VIPROSAL Ointment

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read the package leaflet carefully before using the medicine, because
   2. Table of Contents of the Leaflet:
2. What is Viprosal B and what is it used for
3. Important information before using Viprosal B
   1. When not to use Viprosal B
   2. When to exercise special caution when using Viprosal B
   3. Children and adolescents
   4. Using Viprosal B with other medicines
   5. Pregnancy and breastfeeding
   6. Driving and operating machinery
   7. Important information about some ingredients of Viprosal B
4. How to use Viprosal B
   1. Using Viprosal B in children and adolescents
   2. Using a higher than recommended dose of Viprosal B
   3. Missing a dose of Viprosal B
   4. Stopping the use of Viprosal B
5. Possible side effects
6. How to store Viprosal B
7. Contents of the package and other information
   1. What Viprosal B contains
   2. What Viprosal B looks like and what the package contains
   3. Marketing authorization holder and manufacturer:
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of the last update of the leaflet:

Package Leaflet: Information for the Patient

Viprosal B, ointment

Read the package leaflet carefully before using the medicine, because

it contains important information for the patient.
This medicine should always be used exactly as described in the package leaflet for the patient or
according to the doctor's or pharmacist's instructions.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Viprosal B and what is it used for
• 2. Important information before using Viprosal B
• 3. How to use Viprosal B
• 4. Possible side effects
• 5. How to store Viprosal B
• 6. Contents of the package and other information

1. What is Viprosal B and what is it used for

Viprosal B ointment is used externally as a pain reliever to alleviate neuralgic and joint pains.

2. Important information before using Viprosal B

When not to use Viprosal B

• if the patient has been diagnosed with an allergy (hypersensitivity) to the active substance or any of the other ingredients of Viprosal B,
• on ulcerated or otherwise diseased skin,
• if the patient suffers from cerebral and coronary circulation disorders,
• if the patient has a tendency to vasospasm,
• in the case of severe functional liver or kidney damage

When to exercise special caution when using Viprosal B

Viprosal B ointment should not be applied to damaged skin surfaces. To prevent strong irritation, the eyes should be protected and contact with the mucous membrane should be avoided. To avoid side effects, the skin sensitivity should be determined before using the medicine by applying a small amount of ointment to a small skin area.

Children and adolescents

Due to the lack of data on the use of the medicine in children or adolescents, it is not recommended to use the medicine in these groups.

Using Viprosal B with other medicines

The doctor should be informed about all medicines taken recently, including those available without a prescription.
No interaction studies have been conducted.

Pregnancy and breastfeeding

Before using any medicine, the doctor or pharmacist should be consulted.
There is insufficient data on the use of the active substances of Viprosal B in pregnant women. Due to the lack of data on the safety of using Viprosal B, it should not be used during pregnancy or breastfeeding.

Driving and operating machinery

Viprosal B ointment does not affect the ability to drive and operate machinery.

Important information about some ingredients of Viprosal B

Viprosal B ointment contains cetostearyl alcohol as an excipient, which has biological effects. Due to its content, the medicine may cause local skin reactions (e.g., contact dermatitis).

3. How to use Viprosal B

This medicine should always be used exactly as described in the package leaflet for the patient or
according to the doctor's or pharmacist's instructions. In case of doubts, the doctor or pharmacist should be consulted.
Depending on the size of the affected area, a small amount of Viprosal B ointment (5 to 10 cm)
is applied to the painful areas and rubbed into the skin once or twice a day, depending on the intensity of the pain, until it subsides. The duration of treatment depends on the nature and severity of the disease.
If it is felt that the ointment is working too strongly or too weakly, the doctor or pharmacist should be consulted.

Using Viprosal B in children and adolescents

Due to the lack of data on the use of the medicine in children or adolescents, it is not recommended to use the medicine in these groups.

Using a higher than recommended dose of Viprosal B

No cases of overdose have been reported. After application to the mucous membranes, the ointment causes strong irritation of the mucous membranes. In case of ingestion, the doctor should be contacted and the packaging should be kept. Vomiting should not be induced.
In the event of accidental ingestion by a child, the doctor should be contacted, who will recommend the appropriate course of action. Vomiting should not be attempted.

Missing a dose of Viprosal B

The missed dose should be applied as soon as possible and then proceed according to the prescription.
If the time for the next use is approaching, the appropriate amount of ointment should be applied and treatment continued according to the prescription.
A double dose should not be used to make up for the missed dose.

Stopping the use of Viprosal B

In case of doubts related to the use of the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common(may affect up to 1 in 10 people)
Local reactions:

• Skin inflammation
• Skin dryness
• Local skin peeling
• Redness
• Itching
• Rash
• Skin fragility (risk of mechanical damage)
• Ulcers
• Ulcera

Unknown(frequency cannot be estimated from the available data)

• In the case of skin hypersensitivity to the ingredients of the ointment, its application may cause itching, swelling, or hives. In such a case, treatment should be discontinued and the ointment washed off the skin. The symptoms described above disappear after discontinuation of treatment.

If any of the side effects occur, the doctor or pharmacist should be consulted. This also applies to side effects not listed in the leaflet.
Reporting side effects
If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail:
[email protected].
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Viprosal B

Store at a temperature below 25°C. Do not store in the refrigerator or freeze.
Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the package and other information

What Viprosal B contains

The active substances of the medicine are:
1 g of ointment contains 0.05 IU of viper venom, 30 mg of racemic camphor (Camphora racemica), 30 mg of turpentine oil from maritime pine (Terebinthini aetheroleum), 10 mg of salicylic acid (Acidum salicylicum).
The excipients are: white petrolatum, cetostearyl alcohol, solid paraffin, sodium cetostearyl sulfate, glycerol, sodium chloride, purified water.

What Viprosal B looks like and what the package contains

White or slightly yellowish ointment with a camphor and turpentine smell, 50 g of ointment in an aluminum tube placed in a cardboard box.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Genexo Sp. z o.o.
Gen. Zajączka 26
01-510 Warsaw, Poland

Manufacturer

Tallinn Pharmaceutical Plant
Tondi 33, 11316, Tallinn, Estonia

Date of the last update of the leaflet: