DICLOFENAC 10 mg /G Gel

Зміст інструкції

1. Diclofenac Teva BV 10 mg/g gel
   1. What is Diclofenac Teva BV and what is it used for
   2. What you need to know before using Diclofenac Teva BV
   3. How to use Diclofenac Teva BV
   4. Possible side effects
   5. How to store Diclofenac Teva BV
   6. Contents of the pack and other information
2. Diclofenac Teva BV 20 mg/g gel
   1. What is Diclofenac Teva BV and what is it used for
   2. What you need to know before using Diclofenac Teva BV
   3. How to use Diclofenac Teva BV
   4. Possible side effects
   5. How to store Diclofenac Teva BV
   6. Contents of the pack and other information

Diclofenac Teva BV 10 mg/g gel

diclofenac (as diclofenac diethylammonium)

For adults and adolescents aged 14 years and over

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 have told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you experience any side effects, 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 3-5 days.

Contents of this leaflet

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

1. What is Diclofenac Teva BV and what is it used for

Diclofenac Teva BV contains the active ingredient diclofenac which belongs to a class of medicines
called non-steroidal anti-inflammatory drugs (NSAIDs).
Diclofenac Teva BV is indicated in adults and adolescents aged 14 years and over.

Adults
For the symptomatic treatment of pain:

• associated with acute muscle strains, sprains or bruises resulting from impact trauma;
• of soft tissues adjacent to the joint (for example, bursae, tendons, tendon sheaths, ligaments, muscle insertions and joint capsules) in osteoarthritis of the knee and finger joints;
• in epicondylitis (inflammation of tendon insertions in the elbow area, also known as tennis elbow or golfer's elbow);
• in acute muscle pain, for example in the back.

Adolescents aged 14 years and over
For short-term treatment.
For the symptomatic treatment of localized pain associated with strains, sprains or bruises of an acute type
resulting from impact trauma.

2. What you need to know before using Diclofenac Teva BV

Do not use Diclofenac Teva BV

• if you are allergic to diclofenac or any of the other ingredients of this medicine listed in section 6;
• if you have developed respiratory problems (asthma, bronchospasm), skin reactions (urticaria), inflamed nose or swelling of the face or tongue after taking or using acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) (for example, ibuprofen);
• on open wounds, skin inflammation or infections, eczema or mucous membranes;
• in the last trimester of pregnancy (see “Pregnancy”);
• in children and adolescents under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Diclofenac Teva BV.
If you suffer from asthma, allergic rhinitis, swelling of the nasal mucosa (so-called nasal polyps) or
chronic obstructive bronchopneumopathy, chronic respiratory infections (particularly associated with
symptoms similar to allergic rhinitis) or hypersensitivity to other pain-relieving and anti-rheumatic drugs of
any kind, you are more exposed, compared to other patients, to the risk of asthma attacks (so-called
analgesic intolerance or analgesic asthma), local skin or mucous membrane swelling (so-called
Quincke's edema) and urticaria.
In these patients, Diclofenac Teva BV can only be used with certain precautions
(preparation for emergencies) and under direct medical supervision. The same applies to patients who are
also allergic to other substances and experience, for example, skin reactions, itching or urticaria.
When Diclofenac Teva BV is applied to a large area of skin and for a prolonged period,
the possibility of systemic adverse effects associated with the application cannot be excluded.
Apply Diclofenac Teva BV only to intact, healthy skin without wounds. Avoid contact with the
eyes and oral mucous membranes. The gel should not be ingested.
After applying the gel to the skin, you can use a permeable (non-occlusive) bandage, but
first allow the gel to dry on the skin for a few minutes. Do not use occlusive bandages
that do not allow air to pass through.
Consult your doctor if the gel is used in acute conditions associated with severe
redness, swelling or overheating of the joints, prolonged joint pain or severe
back pain that radiates to the legs and/or is associated with neurological deficits (for example,
numbness, tingling).
Consult your doctor if your symptoms worsen or do not improve within 3-5 days.
The use of Diclofenac Teva BV should be discontinued if you develop a skin rash.
Avoid exposure to sunlight, including solariums, during the use of this medicine.
Take the necessary precautions to prevent children from touching the area to which
the gel is applied.

Children and adolescents
Diclofenac Teva BV is contraindicated in children and adolescents under 14 years of age.

Other medicines and Diclofenac Teva BV
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
To date, no interactions are known to be associated with the intended cutaneous use of Diclofenac Teva BV.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy

Do not useDiclofenac Teva BV during the last trimester of pregnancy as it may harm
the fetus or cause problems at the time of delivery. During the first and second trimester of pregnancy,
Diclofenac Teva BV can only be used after consulting your doctor.
Breastfeeding
During breastfeeding, Diclofenac Teva BV can only be used under medical supervision as
diclofenac is secreted in small amounts into breast milk. If you are breastfeeding, do not apply Diclofenac
Teva BV to the breast or elsewhere on large areas of skin and for a prolonged period.

Driving and operating machinery
Diclofenac Teva BV does not or negligibly alters the ability to drive vehicles or operate
machinery.

Diclofenac Teva BV contains propylene glycol (E1520)
This medicine contains 50 mg of propylene glycol in 1 g of gel.

Diclofenac Teva BV contains fragrances
This medicine contains a fragrance with benzyl alcohol (0.15 mg/g), citral, citronellol, coumarin,
eugenol, farnesol, geraniol, d-limonene and linalool which may cause allergic reactions.
In addition, benzyl alcohol may cause mild local irritation.

3. How to use Diclofenac Teva BV

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

Adults and adolescents aged 14 years and over
Diclofenac Teva BV is used 3-4 times a day.
Depending on the size of the area to be treated, a variable amount of gel is required, ranging from the size of a cherry to a walnut, corresponding to 1-4 g of gel.
The maximum daily dose is 16 g of gel.

Elderly patients
No special dose adjustments are necessary. If you are elderly, you should pay particular attention to side effects and, if necessary, consult your doctor or pharmacist.

Impaired hepatic or renal function
No dose reductions are necessary.

Use in children and adolescents (under 14 years of age)
Diclofenac Teva BV is contraindicated in children and adolescents under 14 years of age (see section 2 “Do not use Diclofenac Teva BV”).

Before using the medicine for the first time, open it as follows:

• 1. Unscrew the cap of the tube. To open the safety seal of the tube, turn the cap over and insert it into the

nozzle. Do not use scissors or other sharp objects.
Do not use the medicine if the seal is broken.

How to apply Diclofenac Teva BV
Diclofenac Teva BV is indicated for external use.
Apply a thin layer of gel to the affected parts of the body and rub gently to allow it to penetrate the skin. Wash your hands after applying the gel, unless they are the area to be treated.

Duration of treatment
The duration of use depends on the symptoms and the underlying disease. Diclofenac Teva BV should not be used for more than one week without consulting a doctor. If symptoms worsen or do not improve within 3-5 days, consult your doctor.

If you use more Diclofenac Teva BV than you should
It is unlikely that an overdose will occur if you apply more Diclofenac Teva BV than you should, as absorption into the bloodstream is poor when the medicine is used on the skin. If a significantly higher dose than recommended is applied to the skin, the gel should be removed and the area rinsed with water.
If you accidentally ingest Diclofenac Teva BV, contact your doctor. They will decide what measures to take.

If you forget to use Diclofenac Teva BV
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.

Some side effects that are rare and very rare can be serious.
If you experience any of the following signs of allergy, stop using Diclofenac Teva BV and
tell your doctor or pharmacist immediately.

• Blistering skin rash; hives (may affect up to 1 in 1000 people).
• Wheezing, shortness of breath or a feeling of tightness in the chest (asthma) (may affect less than 1 in 10,000 people).
• Swelling of the face, lips, tongue or throat (may affect up to 1 in 10,000 people).

Other side effects are possible:

Common side effects(may affect up to 1 in 10 people)
Skin rash, itching, redness, eczema, dermatitis (skin inflammation), including
contact dermatitis.

Uncommon side effects(may affect up to 1 in 100 people)
Scaling, skin dehydration, swelling (edema).

Very rare side effects(may affect up to 1 in 10,000 people)
Rash with the appearance of pustules, gastrointestinal disorders, hypersensitivity reactions (including
hives), light sensitivity with the appearance of skin reactions following exposure to
sunlight.

Side effects with unknown frequency(frequency cannot be estimated based on available data)
Burning sensation at the application site, dry skin.
When Diclofenac Teva BV is applied to an extensive area of skin and for a prolonged period,
the possibility of systemic side effects (e.g., renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions) similar to those that may occur
after systemic administration of medicines containing diclofenac cannot be excluded.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at: 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 Diclofenac Teva BV

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and the tube. The expiry date refers to the last day of that month.
Store the medicine in the original tube to protect it from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Do not apply the gel shortly before bathing or showering.
This will help protect the environment.

6. Contents of the pack and other information

What Diclofenac Teva BV contains

• The active ingredient is diclofenac.
• 1 g contains 11.6 mg of diclofenac diethylammonium corresponding to 10 mg of diclofenac sodium.
• The other ingredients are carbomer, caprylic/capric triglyceride, macrogol cetostearyl ether, liquid paraffin, diethylamine, isopropyl alcohol, propylene glycol (E1520), fragrance (containing citronellol, geraniol, benzyl alcohol, linalool, limonene, citral, farnesol, coumarin, eugenol), purified water.

Description of the appearance of Diclofenac Teva BV and contents of the pack
Diclofenac Teva BV is a homogeneous, white or almost white gel, packaged in laminated aluminium tubes
sealed with a PE seal and screw caps in PP. It is available in the following pack sizes: 30 g, 50 g, 60 g, 100 g, 120 g and 150 g tube.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
TEVA B.V.
Swensweg 5,
2031 GA Haarlem
Netherlands
Manufacturer:
Merckle GmbH
Graf-Arco Strasse 3
D-89079 Ulm
Germany

Diclofenac Teva BV 20 mg/g gel

diclofenac (as diclofenac diethylammonium)

For adults and adolescents aged 14 years and over

Read this leaflet carefully before using this 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 would like 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.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 3-5 days.

Contents of this leaflet

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

2. What is Diclofenac Teva BV and what is it used for

Diclofenac Teva BV contains the active ingredient diclofenac, which belongs to a class of medicines
called non-steroidal anti-inflammatory drugs (NSAIDs).
Diclofenac Teva BV is indicated in adults and adolescents aged 14 years and over.

Adults and adolescents aged 14 years and over
For the symptomatic treatment of local pain associated with acute muscle strains, sprains or
contusions resulting from impact trauma.
For adolescents aged 14 years and over, the medicine is indicated for short-term treatment.

4. What you need to know before using Diclofenac Teva BV

Do not use Diclofenac Teva BV

• if you are allergic to diclofenac or any of the other ingredients of this medicine listed in section 6;
• if you have developed respiratory problems (asthma, bronchospasm), urticaria, inflamed nose or swelling of the face or tongue after taking or using acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) (for example, ibuprofen);
• on open wounds, inflammation or skin infections, on eczema or on mucous membranes;
• in the last trimester of pregnancy (see “Pregnancy”);
• in children and adolescents under 14 years of age.

Warnings and precautions
Talk to your doctor before using Diclofenac Teva BV.
If you suffer from asthma, allergic rhinitis, swelling of the nasal mucosa (so-called nasal polyps) or chronic obstructive bronchopneumonia, chronic respiratory tract infections (particularly associated with symptoms similar to allergic rhinitis) or hypersensitivity to other pain-relieving and anti-rheumatic medicines of any type, you are more exposed, compared to other patients, to the risk of asthma attacks (so-called analgesic intolerance or analgesic asthma), local skin or mucous membrane swelling (so-called Quincke's edema) and urticaria.
In these patients, Diclofenac Teva BV can only be used with certain precautions (preparation for emergencies) and under direct medical supervision. The same applies to patients who are also allergic to other substances and experience, for example, skin reactions, itching or urticaria.
When Diclofenac Teva BV is applied to a large area of skin and for a prolonged period, the possibility of systemic adverse effects associated with the application cannot be excluded.
Apply Diclofenac Teva BV only to intact, healthy skin without wounds. Avoid contact with the eyes and oral mucous membranes. The gel should not be ingested.
After applying the gel to the skin, you can use a permeable (non-occlusive) bandage, but you must first allow the gel to dry on the skin for a few minutes. Do not use occlusive bandages that do not allow air to pass through.
Consult your doctor if your symptoms worsen or do not improve within 3-5 days.
The use of Diclofenac Teva BV should be discontinued if you develop a skin rash.
Avoid exposure to sunlight, including solariums, while using this medicine.
Necessary precautions must be taken to prevent children from touching the area to which the gel has been applied.

Children and adolescents
Diclofenac Teva BV is contraindicated in children and adolescents under 14 years of age.

Other medicines and Diclofenac Teva BV
Tell your doctor or pharmacist if you are taking, have recently taken or might take or use any other medicines.
To date, no interactions are known to be associated with the intended cutaneous use of Diclofenac Teva BV.

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

Do not useDiclofenac Teva BV during the last trimester of pregnancy because it could harm the fetus or cause problems at the time of delivery. During the first and second trimesters of pregnancy, Diclofenac Teva BV can only be used after consulting your doctor.
Breastfeeding
During breastfeeding, Diclofenac Teva BV can only be used under medical supervision as diclofenac is secreted in small amounts in breast milk. If you are breastfeeding, do not apply Diclofenac Teva BV to the breast or elsewhere on large areas of skin for a prolonged period.

Driving and using machines
Diclofenac Teva BV does not or negligibly alters the ability to drive vehicles or use machines.

Diclofenac Teva BV contains propylene glycol (E1520)
This medicine contains 54 mg of propylene glycol in 1 g of gel.

Diclofenac Teva BV contains butylhydroxytoluene (E321)
Butylhydroxytoluene can cause local skin reactions (e.g., contact dermatitis) or irritation to the eyes and mucous membranes.

Diclofenac Teva BVcontains fragrances
This medicine contains a fragrance with benzyl alcohol (0.15 mg/g), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene and linalool which can cause allergic reactions.
In addition, benzyl alcohol can cause mild local irritation.

5. How to use Diclofenac Teva BV

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.

Adults and adolescents aged 14 years and over
Diclofenac Teva BV is used twice a day (preferably in the morning and evening).
Depending on the size of the area to be treated, a variable amount of gel is required, ranging from the size of a cherry to a walnut, corresponding to 1-4 g of gel.
The maximum daily dose is 8 g of gel.

Elderly patients
No special dose adjustments are necessary. If you are elderly, you should pay particular attention to side effects and, if necessary, consult your doctor or pharmacist.

Impairment of hepatic or renal function
No dose reductions are necessary.

Use in children and adolescents (under 14 years of age)
Diclofenac Teva BV is contraindicated in children and adolescents under the age of 14 years (see section 2 “Do not use Diclofenac Teva BV”).

Before using the medicine for the first time, open it as follows:

• 1. Unscrew the cap of the tube. To open the safety seal of the tube, turn the cap over and insert it into the nozzle. Do not use scissors or other sharp objects.

Do not use the medicine if the seal is broken.

How to apply Diclofenac Teva BV
Diclofenac Teva BV is for external use only.
Apply a thin layer of gel to the affected parts of the body and rub gently to allow it to penetrate the skin. Wash your hands after applying the gel, unless they are the area to be treated.

Duration of treatment
The duration of use depends on the symptoms and the underlying disease. Diclofenac Teva BV should not be used for more than one week without consulting a doctor.
If symptoms worsen or do not improve within 3-5 days, consult a doctor.

If you use more Diclofenac Teva BV than you should
It is unlikely that an overdose will occur if you apply more Diclofenac Teva BV than you should, as absorption into the bloodstream is poor when the medicine is used on the skin. If a significantly higher dose than recommended is applied to the skin, the gel should be removed and the area rinsed with water.
If you accidentally ingest Diclofenac Teva BV, contact your doctor. They will decide what measures to take.

If you forget to use Diclofenac Teva BV
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.
manifest.

Some side effects are rare and very rare and can be serious.
If you experience any of the following signs of allergy, stopusing Diclofenac Teva BV and
tell your doctor or pharmacist immediately:

• Blistering skin rash; hives (may affect up to 1 in 1000 people).
• Wheezing, shortness of breath or a feeling of tightness in the chest (asthma) (may affect less than 1 in 10,000 people).
• Swelling of the face, lips, tongue or throat (may affect up to 1 in 10,000 people).

Other side effects are possible:

Common side effects(may affect up to 1 in 10 people)
Skin rash, itching, redness, eczema, dermatitis (skin inflammation), including
contact dermatitis.

Uncommon side effects(may affect up to 1 in 100 people)
Scaling, skin dehydration, swelling (edema).

Very rare side effects(may affect up to 1 in 10,000 people)
Rash with the appearance of pustules, gastrointestinal disorders, hypersensitivity reactions (including
hives), light sensitivity with the appearance of skin reactions following exposure to sunlight
solar.

Side effects with unknown frequency(frequency cannot be estimated on the basis of the available
data)
Burning sensation at the application site, dry skin.
When Diclofenac Teva BV is applied to a large area of skin and for a prolonged period,
the possibility of systemic side effects (e.g., renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions) similar to those that can occur
after systemic administration of medicines containing diclofenac cannot be excluded.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at: 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 Diclofenac Teva BV

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and the tube. The expiry date refers to the last day of that month.
Keep the medicine in the original tube to protect it from light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. Do not apply the gel shortly before bathing or showering.
This will help protect the environment.

6. Contents of the pack and other information

What the medicine containsDiclofenac Teva BV

• The active ingredient is diclofenac.
• 1 g contains 23.2 mg of diclofenac diethylammonium corresponding to 20 mg of diclofenac sodium.
• Excipients: isopropyl alcohol, propylene glycol (E1520), caprylic/capric triglyceride, liquid paraffin, carbomer, cetostearyl macrogol ether, diethylamine, oleic acid, butylhydroxytoluene, fragrance (containing citronellol, geraniol, benzyl alcohol, linalool, limonene, citral, farnesol, coumarin, eugenol), purified water.

Description of the appearance of Diclofenac Teva BV and contents of the pack
Diclofenac Teva BV is a homogeneous, white or almost white gel, packaged in laminated aluminium tubes, sealed with a PE seal and screw caps in PP. It is available in the following pack sizes: 30 g, 50 g, 60 g, 100 g, 150 g and 180 g tube.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
TEVA B.V.
Swensweg 5,
2031 GA Haarlem
Netherlands
Manufacturer:
Merckle GmbH
Graf-Arco Strasse 3
D-89079 Ulm
Germany