VOLTAREN 1 % Гель

Содержание инструкции

1. Voltaren Emulgel 1 % gel
   1. What is Voltaren Emulgel and what is it 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
2. Voltaren Emulgel 1 % gel
   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
3. Voltaren Emulgel 2 % gel
   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. Lift the cap (Figure 1)
   5. Press the tube to dispense the gel and apply it (Figure 2)
   6. Press on the cap to close it (Figure 3)
   7. Possible side effects
   8. How to store Voltaren Emulgel
   9. Contents of the pack and other information

Voltaren Emulgel 1 % gel

diclofenac diethylammonium

Read this leaflet carefully before usingthis 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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 is Voltaren Emulgel and what is it used for

Voltaren Emulgel contains the active ingredient 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 arthritis
• muscles, e.g. contractures or injuries
• tendons and ligaments, e.g. tendinitis

See a 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 VoltarenEmulgel

• if you are allergic to diethylammonium diclofenac or 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 have had an allergic reaction that manifested with 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 (itchy skin rash), or acute rhinitis (runny nose for acute forms of 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.
Pay particular attention:

• do not ingest Voltaren Emulgel; after use, clean your hands with absorbent paper and then wash them (see section 3);
• do not apply Voltaren Emulgel to broken, diseased skin or open wounds;
• avoid getting Voltaren Emulgel into your eyes or mucous membranes such as the mouth or vagina. If this happens, immediately wash the area with running water and contact your doctor;
• do not use Voltaren Emulgel with an occlusive bandage, i.e. covering the affected area with a plastic film that does not allow air to pass through. You can instead use Voltaren Emulgel with a gauze that allows air to pass through;
• if you develop skin rashes, stop treatment with Voltaren Emulgel;
• if you use diclofenac on large areas of skin and for long periods of time, you may experience side effects that affect the whole body; do not exceed the recommended dose.

Children and adolescents
Voltaren Emulgel should not be used in children and adolescents under 14 years of age.

Other medicines and VoltarenEmulgel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
It is unlikely that Voltaren Emulgel will interact with other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Diclofenac should not be used during the first and second trimester of pregnancy unless absolutely necessary.
If you wish to become pregnant or are in the first or second trimester of pregnancy and need to use diclofenac, take
the lowest dose of diclofenac for the shortest possible time.
Diclofenac should not be used during the third trimester of pregnancy because it can cause harm to
the baby and the mother if taken during this period.
Breastfeeding
Diclofenac passes into breast milk in small amounts. Do not use Voltaren Emulgel during
breastfeeding unless you have first consulted your doctor.
If you are breastfeeding, do not apply Voltaren Emulgel to the breast, to large areas of skin and for long periods of
time.

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

VoltarenEmulgel 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 Cream 45 fragrance, a flavour in turn containing benzyl alcohol, citral,
citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, linalool which may cause allergic
reactions.

3. How to use Voltaren Emulgel

Use this medicine following the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Use in adults
Apply Voltaren Emulgel 3 or 4 times a day to the area to be treated and rub in gently. The amount of
medicine to use depends on the extent of the area to be treated (amount varying between a cherry and a
walnut).
Use Voltaren Emulgel only on the skin, for short periods of time and not more than the necessary amount.

Use in adolescents between 14 and 18 years of age
Apply Voltaren Emulgel 3 or 4 times a day to the area to be treated and rub in gently. The amount of
medicine to use depends on the extent of the area to be treated (amount varying between 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 you notice a worsening of symptoms.

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 can 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 for the first use:

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

Pressurized container of 50 g

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

After application:

• clean your hands with paper towel and then wash them, unless they are the area to be treated. The paper towel should be discarded in household waste after use.
• wait for Voltaren Emulgel to dry before showering or bathing.

If you use more VoltarenEmulgel than you should
If you swallow or use an excessive dose of Voltaren Emulgel, inform your doctor immediately or
go to the nearest hospital.
After application to the skin, the amount of diclofenac that reaches the blood is very low, so it is
unlikely that effects due to an excessive dose will occur.
If you swallow the contents of a tube of Voltaren Emulgel, you may experience undesirable effects similar to those
observed after swallowing an excessive dose of diclofenac tablets.

If you forget to use VoltarenEmulgel
Do not use a double dose to make up for a missed dose.
If you have any doubts about using this medicine, ask 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)

• skin reactions of various types 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 the appearance of blisters (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)
• rash with the 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 get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 which is reported on the packaging after Expiry. 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 at a temperature below 30°C. The medicine can be used for 3 years after first opening.
Pressurized container of 50 g
Store at a temperature 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 appropriate space on the packaging.
Store the medicine protected from light. Do not puncture and burn the container, even after
use.
Do not dispose of any medicine in 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 VoltarenEmulgelcontains

• The active ingredient is diclofenac diethylammonium. 100 g of gel contains 1.16 g of diclofenac diethylammonium (equivalent to 1 g of diclofenac sodium).
• The other components are diethylamine, carbomers, macrogol cetostearyl ether, caprylic/capric triglyceride, 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 VoltarenEmulgel and package contents
Voltaren Emulgel is a gel for topical use with a creamy, homogeneous, soft, white or almost
white appearance.
Tube containing 60 g, 100 g, 120 g, 2 tubes of 60 g and tube containing 150 g
Each pack contains a tube of 60 g or 100 g or 120 g or 2 tubes of 60 g or a tube of 150 g of 1% gel.
Pressurized container of 50 g
Each pack contains a pressurized container of 50 g of 1% gel.
Not all pack sizes may be marketed.

Marketing authorisation holder
Novartis Farma S.p.A.,
Origgio (VA)

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

Manufacturer
Tube containing 60 g, 100 g, 120 g, 2 tubes of 60 g and tube containing 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

Voltaren Emulgel 1 % gel

diclofenac diethylammonium

Read this leaflet carefully before you usethis medicine because 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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 you use 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 ingredient 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 arthritis
• muscles, e.g. contractures or injuries
• tendons and ligaments, e.g. tendinitis

See a 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 VoltarenEmulgel

• if you are allergic to diethylammonium diclofenac or 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 have had an allergic reaction that manifested with 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 (itchy rash), or acute rhinitis (runny nose for acute forms of 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.
Pay particular attention:

• do not ingest Voltaren Emulgel; after use, in case of contact with the gel, clean your hands with absorbent paper and then wash them (see section 3);
• do not apply Voltaren Emulgel to broken, diseased or wounded skin;
• avoid getting Voltaren Emulgel into your eyes or mucous membranes such as the mouth or vagina. If this happens, wash the area immediately with running water and contact your doctor;
• do not use Voltaren Emulgel with an occlusive bandage, i.e. covering the affected area with a plastic film that does not allow air to pass through. You can instead use Voltaren Emulgel with a gauze that allows air to pass through;
• if you develop skin rashes, stop treatment with Voltaren Emulgel;
• if you use diclofenac on large areas of skin and for long periods of time, you may experience undesirable effects that affect the whole body; do not exceed the recommended dose.

Children and adolescents
Voltaren Emulgel should not be used in children and adolescents under 14 years of age.

Other medicines and VoltarenEmulgel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
It is unlikely that Voltaren Emulgel will interact with other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Diclofenac should not be used during the first and second trimesters of pregnancy unless in cases of
actual necessity.
If you wish to become pregnant or are in the first or second trimester of pregnancy and need to use diclofenac, take
the lowest dose of diclofenac for the shortest possible time.
Diclofenac should not be used during the third trimester of pregnancy because it can cause harm to
the child and mother if taken during this period.
Breastfeeding
Diclofenac passes into breast milk in small amounts. Do not use Voltaren Emulgel during
breastfeeding unless you have first consulted your doctor.
If you are breastfeeding, do not apply Voltaren Emulgel to the breast, to large areas of skin and for long periods of
time.

Driving and operating machinery
Voltaren Emulgel does not impair the ability to drive vehicles or operate machinery.

VoltarenEmulgel 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 Cream 45 fragrance, a flavour in turn containing benzyl alcohol, citral,
citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, linalool which may cause allergic
reactions.

3. How to use Voltaren Emulgel

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

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

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

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

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

How to use Voltaren Emulgel
120 g tube with applicator cap

• 1. To remove the seal on 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 squeezing out the gel.
• 2. To open the applicator cap (see figure 1): pull the white part. Gently squeeze the tube so that the gel comes out onto the surface of the applicator. Use the applicator on the tube to massage the gel slowly and gently onto the area to be treated. The slight 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 it in water. Do not use solvents or detergents to clean the surface of the applicator. After cleaning, reposition the protective transparent cap on the tube before storing it. Do not reuse the applicator with another tube. Dispose of the tube and applicator following the normal procedures for disposing of medicines in force.

Figure 1:
Remove the protective transparent 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
Squeeze the tube to release the necessary amount of Emulgel
Spread on the skin, pressing lightly to 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 paper towel and then wash them, unless they are the site to be treated. The paper towel should be thrown away with household waste after use.
• wait for Voltaren Emulgel to dry before showering or bathing.

If you use more VoltarenEmulgel than you should
In case of ingestion or use of an excessive dose of Voltaren Emulgel, immediately inform your doctor or go to the nearest hospital.
After application to the skin, the amount of diclofenac that reaches the blood is very low, so it is unlikely that effects due to an excessive dose will occur.
If you ingest the contents of a tube of Voltaren Emulgel, you may experience undesirable effects similar to those observed after ingestion of an excessive dose of diclofenac tablets.

If you forget to use VoltarenEmulgel
Do not use a double dose to make up for a missed dose.
If you have any doubts about using this medicine, ask 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)

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

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

• skin inflammation with the appearance of blisters (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)
• rash with the 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 get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 which is reported on the packaging after Expiry. The date
of expiry refers to the last day of that month.
Tube of 120 g with applicator cap
Store at a temperature below 30°C. The medicine can be used for 3 years after first opening.
Do not dispose of any medicine in wastewater (for example toilet or sink). Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What VoltarenEmulgelcontains

• The active ingredient is diclofenac diethylammonium. 100 g of gel contain 1.16 g of diclofenac diethylammonium (equivalent to 1 g of diclofenac sodium).
• The other ingredients are diethylamine, carbomers, macrogol cetostearyl ether, caprylic/capric triglyceride, 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 VoltarenEmulgel and contents of the pack
Voltaren Emulgel is a gel for topical use with a creamy, homogeneous, soft, white or almost
white appearance.
120 g tube with applicator cap
Each pack contains a 120 g tube of 1% gel with applicator cap.
Not all pack sizes may be marketed.

Marketing authorisation holder
Novartis Farma S.p.A.,
Origgio (VA)

Distributor for sale
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

Voltaren Emulgel 2 % gel

diclofenac diethylammonium

Read this leaflet carefully before usingthis 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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse 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 ingredient diclofenac diethylammonium. 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. contractures or injuries
• tendons and ligaments, e.g. tendinitis

See 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 VoltarenEmulgel

• if you are allergic to diethylammonium diclofenac or 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 have had an allergic reaction that manifested as 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 (itchy skin rash), or acute rhinitis (runny nose for acute forms of 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.
Pay particular attention:

• do not ingest Voltaren Emulgel; after use, clean your hands with absorbent paper and then wash them (see section 3);
• do not apply Voltaren Emulgel to broken, diseased skin or open wounds;
• avoid getting Voltaren Emulgel into contact with the eyes or mucous membranes such as the mouth or vagina. If this occurs, immediately wash the area with running water and contact your doctor;
• do not use Voltaren Emulgel with an occlusive bandage, i.e. covering the affected area with a plastic film that does not allow air to pass through. You can instead use Voltaren Emulgel with a gauze that allows air to pass through;
• if you experience skin rashes, discontinue treatment with Voltaren Emulgel;
• if you use diclofenac on large areas of skin and for long periods of time, you may experience side effects that affect the whole body; do not exceed the recommended dose.

Children and adolescents
Voltaren Emulgel should not be used in children and adolescents under 14 years of age.

Other medicines and VoltarenEmulgel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
It is unlikely that Voltaren Emulgel will interact with other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Diclofenac should not be used during the first and second trimester of pregnancy unless absolutely necessary. If you wish to become pregnant or are in the first or second trimester of pregnancy and need to use
diclofenac, take the lowest dose of diclofenac for the shortest possible time.
Diclofenac should not be used during the third trimester of pregnancy because it can cause harm to
the child and mother if taken during this period.
Breastfeeding
Diclofenac passes into breast milk in small amounts.
However, you should not use Voltaren Emulgel during breastfeeding unless you have first consulted your doctor.
If you are breastfeeding, do not apply Voltaren Emulgel to the breast, to large areas of skin and for long
periods of time.

Driving and using machines
Voltaren Emulgel does not impair the ability to drive vehicles or use machines.

VoltarenEmulgel contains propylene glycol and butylhydroxytoluene
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 butylhydroxytoluene which may cause skin reactions
localized (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
Voltaren Emulgel contains pungent eucalyptus fragrance, an aroma in turn containing benzyl alcohol,
citronellol, coumarin, d-limonene, eugenol, geraniol, linalool which may cause allergic reactions.

3. How to use Voltaren Emulgel

Use this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Use in adults
Apply Voltaren Emulgel 2 times a day to the area to be treated and rub in gently. 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 extent of the area to be treated (amount varying between a
cherry and a walnut).
Use Voltaren Emulgel only on the skin, for short periods of time and no more than necessary.
Do not use Voltaren Emulgel for more than 14 days without consulting your doctor.
Consult your doctor if symptoms persist or worsen after 7 days of treatment.

Use in adolescents between 14 and 18 years of age
Apply Voltaren Emulgel 2 times a day (preferably in the morning and evening) to the area to be treated and
rub in gently. The amount of medicine to use depends on the extent of the area to be treated
(amount varying between 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 you notice a worsening of symptoms.

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

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

How to use Voltaren Emulgel
Tube of 20 g, 60 g, 100 g, 150 g, with screw cap (triangular or round):
To remove the seal on first use:

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

Tube of 100 g with snap cap:

1. Lift the cap (Figure 1)

To easily open the snap cap, use a finger, thumb, side of your hand
or even the edge of a table by lifting the lower part of the cap. You will hear
a “click”. The anti-tampering tabs, positioned on each side of the
snap cap, will break when the cap is opened for the first time.
Before using the product for the first time, check that the tabs are not
broken.

Fig. 1

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

Gently press the tube so that a small amount of gel is dispensed
and apply it to the painful or swollen area, massaging slowly until it is
absorbed. The amount of medicine to use depends on the extent of the
painful or swollen area to be treated (amount varying between a cherry and a walnut).
You may feel a slight cooling effect when applying the gel.
Fig.2

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

After use, if necessary, remove any remaining gel from the snap cap
with a cotton cloth or absorbent paper until it appears
clean and dry. To close the snap cap, press 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 you
open or close it to prevent the gel from leaking.

Fig.3

After application:

• clean your hands with absorbent paper and then wash them, unless they are the site to be treated. The absorbent paper should be discarded in household waste after use.
• wait for Voltaren Emulgel to dry before showering or bathing.

If you use more VoltarenEmulgel than you should
In case of ingestion or use of an excessive dose of Voltaren Emulgel, immediately inform your doctor or
go to the nearest hospital.
After application to the skin, the amount of diclofenac that reaches the blood is very low, so it is
unlikely that effects due to an excessive dose will occur.
If you ingest the contents of a tube of Voltaren Emulgel, you may experience undesirable effects similar to those
observed after ingestion of an excessive dose of diclofenac tablets.

If you forget to use VoltarenEmulgel
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask 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)

• skin reactions of various types 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 the appearance of blisters (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)
• rash with the 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 get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 which is reported on the packaging after Expiry date. The expiry
date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water (for example 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 VoltarenEmulgelcontains

• The active ingredient is diclofenac diethylammonium. 100 g of gel contains 2.32 g of diclofenac diethylammonium (equivalent to 2 g of diclofenac sodium).
• The other ingredients are butylhydroxytoluene, carbomers, caprylic/capric triglyceride, diethylamine, isopropyl alcohol, liquid paraffin, macrogol cetostearyl ether, oleyl alcohol, propylene glycol, eucalyptus pungent 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 VoltarenEmulgel and contents of the pack
Voltaren Emulgel is a gel for topical use with a creamy, homogeneous, soft, white or almost
white appearance.
Each pack contains a tube of 20 g or 60 g, 100 g or 150 g of 2% gel.

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

Distributor for sales
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