Flogopatch 70 Mg 5 Medicated Adhesive Band-Aids

Flogopatch 70 mg 5 medicated plaster

Etofenamate

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need advice or more information, ask your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if it is about side effects that are not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

Package leaflet content

1. What is Flogopatch and what is it used for

2. What you need to know before you use Flogopatch

3. How to use Flogopatch

4. Possible side effects

5. How to store Flogopatch

6. Package contents and additional information

Etofenamate, the active ingredient in this drug, 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.

Do not use Flogopatch:

• If you are allergic to etofenamate or any of the other ingredients of this medicine (listed in section 6);
• 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 entire 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 - see section 3) 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 ever 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 breakdown product of etofenamate, flufenamic acid, is excreted in human milk. However, if your doctor deems it necessary, short-term use of Flogopatch during breast-feeding 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 zero.

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, non-infected skin.

How to apply the dressing

The dressing should be placed on dry skin without folds. If the site to be applied is sweaty or has a lot of hair, this can interfere with the adhesion of the dressing.

First remove the protective foil from the center of the dressing (A) and press directly onto the skin.

Do not touch the sticky part of the dressing with your fingers!

Hold the center of the dressing (A) with the other hand and remove part (B) of the protective foil by folding the dressing out and peeling off the protective foil (B) at the protruding end (see arrow). After peeling off the protective foil, press the dressing directly onto the skin.

Remove part (C) of the protective sheet in the same way as part (B). Press the dressing directly onto the skin.

Press the dressing on the skin for at least 30 seconds to ensure its optimal adherence .

After applying each dressing, make sure you have carefully closed the sachet using the airtight seal.

Treatment duration

For short term use only

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

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

Do not exceed the recommended duration of treatment.

If you use more Flogopatch than you should

Seek medical assistance immediately in case of accidental use by a child.

In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount used / ingested.

If you forget to use Flogopatch

Do not use a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Stop using this medicine 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 rash
• Signs of hypersensitivity and skin reactions such as redness, swelling, peeling, blistering, peeling, or ulceration of the skin

You may experience the following side effects:

Uncommon (may affect up to 1 in 100 people)

Dermatitis, eg reddening of the skin, itching, burning, rash also with formation of papules, pustules or hives.

Rare (may affect up to 1 in 1,000 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 the available data)

Sensitivity to light (photosensitization)

The risk of side effects is increased if the dressing is used over a large area of ​​the skin (eg application of more than one dressing - see section 3) and for a long period of time.

Communication of adverse effects

If you experience any kind of side effect, consult your doctor or pharmacist, even if it is about possible side effects that are not listed in this leaflet. You can also communicate them directly through theSpanish Pharmacovigilance System for Medicines for Human Use: www.notificaRAM.es . By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the sachet and the carton. The expiration date is the last day of the month indicated.

Do not store above 30ºC

Used dressings should be folded sticky side in and disposed of safely.

Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines you do not need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unneeded medicine and containers. This way you will help to protect the environment

This medicine 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 medicamenteux / Lixim 70 mg wirkstoffhaltiges Pflaster / Lixim 70 mg pleister

Spain:                     Flogopatch 70 mg medicated plaster

Hungary:                 Lixim 70 mg gyógyszeres tapasz

Italy:                      Dorsiflex

Poland:                   Lixim

Portugal:                 Lixim 70 mg medicated plaster

Prospectus Flogopatch 70 Mg 5 Medicated Adhesive Dressings