Package Insert: Information for the Patient

Flogopatch 70 mg Adhesive Medicamentous Patch

Etofenamate

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

1. What isFlogopatchand for what it is used

2. What you need to know before starting to useFlogopatch

3. How to useFlogopatch

4. Possible adverse effects

5. Storage ofFlogopatch

6. Contents of the package and additional information

The etofenamate, active principle of this medication, belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), medications that have analgesic and anti-inflammatory properties.

Flogopatch is indicated for the symptomatic treatment of short-term local pain in acute ankle sprains without complications in adults.

You should inform your doctor if you do not improve or worsen after 7 days.

Do not use Flogopatch:

• If you are allergic to etofenamate or any of the other components of this medication (listed in section 6);
• If you have an allergy to other nonsteroidal anti-inflammatory drugs (NSAIDs, medications used for the treatment of pain and inflammation, e.g. acetylsalicylic acid or ibuprofen) that 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 skin inflammation, or skin affected by exudative dermatitis or eczema;
• If you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding, and fertility”);
• In the eyes, lips, or mucous membranes.

Warnings and precautions

If a skin reaction appears, remove the medicated adhesive patch immediately and discontinue treatment.

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 keep the medicated adhesive patch in place.

Difficulty breathing (bronchospasm) may occur in patients who suffer or have previously suffered from asthma or allergies.

Avoid direct exposure to the sun or tanning bed radiation in the treated area during treatment and 2 weeks after removing the patch to reduce the risk of photosensitivity.

The possibility of systemic adverse effects (adverse effects affecting entire organs, organ systems, or the entire body) due to the application of the medicated adhesive patch cannot be ruled out, if the medication is used on extensive areas of the skin (e.g. application of more than one patch – see section 3) and for a prolonged period of time.

Although systemic effects are expected to be minimal.The medicated adhesive 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.

Nonsteroidal anti-inflammatory drugs (NSAIDs) should be used with caution if you are an elderly person, as it is more likely that you will experience adverse effects.

Do not use other medications containing etofenamate or other nonsteroidal anti-inflammatory drugs (NSAIDs) at the same time, both topical (on the skin) and oral.

Children and adolescents

Flogopatch should not be used in children and adolescents under 18 years of age, as the efficacy and safety of this medication have not been established in this age group.

Use of Flogopatch with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

If Flogopatch is used correctly, only a small amount of etofenamate is absorbed into the body, making it unlikely to interact with other medications.

Pregnancy,breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not use this medication during the third trimester of pregnancy.

Only use this medication in the first and second trimesters of pregnancy under the recommendation of your doctor.

A small amount of the etofenamate degradation product, flufenamic acid, is excreted in breast milk. However, if your doctor considers it necessary, it may be possible to use Flogopatch for a short period during breastfeeding. If used during breastfeeding, Flogopatch should not be applied to the mother's breast, nor to extensive areas of the skin, or for a prolonged period of time.

Driving and operating machines

The influence of Flogopatch on the ability to drive and operate machines is negligible or practically negligible.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist.In case of doubt, ask 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 use one patch at a time.

Do not exceed the recommended dose.

Method of administration

For topical use.

Use the patch only on intact, non-infected skin.

How to apply the patch

The patch should be placed on dry, wrinkle-free skin. If the site where the patch is to be applied is sweaty or has a lot of hair, this may interfere with the patch's adhesion.

First, remove the protective liner from the center of the patch (A) and press directly onto the skin.

Do not touch the adhesive part of the patch with your fingers!

Hold the center of the patch (A) with one hand and remove the protective liner (B) by folding the patch outward and peeling the liner off at the protruding end (see arrow). After peeling off the liner, press the patch directly onto the skin.

Remove the protective liner (C) in the same way as the liner (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 close the package tightly using the tamper-evident seal.

Treatment duration

Only for short-term use.

Flogopatch should be used for the shortest time necessary to control symptoms.

The patch should not be used for more than 7 days. If there is no improvement after this period, or if symptoms worsen, please consult your doctor.

Do not exceed the recommended treatment duration.

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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used/ingested.

If you forgot to use Flogopatch

Do not use a double dose to compensate for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Discontinue use of this medication and contact your doctor immediately if you experience the following:

• Signs of allergic reaction such as asthma, unexplained wheezing or shortness of breath, itching, runny nose, or skin rashes
• 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:

Rare (may affect up to 1 in 100 people)

Dermatitis, for example, skin redness, itching, burning, skin eruption also with formation of papules, pustules, or rashes.

Uncommon (may affect up to 1 in 1000 people)

Hypersensitivity reactions, local allergic reactions (contact dermatitis)

Very rare (affects up to 1 in 10,000 people)

Swelling of the skin

Unknown frequency (cannot be estimated from available data)

Sensitivity to light (photosensitivity)

The risk of experiencing adverse effects increases if the dressing is used on a large area of the skin (e.g., application of more than one dressing – see section 3) and for a prolonged period of time.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the label and on the box.The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C

Used dressings must be folded with the adhesive side inward and disposed of safely.

Medications should not be thrown away through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Flogopatch

The active ingredient is etofenamate.

Each medicated adhesive patch contains 70 mg of etofenamate.

The other components are:

Adhesive layer

Trimethylsilylated alpha-hydro-omega-hydroxypoly (dimethylsiloxane) policondensate with dimethicone, macrogol 400, and refined olive oil.

Backing

Polyester elastic fabric.

Protective layer

Fluoropolymer-coated polyester film.

Appearance of the product and contents of the package

Each medicated adhesive patch of 10 cm x 14 cm is made of a white fabric with a colorless and self-adhesive layer and a removable protective film.

Flogopatch is available in cardboard boxes containing a sealed pouch. Each pouch contains 2, 5, or 7 medicated adhesive patches. The pouch is equipped with a hermetic closure to be able to close it after removing the patches.

Only some package sizes may be commercially available.

Marketing Authorization Holder

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L’Hospitalet de Llobregat (Barcelona)

Spain

Responsible for manufacturing

mikle-pharm GmbH,

Sandgasse 17,

76829 Landau,

Germany

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Austria/Germany:Lixim 70 mg medicated plaster

Belgium:Lixim 70 mg medicated plaster / Lixim 70 mg medicated patch / Lixim 70 mg medicated plaster

Spain:Flogopatch 70 mg medicated adhesive patch

Hungary:Lixim 70 mg medicated patch

Italy:Dorsiflex

Poland:Lixim

Portugal:Lixim 70 mg medicated plaster

Last review date of thisleaflet:June 2019

The detailed information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)