Voltaren sport
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Voltaren SPORT (Voltaren Emulgel)
11.6 mg/g (1.16%) gel
Diclofenacum diethylammonium
Voltaren SPORT and Voltaren Emulgel are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
The medicine should always be used exactly as described in this patient leaflet or as advised 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 effects, including any possible adverse effects not listed 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.
Table of contents of the leaflet
- What Voltaren SPORT is and what it is used for
- Important information before using Voltaren SPORT
- How to use Voltaren SPORT
- Possible side effects
- How to store Voltaren SPORT
- Contents of the pack and other information
1. What Voltaren SPORT is and what it is used for
Voltaren SPORT is a white or almost white gel intended for rubbing into the skin.
The active substance of the medicine – 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 acts as an analgesic, anti-inflammatory and anti-edema agent.
It is used for local 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: tendonitis, 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
- if you are allergic to diclofenac or to 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 your doctor or pharmacist. Symptoms of hypersensitivity may include: wheezing or shortness of breath (asthma), blistering skin rash or urticaria, facial or tongue swelling, 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 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 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 recommended, 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 your doctor or pharmacist.
- Concurrent bandaging, commonly used in cases of sprains, may be used, but occlusive (airtight) dressings must not be used.
- 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 in children and adolescents under 14 years of age, Voltaren SPORT must not be used in this age group.
In adolescents over 14 years of age, if treatment for pain is required for longer than 7 days or if symptoms worsen, the patient should consult a doctor.
Voltaren SPORT and other medicines
Tell your doctor or pharmacist about all prescription or over-the-counter 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 difficulties during delivery. During the first six months of pregnancy, Voltaren SPORT should not be used unless necessary and specifically recommended by a doctor. If use is required, the lowest possible dose for the shortest possible time should be administered.
Oral forms of the medicine (e.g. tablets) may cause adverse effects in the unborn child. It is not known whether the same risk applies to Voltaren SPORT when applied to the skin.
During breastfeeding, Voltaren SPORT may be used only 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 to large skin areas or for prolonged periods.
Driving and operating machinery
Use of this medicine does not affect the ability to drive or operate machinery.
Voltaren SPORT contains propylene glycol
Voltaren SPORT contains 200 mg of propylene glycol in the maximum single dose (equivalent to 50 mg/g). Propylene glycol may cause skin irritation.
Voltaren SPORT contains a fragrance (Perfume cream 45)
Voltaren SPORT contains a fragrance (Perfume cream 45) including, among others, benzyl benzoate, benzyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol and 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. If in doubt, consult your doctor or pharmacist.
Voltaren SPORT should be applied topically to the skin three or four times daily, gently rubbed in.
To open the tube for the first time:
- Unscrew the cap, place it upside down on the seal, and twist to remove the seal from the tube.
Gently squeeze a small amount of gel from the tube and apply it to the painful or swollen area of skin, rubbing it 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 the trash.
- Wait several minutes for the gel to dry on the skin before applying a dressing or a breathable bandage.
- After applying Voltaren SPORT, the patient should wait until the medicine is completely dry before bathing.
Do not use the medicine for longer than:
- In adults and adolescents over 14 years of age: 14 days for muscle and joint injuries (sprains, strains, or bruises) and tendonitis.
- 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 your doctor.
Use of more Voltaren SPORT than recommended
If too much Voltaren SPORT is used, remove the excess with a tissue. In case of accidental ingestion, seek immediate medical advice from a doctor.
Missed dose of Voltaren SPORT
If a dose is missed, apply the medicine as soon as remembered, then continue treatment as recommended. Do not use a double dose to make up for a forgotten dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, 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 occur, which may indicate hypersensitivity, stop using the medicine immediately, contact a doctor or go to the nearest hospital:
- Rare (occurring in less than 1 to 10 out of 10,000 people using the medicine): Skin rash with or without blisters; urticaria.
- Very rare (occurring in less than 1 out of 10,000 people using the medicine): Wheezing, shortness of breath or feeling of pressure in the chest (asthma), swelling of the face, lips, tongue or larynx.
Other adverse effects
Other adverse effects that may occur during use of Voltaren SPORT are usually mild and temporary. If any of the symptoms listed below occur, inform your doctor or pharmacist as soon as possible.
- Common (occurring in less than 1 to 10 out of 100 people using the medicine): Skin rash, itching, redness or burning sensation of the skin.
- Very rare (occurring in less than 1 out of 10,000 people using the medicine): increased skin sensitivity to sunlight. Symptoms of photosensitivity include sunburn with itching, swelling and blisters.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring 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
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Voltaren SPORT
Keep this medicine out of sight and reach of children.
Do not store above 25°C. After use, store the tube upright on its cap.
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.
Medicines must not be disposed of via wastewater (sinks or toilets) or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
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.
The other ingredients are: carbomer 974P, cetomacrogol, diethylamine, isopropyl alcohol,
propylene glycol, liquid paraffin, cocoyl caprylocapronate, purified water, fragrance (Perfume cream 45) (containing, among others: benzyl benzoate, benzyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, linalool).
What Voltaren SPORT looks like and contents of the pack
White or almost white gel.
The medicinal product is available in 50 g and 100 g tubes.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Germany, the country of export:
Haleon Germany GmbH
Barthstrasse 4
80339 Munich
Germany
Manufacturer:
Haleon Germany GmbH
Barthstrasse 4
80339 Munich
Germany
Purna Pharmaceuticals
Rijksweg 17
2870 Puurs-Sint-Amands
Belgium
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
German Marketing Authorisation Number (country of export): 520.00.03
Parallel Import Authorisation Number: 178/20