Voltaren Emulgel

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Voltaren Emulgel

11.6 mg/g (1.16%), gel

Diclofenac diethylammonium

The leaflet should be read 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 a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their 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. Package contents 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 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-edema effects.

It is used for local treatment:

Adults and adolescents over 14 years:

• post-traumatic inflammatory conditions of tendons, ligaments, muscles, and joints (e.g., due to sprains, strains, or bruises),
• back pain,
• limited inflammatory conditions of soft tissues, such as tendonitis, tennis elbow, bursitis, or periarthritis.

Adults (over 18 years):

• mild and limited forms of osteoarthritis.

2. Important information before using Voltaren Emulgel

When not to use Voltaren Emulgel

• if the patient is hypersensitive to diclofenac or other nonsteroidal anti-inflammatory drugs used to treat pain, fever, or inflammation, such as ibuprofen or acetylsalicylic acid, or any of the other ingredients of this medicine (listed in section 6). In case of doubt, the patient should consult a doctor or pharmacist. Hypersensitivity to the medicine may manifest as: wheezing or shortness of breath (asthma), skin rash with blisters or hives, swelling of the face or tongue, or inflammation of the nasal mucosa (rhinitis),

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In case of doubt, the patient should 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, or inflammation of the nasal mucosa (rhinitis).

• in the last three months of pregnancy,
• in children under 14 years of age.

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, the patient should discuss it with their doctor or pharmacist.

• The medicine should not be applied to damaged skin, open wounds, or eczema. The patient should stop using the medicine if a skin rash appears after its use.
• The patient should not use more of the product than recommended or for a longer period than recommended, unless advised to do so by a doctor.
• Voltaren Emulgel is for external use only. It should not be taken orally. The patient should avoid contact with the eyes. If the medicine gets into the eyes, they should be rinsed with clean water, and the patient should consult a doctor or pharmacist.
• Bandaging, usually used in the case of sprains, may be used, but it should not be airtight.
• The medicine should be kept out of the sight and reach of children.

In case of any doubts, the patient should 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 of age, the medicine should not be used in this age group.

In adolescents over 14 years of age, if the medicine needs to be used for more than 7 days to treat pain or if the symptoms worsen, the patient should consult a doctor.

Voltaren Emulgel and other medicines

The patient should inform their doctor or pharmacist about all prescription or over-the-counter medicines they are currently taking or have 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 baby, 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 not be used unless it is necessary and recommended by a doctor. If use is necessary, the smallest possible dose should be given for the shortest possible time.

After oral administration (e.g., tablets), side effects may occur in the unborn child. It is not known if the same risk applies to Voltaren Emulgel when used on the skin.

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 machinery.

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The medicine contains 50 mg of propylene glycol in each gram.Propylene glycol may cause skin irritation.

The medicine contains a fragrant substancewith 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 leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should 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, the patient should:

• unscrew the cap, place it upside down on the seal, and twist it to remove the seal from the tube.

The patient should 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: an amount equivalent to the size of a cherry or a walnut is sufficient.

During application, a slight cooling effect may be felt.

Voltaren Emulgel is for use on the skin only.

After using 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 disposed of in the trash.
• wait for the medicine to dry completely before taking a bath.

The medicine should not be used for more than:

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

The patient should use the smallest possible dose for the shortest possible time.

If the pain and swelling do not improve within 7 days or worsen, the patient should consult a doctor.

Using more than the recommended dose of Voltaren Emulgel

In case of using too much Voltaren Emulgel, the excess should be removed with a tissue. If the medicine is swallowed, the patient should immediately consult a doctor.

Missing a dose of Voltaren Emulgel

If a dose is missed, the patient should use the medicine as soon as they remember, and then continue with the recommended dosage. The patient should not use a double dose to make up for the missed dose.

In case of any further doubts about using this medicine, the patient should consult a doctor or pharmacist.

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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 can be serious.

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

• Rare (affecting fewer than 1 in 10,000 people using the medicine):skin rash with or without blisters; hives.
• Very rare (affecting fewer 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 the patient experiences any of the following symptoms, they should inform their doctor or pharmacist as soon as possible.

• Common (affecting fewer than 1 in 100 people using the medicine):skin rash, itching, redness, or burning of the skin.
• Very rare (affecting fewer 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 the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Post-Marketing Surveillance 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

By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Voltaren Emulgel

The medicine should be kept out of the sight and reach of children.

After use, the tube should be stored upright.

The medicine should not be stored at temperatures above 25°C.

Medicines should not be disposed of in the drainage system (sink or toilet) or household waste containers.

The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

The medicine should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.

6. Package contents 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.

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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, cetearyl caprylate, carbomer 974P, isopropyl alcohol, propylene glycol, liquid paraffin, fragrant substance (Perfume cream 45

• with benzyl benzoate, benzyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, linalool), purified water.

What Voltaren Emulgel looks like and what the package contains

White or almost white, gentle, homogeneous gel, with a creamy consistency.

The medicine is available in tubes of 50 g or 100 g.

For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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 by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
German authorization number: 520.00.03

Parallel import authorization number: 268/23

Date of leaflet approval: 30.12.2024

[Information about the trademark]
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