Leaflet: information for the user

Voltaren Emulgel 11.6 mg/g gel

Diclofenac, diethylamine

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

This medication is used in adults and adolescents over 14 years old for the local relief of mild and occasional pain and inflammation.

Do not use Voltaren Emulgel

• If you are allergic to diclofenac or any of the other components of this medication (listed in section 6).

• If you have had allergic reactions after taking medications that contain acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory drugs. The reactions may include asthma (difficulty breathing), urticaria, facial or tongue inflammation, or acute rhinitis (inflammation of the nasal mucosa).
• If you are in the last 3 months of pregnancy.

• If you are under 14 years old.

• Do not apply on wounds, lesions, redness, burns, or mucous membranes.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Voltaren Emulgel

• Apply this gel only on intact and healthy skin surfaces.

• This medication is only for external use. Do not ingest, nor apply on mucous membranes.

• Do not use occlusive or hermetic dressings.

• Do not apply the medication on the eyes. If accidentally happens, rinse the eyes with clean water and consult your doctor or pharmacist.

• Do not expose the treated area to the sun (even on cloudy days) or ultraviolet radiation lamps (UVA rays).

• Avoid applying it on large areas, or for prolonged periods of time, unless medically indicated.

• Do not use in conjunction with other topical medications on the same area.

• Do not use during the first and second trimester of pregnancy, unless medically advised.

• Stop treatment if a skin eruption occurs after applying the medication.

• Be cautious when smoking or near flames due to the risk of severe burns. Voltaren Emulgel contains paraffin, which is potentially flammable when accumulated on fabric (clothing, bedding, dressings, etc.). Washing clothing and bedding may reduce product accumulation, but does not completely eliminate it.

Children and adolescents

Do not use in children under 14 years old.

Other medications and Voltaren Emulgel

Inform your doctor or pharmacist if you are taking or have taken recently, or may take any other medication, including those purchased without a prescription.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using any medication.

Pregnancy

Due to the association of administering medications of this type with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimester of pregnancy, unless strictly necessary and recommended by your doctor.If you need treatment during this period, you should take the minimum dose possible for the shortest time possible.

In the third trimester, the administration of the medication is contraindicated.

Oral formulations (e.g., tablets) of this medication may cause adverse reactions to the fetus. It is unknown if this same risk applies to this medication when used on the skin.

Breastfeeding

This medication is not recommended for use during breastfeeding.

During breastfeeding, do not use this gel, except as advised by your doctor.

Do not apply directly to the breast area.

Driving and operating machinery

No effects of the medication on the ability to drive or operate machinery have been described.

Voltaren Emulgel contains propylene glycol

This medication contains 5 g of propylene glycol (E 1520) in 100 g, equivalent to 50 mg/g.

Propylene glycol may cause skin irritation.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication is only for application on the skin (cutaneous use).

Adults and adolescents over 14 years old

Apply 3 or 4 times a day a small amount of gel to the inflamed or painful area.

The amount of gel will vary depending on the size of the affected area (usually, it will be sufficient to apply an amount similar in size to a cherry or a walnut) (an amount of 2 to 4 grams).

Use the smallest amount for the shortest time necessary.

Apply only to intact and healthy skin surfaces (without open wounds or lesions). Avoid contact with the eyes or mucous membranes.

After application:

Hands must be cleaned with paper towels (not wet wipes) and then washed, unless they are the treatment area. The paper towel must be thrown away after use.

Before showering/bathing or washing any area of the body that includes the treated area, wait for the medication to dry on the skin.

If your symptoms do not improve after 7 days or worsen, inform your doctor.

Your doctor may evaluate your treatment after 2 weeks.

If you use more Voltaren Emulgel than you should

If you accidentally ingest the gel or have used it on a large area of the skin and for a long period of time, you may experience adverse reactions similar to those caused by diclofenac when taken orally (e.g. tablets).

The main symptoms of overdose are: digestive or renal disorders and difficulty breathing.

If you have applied too much of the medication, it is recommended to remove it by washing the affected area with plenty of water, or by removing part of it.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the toxicology information service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Voltaren Emulgel

Do not apply a double dose to compensate for the missed doses.

If you forget to apply a dose, apply the medication as soon as possible and then continue normally. If you do not remember until it is time for the next dose, apply the normal amount and continue as usual.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some rare or very rare side effects may be serious

If you experience a serious side effect,stop taking this medicine and inform your doctor immediately.

Rare:May affect up to 1 in 1,000 people

• Skin inflammation, with blisters (signs of dermatitis herpetiformis).

Very rare:May affect up to 1 in 10,000 people

• Urticaria, with purulent blisters (sign of pustular eruption). Allergic reactions such as itchy rash or buzzing in the chest, difficulty breathing or swallowing, dizziness (signs of hypersensitivity).

• Swelling in the face, lips, mouth, tongue, or throat that may cause difficulty swallowing, breathing, or speaking (signs of angioedema).

• Sudden difficulty breathing and feeling of chest tightness with buzzing or coughing (signs of asthma).

Other non-serious side effects

The following describe other side effects. If you experience any of these side effects or if they worsen, consult your doctor or pharmacist.

Frequent:May affect up to 1 in 10 people.

• Skin rash (signs of dermatitis or rash).
• Skin redness (signs of erythema).

• Itching and burning sensation in the skin (signs of pruritus and eczema).

Very rare:May affect up to 1 in 10,000 people

• Increased skin sensitivity to the sun (signs of photoallergic reactions).

Unknown:Cannot be estimated from available data

• Burning sensation at the application site.
• Dry skin.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use (www.notificaRAM.es).By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Voltaren Emulgel

The active ingredient is diclofenac diethylamine. Each gram of gel contains 11.6 mg of diclofenac diethylamine, which corresponds to 10 mg of diclofenac sodium.

The other components are: diethylamine, acrylic acid polymer, polyoxyethylene cetyl ether, ester alcohol of capric/capric acid, isopropanolol, liquid paraffin, perfume cream, propylene glycol (E 1520), purified water.

Appearance of Voltaren Emulgel and content of the packaging

White, non-greasy, creamy gel, packaged in a sealed aluminum tube with an aluminum membrane and a polypropylene screw cap, containing 60 g of gel.

Holder of the marketing authorization

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona – Spain

Responsible for manufacturing

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstraße 25

90429 Nuremberg

Germany

Last review date of this leaflet:

Other sources of information

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.