Package leaflet: Information for the patient

Viprosal B, ointment
Please read all of this leaflet carefully before using this medicine, because
it contains information important for the patient.
This medicine should always be used exactly as described in this patient information leaflet or
as directed by the doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, consult your doctor.

Table of contents of the leaflet:

What Viprosal B is and what it is used for
Important information before using Viprosal B
How to use Viprosal B
Possible side effects
How to store Viprosal B
Contents of the pack and other information

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

Viprosal B ointment is used externally as an analgesic for relieving neuralgic and joint pains.

2. Important information before using Viprosal B

When not to use Viprosal B

if the patient has a known hypersensitivity (allergy) to the active substance or to any of the other components of Viprosal B,
on ulcerated skin or skin affected by other skin disorders,
if the patient suffers from cerebral or coronary circulatory disorders,
if the patient has a tendency towards blood vessel spasms,
in case of severe impairment of liver or kidney function.

When to exercise special caution when using Viprosal B
Viprosal B ointment should not be applied to damaged skin surfaces. To prevent severe irritation, eyes should be protected and contact with mucous membranes should be avoided. To avoid adverse effects, skin sensitivity should be tested before use by applying a small amount of the ointment to a small area of skin.

Children and adolescents
Due to lack of data on use in children or adolescents, Viprosal B is not recommended for use in these groups.

Using Viprosal B with other medicines
Inform your doctor about all medicines you are currently taking, including those available without a prescription.
No studies on drug interactions have been conducted.

Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine.
There are insufficient data on the use of the active substances in Viprosal B during pregnancy. Due to lack of safety data, Viprosal B should not be used during pregnancy or while breastfeeding.

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

Important information about some of the excipients in Viprosal B
Viprosal B ointment contains cetostearyl alcohol as an excipient, which has biological activity. Due to its presence, 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 patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Depending on the size of the affected area, apply a small amount of Viprosal B ointment (5 to 10 cm) to the painful area and massage gently into the skin once or twice daily, depending on the intensity of pain, until symptoms subside. The duration of treatment depends on the nature and severity of the condition.

If you feel the ointment is too strong or not effective enough, consult your doctor or pharmacist.

Use in children and adolescents
Due to lack of data on use in children or adolescents, Viprosal B is not recommended for use in these groups.

Use of a higher than recommended dose of Viprosal B
No cases of overdose have been reported. If applied to mucous membranes, the ointment may cause severe irritation. In case of accidental ingestion, contact a doctor and keep the packaging. Do not induce vomiting.
If a child accidentally swallows the ointment, contact a doctor immediately for appropriate management. Do not attempt to induce vomiting.

Missed dose of Viprosal B
Apply the missed dose as soon as possible, then continue according to the prescribed schedule.
If it is almost time for the next dose, apply the usual amount and continue treatment as prescribed.
Do not use a double dose to make up for a missed dose.

Stopping use of Viprosal B
If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Very common (may affect up to 1 in 10 people)
Local reactions:

Dermatitis
Skin dryness
Local skin desquamation
Erythema
Itching
Erythematous rash
Skin fragility (risk of mechanical damage)
Abrasions
Ulceration

Unknown frequency (frequency cannot be estimated from the available data)

In case of skin hypersensitivity to the ointment components, its application may cause itching, swelling, or urticaria. In such cases, treatment should be discontinued and the ointment should be washed off the skin. The symptoms described above resolve after discontinuation of treatment.

If any adverse reaction occurs, consult a doctor or pharmacist. This also applies to adverse reactions not listed in this leaflet.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: [email protected].
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Viprosal B

Store below 25°C. Do not store in the refrigerator or freeze.
Keep in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Viprosal B contains
The active substances in this medicine are:
1 g of ointment contains 0.05 I.U. of adder venom, 30 mg of racemic camphor
( Camphora racemica ), 30 mg of turpentine oil from pine ( Terebinthini
aetheroleum ), 10 mg of salicylic acid ( Acidum salicylicum ).
The excipients are: white vaseline, cetostearyl alcohol, hard paraffin, sodium
cetostearyl sulfate, glycerol, sodium chloride, purified water.
What Viprosal B looks like and contents of the pack
A white or slightly yellowish ointment with the smell of camphor and turpentine. 50 g of ointment in an aluminium tube placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
AS GRINDEKS
Krustpils iela 53,
Rīga, LV-1057,
Latvia
tel: +371 67083205
e-mail: [email protected]
Manufacturer
Tallinn Pharmaceutical Plant
Tondi 33, 11316, Tallinn, Estonia