Voltaren Emulgel

Patient Information Leaflet

Voltaren Emulgel 1% gel

diclofenac diethylammonium
Read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

1. What Voltaren Emulgel is and what it is used for
2. What you need to know 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 Voltaren Emulgel is and what it is used for

Voltaren Emulgel contains the active substance diclofenac diethylammonium. Diclofenac belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs) and is used to reduce pain and inflammation.
Voltaren Emulgel is indicated for the local treatment of painful and inflammatory conditions of rheumatic or traumatic origin affecting:

• joints, e.g. osteoarthritis and arthritides
• muscles, e.g. spasms or injuries
• tendons and ligaments, e.g. tendinitis

Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using Voltaren Emulgel

Do not use Voltaren Emulgel

• if you are allergic to diclofenac diethylamine or to any of the other ingredients of this medicine (listed in section 6);
• if in the past, after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), you experienced an allergic reaction such as asthma (difficulty breathing due to inflammation and narrowing of the bronchi), angioedema (swelling of the face, lips, tongue and/or throat causing difficulty swallowing and/or breathing), urticaria (skin rash with itching), or acute rhinitis (runny nose due to acute inflammation of the nasal mucosa);
• if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”);
• if the patient is a child or adolescent under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Voltaren Emulgel.
Take special care:

• do not swallow Voltaren Emulgel; after use, wipe your hands with absorbent paper and then wash them thoroughly (see section 3);
• do not apply Voltaren Emulgel to damaged, diseased or broken skin;
• avoid letting Voltaren Emulgel come into contact with the eyes or mucous membranes (e.g. mouth or vagina). If this occurs, rinse the area immediately with running water and contact your doctor;
• do not use Voltaren Emulgel under an occlusive dressing, i.e. covering the affected area with an airtight plastic film. However, you may use Voltaren Emulgel with a breathable gauze dressing;
• if you develop skin rashes, stop treatment with Voltaren Emulgel;
• if you use diclofenac over large areas of skin and for prolonged periods, you may experience systemic adverse effects; do not exceed the recommended dose.

Children and adolescents
Voltaren Emulgel must not be used in children and adolescents under 14 years of age.
Other medicines and Voltaren Emulgel
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other
medicines, including those without a prescription.
It is unlikely that Voltaren Emulgel will interact with other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Diclofenac should not be used during the first and second trimesters of pregnancy unless clearly necessary.
If you are trying to become pregnant, or are in the first or second trimester of pregnancy and need to use diclofenac, use the lowest possible dose for the shortest possible time.
Diclofenac must not be used during the third trimester of pregnancy, as it may cause harm to the unborn baby and to the mother if taken during this period.
Breastfeeding
Diclofenac passes into breast milk in small amounts. You must not use Voltaren Emulgel while breastfeeding unless you have first consulted your doctor.
If you are breastfeeding, do not apply Voltaren Emulgel to the breast, over large areas of skin, or for prolonged periods.

Driving and using machines
Voltaren Emulgel does not impair the ability to drive or operate machinery.

Voltaren Emulgel contains propylene glycol and benzyl benzoate
Voltaren Emulgel contains 200 mg of propylene glycol per dose (4 g), equivalent to 50 mg/g, and 4 mg of benzyl benzoate per dose (4 g), equivalent to 1 mg/g, which may cause skin irritation.
Voltaren Emulgel contains fragrance Cream 45, a scent which itself contains benzyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, and linalool, which may cause allergic reactions.

3. How to use Voltaren Emulgel

Use this medicine exactly as described in this leaflet, or as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

Use in adults
Apply Voltaren Emulgel 3 or 4 times a day to the affected area and gently rub in. The amount of medicine to use depends on the size of the area to be treated (amount varying from cherry-sized to walnut-sized).

Use Voltaren Emulgel only on the skin, for short periods of time, and use no more than the necessary amount.

Use in adolescents aged 14 to 18 years
Apply Voltaren Emulgel 3 or 4 times a day to the affected area and gently rub in. The amount of medicine to use depends on the size of the area to be treated (amount varying from cherry-sized to walnut-sized).

Consult your doctor if the condition does not improve within 7 days of starting treatment with Voltaren Emulgel or if symptoms worsen.

Use in children under 14 years of age
Voltaren Emulgel must not be used in children under 14 years of age.

Use in elderly patients (over 65 years of age)
Elderly patients may use the doses recommended for adults.

How to use Voltaren Emulgel
Tube of 60 g, 100 g, 120 g and 150 g
To remove the seal at first use:

• unscrew and remove the cap
• use the back of the cap to remove the seal from the tube

Pressurised container of 50 g

• To dispense the gel, press the dispenser for sufficient time to release the required amount of gel.
• Gently squeeze the tube so that a small amount of gel comes out, then apply it to the painful or swollen area, massaging slowly until absorbed.

After application:

• clean your hands with absorbent paper and then wash them, unless the hands are the area being treated. The absorbent paper must be disposed of in household waste after use.
• wait for Voltaren Emulgel to dry before taking a shower or bath.

If you use more Voltaren Emulgel than you should
If you ingest or use an excessive dose of Voltaren Emulgel, contact your doctor immediately or go to the nearest hospital.

After application to the skin, the amount of diclofenac that reaches the bloodstream is very low, so it is unlikely that overdose effects will occur.
If you swallow the contents of a tube of Voltaren Emulgel, you may experience adverse effects similar to those observed after ingestion of an excessive dose of diclofenac tablets.

If you forget to use Voltaren Emulgel
Do not use a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Common side effects (may affect up to 1 in 10 people)

• various skin reactions characterized by rash, skin irritation, redness, itching and swelling (dermatitis, eczema).

Rare side effects (may affect up to 1 in 1,000 people)

• skin inflammation with blister formation (bullous dermatitis).

Very rare side effects (may affect up to 1 in 10,000 people)

• allergic reactions including urticaria
• angioedema (swelling of the face, lips, tongue and/or throat with difficulty in swallowing and/or breathing)
• skin rash with appearance of pustules
• asthma (difficulty breathing caused by inflammation and narrowing of the bronchi)
• appearance of spots or redness on the skin following exposure to sunlight or sunlamps.

Side effects with unknown frequency

• burning sensation at the site of application
• dry skin.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Voltaren Emulgel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Tube of 60 g, 100 g, 120 g, 2 tubes of 60 g and tube of 150 g.
Store below 30°C. The medicine can be used for 3 years after first opening.
Pressurised container of 50 g
Store below 30°C. The medicine can be used for 1 year after first opening.
Mark the date of first opening of the container in the designated space on the packaging.
Keep the medicine away from light. Do not pierce or burn the container, even after use.
Do not dispose of any medicine via wastewater (e.g. toilet or sink). Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Voltaren Emulgel contains

• The active substance is diethylamine diclofenac. 100 g of gel contain 1.16 g of diethylamine diclofenac (equivalent to 1 g of sodium diclofenac).
• The other components are diethylamine, carbomers, macrogol cetostearyl ether, coco-caproyl caprate, isopropyl alcohol, liquid paraffin, Cream 45 fragrance (contains benzyl benzoate), propylene glycol, purified water. This medicine contains 50 mg of propylene glycol per gram of gel and 1 mg of benzyl benzoate per gram of gel.

Description of the appearance of Voltaren Emulgel and contents of the pack
Voltaren Emulgel is a creamy, homogeneous, soft gel for topical use, white or almost white in appearance.
Tubes of 60 g, 100 g, 120 g, two tubes of 60 g, and tube of 150 g.
Each pack contains one tube of 60 g or 100 g or 120 g or two tubes of 60 g or one tube of 150 g of 1% gel.
Pressurized container of 50 g.
Each pack contains one pressurized container of 50 g of 1% gel.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Novartis Farma S.p.A.,
Origgio (VA)
Marketing Authorization Holder for Sale
GlaxoSmithKline Consumer Healthcare Srl,
Via Zambeletti s.n.c.
Baranzate (MI)
Manufacturer
Tubes of 60 g, 100 g, 120 g, two tubes of 60 g, and tube of 150 g:
Novartis Farma S.p.A
Via Provinciale Schito, 131
Torre Annunziata (NA) – Italy
Novartis Pharma Produktions GmbH
Oeflingerstrasse, 44 Baden Wehr
Germany
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
Barthstraße 4
80339 Munich
Germany
Purna Pharmaceuticals NV
Rijksweg 17,
B-2870 Puurs
Belgium
Pressurized container of 50 g:
Novartis Farma S.p.A
Via Provinciale Schito, 131
Torre Annunziata (NA) – Italy

Patient Information Leaflet

Voltaren Emulgel 1% gel

diclofenac diethylammonium
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

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

Voltaren Emulgel contains the active substance diclofenac diethylammonium. Diclofenac belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs) and is used to reduce pain and inflammation.
Voltaren Emulgel is indicated for the local treatment of painful and inflammatory conditions of rheumatic or traumatic origin affecting:

• joints, e.g. osteoarthritis and arthritides
• muscles, e.g. spasms or injuries
• tendons and ligaments, e.g. tendinitis

Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using Voltaren Emulgel

Do not use Voltaren Emulgel

• if you are allergic to diclofenac diethylammonium or to any of the other ingredients of this medicine (listed in section 6);
• if in the past, after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), you experienced an allergic reaction such as asthma (difficulty breathing due to inflammation and narrowing of the bronchi), angioedema (swelling of the face, lips, tongue and/or throat causing difficulty swallowing and/or breathing), urticaria (skin rash with itching), or acute rhinitis (runny nose due to acute inflammation of the nasal mucosa);
• if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”);
• if the patient is a child or adolescent under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Voltaren Emulgel.
Take particular care:

• do not swallow Voltaren Emulgel; after use, if you come into contact with the gel, clean your hands with absorbent paper and then wash them (see section 3);
• do not apply Voltaren Emulgel to damaged, diseased or broken skin;
• avoid letting Voltaren Emulgel come into contact with the eyes or mucous membranes, for example those of the mouth or vagina. If this occurs, rinse the area immediately with running water and contact your doctor;
• do not use Voltaren Emulgel under an occlusive dressing, i.e. covering the affected area with an airtight plastic film. However, you may use Voltaren Emulgel with a gauze dressing that allows air to pass through;
• if you develop skin rashes, stop treatment with Voltaren Emulgel;
• if you use diclofenac over large areas of skin and for prolonged periods, you may experience systemic adverse effects; do not exceed the recommended dose.

Children and adolescents
Voltaren Emulgel must not be used in children and adolescents under 14 years of age.
Other medicines and Voltaren Emulgel
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those not requiring a prescription.
It is unlikely that Voltaren Emulgel will interact with other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Diclofenac should not be used during the first and second trimesters of pregnancy unless clearly necessary.
If you are trying to become pregnant or are in the first or second trimester of pregnancy and need to use diclofenac, use the lowest possible dose for the shortest possible time.
Diclofenac must not be used during the third trimester of pregnancy, as it may cause harm to the unborn baby and to the mother if taken during this period.
Breastfeeding
Diclofenac passes into breast milk in small amounts. You must not use Voltaren Emulgel while breastfeeding unless you have first consulted your doctor.
If you are breastfeeding, do not apply Voltaren Emulgel to the breast, over large areas of skin, or for prolonged periods.
Driving and using machines
Voltaren Emulgel does not impair the ability to drive or operate machinery.
Voltaren Emulgel contains propylene glycol and benzyl benzoate
Voltaren Emulgel contains 200 mg of propylene glycol per dose (4 g), equivalent to 50 mg/g, and 4 mg of benzyl benzoate per dose (4 g), equivalent to 1 mg/g, which may cause skin irritation.
Voltaren Emulgel contains fragrance Cream 45, a scent which itself contains benzyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, and linalool, which may cause allergic reactions.

3. How to use Voltaren Emulgel

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Use in adults
Apply Voltaren Emulgel 3 or 4 times a day to the affected area and rub in gently. The amount of medicine to use depends on the size of the area to be treated (amount varying between that of a cherry and a walnut).
Use Voltaren Emulgel only on the skin, for short periods of time, and use no more than the necessary amount.

Use in adolescents aged 14 to 18 years
Apply Voltaren Emulgel 3 or 4 times a day to the affected area and rub in gently. The amount of medicine to use depends on the size of the area to be treated (amount varying between that of a cherry and a walnut).
Consult your doctor if the condition does not improve within 7 days of starting treatment with Voltaren Emulgel or if symptoms worsen.

Use in children under 14 years of age
Voltaren Emulgel must not be used in children under 14 years of age.

Use in elderly patients (over 65 years of age)
Elderly patients may use the doses recommended for adults.

How to use Voltaren Emulgel
120 g tube with applicator cap

1. To remove the seal for first use (see Figure 1): remove the transparent cap and unscrew the applicator cap. Use the star-shaped groove on the side of the applicator cap to remove the safety seal from the tube. Screw the applicator cap back onto the tube before dispensing the gel.
2. To open the applicator cap (see Figure 1): pull the white part. Gently press the tube so that the gel emerges onto the applicator surface. Use the applicator to slowly and gently massage the gel into the affected area. The light pressure of the massage automatically closes the white part of the applicator.
3. After use (see Figure 1): clean the applicator with a cotton cloth or paper towel until it appears dry and clean. Do not rinse or immerse in water. Do not use solvents or detergents to clean the applicator surface. After cleaning, replace the transparent protective cap on the tube before storing. Do not reuse the applicator with another tube. Dispose of the tube and applicator according to standard procedures for medicinal waste disposal.

Figure 1:
Remove the transparent protective cap
Unscrew the applicator cap
Use the groove on the applicator cap to remove the safety seal from the tube
Screw the applicator cap back onto the tube
Pull the white part to open
Press the tube to dispense the required amount of Emulgel
Spread on the skin, applying light pressure to automatically close the white part
Clean the applicator with a cotton cloth or paper towel until it appears dry and clean.

After application:

• Clean your hands with a paper towel and then wash them, unless the hands are the area being treated. Used paper towels should be disposed of in household waste.
• Wait until Voltaren Emulgel has dried before taking a shower or bath.

If you use more Voltaren Emulgel than you should
If you ingest or apply too much Voltaren Emulgel, contact your doctor immediately or go to the nearest hospital.
After application to the skin, the amount of diclofenac that reaches the bloodstream is very low, so it is unlikely that overdose effects will occur.
If you ingest the contents of a tube of Voltaren Emulgel, you may experience adverse effects similar to those observed after an overdose of diclofenac tablets.

If you forget to use Voltaren Emulgel
Do not apply a double dose to make up for a missed application.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Common side effects (may affect up to 1 in 10 people)

• various skin reactions characterized by rash, skin irritation, redness, itching and swelling (dermatitis, eczema).

Rare side effects (may affect up to 1 in 1,000 people)

• skin inflammation with blister formation (bullous dermatitis).

Very rare side effects (may affect up to 1 in 10,000 people)

• allergic reactions including urticaria
• angioedema (swelling of the face, lips, tongue and/or throat with difficulty swallowing and/or breathing)
• skin rash with appearance of pustules
• asthma (difficulty breathing caused by inflammation and narrowing of the bronchi)
• appearance of spots or redness on the skin following exposure to sunlight or sunlamps.

Side effects with unknown frequency

• burning sensation at the application site
• dry skin.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Voltaren Emulgel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
120 g tube with applicator cap
Store below 30°C. The medicine can be used for 3 years after first opening.
Do not dispose of medicines via wastewater (e.g. toilet or sink). Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Voltaren Emulgel contains

• The active substance is diethylammonium diclofenac. 100 g of gel contain 1.16 g of diethylammonium diclofenac (equivalent to 1 g of sodium diclofenac).
• The other ingredients are diethylamine, carbomers, macrogol cetyl stearyl ether, coco-caprylocaprate, isopropyl alcohol, liquid paraffin, Cream 45 fragrance (contains benzyl benzoate), propylene glycol, purified water. This medicine contains 50 mg of propylene glycol per gram of gel and 1 mg of benzyl benzoate per gram of gel.

Description of the appearance of Voltaren Emulgel and package contents
Voltaren Emulgel is a topical gel with a creamy, homogeneous, soft appearance, white or almost white.
120 g tube with an applicator cap.
Each package contains one 120 g tube of 1% gel with an applicator cap.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Novartis Farma S.p.A.,
Origgio (VA)

Responsible for sales
GlaxoSmithKline Consumer Healthcare Srl,
Via Zambeletti s.n.c.
Baranzate (MI)

Manufacturer
120 g tube with applicator cap
Novartis Farma S.p.A
Via Provinciale Schito, 131
Torre Annunziata (NA) – Italy
Novartis Pharma Produktions GmbH
Oeflingerstrasse, 44 Baden Wehr
Germany
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
Barthstraße 4
80339 Munich
Germany

Patient Information Leaflet

Voltaren Emulgel 2% gel

diclofenac diethylammonium
Read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

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

Voltaren Emulgel contains the active substance diclofenac diethylamine. Diclofenac belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs) and is used to reduce pain and inflammation.
Voltaren Emulgel contains a component, oleic alcohol, which facilitates skin penetration.
Voltaren Emulgel is indicated for the local treatment of painful and inflammatory conditions of rheumatic or traumatic origin affecting:

• joints, e.g. osteoarthritis and arthritis
• muscles, e.g. muscle spasms or injuries
• tendons and ligaments, e.g. tendinitis

Consult your doctor if you do not feel better or feel worse after 7 days.

2. What you should know before using Voltaren Emulgel

Do not use Voltaren Emulgel

• if you are allergic to diclofenac diethylammonium or to any of the other ingredients of this medicine (listed in section 6);
• if in the past, after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), you experienced an allergic reaction manifested by asthma (difficulty breathing caused by inflammation and narrowing of the bronchi), angioedema (swelling of the face, lips, tongue and/or throat with difficulty swallowing and/or breathing), urticaria (skin rash with itching), or acute rhinitis (runny nose due to acute inflammation of the nasal mucosa);
• if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”);
• if the patient is a child or adolescent under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Voltaren Emulgel.
Be especially careful:

• do not swallow Voltaren Emulgel; after use, clean your hands with absorbent paper and then wash them (see section 3);
• do not apply Voltaren Emulgel to damaged, diseased or broken skin;
• avoid letting Voltaren Emulgel come into contact with the eyes or mucous membranes, for example of the mouth or vagina. If this occurs, immediately rinse the area with running water and contact your doctor;
• do not use Voltaren Emulgel under an occlusive dressing, i.e. covering the affected area with an airtight plastic film. However, you may use Voltaren Emulgel with a breathable gauze dressing;
• if you develop skin rashes, stop treatment with Voltaren Emulgel;
• if you use diclofenac over large areas of skin and for long periods of time, you may experience unwanted effects affecting the whole body; do not exceed the recommended dose.

Children and adolescents
Voltaren Emulgel must not be used in children and adolescents under 14 years of age.
Other medicines and Voltaren Emulgel
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those not requiring a prescription.
It is unlikely that Voltaren Emulgel will interact with other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Diclofenac should not be used during the first and second trimesters of pregnancy unless strictly necessary. If you are trying to become pregnant or are in the first or second trimester of pregnancy and need to use diclofenac, use the lowest possible dose for the shortest possible time.
Diclofenac must not be used during the third trimester of pregnancy because it may cause harm to the unborn child and the mother if taken during this period.
Breastfeeding
Diclofenac passes into breast milk in small amounts.
However, you must not use Voltaren Emulgel while breastfeeding unless you have first consulted your doctor.
If you are breastfeeding, do not apply Voltaren Emulgel to the breast, over large areas of skin, or for prolonged periods of time.
Driving and using machines
Voltaren Emulgel does not affect your ability to drive or operate machinery.
Voltaren Emulgel contains propylene glycol and butylated hydroxytoluene
Voltaren Emulgel contains 200 mg of propylene glycol per dose (4 g), equivalent to 50 mg/g, which may cause skin irritation. Voltaren Emulgel contains butylated hydroxytoluene, which may cause localized skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
Voltaren Emulgel contains eucalyptus fragrance, an aroma which itself contains benzyl alcohol, citronellol, coumarin, d-limonene, eugenol, geraniol, linalool, which may cause allergic reactions.

3. How to use Voltaren Emulgel

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Use in adults
Apply Voltaren Emulgel twice daily to the affected area and gently rub in. Apply Voltaren Emulgel preferably in the morning and evening. The effect of Voltaren Emulgel lasts up to 12 hours after application.
The amount of medicine to use depends on the size of the area to be treated (amount varying between that of a cherry and a walnut).
Use Voltaren Emulgel only on the skin, for short periods of time, and use no more than the necessary amount.
Do not use Voltaren Emulgel for longer than 14 days without medical advice.
Consult your doctor if symptoms persist or worsen after 7 days of treatment.
Use in adolescents aged 14 to 18 years
Apply Voltaren Emulgel twice daily (preferably in the morning and evening) to the affected area and gently rub in. The amount of medicine to use depends on the size of the area to be treated (amount varying between that of a cherry and a walnut).
Consult your doctor if the condition does not improve within 7 days of starting treatment with Voltaren Emulgel or if symptoms worsen.
Use in children under 14 years of age
Voltaren Emulgel must not be used in children under 14 years of age.
Use in elderly patients (over 65 years of age)
Elderly patients may use the doses recommended for adults.
How to use Voltaren Emulgel
20 g, 60 g, 100 g, 150 g tubes with screw cap (triangular or round):
To remove the seal at first use:

• unscrew and remove the cap
• use the back of the cap to pierce and remove the seal from the tube
• gently squeeze the tube so that a small amount of gel comes out, then apply it to the painful or swollen area, massaging slowly until absorbed

100 g tube with snap-off cap:

1. Lift the lid (Figure 1)

To easily open the snap-off cap, use a finger, the thumb, the side of the hand,
or even the edge of a table to lift the lower part of the lid. You will hear
a "click". The anti-tampering tabs, located on each side of the snap-off cap,
will break when the cap is opened for the first time.
Before using the product for the first time, check that the tamper-evident tabs
are not broken.
Fig. 1

2. Squeeze the tube to dispense the gel and apply it (Figure 2)

Gently squeeze the tube so that a small amount of gel comes out
and apply it to the painful or swollen area, massaging slowly until
fully absorbed. The amount of medication to use depends on the size
of the painful or swollen area to be treated (amount ranging from
cherry-sized to walnut-sized).
You may feel a slight cooling sensation when applying the gel.
Fig.2

3. Press the cap to close it (Figure 3)

After use, if necessary, remove any remaining gel from the snap cap using a cotton or paper towel until it appears clean and dry. To close the snap cap, press down on the cap with your fingers, the side of your hand, or against the edge of a table or other flat surface until you hear a "click". Hold the tube with the cap facing upwards when opening or closing it to prevent the gel from leaking out.
Fig.3
After application:

• Clean your hands with a paper towel and then wash them, unless your hands are the area being treated. Used paper towels should be disposed of in household waste after use.
• Wait for Voltaren Emulgel to dry before taking a shower or bath.

If you use more Voltaren Emulgel than you should
If Voltaren Emulgel is swallowed or used in excess, contact your doctor immediately or go to the nearest hospital.
After application to the skin, the amount of diclofenac that enters the bloodstream is very low, so it is unlikely that overdose effects will occur.
However, if you swallow the contents of a tube of Voltaren Emulgel, you may experience adverse effects similar to those observed after swallowing an excessive dose of diclofenac tablets.

If you forget to use Voltaren Emulgel
Do not apply a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Common side effects (may affect up to 1 in 10 people)

• various skin reactions characterized by rash, skin irritation, redness, itching and swelling (dermatitis, eczema).

Rare side effects (may affect up to 1 in 1,000 people)

• skin inflammation with blister formation (bullous dermatitis).

Very rare side effects (may affect up to 1 in 10,000 people)

• allergic reactions including urticaria
• angioedema (swelling of the face, lips, tongue and/or throat with difficulty in swallowing and/or breathing)
• skin rash with appearance of pustules
• asthma (difficulty breathing caused by inflammation and narrowing of the bronchi)
• appearance of spots or redness on the skin following exposure to sunlight or sunbeds.

Side effects with unknown frequency

• burning sensation at the site of application
• dry skin.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Voltaren Emulgel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater (e.g. toilet or sink). Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Voltaren Emulgel contains

• The active substance is diclofenac diethylammonium. 100 g of gel contain 2.32 g of diclofenac diethylammonium (equivalent to 2 g of sodium diclofenac).
• The other ingredients are butylhydroxytoluene, carbomers, coco-caprylocaprate, diethylamine, isopropyl alcohol, liquid paraffin, macrogol cetostearyl ether, oleic alcohol, propylene glycol, eucalyptus globulus fragrance, purified water. This medicine contains 50 mg of propylene glycol per gram of gel and 0.2 mg of butylhydroxytoluene per gram of gel.

Description of the appearance of Voltaren Emulgel and contents of the pack
Voltaren Emulgel is a topical gel with a creamy, homogeneous, soft appearance, white or almost white.
Each pack contains a tube of 20 g, 60 g, 100 g or 150 g of 2% gel.

Marketing Authorization Holder
Novartis Farma S.p.A.
Origgio (VA)
Selling Agent
GlaxoSmithKline Consumer Healthcare S.r.l.
Via Zambeletti s.n.c.
Baranzate (MI)
Manufacturer
Novartis Farma S.p.A.
Via Provinciale Schito, 131
Torre Annunziata (NA) – Italy
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
Barthstraße 4
80339 Munich
Germany