Voltaren Emulgel

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Voltaren Emulgel(Voltarène Emulgel)
11.6 mg/g, gel
Diclofenac diethylammonium
Voltaren Emulgel and Voltarène Emulgel are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as advised by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If pain and swelling do not improve within 7 days or worsen, you should contact your doctor.

Table of contents of the leaflet

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

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

Voltaren Emulgel is a white gel for topical use. The active substance of the drug, diclofenac, belongs to a group of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). Due to its water-alcohol base, Voltaren Emulgel also has a soothing and cooling effect.
The drug has analgesic, anti-inflammatory, and anti-edema effects.
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),
• back pain,
• limited inflammatory conditions of soft tissues, such as tendonitis, tennis elbow, bursitis, or periarthritis.

Adults (over 18 years old):

• mild and limited forms of osteoarthritis.

2. Important information before using Voltaren Emulgel

When not to use Voltaren Emulgel

• symptoms of hypersensitivity to the drug may include: wheezing or shortness of breath (asthma), skin rash with blisters or hives, swelling of the face or tongue, rhinitis (hay fever),
• during the third trimester of pregnancy,
• in children under 14 years old.

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

Warnings and precautions

Before starting to use Voltaren Emulgel, you should discuss it with your doctor or pharmacist.

• Do not apply the drug to damaged skin, open wounds, or eczema. You should stop using the drug if a skin rash appears after its use.
• Do not use more of the product than recommended or for a longer period than recommended, unless advised by your doctor.
• Voltaren Emulgel is for external use only. Do not use it in the mouth. Avoid contact with the eyes. If the drug gets into your eyes, rinse them with clean water and consult your doctor or pharmacist.
• Concomitant bandaging, usually used in the case of sprains, may be used, but it should not be airtight.

If you have any questions, you should consult your doctor or pharmacist before using Voltaren Emulgel.

Children and adolescents

Since the data on the efficacy and safety of using Voltaren Emulgel in children and adolescents under 14 years old are insufficient, the drug should not be used in this age group.
In adolescents over 14 years old, if the drug needs to be used for more than 7 days to treat pain or if symptoms worsen, the patient should consult a doctor.

Voltaren Emulgel and other drugs

You should tell your doctor or pharmacist about all prescription or over-the-counter drugs you are currently taking or have recently taken, as well as any drugs 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, you should consult your doctor or pharmacist before using this drug.
Voltaren Emulgel should not be used 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 Emulgel should only be used on the advice of a doctor, with the lowest possible dose and for the shortest possible duration.
During breastfeeding, Voltaren Emulgel may be used only on the advice of a doctor, as diclofenac passes into breast milk in small amounts. In such cases, the drug should not be applied to the breasts of nursing women or to large areas of skin or for extended periods.

Driving and operating machinery

Using the drug does not affect driving or operating machinery.

Important information about some ingredients of Voltaren Emulgel

The drug contains propylene glycol and benzyl benzoate, which may cause skin irritation.
Voltaren Emulgel contains fragrances with benzyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, linalool, which may cause allergic reactions.

3. How to use Voltaren Emulgel

This medicine should always be used exactly as described in the patient leaflet or as advised 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 a day, gently rubbing it in.
To open the tube, before the first use, you should unscrew the cap, put it upside down on the seal, and turn it, which will allow you 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, slowly rubbing it in. The amount of gel should be adjusted to the size of the affected area:
a amount corresponding to the size of a cherry or a walnut is sufficient.
During application, you may notice a slight cooling effect.
Voltaren Emulgel is for external use only.
After applying the drug, you should:

• Wipe your hands with a tissue, and then wash your hands, unless they are the area being treated. The used tissue should be thrown away.
• The patient should wait until the drug is completely dry before taking a bath.

Do notuse the drug for longer than:

• In adults and adolescents over 14 years old: 14 days in the case of muscle and joint injuries (sprains, strains, or bruises) and tendonitis.
• In adults (over 18 years old): 21 days in the case of pain associated with osteoarthritis, unless otherwise advised by a doctor.

Use the lowest recommended dose for the shortest possible time.
If pain and swelling do not improve within 7 days or worsen, you should contact your doctor.

Using more than the recommended dose of Voltaren Emulgel

In case of using an excessive amount of Voltaren Emulgel, you should remove the excess with a tissue. If you swallow the drug, you should immediately contact your doctor.

Missing a dose of Voltaren Emulgel

If you miss a dose, you should use the drug as soon as you remember.
Then continue with the recommended dosage. Do not use a double dose to make up for the missed dose.
If you have any questions about how to use Voltaren Emulgel, consult your doctor or pharmacist.

4. Possible side effects

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

Some side effects are rare or very rare and may be serious.

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

• Rare (occurring in less than 1 in 10,000 people using the drug):skin rash with blisters or without blisters; hives.
• Very rare (occurring in less than 1 in 10,000 people using the drug): wheezing, shortness of breath, or feeling of compression in the chest (asthma), swelling of the face, lips, tongue, or larynx.

Other side effects

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

• Common (occurring in less than 1 in 100 people using the drug):skin rash, itching, redness, or burning of the skin.
• Very rare (occurring in less than 1 in 10,000 people using the drug): 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 any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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 side effects, you can help provide more information on the safety of the drug.

5. How to store Voltaren Emulgel

The drug should be stored out of sight and reach of children.
Do not store above 30°C.
Do not use the drug after the expiration date stated on the packaging. The expiration date is the last day of the specified month.
Shelf life after first opening – 6 months.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Voltaren Emulgel contains

The active substance of the drug is diclofenac diethylammonium. 1 gram of gel contains 11.6 mg of diclofenac diethylammonium, which corresponds to 10 mg (1%) of diclofenac sodium.
1 gram of the drug contains 50 mg of propylene glycol and 1 mg of benzyl benzoate.
The other ingredients of the drug are: diethylamine, ester of caprylic and capric acid with fatty alcohol from C12 to 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 what the packaging contains

White or almost white, gentle, homogeneous gel, with a creamy consistency.
The drug is available in a tube containing 50 g of gel, in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in France, the country of export:3400937230414
Parallel import authorization number:420/22
Date of leaflet approval: 29.11.2022
[Information about the trademark]