Voltaren Emulgel

Leaflet attached to the packaging: patient information

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

Voltaren Emulgel

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 the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If pain and swelling do not improve within 7 days or worsen, consult a 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 application to the skin. 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 Emulgel also has a soothing and cooling effect.
The medicine has analgesic, anti-inflammatory, and anti-swelling effects.
It is used for local treatment of:

• post-traumatic inflammatory conditions of tendons, ligaments, muscles, and joints (e.g., resulting from 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 medicine 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 the patient, they should not use Voltaren Emulgel.

Warnings and precautions

Before starting to use Voltaren Emulgel, discuss it with a doctor or pharmacist.

• The medicine should not be applied to damaged skin, open wounds, or skin eruptions. Use of the medicine should be stopped if a skin rash appears after its application.
• The medicine should not be used in larger quantities or for longer than recommended, unless advised by a doctor.
• Voltaren Emulgel is for external use only. It should not be taken orally. Contact with the eyes should be avoided. If the medicine gets into the eyes, they should be rinsed with clean water, and a doctor or pharmacist should be consulted.
• Concomitant bandaging, usually used in cases of sprains, may be used, but it should not be airtight.

In case of any questions, consult a doctor or pharmacist before using Voltaren Emulgel.

Children and adolescents

Since there is insufficient data on the efficacy and safety of using Voltaren Emulgel in children and adolescents under 14 years old, the medicine should not be used in this age group.
In adolescents over 14 years old, if the medicine 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 medicines

Inform a doctor or pharmacist about all prescription or over-the-counter medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
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 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 machines.

Important information about some ingredients of Voltaren Emulgel

The medicine 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 directed by a doctor or pharmacist. In case of doubt, consult a 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, twist the cap, place it upside down on the seal, and twist it, which will allow the seal to be removed 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.
While rubbing in the gel, a slight cooling effect may be felt.
Voltaren Emulgel is for external use only.
After applying the medicine, the patient should:

• wipe their hands with a tissue and then wash them, unless the hands are the area being treated. The used tissue should be thrown away.
• wait for the medicine to dry completely before taking a bath.

Do notuse the medicine for longer than:

• In adults and adolescents over 14 years old: 14 days in case of muscle and joint injuries (sprains, strains, or bruises) and tendonitis.
• In adults (over 18 years old): 21 days in case of 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 worsen, consult a doctor.

Using more than the recommended dose of Voltaren Emulgel

In case of using an excessive amount of Voltaren Emulgel, the excess should be removed with a tissue. If the medicine is swallowed, consult a doctor immediately.

Missing a dose of Voltaren Emulgel

If a dose is missed, apply the medicine as soon as possible, and then continue with the recommended dosing schedule. Do not use a double dose to make up for the missed dose.
In case of any questions about using Voltaren Emulgel, consult a doctor or pharmacist.

4. Possible side effects

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

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

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

• Rare (occurring in less than 1 in 10,000 people using the medicine):skin rash with blisters or without blisters; hives.
• Very rare (occurring in less than 1 in 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 side effects

Other side effects that may occur when using Voltaren Emulgel are usually mild and temporary. If any of the following symptoms occur, inform a 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 rare (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 any side effects occur, including any possible side effects not listed in the leaflet, inform a doctor or pharmacist. 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Voltaren Emulgel

Keep the medicine out of the sight and reach of children.
Store in a temperature below 30°C.
After use, store the tube in an upright position.
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.
Medicines should not be disposed of via wastewater or household waste. Ask a 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 medicine is diclofenac diethylammonium. 1 gram of gel contains 11.6 mg of diclofenac diethylammonium (as diclofenac diethylammonium salt).
1 gram of the medicine contains 50 mg of propylene glycol and 1 mg of benzyl benzoate.
The other ingredients of the medicine are: diethylamine, cetomacrogol, carbomer 974P, isopropyl alcohol, liquid paraffin, fragrance (Perfume cream 45 – contains benzyl benzoate), purified water.

What Voltaren Emulgel looks like and what the packaging contains

The medicine is available in tubes (aluminum or laminated) of 50 g and 100 g, in a cardboard box.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
Barthstrasse 4
80339 Munich
Germany

Manufacturer:

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
Barthstrasse 4
80339 Munich
Germany
Purna Pharmaceuticals NV
Rijksweg 17
B-2870 Puurs
Belgium

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 Germany, the country of export:520.00.03
Parallel import authorization number:736/12
Date of leaflet approval: 18.11.2022
[Information about the trademark]