Voltaren Sport

Patient Information Leaflet: Information for the Patient

Voltaren SPORT,11.6 mg/g, gel
Diclofenac diethylammonium

Read the 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 information leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those 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 your doctor.

Table of Contents of the Leaflet

• 1. What is Voltaren SPORT and what is it 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 is Voltaren SPORT and what is it used for

Voltaren SPORT is a white gel for topical use. 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, Voltaren SPORT also has a soothing and cooling effect.

The medicine acts as a pain reliever, anti-inflammatory, and anti-swelling agent.
It is used for local treatment:

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

Adults (over 18 years of age):

• of mild and limited forms of degenerative joint disease.

2. Important information before using Voltaren SPORT

When not to use Voltaren SPORT

may include: wheezing or shortness of breath (asthma), skin rash with blisters or hives,
swelling of the face or tongue, inflammation of the nasal mucosa (rhinitis),

• during the last three months of pregnancy,
• in children under 14 years of age.

If any of the above statements apply to you, do not use Voltaren SPORT.

Warnings and precautions

Before starting to use Voltaren SPORT, discuss it with your doctor or pharmacist.

• Do not use the medicine on damaged skin, open wounds, or eczema. Stop using the medicine if a skin rash appears after its use.
• Do not use more of the product than recommended or for longer than recommended, unless advised by a doctor.
• Voltaren SPORT is for external use only. Do not use it in the mouth. Avoid contact of the gel with the eyes. If the medicine gets into the eyes, rinse them with clean water and consult a doctor or pharmacist.
• Concomitant bandaging, usually used in the case of sprains, may be used, but they should not be airtight bandages.
• Keep the medicine out of the sight and reach of children.

In case of any doubts, consult your doctor or pharmacist before using Voltaren SPORT.

Children and adolescents

Since the data on the efficacy and safety of use in children and adolescents under 14 years of age are insufficient, Voltaren SPORT 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 for pain treatment or if the symptoms worsen, the patient should contact a doctor.

Voltaren SPORT and other medicines

Tell your doctor or pharmacist about all the prescription or 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 plan to have a child, consult your doctor or pharmacist before using this medicine.
Do not use Voltaren SPORT during the last three months of pregnancy, as it may have a harmful effect on the unborn child or cause difficulties during delivery. During the first six months of pregnancy, do not use Voltaren SPORT unless it is necessary and advised by a doctor. If use is necessary, administer the smallest possible dose for the shortest possible time.
After oral administration (e.g., tablets), adverse reactions may occur in the unborn child. It is not known whether the same risk applies to Voltaren SPORT when used on the skin.
During breastfeeding, Voltaren SPORT may be used only 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 extended periods.

Driving and using machines

Using the medicine does not affect driving or operating machinery.
The medicine contains 50 mg of propylene glycol in each gram.Propylene glycol may cause skin irritation.
Voltaren SPORT contains a fragrancewith 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 your doctor or pharmacist.

Voltaren SPORT should be applied topically to the skin three or four times a day, gently rubbing it in.

The container with the applicator can be used upside down.

Press the pump button to release the recommended amount of gel. Gently rub a small amount of gel into the painful or swollen area of skin. The amount of gel should be adjusted to the size of the affected area: a amount corresponding to the size of a cherry to a walnut is sufficient.

A mild cooling effect may be noticed when rubbing in the gel.

Voltaren SPORT is for external use only.

After applying the medicine:

• Wipe your hands with a tissue and then wash them, unless they are the area being treated. Dispose of the used tissue in a household waste bin, do not flush it down the toilet to prevent the product from entering the drainage system.
• Before applying a dressing or a breathable bandage, wait a few minutes until the gel has dried on the skin. If you need to take a shower or bath, apply the product later. Do notuse the medicine for longer than:
• For adults and adolescents over 14 years of age: 14 days in case of muscle and joint injuries (sprains, strains, or bruises) and tendonitis.
• For adults (over 18 years of age): 21 days in case of pain associated with degenerative joint disease, unless otherwise advised by a doctor.

Use the smallest recommended dose for the shortest possible time.

If the pain and swelling do not improve within 7 days or worsen, consult a doctor.

Using more than the recommended dose of Voltaren SPORT

In case of excessive use of Voltaren SPORT, remove the excess with a tissue. If the medicine is swallowed, contact a doctor immediately.

Missing a dose of Voltaren SPORT

If you miss a dose, use the medicine as soon as you remember, and then continue with the recommended dosage. Do not use a double dose to make up for the missed dose.

In case of any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Some side effects that occur rarely or very rarely can be serious.

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

• Rarely(occurring in less than 1 in 10,000 people using the medicine): Skin rash with blisters or without blisters; hives.
• Very rarely (occurring in 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.

Other side effects

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

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety Monitoring of 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Voltaren SPORT

Keep the medicine out of the 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 month stated.

Store in a temperature below 25°C.

Medicines should not be disposed of via wastewater (sink or toilet) or household waste bins. 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 Voltaren SPORT contains

The active substance of the medicine is diclofenac diethylammonium. 1 gram of gel contains 11.6 mg of diclofenac diethylammonium.

1 gram of the medicine contains 50 mg of propylene glycol.

The other ingredients of the medicine are: diethylamine, cetiol LC, cetomacrogol 1000, Carbopol 974P, isopropyl alcohol, liquid paraffin, fragrance (with benzyl benzoate, benzyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, linalool), purified water.

What Voltaren SPORT looks like and contents of the pack

White or almost white, gentle, homogeneous gel, with a creamy consistency.

The medicine is available in tubes with an applicator of 50 ml and 75 ml.

Not all pack sizes may be marketed.

Marketing authorization holder:

Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
Phone: 800 702 849

Importer:

Haleon Germany GmbH
Barthstrasse 4
80339 Munich
Germany

Date of last revision of the leaflet: December 2024

5. How to store Voltaren SPORT medicine

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. Store in a temperature below 25°C. Medicines should not be disposed of via wastewater (sink or toilet) or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Voltaren SPORT medicine contains

The active substance of the medicine is diclofenac diethylamine. 1 gram of gel contains 11.6 mg of diclofenac diethylamine. 1 gram of the medicine contains 50 mg of propylene glycol. The other ingredients of the medicine are: diethylamine, cetiol LC, cetomacrogol 1000, Carbopol 974P, isopropyl alcohol, liquid paraffin, fragrance (with benzyl benzoate, benzyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, linalool), purified water.

What Voltaren SPORT medicine looks like and what the pack contains

White or almost white, gentle, homogeneous gel, with a creamy consistency. The medicine is available in tubes (aluminum or laminated), 75 g, 100 g. Not all pack sizes may be marketed.

Marketing authorization holder:

Haleon Poland Sp. z o.o., ul. Rzymowskiego 53, 02-697 Warsaw, tel. 800 702 849

Importer:

Haleon Germany GmbH, Barthstrasse 4, 80339 Munich, Germany, Date of last update of the leaflet:December 2024