Indications
Voltarenplast 1% is used in the short-term local treatment of painful minor trauma: sprains, strains or bruises.
For cutaneous application only.
Dosage
Always use Voltarenplast 1% according to your doctor's instructions or as described in this leaflet.
If in doubt, consult your doctor or pharmacist.
The usual dose is:
Adults:
Apply a painkiller plaster to the painful area twice a day (morning and evening). The maximum total dose that can be used is two plasters 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:
This medicine should be used with caution in elderly patients who are more susceptible to adverse reactions.
Patients with renal or hepatic impairment:
This drug should be used with caution in patients with renal or hepatic impairment.
To be used only on intact and healthy skin. For application to the skin only.
Do not apply when bathing or showering. Do not ingest.
- Open the bag containing the plaster, cutting along the dotted line.
- Take out a plaster and carefully close the bag by pressing the closure.
- Remove the protective film from the adhesive surface of the plaster.
- Then apply the plaster to the painful area.
If necessary, hold the plaster in place with an elastic bandage.
Never cover the plaster with an airtight (occlusive) bandage.
Never cut the plaster.
After using the plaster, fold it in half with the adhesive side facing inwards.
Based on the limited data available, a short treatment period is recommended.
Never use Voltarenplast 1% for more than three days without consulting your doctor. There is no therapeutic benefit if you use Voltarenplast 1% for more than 7 days.
In adolescents over 16 years of age and adults, if use for more than 7 days is required to relieve pain or if symptoms worsen, parents of adolescents/patients are advised to consult a physician.
If you feel that the effect of Voltarenplast 1% is too strong or too weak, consult your doctor or pharmacist.
Precautions for use
If you have or have had asthma or allergies, the use of this medicine may cause a spasm of the bronchial muscles (bronchospasm), which may cause difficulty in breathing.
If a rash appears after application, treatment should be stopped immediately.
In case of renal, cardiac or hepatic disease, in case of a history of gastrointestinal ulcers,
In case of inflammatory bowel disease or digestive bleeding.
The occurrence of adverse effects can be minimized by using the lowest possible dose for the shortest possible duration of treatment necessary to relieve symptoms.
If symptoms persist for more than 3 days, a doctor should be consulted.
Never apply the plaster to the eyes or mucous membranes and avoid contact with the eyes and mucous membranes.
Voltarenplast 1% should be applied to intact, healthy skin and should not be applied to a wound or open wound.
Do not use the plaster under an occlusive dressing.
Voltarenplast 1% should be used with caution in elderly patients, who are more prone to adverse reactions.
After removal of the plaster, avoid exposure of the treated area to sunlight (sun or UV booths) for approximately one day to reduce any risk of photosensitivity.
Do not use any medication containing diclofenac or other NSAIDs, either orally or topically, at the same time.
Pregnancy and Lactation
Although rare, abnormalities have been reported in infants whose mothers took NSAIDs during pregnancy.
During the first 6 months of pregnancy, Voltarenplast 1% should only be used on the advice of your doctor.
During the last three months of pregnancy, Voltarenplast 1% should not be used under any circumstances because of the risk of increased serious consequences for the mother and the child.
Diclofenac is excreted in very small quantities in breast milk. As no adverse effects have been observed in infants, it is generally not necessary to discontinue breastfeeding during short-term use. Voltaren 1% should never be applied directly to the breast.
Ask your doctor or pharmacist for advice before taking any medication.
Fertility:
Voltaren 1% is not recommended for women who want to conceive a child, who have difficulties in conceiving a child or who are under investigation for infertility
Contraindications
Never use Voltarenplast 1%:
- If you are allergic (hypersensitive) to diclofenac, propylene glycol, butylated hydroxytoluene, or any of the other ingredients in Voltarenplast 1%.
- If you are allergic (hypersensitive) to other non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid or ibuprofen.
- If you have a history of asthma, skin reaction or swelling inside your nose causing irritation from acetylsalicylic acid or other NSAIDs.
- If you have an active digestive ulcer.
- On any type of skin wound (e.g., abrasions, cuts, burns), exudative dermatitis, infected skin lesions or eczema.
- During the last three months of pregnancy.
- In children and adolescents under 16 years of age.
Undesirable effects
Like all medicines, Voltarenplast 1% may have side effects, although not everyone is susceptible to them.
By convention, the frequency of adverse reactions is classified as follows:
- Very common: affecting more than 1 in 10 treated patients.
- Common: affecting 1 to 10 out of every 100 patients treated.
- Uncommon: affecting 1 to 10 treated patients in 1000.
- Rare: 1 to 10 in 10,000 patients treated.
- Very rare: affects less than 1 in 10,000 patients treated.
- Unknown frequency: frequency cannot be assessed with the available data.
Consult your doctor immediately and stop using the plaster if you experience any of the following: sudden itchy skin rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat; difficulty breathing; decrease in blood pressure or fatigue.
Possible side effects include the following:
Common: skin reactions at the application site, redness of the skin, eczema, inflammatory redness of the skin (including contact and allergic dermatitis), swelling of the skin, itching and burning sensations,
Uncommon: generalized skin redness, hypersensitivity reaction (including urticaria), swelling of the skin and mucous membranes, and generalized allergic reactions.
Rare: blisters, dry skin.
Very rare: asthma attack, severe eczema, skin lesion with pustules, skin lesion with ulcerations and skin sensitivity to light.
Unknown frequency: Hematoma at the application site.
After dermal application, the absorption of diclofenac into the blood and the level of diclofenac in the blood are also extremely low, compared to the blood levels that are achieved after oral administration of diclofenac. The risk of systemic adverse events (e.g., gastrointestinal, liver, kidney, or breathing problems) is therefore very low after dermal application compared to the incidence of adverse events associated with oral diclofenac. If diclofenac is used over a large area of the skin or for a prolonged period of time, systemic adverse reactions may occur.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
Composition
Diclofenac sodium: 140 mg
For one medicated plaster.
Glycerol, propylene glycol (E1520), di-isopropyl adipate, liquid crystallizable sorbitol (E420), sodium carmellose, sodium polyacrylate, basic copolymer of butyl methacrylate, disodium edetate, anhydrous sodium sulphite (E221), butylated hydroxytoluene (E321), potassium aluminium sulphate, anhydrous colloidal silica, light kaolin (natural), macrogol lauric ether, levomenthol, tartaric acid, purified water.
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