Venogel

Package Leaflet: Information for the Patient

Venogel,(12 mg + 10 mg + 5 mg)/g, gel
Diclofenac sodium + Tribenoside + Escin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 7 days, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Venogel and what is it used for
• 2. Important information before using Venogel
• 3. How to use Venogel
• 4. Possible side effects
• 5. How to store Venogel
• 6. Package contents and other information

1. What is Venogel and what is it used for

Venogel is a medicine for topical use. It is a white gel.
It has analgesic, anti-inflammatory, and anti-edematous effects.
Indications for use:

• phlebitis of the lower limbs;
• postoperative and post-traumatic edema, venous stasis edema of the lower limbs;
• pain syndromes associated with spinal diseases;
• post-traumatic muscle and joint pain (bruises, sprains, strains);
• limited and mild forms of arthritis.

2. Important information before using Venogel

When not to use Venogel:

• 1. if the patient is allergic to diclofenac, tribenoside, escin, or any of the other ingredients of this medicine (listed in section 6);
• 2. in case of skin damage, inflammatory skin changes, and open wounds;
• 3. during the last three months of pregnancy and during breastfeeding;
• 4. occurrence of asthma attacks, hives, or acute rhinitis after using acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

Warnings and precautions

Before starting to use Venogel, the patient should discuss it with their doctor or pharmacist.
Particular caution should be exercised when using the medicine for a long time and on a large skin surface.
Venogel should not be used:

• on mucous membranes and in the eyes; if the gel gets into the eyes or on mucous membranes, it should be removed by rinsing with plenty of water;
• under bandages (dressings, plasters); orally.

During treatment and for 2 weeks after the end of treatment, direct sunlight (including solarium) should be avoided.
Venogel should not be used if the appearance or smell of the gel changes.

Children and adolescents

The use of Venogel in children under 12 years of age is not recommended.

Venogel and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
During proper use, the occurrence of interactions between the active substances of Venogel and other medicines is unlikely.
Venogel can be used at the same time as other pharmaceutical forms of diclofenac, tribenoside, and escin (tablets, suppositories, etc.). However, in the case of long-term use of the medicine on large skin surfaces, it cannot be entirely ruled out that the components of Venogel may interact with other medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Venogel should not be used during the last three months of pregnancy.
Due to the insufficient amount of clinical data, Venogel should not be used during the first 6 months of pregnancy, unless it is necessary and recommended by a doctor. If use is necessary, the smallest possible dose should be administered for the shortest possible time. In these cases, Venogel can only be used if the doctor believes that the benefit to the mother outweighs the potential risk to the fetus.
After oral administration of diclofenac (e.g., tablets), adverse reactions may occur in the unborn child. It is not known if the same risk applies to Venogel when used on the skin.
Breastfeeding
The use of Venogel in breastfeeding women is contraindicated.

Driving and using machines

Venogel has no effect on the ability to drive and use machines.
Venogel contains methyl parahydroxybenzoate and propyl parahydroxybenzoate,which can cause allergic reactions (possible late-type reactions).

3. How to use Venogel

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Venogel should be applied topically to the skin, 3 to 4 times a day, at intervals of several hours.
The amount of gel used should be adjusted to the size of the affected area. Usually, a strip of gel about 4 cm long is recommended for single use.
After applying the gel, it should be spread and gently massaged until completely absorbed.
After using the medicine, the hands should be washed, unless they are being treated.
The duration of treatment depends on the type of disease and the response to treatment. Usually, treatment lasts no longer than a few weeks (usually up to 4 weeks). If there is no improvement or the symptoms worsen, a doctor's check-up is recommended after 7 days of using the gel.
If there is no improvement or the patient feels worse after 7 days of using the gel, they should contact their doctor.

Using more than the recommended dose of Venogel

There are no known cases of overdose when using the medicine topically.
If the medicine is accidentally ingested, the patient should immediately contact their doctor.

Missing a dose of Venogel

In case of a missed dose, treatment should be continued as directed (see section 3).

4. Possible side effects

Like all medicines, Venogel can cause side effects, although not everybody gets them.
Side effects may occur with the following frequency:
very common: more than 1 in 10 people
common: 1 in 10 to 1 in 100 people
uncommon: 1 in 100 to 1 in 1,000 people
rare: 1 in 1,000 to 1 in 10,000 people
very rare: less than 1 in 10,000 people
frequency not known: frequency cannot be estimated from the available data
Disorders of the skin and subcutaneous tissue
Rare:local skin irritation (redness, burning, itching, rash, photosensitivity reactions, edema), which disappears after discontinuation of the medicine.
In case of long-term use of the medicine on large skin surfaces, side effects may occur due to the systemic effect of diclofenac (e.g., nausea, diarrhea, abdominal pain, headache, skin rash, angioedema, urticaria). The frequency of these reactions is not known.
In such cases, the patient should inform their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. 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
Al. Jerozolimskie 181C, 02-222 Warsaw
tel. +48 22 49 21 301, fax +48 22 49 22 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Venogel

Store at a temperature below 25°C. Do not store in the refrigerator or freeze.
The medicine should be stored out of sight and reach 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 should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Venogel contains

• The active substances of the medicine are: diclofenac sodium (12 mg/g), tribenoside (10 mg/g), and escin (5 mg/g).
• The other ingredients are: methyl parahydroxybenzoate, propyl parahydroxybenzoate, carbomer, sodium hydroxide, purified water.

What Venogel looks like and what the package contains

Venogel is a white gel in an aluminum tube and a cardboard box.
The package contains 50 g or 100 g of gel.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +48 17 865 51 00

Manufacturer

EMO-FARM Sp. z o.o.
ul. Łódzka 52
95-054 Ksawerów

Date of the last update of the leaflet: