Voltaren Actigo 140 mg, 7 Medicated Patches

Voltaren Actigo 140 mg 7 Medicated Patches is used for the short-term, local treatment of minor painful injuries: strains, sprains, or bruises.

For topical use only.

Dosage Voltaren Actigo 140 mg 7 Medicated Patches

 Always follow the dosage instructions provided by your doctor or described in this package insert for the use of Voltaren Actigo 1%.

If in doubt, consult your doctor or pharmacist.

The usual dose is:

Adults:
Apply one pain-relieving patch to the painful area twice daily (morning and evening). The maximum total dose that may be used is two patches per day, even if there is more than one injury to treat. Do not treat more than one painful area at a time.

Children and adolescents under 16 years of age:
Due to the lack of specific studies, Voltaren 1% should not be used in children and adolescents under 16 years of age.

Elderly patients:
This medication should be used with caution in elderly patients, who are more prone to adverse effects.

Patients with renal or hepatic impairment:
This medication should be used with caution in patients with hepatic or renal impairment.

• Method of Administration

For external use only on intact, healthy skin. For topical application only.

Do not apply while bathing or showering. Do not ingest.

1. Open the packet containing the patch by cutting along the dotted line.
2. Remove one patch and carefully reseal the packet by pressing down on the closure.
3. Remove the protective film from the adhesive side of the patch.
4. Then, apply the patch to the painful area.

If necessary, secure the pain-relief patch using an elastic bandage.
Never cover the patch with an occlusive dressing.
Never cut the patch.
After using the patch, fold it in half with the adhesive side facing inward.

• Duration of Treatment

Based on the limited data available, short-term treatment is recommended.

Never use Voltarenplast 1% for more than three days without consulting your doctor. There is no therapeutic benefit to using Voltarenplast 1% for more than 7 days.

For adolescents over 16 years of age and adults, if use for more than 7 days is necessary to relieve pain or if symptoms worsen, the parents of adolescents or the patients themselves are advised to consult a doctor.

If you feel that the effect of Voltarenplast 1% is too strong or too weak, consult your doctor or pharmacist.

Precautions 

• Special Warnings

Pregnancy and Breastfeeding

Although rare, birth defects have been reported in infants whose mothers took NSAIDs during pregnancy.

During the first 6 months of pregnancy, Voltarenplast 1% may only be used on the advice of your doctor. 

During the last three months of pregnancy, Voltaren 1% must not be used under any circumstances due to the risk of increased serious consequences for both the mother and the child.

Very small amounts of diclofenac pass into breast milk. Since no adverse effects have been observed in infants, it is generally not necessary to discontinue breastfeeding during short-term use. However, Voltaren 1% should never be applied directly to the breasts.

Consult your doctor or pharmacist before taking any medication.

Fertility:
The use of Voltaren 1% is not recommended for women who are trying to conceive, who are having difficulty conceiving, or who are undergoing testing to determine the cause of infertility. 

Contraindications

Never use Voltarenplast 1%:

• If you are allergic (hypersensitive) to diclofenac, propylene glycol, butylhydroxytoluene, or any of the other ingredients in Voltarenplast 1%.
• If you are allergic (hypersensitive) to other nonsteroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid or ibuprofen.
• If you have a history of asthma, a skin reaction, or swelling inside the nose causing irritation following the use of acetylsalicylic acid or other NSAIDs.
• If you have an active peptic ulcer.
• On any type of skin wound (e.g., scrapes, cuts, burns), exudative dermatitis, infected skin lesions, or eczema lesions.
• During the last three months of pregnancy.
• In children and adolescents under 16 years of age.

Side Effects

Like all medications, Voltarenplast 1% may cause side effects, although not everyone will experience them.

By convention, the frequency of side effects is classified as follows:

• Very common: affecting more than 1 in 10 treated patients.
• Common: affects 1 to 10 out of every 100 treated patients.
• Uncommon: affects 1 to 10 out of every 1,000 treated patients.
• Rare: affects 1 to 10 out of every 10,000 treated patients.
• Very rare: affects fewer than 1 in 10,000 treated patients.
• Frequency unknown: cannot be estimated from the available data.

Consult your doctor immediately and stop using the patch if you experience any of the following: sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth, or throat; difficulty breathing; low blood pressure; or fatigue.

Possible side effects include the following:

Common: skin reactions at the application site, skin redness, eczema, inflammatory skin redness (including contact and allergic dermatitis), skin swelling, itching, and a burning sensation;

Uncommon: generalized skin redness, hypersensitivity reactions (including hives), swelling of the skin and mucous membranes, and generalized allergic reactions.

Rare: blisters, dry skin.

Very rare: asthma attack, severe eczema, skin lesions with pustules, skin lesions with ulcerations, and skin sensitivity to light.

Frequency unknown: hematoma at the application site.

After topical application, the absorption of diclofenac into the bloodstream and the blood levels of diclofenac are also extremely low compared to the blood levels achieved after oral administration of diclofenac. The risk of systemic adverse effects (e.g., gastrointestinal disorders, liver or kidney problems, or difficulty breathing) is therefore very low following topical application compared to the frequency of adverse effects associated with oral diclofenac. If diclofenac is used on a large area of skin or for a prolonged period, systemic side effects may occur.

If you notice any side effects not listed in this leaflet, or if any side effects become severe, please inform your doctor or pharmacist.

Composition Voltaren Actigo 140 mg 7 Medicated Patches

Active Ingredients

Diclofenac sodium: 140 mg
Per medicated patch.

 

Voltaren Actigo 140 mg 7 Medicated Patches is used for the short-term local treatment of minor painful injuries: strains, sprains, or bruises.

For topical use only.

Dosage Voltaren Actigo 140 mg 7 Medicated Patches

 Always follow the dosage instructions provided by your doctor or described in this package insert for the use of Voltaren Actigo 1%.

If in doubt, consult your doctor or pharmacist.

The usual dose is:

Adults:
Apply one pain-relieving patch to the painful area twice daily (morning and evening). The maximum total dose that may be used is two patches per day, even if there is more than one injury to treat. Do not treat more than one painful area at a time.

Children and adolescents under 16 years of age:
Due to the lack of specific studies, Voltaren 1% should not be used in children and adolescents under 16 years of age.

Elderly patients:
This medication should be used with caution in elderly patients, who are more prone to adverse effects.

Patients with renal or hepatic impairment:
This medication should be used with caution in patients with hepatic or renal impairment.

• Method of Administration

For external use only on intact, healthy skin. For topical application only.

Do not apply while bathing or showering. Do not ingest.

1. Open the packet containing the patch by cutting along the dotted line.
2. Remove one patch and carefully reseal the pouch by pressing the closure.
3. Remove the protective film from the adhesive side of the patch.
4. Then, apply the patch to the painful area.

If necessary, secure the pain-relieving patch using an elastic bandage.
Never cover the patch with an occlusive dressing.
Never cut the patch.
After using the patch, fold it in half with the adhesive side facing inward.

• Duration of Treatment

Based on the limited data available, short-term treatment is recommended.

Never use Voltarenplast 1% for more than three days without consulting your doctor. There is no therapeutic benefit to using Voltarenplast 1% for more than 7 days.

For adolescents over 16 years of age and adults, if use for more than 7 days is necessary to relieve pain or if symptoms worsen, the parents of adolescents or the patients themselves are advised to consult a doctor.

If you feel that the effect of Voltarenplast 1% is too strong or too weak, consult your doctor or pharmacist.

Precautions 

• Special Warnings

Pregnancy and Breastfeeding

Although rare, birth defects have been reported in infants whose mothers took NSAIDs during pregnancy.

During the first 6 months of pregnancy, Voltarenplast 1% may only be used on the advice of your doctor. 

During the last three months of pregnancy, Voltaren 1% must not be used under any circumstances due to the risk of increased serious consequences for both the mother and the child.

Very small amounts of diclofenac pass into breast milk. Since no adverse effects have been observed in infants, it is generally not necessary to discontinue breastfeeding during short-term use. However, Voltaren 1% should never be applied directly to the breasts.

Consult your doctor or pharmacist before taking any medication.

Fertility:
The use of Voltaren 1% is not recommended for women who are trying to conceive, who are having difficulty conceiving, or who are undergoing testing to determine the cause of infertility. 

Contraindications

Never use Voltarenplast 1%:

• If you are allergic (hypersensitive) to diclofenac, propylene glycol, butylhydroxytoluene, or any of the other ingredients in Voltarenplast 1%.
• If you are allergic (hypersensitive) to other nonsteroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid or ibuprofen.
• If you have a history of asthma, a skin reaction, or swelling inside the nose causing irritation following the use of acetylsalicylic acid or other NSAIDs.
• If you have an active peptic ulcer.
• On any type of skin wound (e.g., scrapes, cuts, burns), exudative dermatitis, infected skin lesions, or eczema lesions.
• During the last three months of pregnancy.
• In children and adolescents under 16 years of age.

Side Effects

Like all medications, Voltarenplast 1% may cause side effects, although not everyone will experience them.

By convention, the frequency of side effects is classified as follows:

• Very common: affecting more than 1 in 10 treated patients.
• Common: affects 1 to 10 out of every 100 treated patients.
• Uncommon: affects 1 to 10 out of every 1,000 treated patients.
• Rare: affects 1 to 10 out of every 10,000 treated patients.
• Very rare: affects fewer than 1 in 10,000 treated patients.
• Frequency unknown: cannot be estimated from the available data.

Consult your doctor immediately and stop using the patch if you notice any of the following: sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth, or throat; difficulty breathing; low blood pressure; or fatigue.

Possible side effects include the following:

Common: skin reactions at the application site, skin redness, eczema, inflammatory skin redness (including contact and allergic dermatitis), skin swelling, itching, and a burning sensation;

Uncommon: generalized skin redness, hypersensitivity reactions (including hives), swelling of the skin and mucous membranes, and generalized allergic reactions.

Rare: blisters, dry skin.

Very rare: asthma attack, severe eczema, skin lesions with pustules, skin lesions with ulcerations, and skin sensitivity to light.

Frequency unknown: hematoma at the application site.

After topical application, the absorption of diclofenac into the bloodstream and the blood levels of diclofenac are also extremely low compared to the blood levels achieved after oral administration of diclofenac. The risk of systemic adverse effects (e.g., gastrointestinal disorders, liver or kidney problems, or difficulty breathing) is therefore very low following topical application compared to the frequency of adverse effects associated with oral diclofenac. If diclofenac is used on a large area of skin or for a prolonged period, systemic side effects may occur.

If you notice any side effects not listed in this package insert, or if any side effects become severe, please inform your doctor or pharmacist.

Composition Voltaren Actigo 140 mg 7 Medicated Patches

Active Ingredients

Diclofenac sodium: 140 mg
Per medicated patch.

 

Voltaren Actigo 140 mg 7 Medicated Patches is used for the short-term, local treatment of minor painful injuries: strains, sprains, or bruises.

For topical use only.

Dosage Voltaren Actigo 140 mg 7 Medicated Patches

 Always follow the dosage instructions provided by your doctor or described in this package insert for the use of Voltaren Actigo 1%.

If in doubt, consult your doctor or pharmacist.

The usual dose is:

Adults:
Apply one pain-relieving patch to the painful area twice daily (morning and evening). The maximum total dose that may be used is two patches per day, even if there is more than one injury to treat. Do not treat more than one painful area at a time.

Children and adolescents under 16 years of age:
Due to the lack of specific studies, Voltaren 1% should not be used in children and adolescents under 16 years of age.

Elderly patients:
This medication should be used with caution in elderly patients, who are more prone to adverse effects.

Patients with renal or hepatic impairment:
This medication should be used with caution in patients with hepatic or renal impairment.

• Method of Administration

For external use only on intact, healthy skin. For topical application only.

Do not apply while bathing or showering. Do not ingest.

1. Open the packet containing the patch by cutting along the dotted line.
2. Remove one patch and carefully reseal the pouch by pressing the closure.
3. Remove the protective film from the adhesive side of the patch.
4. Then, apply the patch to the painful area.

If necessary, secure the pain-relieving patch using an elastic bandage.
Never cover the patch with an occlusive dressing.
Never cut the patch.
After using the patch, fold it in half with the adhesive side facing inward.

• Duration of Treatment

Based on the limited data available, short-term treatment is recommended.

Never use Voltarenplast 1% for more than three days without consulting your doctor. There is no therapeutic benefit to using Voltarenplast 1% for more than 7 days.

For adolescents over 16 years of age and adults, if use for more than 7 days is necessary to relieve pain or if symptoms worsen, the parents of adolescents or the patients themselves are advised to consult a doctor.

If you feel that the effect of Voltarenplast 1% is too strong or too weak, consult your doctor or pharmacist.

Precautions 

• Special Warnings

Pregnancy and Breastfeeding

Although rare, birth defects have been reported in infants whose mothers took NSAIDs during pregnancy.

During the first 6 months of pregnancy, Voltarenplast 1% may only be used on the advice of your doctor. 

During the last three months of pregnancy, Voltaren 1% must not be used under any circumstances due to the risk of increased serious consequences for both the mother and the child.

Very small amounts of diclofenac pass into breast milk. Since no adverse effects have been observed in infants, it is generally not necessary to discontinue breastfeeding during short-term use. However, Voltaren 1% should never be applied directly to the breasts.

Consult your doctor or pharmacist before taking any medication.

Fertility:
The use of Voltaren 1% is not recommended for women who are trying to conceive, who are having difficulty conceiving, or who are undergoing testing to determine the cause of infertility. 

Contraindications

Never use Voltarenplast 1%:

• If you are allergic (hypersensitive) to diclofenac, propylene glycol, butylhydroxytoluene, or any of the other ingredients in Voltarenplast 1%.
• If you are allergic (hypersensitive) to other nonsteroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid or ibuprofen.
• If you have a history of asthma, skin reactions, or swelling inside the nose causing irritation following the use of acetylsalicylic acid or other NSAIDs.
• If you have an active peptic ulcer.
• On any type of skin wound (e.g., scrapes, cuts, burns), exudative dermatitis, infected skin lesions, or eczema lesions.
• During the last three months of pregnancy.
• In children and adolescents under 16 years of age.

Side Effects

Like all medications, Voltarenplast 1% may cause side effects, although not everyone will experience them.

By convention, the frequency of side effects is classified as follows:

• Very common: affecting more than 1 in 10 treated patients.
• Common: affects 1 to 10 out of every 100 treated patients.
• Uncommon: affects 1 to 10 out of every 1,000 treated patients.
• Rare: affects 1 to 10 out of every 10,000 treated patients.
• Very rare: affects fewer than 1 in 10,000 treated patients.
• Frequency unknown: cannot be estimated from the available data.

Consult your doctor immediately and stop using the patch if you notice any of the following: sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth, or throat; difficulty breathing; low blood pressure; or fatigue.

Possible side effects include the following:

Common: skin reactions at the application site, skin redness, eczema, inflammatory skin redness (including contact and allergic dermatitis), skin swelling, itching, and a burning sensation;

Uncommon: generalized skin redness, hypersensitivity reactions (including hives), swelling of the skin and mucous membranes, and generalized allergic reactions.

Rare: blisters, dry skin.

Very rare: asthma attack, severe eczema, skin lesions with pustules, skin lesions with ulcerations, and skin sensitivity to light.

Frequency unknown: hematoma at the application site.

After topical application, the absorption of diclofenac into the bloodstream and the blood levels of diclofenac are also extremely low compared to the blood levels achieved after oral administration of diclofenac. The risk of systemic adverse effects (e.g., gastrointestinal disorders, liver or kidney problems, or difficulty breathing) is therefore very low following topical application compared to the frequency of adverse effects associated with oral diclofenac. If diclofenac is used on a large area of skin or for a prolonged period, systemic side effects may occur.

If you notice any side effects not listed in this leaflet, or if any side effects become severe, please inform your doctor or pharmacist.

Composition Voltaren Actigo 140 mg 7 Medicated Patches

Active Ingredients

Diclofenac sodium: 140 mg
Per medicated patch.

 

Voltaren Actigo 140 mg 7 Medicated Patches is used for the short-term, local treatment of minor painful injuries: strains, sprains, or bruises.

For topical use only.

Dosage Voltaren Actigo 140 mg 7 Medicated Patches

 Always follow the dosage instructions provided by your doctor or described in this package insert for the use of Voltaren Actigo 1%.

If in doubt, consult your doctor or pharmacist.

The usual dose is:

Adults:
Apply one pain-relieving patch to the painful area twice daily (morning and evening). The maximum total dose that may be used is two patches per day, even if there is more than one injury to treat. Do not treat more than one painful area at a time.

Children and adolescents under 16 years of age:
Due to the lack of specific studies, Voltaren 1% should not be used in children and adolescents under 16 years of age.

Elderly patients:
This medication should be used with caution in elderly patients, who are more prone to adverse effects.

Patients with renal or hepatic impairment:
This medication should be used with caution in patients with hepatic or renal impairment.

• Method of Administration

For external use only on intact, healthy skin. For topical application only.

Do not apply while bathing or showering. Do not ingest.

1. Open the packet containing the patch by cutting along the dotted line.
2. Remove one patch and carefully reseal the packet by pressing down on the closure.
3. Remove the protective film from the adhesive side of the patch.
4. Then, apply the patch to the painful area.

If necessary, secure the pain-relieving patch using an elastic bandage.
Never cover the patch with an occlusive dressing.
Never cut the patch.
After using the patch, fold it in half with the adhesive side facing inward.

• Duration of Treatment

Based on the limited data available, short-term treatment is recommended.

Never use Voltarenplast 1% for more than three days without consulting your doctor. There is no therapeutic benefit to using Voltarenplast 1% for more than 7 days.

For adolescents over 16 years of age and adults, if use for more than 7 days is necessary to relieve pain or if symptoms worsen, the parents of adolescents or the patients themselves are advised to consult a doctor.

If you feel that the effect of Voltarenplast 1% is too strong or too weak, consult your doctor or pharmacist.

Precautions 

• Special Warnings

Pregnancy and Breastfeeding

Although rare, birth defects have been reported in infants whose mothers took NSAIDs during pregnancy.

During the first 6 months of pregnancy, Voltarenplast 1% may only be used on the advice of your doctor. 

During the last three months of pregnancy, Voltaren 1% must not be used under any circumstances due to the risk of increased serious consequences for both the mother and the child.

Very small amounts of diclofenac pass into breast milk. Since no adverse effects have been observed in infants, it is generally not necessary to stop breastfeeding during short-term use. However, Voltaren 1% should never be applied directly to the breasts.

Consult your doctor or pharmacist before taking any medication.

Fertility:
The use of Voltaren 1% is not recommended for women who are trying to conceive, who are having difficulty conceiving, or who are undergoing testing to determine the cause of infertility. 

Contraindications

Never use Voltarenplast 1%:

• If you are allergic (hypersensitive) to diclofenac, propylene glycol, butylhydroxytoluene, or any of the other ingredients in Voltarenplast 1%.
• If you are allergic (hypersensitive) to other nonsteroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid or ibuprofen.
• If you have a history of asthma, a skin reaction, or swelling inside the nose causing irritation following the use of acetylsalicylic acid or other NSAIDs.
• If you have an active peptic ulcer.
• On any type of skin wound (e.g., scrapes, cuts, burns), exudative dermatitis, infected skin lesions, or eczema lesions.
• During the last three months of pregnancy.
• In children and adolescents under 16 years of age.

Side Effects

Like all medications, Voltarenplast 1% may cause side effects, although not everyone will experience them.

By convention, the frequency of side effects is classified as follows:

• Very common: affecting more than 1 in 10 treated patients.
• Common: affects 1 to 10 out of every 100 treated patients.
• Uncommon: affects 1 to 10 out of every 1,000 treated patients.
• Rare: affects 1 to 10 out of every 10,000 treated patients.
• Very rare: affects fewer than 1 in 10,000 treated patients.
• Frequency unknown: cannot be estimated from the available data.

Consult your doctor immediately and stop using the patch if you notice any of the following: sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth, or throat; difficulty breathing; low blood pressure; or fatigue.

Possible side effects include the following:

Common: skin reactions at the application site, skin redness, eczema, inflammatory skin redness (including contact and allergic dermatitis), skin swelling, itching, and a burning sensation;

Uncommon: generalized skin redness, hypersensitivity reactions (including hives), swelling of the skin and mucous membranes, and generalized allergic reactions.

Rare: blisters, dry skin.

Very rare: asthma attack, severe eczema, skin lesions with pustules, skin lesions with ulcerations, and skin sensitivity to light.

Frequency unknown: hematoma at the application site.

After topical application, the absorption of diclofenac into the bloodstream and the blood levels of diclofenac are also extremely low compared to the blood levels achieved after oral administration of diclofenac. The risk of systemic adverse effects (e.g., gastrointestinal disorders, liver or kidney problems, or difficulty breathing) is therefore very low following topical application compared to the frequency of adverse effects associated with oral diclofenac. If diclofenac is used on a large area of skin or for a prolonged period, systemic side effects may occur.

If you notice any side effects not listed in this leaflet, or if any side effects become severe, please inform your doctor or pharmacist.

Composition Voltaren Actigo 140 mg 7 Medicated Patches

Active Ingredients

Diclofenac sodium: 140 mg
Per medicated patch.