FASTUFLEX 180 mg Medicated Patch

Зміст інструкції

1. FASTUFLEX 180 mg medicated patch
   1. What is FASTUFLEX and what is it used for
   2. What you need to know before using FASTUFLEX
   3. How to use FASTUFLEX
   4. Possible side effects
   5. How to store FASTUFLEX
   6. Contents of the pack and other information

FASTUFLEX 180 mg medicated patch

Diclofenac epolamine

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• 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 a short period of treatment.

Contents of this leaflet:

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

1. What is FASTUFLEX and what is it used for

FASTUFLEX belongs to a class of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs). NSAIDs reduce pain and inflammation.
FASTUFLEX is used to relieve painful and inflammatory conditions of rheumatic or traumatic origin affecting the
joints, muscles, tendons and ligaments.
Consult your doctor if you do not feel better or if you feel worse after a short period of using
FASTUFLEX.

2. What you need to know before using FASTUFLEX

Do not use FASTUFLEX:

• if you are allergic to diclofenac, acetylsalicylic acid (aspirin) or any other NSAID;
• if you are allergic to any of the other ingredients of FASTUFLEX (listed in section 6);
• if you have had asthma, breathing problems, skin rash or rhinitis (runny nose) after taking acetylsalicylic acid (aspirin) or other NSAIDs;
• if you are entering or have already passed the 6th month of pregnancy;
• if you currently have a stomach ulcer (peptic ulcer);
• if you have damaged skin, including areas with exudation or infected, eczema, burns or wounds;
• if the subject to be treated is a child or adolescent under the age of 16. If any of the above conditions apply to you, consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before using FASTUFLEX if:

• you suffer from heart disease;
• you suffer from kidney disease;
• you suffer from liver disease;
• you have previously suffered from stomach ulcers;
• you suffer from inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, or are prone to intestinal bleeding;
• you suffer from asthma;
• you have breathing problems, skin rash or runny nose after taking acetylsalicylic acid (aspirin) or other NSAIDs;
• you are taking diclofenac or other NSAIDs, in oral or topical form;
• you regularly use tanning beds or are exposed to direct sunlight;
• you are elderly, as you are more susceptible to the onset of undesirable effects.

Other important information
Always use the lowest effective dose of FASTUFLEX for the shortest period necessary to control the
symptoms.
FASTUFLEX must be used with caution in elderly patients who may be more easily
subject to adverse effects.
In order to minimize the occurrence of adverse effects, it is recommended to use the lowest
effective dose and for the shortest possible time.

Children and adolescents
Do not apply the patch to children and adolescents under the age of 16.

Other medicines and FASTUFLEX
If FASTUFLEX is used correctly, the risk of interaction with other medicines is very low.
However, tell your doctor or pharmacist if you have used or taken recently or are using or taking
currently any other medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding with milk
ask your doctor or pharmacist for advice before taking this medicine.
You should not use FASTUFLEX if you are entering or have already passed the 6th month of pregnancy, as it may
harm the fetus or cause problems during childbirth. FASTUFLEX should be used exclusively
under medical advice before the 6th month of pregnancy, the dose should be kept as low as possible and
the duration of treatment as short as possible.
FASTUFLEX should be used exclusively under medical advice during breastfeeding with milk
mother, as diclofenac passes into breast milk in small amounts. However, FASTUFLEX should not
be applied to the breasts of breastfeeding mothers, nor elsewhere on large areas of skin or for a
prolonged period of time.
If you are pregnant or breastfeeding, consult your doctor or pharmacist for further
information.

Driving and using machines
The application of the medicated patch based on diclofenac does not alter the ability to drive vehicles and use
machinery.

FASTUFLEX contains

• preservatives such as parabens which may cause allergic reactions (even delayed)
• propylene glycol, which may cause skin irritation.

3. How to use FASTUFLEX

Use FASTUFLEX always following exactly the doctor's instructions.

Adults and adolescents aged 16 years or over
How many patches to use
The recommended dose of FASTUFLEX is one (1) patch on the most painful area one or two times a day
(one application every 12 or 24 hours) for a maximum of 14 consecutive days. If you do not experience any
improvement within the recommended treatment period or if symptoms worsen, consult
your doctor.

Use in children and adolescents (under 16 years of age)
There is no data on efficacy and safety in children and adolescents under 16 years of age
(see Do not use FASTUFLEX).

In adolescents aged 16 years or over, if symptoms worsen, the patient/adolescent’s parents are advised to
consult a doctor.
How to apply FASTUFLEX
Cut the top of the resealable sachet and remove a patch.

Carefully reseal the sachet.

Remove the plastic backing that protects the adhesive side of the patch.

Apply the patch to the skin around the painful or swollen area.

• If necessary, the patch can be held in place with a wide-mesh gauze or with thin strips of adhesive tape.
• Do not cover the patch with any other type of dressing.
• The medicated patch must be applied exclusively to intact skin and not on broken skin or open wounds and must not be worn during bathing or showering.
• Keep the patch away from eyes, nose, mouth and the genital and anal area. If the patch comes into contact with these areas, rinse with water.
• The patch must not be cut.

Patch replacement.

• Remove the patch every 12 or 24 hours and apply a new one.
• If you forget to use FASTUFLEXDo not apply an extra patch to make up for the forgotten one. Just apply the next patch as scheduled. If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, FASTUFLEX can cause side effects, although not everybody gets them.
manifest.

Some uncommon and very rare side effects can be serious
If you experience any of the following signs of allergy, STOP using FASTUFLEX and consult
your doctor or pharmacist immediately:

• swelling of the lips, eyes or tongue, wheezing or asthma attack, signs of a severe allergic reaction (affect less than 1 in 10,000 users);
• skin rash, irritation or burningat the site of patch application (affect 1 to 10 users out of 1,000). Other possible side effects are usually mild, transient and harmless (if you are concerned,consult your doctor or pharmacist).Common side effects (affect 1 to 10 users out of 100)
• Itching Uncommon side effects (affect 1 to 10 users out of 1,000)
• Skin rash
• Redness of the skin
• Very small red or purple spots under the skin Rare side effects (affect 1 to 10 users out of 10,000)
• Dry and flaky skin
• Swelling at the site of patch application. Very rare side effects (affect less than 1 in 10,000 users)
• Skin rashes worsened by sunlight Since FASTUFLEX is applied to the skin at the affected area, there is a lower risk of side effects, such as stomach problems including pain, digestive disorders or signs of bleeding in the stomach or intestines, which can occur after taking diclofenac orally. However, if FASTUFLEX is not used correctly, these side effects can occur. Reporting of side effectsIf 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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione- avversa. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store FASTUFLEX

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 expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Do not use this medicine 4 months after the first opening of the sachet.
After extracting each patch, ensure that the sachet has been closed again.
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. Contents of the pack and other information

What FASTUFLEX contains
The active ingredient is diclofenac epolamine. Each medicated patch contains a total of 180 mg of diclofenac
epolamine, corresponding to 140 mg of diclofenac sodium.
The other ingredients are gelatin, povidone (K90), liquid sorbitol (non-crystallizing), heavy kaolin,
titanium dioxide (E171), propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate
(E216), disodium edetate (E385), tartaric acid, aluminum glycinate, sodium carboxymethyl cellulose, sodium polyacrylate,
1,3-butylene glycol, polysorbate 80, purified water.
The non-woven support layer is made of polyester.
The removable protective layer is made of polypropylene.

Description of the appearance of FASTUFLEX and contents of the pack
Each medicated patch consists of a dressing impregnated with a paste of color from white to light yellow,
with a removable transparent plastic backing film that protects an adhesive layer. The resealable pouches contain 5 patches.
FASTUFLEX is available in packs of 5 or 10 patches. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder

• A. Menarini Industrie Farmaceutiche Riunite s.r.l. - Via Sette Santi, 3 – 50131 Florence Manufacturer Miat S.p.A. Via Menabrea 20 20159 Milan (Italy)

This medicinal product is authorised in the Member States of the EEA under the following denominations:
Greece FASTAIN
Italy FASTUFLEX
Portugal FASTINE