DORSIFLEX 70 мг Трансдермальный пластырь

Содержание инструкции

1. Dorsiflex 70 mg medicated patch
   1. What is Dorsiflex and what is it used for
   2. What you need to know before using Dorsiflex
   3. How to use Dorsiflex
   4. Possible side effects
   5. How to store Dorsiflex
   6. Package contents and other information

Dorsiflex 70 mg medicated patch

For use in adults
Etofenamate

important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet

• 1. What Dorsiflex is and what it is used for
• 2. What you need to know before you use Dorsiflex
• 3. How to use Dorsiflex
• 4. Possible side effects
• 5. How to store Dorsiflex
• 6. Contents of the pack and other information

1. What is Dorsiflex and what is it used for

The active ingredient of this medicine – etofenamate – belongs to a class of drugs known
as non-steroidal anti-inflammatory drugs (NSAIDs), drugs that have analgesic
and anti-inflammatory properties.
Dorsiflex is indicated for the symptomatic treatment of short duration of local pain states associated with
acute ankle sprain without complications in adults.
See a doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using Dorsiflex

Do not use Dorsiflex:

• 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 such as, for example, acetylsalicylic acid or ibuprofen) and you have experienced asthma, breathing difficulties (bronchospasm), runny nose, swelling or hives;
• if you have broken skin (for example, skin abrasions, cuts, burns, open wounds), infected or inflamed skin or if you have exudative dermatitis or eczema;
• if you are in the last three months of pregnancy (see section “Pregnancy, breastfeeding and fertility”);
• on eyes, lips or mucous membranes.

Warnings and precautions
If a rash appears, remove the medicated patch immediately and stop the
treatment.
In order to minimize the occurrence of any undesirable effects, it is recommended to use the patch
only for the minimum time necessary to relieve the symptoms.
Do not use bandages to hold the medicated patch in place.
In patients who suffer from or have suffered from bronchial asthma or allergies in the past, breathing
difficulties (bronchospasm) may occur.
During treatment and for the 2 weeks following removal of the patch, avoid
exposing the treated area to direct sunlight or solarium radiation to reduce the risk of
photosensitization.
The possibility of systemic undesirable effects (undesirable effects that affect entire organs, systems
of organs or the entire body) associated with the application of the medicated patch cannot be excluded in
the case where the medicine is used on extensive skin areas (i.e. in case of application of more than
one patch – see section 3) and for a prolonged period.
Although systemic effects (effects that affect entire organs, systems of organs or the entire body)
should be minimal, the medicated patch must be used with caution in patients with

• kidney, heart or liver problems
• active gastrointestinal ulcer or a history of gastrointestinal ulcer, intestinal inflammation or a predisposition to bleeding.

Non-steroidal anti-inflammatory drugs (NSAIDs) should be used with caution if you are elderly,
because you are more prone to developing undesirable effects.
Do not use the patch in conjunction with other medicines containing etofenamate or with any other
non-steroidal anti-inflammatory drug (NSAID) administered topically (application to the
skin) or orally.

Children and adolescents
Dorsiflex should not be used in children and adolescents under the age of 18 years as the
safety and efficacy of this medicine have not yet been established for patients in this age
group.

Other medicines and Dorsiflex
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
If Dorsiflex is used correctly, only a small amount of etofenamate is absorbed
by the body and it is unlikely that interactions with other medicines will occur.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
The medicine should not be used by women in the third trimester of pregnancy.
During the first and second trimester of pregnancy, use the medicine only on your doctor's advice.
Small amounts of the etofenamate degradation product, flufenamic acid, are excreted
into breast milk. However, if your doctor deems it necessary, short-term use of
Dorsiflex during breastfeeding may be possible. If used during breastfeeding,
Dorsiflex should not be applied to the breasts of breastfeeding mothers, nor elsewhere on extensive
areas of skin or for prolonged periods of time.

Driving and operating machinery
Dorsiflex does not alter or alters negligibly the ability to drive vehicles and operate machinery.

3. How to use Dorsiflex

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

Adults and the elderly:
Apply one (1) patch every 12 hours (for a total of 2 patches per day), for no more than 7 days.
Use only one patch at a time.
Do not exceed the recommended dose.

Method of administration
For cutaneous use.
Use the patch only on intact and uninfected skin.

How to apply the patch

The patch must be applied to dry skin without forming folds. The presence of sweat or of

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

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

While holding the center of the patch (A) with your other hand, remove part (B) of the protective
film by folding the patch outwards and removing the protective film (B) by pulling on the
protruding tab (see arrow). While removing the protective film, press the patch directly
onto the skin.

Remove part (C) of the protective film following the same procedure as for part

• (B). Press the patch directly onto the skin.

The applied patch must be held firmly on the skin for at least 30 seconds to
ensure optimal adhesion.
After each application, be sure to carefully reseal the bag using the appropriate zipper.

Duration of treatment
For short-term use only.
Dorsiflex should be used for the shortest time necessary to relieve symptoms.
The patch should not be used for more than 7 days. If, after this period, you do not see any
improvement or if symptoms worsen, consult your doctor.
Do not exceed the recommended duration of treatment.

If you use more Dorsiflex than you should
In case of overdose or accidental use of the medicine by a child, seek medical assistance immediately.

If you forget to use Dorsiflex
Do not use a double dose to make up for a missed patch.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using this medicine and contact your doctor immediately if you experience any of the
following side effects:

• signs of an allergic reaction such as asthma, unjustified wheezing or shortness of breath, itching, runny nose, skin rashes.
• signs of hypersensitivity and skin reactions such as redness, swelling, exfoliation, blister formation, scaling or ulceration of the skin.

The following side effects may occur:

Uncommon (may affect up to 1 in 100 people):
Dermatitis, for example, redness of the skin, itching, burning, rash, also accompanied by the
formation of papules, pustules or blisters.

Rare (may affect up to 1 in 1,000 people):
Hypersensitivity reactions, local allergic reactions (contact dermatitis).

Very rare (may affect up to 1 in 10,000 people):
Skin swelling.

Not known (frequency cannot be estimated from available data):
Light sensitivity (photosensitization).
The risk of side effects increases if the patch is used on large areas of skin (i.e. in
case of applying more than one patch – see section 3) and for a prolonged period.

Reporting suspected adverse reactions
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Dorsiflex

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 package. The expiry
date refers to the last day of that month.
Do not store at a temperature above 30ºC.
Used patches must be folded with the adhesive side facing inwards and disposed of safely.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dorsiflex contains

• The active ingredient is etofenamate. Each medicated patch contains 70 mg of etofenamate .
• The other ingredients are as follows:

Adhesive layer
Polysilicate-alpha-hydroxy-omega-hydroxypoly(dimethylsiloxane) condensate trimethylsilylated with
dimethicone, macrogol 400 and refined olive oil
Backing
Bi-elastic polyester fabric
Protective film
Polyester film coated with fluoropolymer

Description of Dorsiflex and package contents
Each 10 cm x 14 cm patch consists of white fabric with a colorless self-adhesive layer
and a removable protective film.
Dorsiflex is available in a cardboard box containing a sealed bag. Each bag contains
2, 5 or 7 medicated patches. The bag has a zipper that allows it to be resealed after removing the
individual patches.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:
Drossapharm Arzneimittel Handelsgesellschaft mbH
Wallbrunnstrasse 24
79539 Lörrach
Germany

Manufacturer:
Vektor Pharma TF mbH
Hauptstrasse 13 and 17
88524 Uttenweiler
Germany

This medicinal product is authorised in the Member States of the EEA under the
following denominations:
Austria/Germany: Lixim 70 mg wirkstoffhaltiges Pflaster
Belgium: Lixim 70 mg emplâtre médicamenteux / Lixim70 mg wirkstoffhaltiges Pflaster / Lixim 70 mg
cutaneous plaster
Spain: Lixim 70 mg apósito adhesivo medicamentoso
Hungary: Lixim 70 mg gyógyszeres tapasz
Italy: Dorsiflex
Poland: Lixim
Portugal: Lixim 70 mg emplastro medicamentoso