Leaflet: information for the user

Flectormed 180mg adhesive medicated plaster

diclofenaco epolamine

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

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

-Keep this leaflet, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

-You should consult a doctor if it worsens or does not improve after 7days.

1.What Flectormed is and for what it is used

2.What you need to know before starting to use Flectormed

3.How to use Flectormed

4.Possible adverse effects

5.Storage of Flectormed

6. Contents of the package and additional information

Indicated in adults and adolescents over 16 years old.years old.

Flectormed belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.

Flectormed is used for the symptomatic treatment and short-term relief of minor painful disorders affecting the joints, muscles, tendons, and ligaments.

Children and adolescents under 16 years old.years old

It is not recommended to use this medication in children and adolescents under 16 years old, as there is insufficient data available regarding the safety and efficacy of this medication.years old

Do not use Flectormed:

•if you are allergic to diclofenaco epolamina or any of the other components of this medication (listed in section6);

•if you are allergic to any pain medication (analgesic) or anti-inflammatory (NSAID);

•if you have asthma, breathing problems, skin rash, or nasal discharge after taking acetylsalicylic acid (aspirin) or other NSAIDs;

•if you have skin lesions, including infected or suppurating areas, eczema, burns, or wounds;

•if you are entering your 6th month of pregnancy or if your pregnancy is more advanced;

•if you currently have a stomach ulcer (gastroduodenal ulcer).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Flectormed if:

•you have breathing problems (allergic rhinitis, nasal polyps, asthma, chronic bronchitis);

•you have a kidney, heart, or liver disease;

•you have had stomach or duodenal ulcers;

•you have had inflammatory bowel disease;

•you are prone to bleeding;

•you are in the first 6 months of pregnancy or breastfeeding.

Other important information

Always use the lowest effective dose of Flectormed for the shortest period of time necessary to control symptoms.

This medication should be used with caution in elderly patients who may be prone to adverse effects.

To minimize the frequency of adverse effects, it is recommended to use the lowest effective dose for the shortest possible time.

Do not use this medication simultaneously with another medication containing diclofenaco or with other nonsteroidal anti-inflammatory drugs (NSAIDs).

Do not expose yourself to direct sunlight or a tanning bed for at least one day after removing the patch to reduce the risk of photosensitivity.

Pay attention to the use of non-occlusive dressings, avoiding only occlusive dressings.

Stop using the adhesive patch and inform your doctor or pharmacist if a skin rash appears when applying the patch or general hypersensitivity events occur, especially after prolonged treatment.

Children and adolescents

Not to be used in children under 16 years.

Older adults

In this case, you should pay more attention while using the medication to detect possible adverse effects.

Patients with liver or kidney problems

If you have liver or kidney problems, pay more attention while using the medication to detect possible adverse effects.

Other medications and Flectormed

If used correctly, the risk of interaction with other medications is very low. However, inform your doctor or pharmacist if you are using or taking any other medication, even if it has been recently or will be in the future.

Pregnancy

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication. Flectormed should not be used if you are entering the 6th month of pregnancy or if your pregnancy is more advanced, as it may cause damage to your fetus or complications during delivery.

Lactation

During breastfeeding, do not apply the patch to the breasts of women who are breastfeeding or to large areas of the skin or for a prolonged period.

Fertility

Like other NSAIDs, the use of diclofenaco may alter female fertility and is not recommended if you are planning to become pregnant. In women who may have difficulty conceiving or are undergoing infertility treatment, the use of diclofenaco should be avoided.

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible.

This medication contains

• 420 mg of propylene glycol, which may cause skin irritation.
• parahydroxybenzoic acid methyl ester (E-218), parahydroxybenzoic acid propyl ester (E-216), and perfume DH Dalin, which contains amyl cinnamaldehyde, amyl cinnamaldehyde alcohol, benzyl alcohol, benzyl benzoate, salicylic acid benzyl ester, cinnamaldehyde, cinnamic alcohol, citronellol, d-Limonene, eugenol, farnesol, geraniol, hexyl cinnamaldehyde, hydroxycitronellal, isoeugenol, linalool, methyl heptine carbonate, which may cause allergic reactions (possibly delayed).

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Adults and adolescents over 16 years oldyears old

Use one adhesive patch per day for a maximum period of 7days. You should consult a doctor if you do not observe improvement throughout the recommended duration of treatment, or if symptoms worsen.

This medicated adhesive patch should not be used in children or adolescents under 16years old, as there are not sufficient data available regarding the safety and efficacy of this medication.

Administration form

Instructions for use for the 2, 5 and 10 medicated adhesive patches packaging:

a) Cut the top of the sealed envelope along the dotted line.

b) Remove a medicated adhesive patch and close the seal carefully by pressing the self-closure.

c) Remove the plastic backing that protects the adhesive side of the medicated adhesive patch.

d) Apply the medicated adhesive patch to the skin, in the painful or inflamed area.

Instructions for use only for the 7 medicated adhesive patches packaging:

a) Cut the top of the sealed envelope along the dotted line and remove the medicated adhesive patch.

b) Remove the plastic backing that protects the adhesive side of the medicated adhesive patch.

c) Apply the medicated adhesive patch to the skin, in the painful or inflamed area.

If necessary, the patch can be kept in place using a gauze with open weave or using the elastic mesh contained in the box, avoiding the use of occlusive bandages.

The medicated adhesive patch should only be applied to intact skin, which is not damaged, avoiding applying it to open wounds or lesions. The patch should not be used during bathing or showering.

The patch should be used whole, for the shortest possible treatment period, in accordance with the usage instructions.

If you forgot to use Flectormed

Do not use more than one patch at the same time. If you need more information, contact your doctor or pharmacist.

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

Some rare and very rare adverse effects could be severe

If you experience any of the following signs of allergy, STOP using Flectormed and consult a doctor or pharmacist immediately:

• Swelling of lips, eyes, or tongue, wheezing or asthma attack, which are signs of severe allergic reaction.
• Burning or stinging sensation at the site where the adhesive patch was applied.

Generally, adverse effects are related to the application site.

Frequent Adverse Effects(affect between 1 and 10 out of 100 users)

Skin reactions: skin rash, dermatitis, redness, and inflammation of the skin, pruritus.

Other Adverse Effects

Rare, rare, and very rare: skin rash with blister or vesicle formation, dry skin, allergic reaction also after exposure of the skin to sunlight or a sunbath (photosensitivity), urticaria.

If the medicated adhesive patches are used correctly, the risk of adverse effects is very low, whereas if they are used for prolonged periods of treatment or used with other medications containing diclofenac, especially by oral route, the risk of generalized adverse effects cannot be ruled out.

Reporting Adverse Effects

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

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

Store below 30°C.

Only for packaging of 2, 5, and 10 medicated adhesive strips: do not use after 3 months from the first opening of the package. After removing each adhesive strip, ensure the package is resealed.

Do not use this medication after the expiration date that appears on the package and on the box after CAD.

Do not dispose of unused adhesive strips in the trash. They must be disposed of in accordance with local regulations. Used adhesive strips should not be flushed down the toilet or deposited in liquid waste disposal systems.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Flectormed

The active ingredient is diclofenac epolamine. Each medicated adhesive plaster contains a total of 180mg of diclofenac epolamine equivalent to 140mg of diclofenac sodium (1% p/p).

The other components are gelatin, povidone (K90), sodium heparin, liquid sorbitol, kaolin, titanium dioxide (E171), propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate (E385), tartaric acid, aluminum glycinate, sodium carmellose, sodium polycarboxylate, 1,3-butanediol, polysorbate80, fragrance (containing, amylcinnamaldehyde,amylcinnamaldehyde alcohol, benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnamaldehyde, cinnamic alcohol, citronellol, d-Limonene, eugenol, farnesol, geraniol, hexyl cinnamaldehyde, hydroxycitronellal, isoeugenol, linalool, methyl heptine carbonate), purified water, and polyester non-woven fabric.

Appearance of the product and contents of the package

Each medicated adhesive plaster consists of a paste of a color between white and pale yellow, impregnated in a plaster with a transparent removable plastic backing that protects the adhesive layer.

The box contains 2, 5, 10adhesive medicated plasters in 1 or 2self-sealing pouches, while the box of 7 adhesive medicated plasters contains 7 sealed pouches with an adhesive plaster each.

A tubular mesh is included.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

IBSA Farmaceutici Italia srl

Via Martiri di Cefalonia, 2

26900 Lodi, Italy

Manufacturer

Altergon Italia srl

ASI Industrial Area

83040 Morra De Sanctis (Av), Italy

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Angelini Pharma España, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Edificio Australia

08840 Viladecans, Barcelona, Spain

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

BelgiumFlalgo/Flectoflex

Czech RepublicFlalgo

HungaryFlectorin

ItalyCalminemed

SlovakiaFlectopar

SpainFlectormed

Last review date of this leaflet:October 2023

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