Veral

Package leaflet: Information for the patient

Veral, 10 mg/g (1%) gel
Diclofenacum natricum
Please read this leaflet carefully before using the medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

Table of contents

1. What Veral is and what it is 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 Veral is and what it is used for

Veral is a transparent gel intended for topical application to the skin. The active substance, diclofenac, belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Due to its aqueous-alcoholic base, Veral also has a soothing and cooling effect.
The medicine exerts analgesic, anti-inflammatory and anti-edematous effects.
It is used locally in the treatment of:
Adults and adolescents above 14 years of age:

• Post-traumatic inflammatory conditions of tendons, ligaments, muscles and joints (e.g. resulting from sprains, strains or contusions)
• Back pain
• Localized inflammatory conditions of soft tissues, such as: tendinitis, tennis elbow, bursitis, periarthritis.

Adults (above 18 years of age):

• Localized and mild forms of osteoarthritis.

2. Important information before using Veral

When not to use Veral

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has ever had an allergic reaction (e.g. rash, difficulty breathing or coughing attack) after taking medicines containing acetylsalicylic acid, ibuprofen, or other medicines used to treat joint and muscle pain.
• during the third trimester of pregnancy.
• in individuals under 14 years of age.

This medicine must 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 rashes. Discontinue use if a skin rash appears after application.
• Avoid applying the medicine over large areas of skin or for prolonged periods unless specifically directed by a doctor.
• Veral is for external use only. Do not use in the mouth. Hands should be washed after application. Avoid contact of the gel with the eyes. If the medicine gets into the eyes, rinse thoroughly with clean water and contact a doctor or pharmacist.
• Concurrent use of bandaging, typically used for sprains, is acceptable, but occlusive (airtight) dressings must not be used.

Veral and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
No clinically significant interactions have been observed following topical administration.

Children and adolescents
Due to insufficient data on efficacy and safety, Veral must not be used in children and adolescents under 14 years of age.
In adolescents over 14 years of age, if treatment is required for longer than 7 days for pain or if symptoms worsen, the patient should consult a doctor.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
Veral must not be used during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. During the first six months of pregnancy, Veral should only be used on medical advice, using the lowest possible dose for the shortest possible duration.
During breastfeeding, Veral may only be used on medical advice, as diclofenac passes into breast milk in small amounts. In such cases, the medicine should not be applied to the breasts of breastfeeding women, nor over large skin areas or for prolonged periods.
In case of any further doubts regarding the use of Veral in pregnant or breastfeeding women, medical or pharmaceutical advice should be sought.

Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.

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

3. How to use Veral

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Veral should be applied topically to the skin three or four times daily, gently rubbing it in. The amount used should be adjusted according to the size of the affected area: 2 g to 4 g of Veral gel (corresponding in size from a cherry fruit to a walnut) is sufficient to treat an area of approximately 400 cm² to 800 cm². After applying the medicine, hands should be washed unless they are the treated area.

Do not use the medicine for longer than:

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

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

Use of more than the recommended dose of Veral
Seek immediate medical advice if an excessive amount of Veral has been used or if the gel has been accidentally swallowed.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some adverse reactions occurring rarely or very rarely may be serious.
If any of the symptoms listed below occur, which may be signs of
hypersensitivity, stop using the medicine immediately, contact your doctor or go
to the nearest hospital:

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

Other adverse reactions
Other adverse reactions that may occur during treatment with Veral are usually mild,
harmless and transient. If any of the symptoms listed occur, inform your doctor or pharmacist
as soon as possible.

• Common (affecting less than 1 in 10 to 1 in 100 people taking the medicine): Skin rash, itching, redness or burning of the skin.
• Very rare (affecting less than 1 in 10,000 people taking the medicine): increased sensitivity of the skin to sunlight. Symptoms of photosensitivity include sunburn with itching, swelling and blistering.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Drug Reactions 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 21 309, website:
https://smz.ezdrowie.gov.pl .
Adverse reactions can also be reported to the marketing authorization holder or its representative
in Poland.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Veral

Keep 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 outer carton after: "Expiry date (EXP)" and on the tube after: "EXP". 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 in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Veral contains

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

What Veral looks like and contents of the pack
A homogeneous, colourless, transparent gel with a characteristic alcoholic odour.
Aluminium tube with a membrane, closed with a cap made of PE or PP, in a cardboard box.
Laminated tube (PE/Aluminium/PE or PE/EVOH/PE) with a polypropylene cap in a cardboard box.
Pack sizes: 55 g gel, 100 g gel.
Marketing Authorisation 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