Flogopatch 70 mg medicated patch
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Flogopatch 70 mg medicated adhesive patch
Etolfenamate
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days.
Contents of the leaflet
- What Flogopatch is and what it is used for
- What you need to know before using Flogopatch
- How to use Flogopatch
- Possible adverse effects
- Storage of Flogopatch
- Contents of the pack and other information
1. What Flogopatch is and what it is used for
Etofenamate, the active substance of this medicine, belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), medications which have analgesic and anti-inflammatory properties.
Flogopatch is indicated for the short-term symptomatic treatment of local pain associated with uncomplicated acute ankle sprains in adults.
You should inform your doctor if you do not improve or if your condition worsens after 7 days.
2. What you need to know before using Flogopatch
Do not use Flogopatch:
- If you are allergic to etofenamate or to any of the other ingredients of this medicine (listed in section 6);
- If you are allergic to other non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to treat pain and inflammation, e.g. acetylsalicylic acid or ibuprofen), which manifests as asthma, difficulty breathing (bronchospasm), runny nose, swelling, or hives;
- If you have skin lesions (e.g. abrasions, cuts, burns, open wounds), skin infection or inflammation, or skin affected by exudative dermatitis or eczema;
- If you are in the third trimester of pregnancy (see section “Pregnancy, lactation and fertility”);
- On eyes, lips, or mucous membranes.
Warnings and precautions
If a skin reaction occurs, remove the medicated patch immediately and discontinue treatment.
To minimize the occurrence of adverse effects, it is recommended to use the patch for the shortest duration necessary to control symptoms.
Do not use a bandage to secure the medicated patch in place.
Difficulty in breathing (bronchospasm) may occur in patients who currently have or have previously had bronchial asthma or allergies.
Avoid direct exposure to sunlight or solarium radiation on the treated area during treatment and for 2 weeks after removing the patch, in order to reduce the risk of photosensitivity.
Systemic adverse effects (adverse effects affecting entire organs, organ systems, or the whole body) cannot be ruled out due to application of the medicated patch, especially if the medicine is used over large areas of skin (e.g. application of more than one patch – see section 3) and for prolonged periods of time.
Although systemic effects (effects affecting entire organs, organ systems, or the whole body) are expected to be minimal, the medicated patch should be used with caution in patients with:
- Kidney, liver, or heart problems;
- If you have or have had gastrointestinal ulcers, intestinal inflammation, or a tendency to bleed.
Non-steroidal anti-inflammatory drugs (NSAIDs) should be used with caution if you are elderly, as you may be 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, either topical (on the skin) or oral.
Children and adolescents
Flogopatch must 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.
Use of Flogopatch with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
If Flogopatch is used correctly, only a small amount of etofenamate is absorbed into the body, so interactions with other medicines are unlikely.
Pregnancy, lactation and fertility
If you are pregnant or breastfeeding, 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.
Use this medicine during the first and second trimesters of pregnancy only under medical advice.
A small amount of etofenamate’s degradation product, flufenamic acid, is excreted in breast milk. However, if your doctor considers it necessary, short-term use of Flogopatch during breastfeeding may be possible. If used during breastfeeding, Flogopatch must not be applied to the breast of the nursing mother, nor to extensive areas of skin or for prolonged periods.
Driving and use of machines
The influence of Flogopatch on the ability to drive and use machines is negligible or none.
3. How to use Flogopatch
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults and elderly patients:
Apply one (1) patch every 12 hours (a total of 2 patches per day), for no more than 7 days.
Only one patch should be used at a time.
Do not exceed the recommended dose.
Method of administration
For cutaneous use.
Use the patch only on intact, non-infected skin.
How to apply the patch
The patch should be applied to dry, wrinkle-free skin. If the application site is sweaty or hairy, this may interfere with the patch's adhesion.
First, remove the central protective liner from the patch (A) and press directly onto the skin.
Do not touch the sticky part of the patch with your fingers!
Hold the center of the patch (A) with the other hand and remove part (B) of the protective liner by folding the patch outward and peeling off the protective liner (B) at the protruding end (see arrow). After removing the protective liner, press the patch directly onto the skin.
Remove part (C) of the protective liner in the same way as part (B). Press the patch directly onto the skin.
Press the patch onto the skin for at least 30 seconds to ensure optimal adhesion.
After applying each patch, make sure to carefully reseal the pouch using the airtight closure.
Duration of treatment
For short-term use only.
Flogopatch should be used for the shortest time necessary to control symptoms.
The patch must not be used for longer than 7 days. If there is no improvement after this period, or if symptoms worsen, please consult your doctor.
Do not exceed the recommended duration of treatment.
If you use more Flogopatch than you should
Seek immediate medical attention in case of accidental use by a child.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount used/ingested.
If you forget to use Flogopatch
Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Stop using this medicine and contact your doctor immediately if you experience the following:
- Signs of an allergic reaction such as asthma, unexplained wheezing or shortness of breath, itching, runny nose, or skin rash
- Signs of hypersensitivity and skin reactions such as redness, swelling, peeling, blisters, scaling, or ulceration of the skin
You may experience the following adverse effects:
Uncommon (may affect up to 1 in 100 people)
Dermatitis, for example, skin redness, itching, burning sensation, skin rash also with formation of papules, pustules, or hives.
Rare (may affect up to 1 in 1000 people)
Hypersensitivity reactions, local allergic reactions (contact dermatitis)
Very rare (may affect up to 1 in 10,000 people)
Skin swelling
Frequency not known (cannot be estimated from the available data)
Sensitivity to light (photosensitization)
The risk of experiencing adverse effects increases if the dressing is used over a large area of skin (e.g. application of more than one dressing – see section 3) and for a prolonged period of time.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Flogopatch
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and on the carton. The expiry date refers to the last day of the month indicated.
Do not store above 30°C.
Used patches should be folded with the adhesive side inwards and safely discarded.
Medicines must not be disposed of via wastewater drains or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Flogopatch
The active substance is etofenamate.
Each medicated adhesive patch contains 70 mg of etofenamate.
The other components are:
Adhesive layer
Trimethylsilyl-modified alpha-hydro-omega-hydroxypoly (dimethylsiloxane) condensed with dimethicone, macrogol 400 and refined olive oil.
Backing layer
Bi-elastic polyester fabric.
Protective liner
Fluoropolymer-coated polyester film.
Appearance of the medicinal product and contents of the pack
Each medicated adhesive patch of 10 cm x 14 cm consists of a white fabric with a colorless, self-adhesive layer and a peelable protective film.
Flogopatch is available in cardboard boxes containing a sealed sachet. Each sachet contains 2, 5 or 7 medicated adhesive patches. The sachet is equipped with a resealable closure to allow it to be closed again after removing the patches.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
CHIESI ESPAÑA, S.A.U.
Plaça d’Europa, 41-43, planta 10
08908 L’Hospitalet de Llobregat (Barcelona)
Spain
Manufacturer
mikle-pharm GmbH,
Sandgasse 17,
76829 Landau,
Germany
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria/Germany: Lixim 70 mg wirkstoffhaltiges Pflaster
Belgium: Lixim 70 mg emplâtre médicamenteux / Lixim 70 mg wirkstoffhaltiges Pflaster / Lixim 70 mg pleister
Spain: Flogopatch 70 mg apósito adhesivo medicamentoso
Hungary: Lixim 70 mg gyógyszeres tapasz
Italy: Dorsiflex
Poland: Lixim
Portugal: Lixim 70 mg emplastro medicamentoso
Date of the most recent review of this summary: June 2019
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)