Voltaren sport

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Voltaren Sport (Voltarène Emulgel)
11.6 mg/g, gel
Diclofenacum diethylammonium
Voltaren Sport and Voltarène Emulgel are different trade names for the same medicine.
Please read the following 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 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, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not mentioned in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Leaflet contents

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

1. What Voltaren Sport is and what it is used for

Voltaren Sport is a white 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 water-alcohol base, Voltaren Sport also has a soothing and cooling effect.
The medicine has analgesic, anti-inflammatory and anti-edematous properties.
It is used locally for the treatment of:
Adults and adolescents over 14 years of age:

• 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 (over 18 years of age):

• Localized and mild forms of osteoarthritis.

2. Important information before using Voltaren Sport

When not to use Voltaren Sport
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• if the patient is allergic to diclofenac or other non-steroidal anti-inflammatory drugs used to treat pain, fever or inflammation, such as ibuprofen or acetylsalicylic acid, or to any of the other ingredients of this medicine (listed in section 6). If in doubt, consult a doctor or pharmacist. Symptoms of hypersensitivity may include wheezing or shortness of breath (asthma), blistering skin rash or hives, swelling of the face or tongue, or inflammation of the nasal mucosa (rhinitis),
• during the last three months of pregnancy,
• in individuals under 14 years of age.

If any of the above apply, do not use Voltaren Sport.
Warnings and precautions
Before using Voltaren Sport, discuss it with your doctor or pharmacist.

• Do not apply the medicine to damaged skin, open wounds, or rashes. Discontinue use if a skin rash appears after application.
• Do not use more of the product than recommended or for longer than advised, unless directed by a doctor.
• Voltaren Sport is intended for external use only. Do not use in the mouth. 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.
• Occlusive dressings commonly used for sprains may be used, but non-breathable (occlusive) bandages should be avoided.
• Keep the medicine out of sight and reach of children.

If you have any doubts, consult your doctor or pharmacist before using Voltaren Sport.
Children and adolescents
Due to insufficient data on efficacy and safety, Voltaren Sport must not be used in children and adolescents under 14 years of age.
In adolescents aged over 14 years, if treatment for pain lasts longer than 7 days or if symptoms worsen, the patient should consult a doctor.
Voltaren Sport and other medicines
Inform your doctor or pharmacist about all prescription and non-prescription medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Do not use Voltaren Sport 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, do not use Voltaren Sport unless necessary and specifically recommended by a doctor. If use is required, the lowest effective dose should be used for the shortest possible duration.
Adverse effects on the unborn child have been reported with oral formulations (e.g. tablets). It is unknown whether the same risk applies to Voltaren Sport when applied to the skin.
During breastfeeding, Voltaren Sport should 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 nursing women, nor to large skin areas or for prolonged periods.
Driving and operating machinery
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Voltaren Sport has no effect on the ability to drive or operate machinery.
This medicine contains 50 mg of propylene glycol per gram. Propylene glycol may cause skin irritation.
Voltaren Sport contains a fragrance composed of benzyl benzoate, benzyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, linalool, which may cause allergic reactions. The medicine may cause mild local irritation.

3. How to use Voltaren Sport

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.
Voltaren Sport should be applied locally to the skin, three or four times daily, gently massaged in.
Aluminium tubes with lacquer coating – before first use, the protective membrane must be pierced using the reverse side of the cap.
Laminated tubes with an aluminium layer – to open the tube before first use:

• unscrew the cap, place it on the closure upside down and twist to remove the protective seal from the tube.

Gently squeeze out a small amount of gel from the tube and apply it to the painful or swollen area of skin, rubbing in slowly. The amount of gel should be adjusted according to the size of the affected area: an amount corresponding to the size of a cherry up to a walnut is sufficient.
A slight cooling sensation may be noticed during application of the gel.
Voltaren Sport is intended for topical use on the skin only.
After applying the medicine:

• Wipe hands with a tissue and then wash them, unless the hands themselves are the treated area. The used tissue should be disposed of in household waste, not flushed down the toilet, to prevent the product from entering the sewage system.
• Wait several minutes for the gel to dry on the skin before applying a dressing or an air-permeable bandage.
• If a shower or bath is needed, apply the product afterwards.

Do not use this medicine for longer than:

• In adults and adolescents over 14 years of age: 14 days for muscle and joint injuries (sprains, strains or contusions) and tendon inflammation.
• In adults (over 18 years of age): 21 days for pain associated with osteoarthritis, unless otherwise advised by a doctor.

Use the lowest recommended dose for the shortest possible duration.
If pain and swelling do not improve within 7 days or worsen, consult a doctor.
Use of more Voltaren Sport than recommended
If too much Voltaren Sport is used, remove the excess with a tissue.
If this medicine is swallowed, contact a doctor immediately.
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Missed dose of Voltaren Sport
If a dose is missed, apply the medicine as soon as remembered, then continue as directed. Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, Voltaren Sport may cause adverse effects, although not everyone will experience them.
Some adverse effects occurring rarely or very rarely may be serious.
If any of the symptoms listed below, which may be signs of hypersensitivity, occur, discontinue use of the medicine immediately and contact a doctor or go to the nearest hospital:

• Rare (occur in less than 1 in 10,000 people using the medicine): Skin rash with or without blisters; urticaria.
• Very rare (occur in less than 1 in 10,000 people using the medicine): Wheezing, shortness of breath or feeling of tightness in the chest (asthma), swelling of the face, lips, tongue or throat.

Other adverse effects
Other adverse effects that may occur during use of Voltaren Sport are usually mild and transient. If any of the listed symptoms occur, inform your doctor or pharmacist as soon as possible.

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

Reporting adverse effects
If any adverse effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse.
Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, more information on the safety of the medicine can be collected.

5. How to store Voltaren Sport

Keep this medicine out of sight and reach of children.
Laminated tube with aluminium layer: Do not store above 30°C.
Coated aluminium tube: Do not store above 25°C.
Use within 6 months after first opening of the tube.
Medicines should not be disposed of via wastewater (sink or toilet) or household waste.
Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.
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Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.

6. Contents of the packaging and other information

What Voltaren Sport contains
The active substance is diclofenac diethylammonium. 1 gram of gel contains 11.6 mg of diclofenac diethylammonium.
1 gram of the medicinal product contains 50 mg of propylene glycol and 1 mg of benzyl benzoate.
The other ingredients of the medicinal product are: diethylamine, cetiol LC (caprylic/capric acid ester with fatty alcohol (C12-C18)), cetomacrogol 1000, Carbopol 974P, isopropyl alcohol, propylene glycol, liquid paraffin, fragrance (Perfume cream 45 – contains, among others, benzyl benzoate), purified water.

What Voltaren Sport looks like and contents of the pack
White or almost white, soft, homogeneous gel with a creamy consistency.
The medicinal product is available in tubes (made of lacquered aluminium or laminated material) containing 50 g or 100 g.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in France, the country of export:
Haleon France, 23 rue François Jacob, 92500 Rueil Malmaison, France

Manufacturer:
Haleon France, 23 rue François Jacob, 92500 Rueil Malmaison, France

Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation Numbers in France, the country of export:
34009 372 304 1 4
34009 328 869 7 5
34009 372 305 8 2
34009 328 870 5 7

Parallel Import Licence Number: 322/21
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