Voltaren emulgel
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Voltaren Emulgel
11.6 mg/g (1.16%) gel
Diclofenacum diethylammonium
Please read the entire leaflet carefully before use, 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 for future reference.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
- If there is no improvement or if you feel worse after 7 days, consult your doctor.
Table of contents of the leaflet
- What Voltaren Emulgel is and what it is used for
- Important information before using Voltaren Emulgel
- How to use Voltaren Emulgel
- Possible side effects
- How to store Voltaren Emulgel
- Contents of the pack and other information
1. What Voltaren Emulgel is and what it is used for
Voltaren Emulgel is a white gel intended for rubbing into 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 Emulgel also has a soothing and cooling effect.
The medicine acts as an analgesic, anti-inflammatory, and anti-edematous agent.
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):
- Limited and mild forms of osteoarthritis.
2. Important information before using Voltaren Emulgel
When not to use Voltaren Emulgel
-
if the patient is allergic to diclofenac or to other non-steroidal anti-inflammatory drugs (NSAIDs) 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). In case of
doubt, consult a doctor or pharmacist. Symptoms of hypersensitivity to
the medicine may include: wheezing or shortness of breath (asthma), blistering skin rash or
urticaria, facial or tongue swelling, nasal mucosa inflammation (rhinitis), -
during the last three months of pregnancy,
-
in individuals under 14 years of age.
If any of the above apply to the patient, Voltaren Emulgel must not be used.
Warnings and precautions
Before starting to use Voltaren Emulgel, discuss it with a 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 a longer period than advised, unless directed by a doctor.
- Voltaren Emulgel is intended for external use only. It must not be applied inside the mouth. Avoid contact of the gel with the eyes. If the medicine gets into the eyes, rinse thoroughly with clean water and consult a doctor or pharmacist.
- Concurrent use of bandaging, typically used for sprains, is acceptable, but occlusive (airtight) bandages must not be used.
- Keep the medicine out of sight and reach of children.
If in doubt, consult a doctor or pharmacist before using Voltaren Emulgel.
Children and adolescents
As data on efficacy and safety in children and adolescents under 14 years of age are insufficient, Voltaren Emulgel must not be used in this age group.
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.
Voltaren Emulgel and other medicines
Inform your doctor or pharmacist about all prescription and non-prescription medicines currently or recently used, as well as any medicines planned for future use.
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 or pharmacist before using this medicine.
Do not use Voltaren Emulgel during the last three months of pregnancy, as it may harm the unborn baby or cause complications 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 necessary, the lowest possible dose should be applied for the shortest possible duration.
Oral forms (e.g. tablets) of this medicine 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 Emulgel 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.
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This medicine contains 50 mg of propylene glycol per gram. Propylene glycol may cause skin irritation.
This medicine 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 Emulgel
This medicine should always be used exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Voltaren Emulgel 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 onto 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 the size of a cherry to a walnut is sufficient.
A mild cooling sensation may be noticed during application of the gel.
Voltaren Emulgel is intended for topical use on the skin only.
After applying the medicine:
- Wipe your 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.
- After applying Voltaren Emulgel, the patient should wait until the medicine is completely dry before bathing.
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 bruises) and tendon inflammation.
- In adults (over 18 years of age): 21 days for pain associated with degenerative joint disease, unless otherwise directed 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.
Using more Voltaren Emulgel than recommended
If too much Voltaren Emulgel is applied, wipe off the excess with a tissue. If the medicine is swallowed, contact a doctor immediately.
Missing a dose of Voltaren Emulgel
If a dose is missed, apply the medicine as soon as remembered, then continue treatment as recommended. Do not apply 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.
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4. Possible adverse reactions
Like all medicines, Voltaren Emulgel can cause adverse reactions, although not everyone experiences them.
Some adverse reactions occurring rarely or very rarely may be serious.
If any of the following symptoms occur, which may indicate hypersensitivity, stop using the medicine immediately, contact your doctor or go to the nearest hospital:
- Rare (affects fewer than 1 in 10,000 people using the medicine): Skin rash with or without blisters; urticaria.
- Very rare (affects fewer than 1 in 10,000 people using the medicine): Wheezing, shortness of breath or tightness in the chest (asthma), swelling of the face, lips, tongue or throat.
Other adverse reactions
Other adverse reactions that may occur during the use of Voltaren Emulgel are usually mild and temporary. If any of the listed symptoms occur, inform your doctor or pharmacist as soon as possible.
- Common (affects fewer than 1 in 10 people using the medicine): Skin rash, itching, redness or burning sensation of the skin.
- Very rare (affects fewer 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 blistering.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Voltaren Emulgel
Keep this medicine out of sight and reach of children.
After use, store the tube in an upright position.
Do not store above 25°C.
Medicines must not be disposed of via wastewater (sinks or toilets) or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect
the environment.
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 Emulgel contains
The active substance is diclofenac diethylammonium. 1 gram of gel contains 11.6 mg of diclofenac diethylammonium.
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1 gram of the medicinal product contains 50 mg of propylene glycol and 1 mg of benzyl benzoate.
The other ingredients are: diethylamine, cococaprylocaprate, cetomacrogol, carbomer 974P, isopropyl alcohol, propylene glycol, liquid paraffin, fragrance (Perfume cream 45
- containing benzyl benzoate, benzyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, linalool), purified water.
What Voltaren Emulgel 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 of 50 g or 100 g.
For more detailed information, please contact the Marketing Authorisation Holder 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
German Marketing Authorisation Number, country of export: 520.00.03
Parallel Import Licence Number: 268/23
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