urticaria, contact dermatitis, inflammation resulting from a new infection in patients with an existing infection (superinfection).

Reporting adverse reactions

If you experience any unwanted reaction, you should inform your doctor or pharmacist. This includes any possible side effects that are not listed in this guide. By reporting side effects, you can help evaluate the safety of this medicine. You can report suspected adverse reactions to the Agency for Medicines and Medical Devices of Serbia (ALIMS):

Agency for Medicines and Medical Devices of Serbia

National Center for Pharmacovigilance

Vojvode Stepe 458, 11221 Belgrade

Republic of Serbia

website: www.alims.gov.rs

e-mail: nezeljene.reakcije@alims.gov.rs

5. How to store VIOPLEX-T

Keep the medicine out of the sight and reach of children.

You must not use VIOPLEX-T after the expiry date indicated on the outer packaging and bottle after "Expiry until:". The expiration date refers to the last day of the specified month.

Store at a temperature of up to 25°C, in the original packaging.

Shelf life after first opening is 6 months, at a temperature of up to 25°C.

The bottle is pressurized, filled with gas that does not damage the ozone layer.

Do not expose to sunlight or direct heat sources (radiators, heaters...).

Do not spray in the direction of an open flame.

Do not open, puncture or burn the bottle even when it is empty.

Do not open the bottle by force.

Unusable medicines are handed over to the pharmacy, which has a notice that the pharmacy collects unusable medicines from citizens. Unusable medicines must not be thrown into the sewer or together with municipal waste. These measures will help protect the environment.

6. Contents of the package and other information

What does VIOPLEX-T contain?

Active substances are: neomycin and bacitracin.

1g of skin spray, powder contains: 1338.22 ij neomycin (in the form of neomycin sulfate) i 103.80 ij bacitracin.

Auxiliary substances are: silicon dioxide, colloidal, anhydrous; propellant liquid petroleum, gas (LPG) (propane-butane mixture 80/20); n-pentane.

What VIOPLEX-T looks like and contents of the package:

Skin spray, powder, in pressurized container. is a white to almost white powder, with a characteristic smell (slight smell of propane/butane).

The inner packaging is an aluminum container with a protective varnish and a valve made of polyethylene, continuous flow, with a protective transparent cap. The container contains 121.4 g of skin spray, powder.

The outer packaging is a collapsible cardboard box containing 1 container and an instruction manual.

License holder and manufacturer

License holder:

GMG HEALTH MANAGEMENT SOLUTIONS DOO BELGRADE,

Šejkina 41 A, Belgrade - Zvezdara

Manufacturer:

MEDICAIR BIOSCIENCE LABORATORIES SA;

61 st km National Road Athinon-Lamias, Sximatari Viotias, Greece

This instruction was last approved

August, 2021.

Mode of administration of the drug:

The drug is issued without a doctor's prescription.

License number and date:

515-01-00008-19-002 from 11.08.2021.

Packaging: spray powder 1X121.4 G

Before use, study the instructions in detail. Consult your doctor or pharmacist about indications, precautions and adverse drug reactions.