Veral

Package Leaflet: Information for the Patient

Veral, 10 mg/g (1%), Gel

Diclofenac Sodium

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 the package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact a doctor.

Table of Contents of the Leaflet

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

1. What is Veral and what is it used for

Veral is a clear gel for topical application to the skin. The active substance of the medicine, diclofenac, belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs). Due to its water-alcohol base, Veral also has a soothing and cooling effect. The medicine has analgesic, anti-inflammatory, and anti-edema effects. It is used for local treatment of:

Adults and adolescents over 14 years:

• post-traumatic inflammatory conditions of tendons, ligaments, muscles, and joints (e.g., resulting from sprains, strains, or bruises)
• back pain
• limited inflammatory conditions of soft tissues, such as tendonitis, tennis elbow, bursitis, or periarthritis.

Adults (over 18 years)

• mild and limited forms of osteoarthritis

2. Important information before using Veral

When not to use Veral

• during the third trimester of pregnancy.
• in children under 14 years of age.

The medicine should not be used during the third trimester of pregnancy. Do not use in children and adolescents under 14 years of age.

Warnings and precautions

• Do not apply the medicine to damaged skin, open wounds, or skin eruptions. Stop using the medicine if a skin rash appears after its use.
• Avoid applying the medicine to large areas of skin or for an extended period, unless advised by a doctor.
• Veral is for external use only. Do not use it in the mouth. After use, wash your hands. Avoid contact with the eyes. If the medicine gets into your eyes, rinse them with clean water and consult a doctor or pharmacist.
• Conventional bandaging, usually used for sprains, may be used, but not airtight bandages.

Veral and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to use. After topical application, no clinically significant interactions have been found.

Children and adolescents

Since there is insufficient data on the efficacy and safety of using Veral in children and adolescents under 14 years of age, the medicine should not be used in this age group. In adolescents over 14 years of age, if the medicine needs to be used for more than 7 days to treat pain or if symptoms worsen, the patient should consult a doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Veral should not be used during the last three months of pregnancy, as it may harm the unborn child or cause difficulties during delivery. During the first six months of pregnancy, Veral should only be used on the advice of a doctor, with the lowest possible dose and for the shortest possible duration. During breastfeeding, Veral may only be used on the advice of a doctor, as diclofenac passes into breast milk in small amounts. In such cases, the medicine should not be applied to the breasts of nursing women or to large areas of skin or for an extended period. If you have any further questions on the use of Veral in pregnant or breastfeeding women, consult a doctor or pharmacist.

Driving and using machines

The medicine does not affect the ability to drive or use machines.

Veral contains ethanol

This medicine contains 600 mg of alcohol (ethanol) in each 4 g dose of gel, which is equivalent to 15 g/100 g. It may cause a burning sensation on damaged skin.

3. How to use Veral

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist. Veral should be applied topically to the skin three or four times a day, gently rubbing it in. The amount of gel should be adjusted to the size of the affected area: 2 g to 4 g of Veral (an amount equivalent to the size of a cherry to a walnut) is sufficient to treat an area of about 400 cm to 800 cm. After applying the medicine, wash your hands unless they are the area being treated. Do notuse the medicine for longer than:

• In adults and adolescents over 14 years: 14 days in case of muscle and joint injuries (sprains, strains, or bruises) and tendonitis.
• In adults (over 18 years): 21 days in case of pain associated with osteoarthritis, unless otherwise advised by a doctor. If pain and swelling do not improve within 7 days or worsen, consult a doctor.

Missing a dose of Veral

Do not use a double dose to make up for a missed dose.

Using more Veral than recommended

Immediately consult a doctor if you use more Veral than recommended or accidentally swallow it.

4. Possible side effects

Like all medicines, Veral can cause side effects, although not everybody gets them.

Some side effects are rare or very rare but can be serious.

If you experience any of the following symptoms, which may be signs of an allergic reaction, stop using the medicine immediately, consult a doctor, or go to the nearest hospital:

• Rare (affects less than 1 in 10,000 people using the medicine): Skin rash with blisters, peeling skin, burning sensation.
• Very rare (affects less than 1 in 10,000 people using the medicine): Wheezing, shortness of breath, or feeling of compression in the chest (asthma); swelling of the face, lips, tongue, or throat; hives.

Other side effects

Other side effects that may occur when using Veral are usually mild, harmless, and temporary. If you experience any of these symptoms, inform your doctor or pharmacist as soon as possible.

• Common (affects less than 1 in 100 people using the medicine): Skin rash, itching, redness, or burning sensation.
• Very rare (affects less than 1 in 10,000 people using the medicine): Increased skin sensitivity to sunlight. Symptoms of hypersensitivity are sunburn with itching, swelling, and blisters.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Veral

Store in the original packaging to protect from light. Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton after "EXP" and on the tube after "EXP". The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Veral contains

• The active substance is diclofenac sodium. 1 g of gel contains 10 mg of diclofenac sodium.
• The other ingredients are: ethanol 96%, isopropyl alcohol, trometamol, carbomer, purified water.

What Veral looks like and contents of the pack

Homogeneous, colorless, transparent gel with a characteristic smell of alcohol. Aluminum tube with a membrane, closed with a PE or PP cap, in a cardboard box. Laminated tube (PE/Aluminum/PE or PE/EVOH/PE) with a polypropylene cap in a cardboard box. Pack size: 55 g gel, 100 g gel.

Marketing authorization holder

Herbacos Recordati s.r.o., Pardubice, Štrossova 239, PSČ 53003, Czech Republic

Manufacturer

Herbacos Recordati s.r.o., Generála Svobody 335, čísla staveních parcel 83/1, 83/2, 726/2, Pardubice – Rosice nad Labem, 533 51, Czech Republic

Date of last revision of the leaflet: