Flogopatch 70 mg 5 apósitos adhesivos
Etofenamate continuous release patches for pain relief
What Flogopatch is and what it is used for
Etofenamate, the active ingredient in this medicine, belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), drugs that have analgesic and anti-inflammatory properties.
Flogopatch is indicated for the short-term symptomatic treatment of local pain in acute ankle sprains without complications in adults.
You should inform your doctor if it does not improve or if it worsens after 7 days.
What you need to know before you use Flogopatch
Do not use Flogopatch if:
If you are allergic to etofenamate or any of the other ingredients of this medicine;
If you have an allergy to other non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to treat pain and inflammation, eg acetylsalicylic acid or ibuprofen) manifesting as asthma, shortness of breath (bronchospasm), runny nose, swelling or hives ;
If you have skin lesions (eg abrasions, cuts, burns, open wounds), infection or inflammation of the skin, or skin affected by exudative dermatitis or eczema;
If you are in the third trimester of pregnancy (see section “Pregnancy, breast-feeding and fertility”);
In eyes, lips, or mucous membranes.
Warnings and cautions
If a skin reaction occurs, remove the medicated plaster immediately and stop treatment.
In order to minimize the occurrence of adverse effects, it is recommended to use for the shortest time necessary to control symptoms.
Do not use a bandage to hold the medicated plaster in place.
Difficulty breathing (bronchospasm) may occur in patients who suffer or have previously suffered from bronchial asthma or allergies.
Avoid direct exposure to the sun or solarium radiation in the treated area, during treatment and 2 weeks after removing the dressing to reduce the risk of sensitivity to light.
The possibility of systemic adverse effects (adverse effects affecting whole organs, organ systems or the whole body) cannot be ruled out due to the application of the medicated plaster if the medicine is used on large areas of the skin (eg. eg application of more than one dressing) and for a prolonged period of time.
Although systemic effects (effects affecting entire organs, organ systems, or the entire body) are expected to be minimal. The medicated plaster should be used with caution in patients with:
Kidney, liver, or heart problems
If you have or have had a gastrointestinal ulcer, intestinal inflammation or a tendency to bleed.
Non-steroidal anti-inflammatory drugs (NSAIDs) should be used with caution if you are elderly, as you are more likely to experience adverse effects.
Do not use other medicines containing etofenamate or other non-steroidal anti-inflammatory drugs (NSAIDs) at the same time, both topically (on the skin) and orally.
Children and adolescents
Flogopatch should not be used in children and adolescents under 18 years of age, as the efficacy and safety of this medicine have not been established in this age group.
Using Flogopatch with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If Flogopatch is used correctly, only a small amount of etofenamate is absorbed into the body, so drug interactions are unlikely.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you might be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not use this medicine during the third trimester of pregnancy.
Only use this medicine in the first and second trimesters of pregnancy on the recommendation of the doctor.
A small amount of the etofenamate breakdown product, flufenamic acid, is excreted in human milk. However, if your doctor deems it necessary, short-term use of Flogopatch during breastfeeding may be possible. If used during lactation, Flogopatch should not be applied to the breast of the nursing mother, or to any large area of the skin or for an extended period of time.
Driving and using machines
The influence of Flogopatch on the ability to drive and use machines is zero or practically non-existent.
How to use Flogopatch
Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is:
Adults and the elderly:
Apply one (1) dressing every 12 hours (a total of 2 dressings per day), for no more than 7 days.
Only one dressing should be used at a time.
Do not exceed recommended dose.
Method of administration
For cutaneous use.
Use the dressing only on intact, uninfected skin.
LEAFLET