VOLTAREN EMULGEL 11.6 mg/g GEL

Introduction

Package Leaflet: Information for the User

Voltaren Emulgel 11.6 mg/g Gel

Diclofenac, Diethylamine

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Voltaren Emulgel and what is it used for
2. What you need to know before you start using Voltaren Emulgel
3. How to use Voltaren Emulgel
4. Possible side effects
5. Storage of Voltaren Emulgel

1. Contents of the Pack and Further Information

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

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

2. What you need to know before you start using Voltaren Emulgel

Do not use Voltaren Emulgel

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

• If you have had allergic reactions after taking medicines containing acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs. Reactions can include asthma (difficulty breathing), hives, facial or tongue swelling, 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 to wounds, reddened lesions, burns, or mucous membranes.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Voltaren Emulgel

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

• This medicine is for external use only. It must not be ingested or applied to mucous membranes.

• Do not use occlusive or airtight dressings.

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

• Do not expose the treated area to sunlight (even if cloudy) or to ultraviolet radiation lamps (UVA rays).

• Avoid applying it to large areas or for prolonged periods, unless medically indicated.

• Do not use in combination with other topical medicines on the same area.

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

• You should stop treatment if a skin rash occurs after applying the medicine.

• Be careful 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 the accumulation of products, but it does not eliminate it completely.

Children and Adolescents

Do not use in children under 14 years old.

Other Medicines and Voltaren Emulgel

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including those obtained without a prescription.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Because the administration of this type of medicine has been associated with an increased risk of congenital anomalies/abortions, it is not recommended 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 for the shortest possible time.

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

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

Breastfeeding

The use of this medicine is not recommended during breastfeeding.

During breastfeeding, do not use this gel unless your doctor has indicated it.

Under no circumstances should it be applied directly to the breast area.

Driving and Using Machines

No effects of the medicine on the ability to drive or use machines have been described.

Voltaren Emulgel contains Propylene Glycol

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

Propylene glycol may cause skin irritation.

3. How to use Voltaren Emulgel

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

This medicine is for cutaneous use only (external 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 (normally, it will be sufficient to apply an amount similar to the size of a cherry or a walnut) (an amount of 2 to 4 grams).

Use the smallest amount necessary for the shortest duration possible.

Apply only to intact and healthy skin surfaces (without open wounds or lesions). It should be avoided to come into contact with the eyes or mucous membranes.

After application:

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

Before showering/bathing or washing any part of the body that includes the treated area, you should wait until the medicine has dried 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 if you have used it on a large skin area and for a long period, adverse reactions similar to those produced by diclofenac when taken orally (e.g., tablets) may occur.

The main symptoms of overdose are: gastrointestinal or kidney disorders and difficulty breathing.

If you have applied too much of the medicine, it is recommended to eliminate it by washing the affected area with plenty of water or by removing a 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 medicine and the amount ingested.

If you forget to use Voltaren Emulgel

Do not apply a double dose to make up for forgotten doses.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some rare or very rare side effects can be serious

If you experience any serious side effect, stop treatment with this medicine and inform your doctor immediately.

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

• Skin inflammation with blisters (signs of bullous dermatitis).

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

• Hives with pus-filled blisters (sign of pustular eruption). Allergic reactions such as rash with itching or wheezing in the chest, difficulty breathing or swallowing, dizziness (signs of hypersensitivity).

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

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

Other non-serious side effects

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

Common:May affect up to 1 in 10 people.

• Skin rash (signs of dermatitis or rash).
• Redness of the skin (signs of erythema).

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

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

• Increased sensitivity of the skin to sunlight (signs of photosensitivity reactions).

Not Known:Cannot be estimated from the available data

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

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Voltaren Emulgel

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

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Voltaren Emulgel

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

The other ingredients are: diethylamine, acrylic acid polymer, polyoxyethylene cetylether, capric/caprylic acid ester of alcohol, isopropanol, liquid paraffin, perfume cream, propylene glycol (E 1520), purified water.

Appearance of Voltaren Emulgel and Contents of the Pack

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.

Marketing Authorisation Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona – Spain

Manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstraße 25

90429 Nuremberg

Germany

Date of Last Revision of this Package Leaflet:

Other Sources of Information

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es./