Voltaren emulgel
Poland
Table of Contents
Patient Information Leaflet
Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Voltaren Emulgel (Voltarène Emulgel)
11.6 mg/g, gel
Diclofenacum diethylammonium
Voltaren Emulgel and Voltarène 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.
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 effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If pain and swelling do not improve within 7 days, or if symptoms worsen, consult your doctor.
Table of contents
- 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 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 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 soft tissue inflammatory conditions 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 Emulgel
When not to use Voltaren Emulgel
- if the patient is allergic to diclofenac or other non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain, fever or inflammation, such as ibuprofen or aspirin, or to any of the other ingredients of this medicine. If in doubt, consult a doctor or pharmacist,
- symptoms of hypersensitivity to the medicine may include: wheezing or shortness of breath (asthma), skin rash with blisters or hives, swelling of the face or tongue, nasal mucosal inflammation (rhinitis),
- during the third trimester of pregnancy,
- in individuals under 14 years of age.
If any of the above apply to the patient, Voltaren Emulgel should not be used.
Warnings and precautions
Before starting to use Voltaren Emulgel, discuss this 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 instructed by a doctor.
- Voltaren Emulgel is for external use only. It should 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 contact a doctor or pharmacist.
- Concurrent use of bandaging, typically used for sprains, is acceptable, but occlusive (airtight) dressings must not be used.
If you have any questions, consult a doctor or pharmacist before using
Voltaren Emulgel.
Children and adolescents
Due to insufficient data on efficacy and safety in children and adolescents under 14 years of age, 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 relief, or if symptoms worsen, the patient should contact a doctor.
Voltaren Emulgel and other medicines
Tell your doctor or pharmacist about all prescription medicines or over-the-counter products currently used, recently used, or planned for use.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Voltaren Emulgel 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, Voltaren Emulgel should only be used on a doctor's advice, using the lowest possible dose and for the shortest duration necessary.
During breastfeeding, Voltaren Emulgel may only be used on medical advice, as diclofenac passes into breast milk in small amounts. In such cases, the gel 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.
Important information about certain ingredients of Voltaren Emulgel
This medicine contains propylene glycol and benzyl benzoate, which may cause skin irritation.
Voltaren Emulgel contains fragrance ingredients including benzyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, and linalool, which may cause allergic reactions.
3. How to use Voltaren Emulgel
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 Emulgel should be applied locally to the skin three or four times daily, gently rubbed in.
To open the tube for the first time, unscrew the cap, place it on the seal upside down 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.
While rubbing in the gel, you may notice a mild cooling effect.
Voltaren Emulgel is intended for use on the skin only.
After applying the medicine:
- Wipe your hands with a tissue, then wash your hands, unless the hands are the area being treated. The used tissue should be disposed of in the trash.
- After applying Voltaren Emulgel, the patient should wait until the medicine has completely dried before bathing.
Do not use the medicine for longer than:
- Adults and adolescents over 14 years of age: 14 days for muscle and joint injuries (sprains, strains, or bruises) and tendon inflammation.
- Adults (over 18 years of age): 21 days for pain associated with osteoarthritis, unless otherwise advised by a doctor.
Use the smallest recommended dose for the shortest possible time.
If pain and swelling do not improve within 7 days, or if they worsen, consult your doctor.
Use of more than the recommended dose of Voltaren Emulgel
If too much Voltaren Emulgel is applied, wipe off the excess with a tissue. In case of ingestion of this medicine, seek medical advice immediately.
Missed dose of Voltaren Emulgel
If a dose is missed, apply the medicine as soon as remembered, then continue using it as directed. Do not use a double dose to make up for a missed dose.
If you have any questions about how to use Voltaren Emulgel, consult your doctor or pharmacist.
4. Possible adverse reactions
Like any medicine, Voltaren Emulgel may cause adverse reactions, although not everyone will
experience them.
Some adverse reactions occurring rarely or very rarely may be serious.
If any of the symptoms listed below, which may indicate hypersensitivity, occur, stop using the
medicine immediately and 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 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 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 sensitivity of the skin to sunlight. Symptoms of photosensitivity include sunburn with itching, swelling, and blisters.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting adverse reactions, more information on the safety of the medicine can be collected.
5. How to store Voltaren Emulgel
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
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.
Usable period after first opening – 6 months.
Medicines should not be disposed of via wastewater 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 pack and other information
What Voltaren Emulgel contains
The active substance is diclofenac diethylammonium. 1 gram of gel contains 11.6 mg of diclofenac
diethylammonium, equivalent to 10 mg (1%) of sodium diclofenac.
1 gram of the medicinal product contains 50 mg of propylene glycol and 1 mg of benzyl benzoate.
The other ingredients are: diethylamine, caprylic/capric acid ester with fatty alcohols C12-C18 (Cetiol LC), cetomacrogol 1000, carbomer 974 P, isopropyl alcohol, liquid paraffin, fragrance (Perfume cream 45 – contains: benzyl benzoate, lavender essential oil, Brazilian rosewood essential oil, lavandin essential oil, benzyl alcohol, terpenyl acetate, geraniol), purified water.
What Voltaren Emulgel looks like and contents of the pack
White or almost white, soft, homogeneous gel with a creamy consistency.
The medicine is available in a tube containing 50 g of gel, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in France, the country of export:
GLAXOSMITHKLINE SANTÉ GRAND PUBLIC
23 Rue François Jacob
92500 Rueil Malmaison, France
Manufacturer:
GLAXOSMITHKLINE SANTÉ GRAND PUBLIC
23 Rue François Jacob
92500 Rueil Malmaison, France
Novartis Pharma S.A.S
26 Rue de la Chapelle
68330 Huningue, France
Centre Specialites Pharmaceutiques
Z.A.C. de la Barogne
77230 Moussy-le-Neuf, France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in France, the country of export: 3400937230414
Parallel import licence number: 420/22