Flectormed 180 mg medicated patch
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Flectormed 180mg medicated adhesive patch
diclofenac epolamine
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Always follow exactly the instructions for use of the medicine as described in this leaflet or as advised by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days.
Contents of the leaflet
- What Flectormed is and what it is used for
- What you need to know before using Flectormed
- How to use Flectormed
- Possible adverse effects
- How to store Flectormed
- Contents of the pack and other information
1. What Flectormed is and what it is used for
Indicated in adults and adolescents over 16 years of age.
Flectormed belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.
Flectormed is used for the short-term local symptomatic treatment of minor painful conditions affecting the joints, muscles, tendons, and ligaments.
Children and adolescents under 16 years of age
Use of this medicine is not recommended in children and adolescents under 16 years of age, as there is insufficient data available on the safety and efficacy of this medicine.
2. What you need to know before using Flectormed
Do not use Flectormed:
- if you are allergic to diclofenac epolamine or to any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to any painkiller (analgesic) or anti-inflammatory medicine (NSAID);
- if you have asthma, breathing difficulties, skin rash, or nasal discharge after taking acetylsalicylic acid (aspirin) or other NSAIDs;
- if you have skin lesions, including infected areas or areas with pus, 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 (peptic ulcer).
Warnings and precautions
Talk to your doctor or pharmacist before using Flectormed if:
- you have breathing problems (allergic rhinitis, nasal polyps, asthma, chronic bronchial diseases);
- you have 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 are breastfeeding.
Other important information
Always use the lowest effective dose of Flectormed for the shortest duration necessary to control symptoms.
This medicine should be used with caution in elderly patients who may be more susceptible 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 medicine simultaneously with another medicine containing diclofenac or with other non-steroidal anti-inflammatory drugs (NSAIDs).
Avoid direct sunlight and sunbed exposure for at least one day after removing the patch, to reduce the risk of photosensitivity.
Take care when using 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 if general signs of sensitization (hypersensitivity) occur, especially after prolonged treatment.
Children and adolescents
Do not use in individuals under 16 years of age.
Elderly patients
In this case, extra caution is required while using the medicine to detect possible adverse effects.
Patients with hepatic or renal impairment
If you have liver or kidney problems, exercise greater caution while using the medicine to detect possible adverse effects.
Other medicines and Flectormed
When used correctly, the risk of interaction with other medicines is very low. However, inform your doctor or pharmacist if you are using or taking any other medicines, even if recently started or if they will be used in the future.
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Flectormed must not be used if you are entering the 6th month of pregnancy or beyond, as it may cause harm to your fetus or complications during delivery.
Breast-feeding
During breastfeeding, do not apply the patch on the breasts of nursing women, nor on large areas of skin or for prolonged periods.
Fertility
As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended if you are trying to conceive. Diclofenac should be avoided in women who have difficulty conceiving or who are undergoing infertility treatment.
Driving and using machines
This medicine has no influence on the ability to drive or operate machinery.
This medicine contains
- 420 mg of propylene glycol, which may cause skin irritation.
- methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), and perfume DH Dalin, which contains amyl cinnamaldehyde, amyl cinnamyl alcohol, benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnamaldehyde, cinnamyl alcohol, citronellol, d-Limonene, eugenol, farnesol, geraniol, hexyl cinnamaldehyde, hydroxycitronellal, isoeugenol, linalool, methyl heptine carbonate, which may cause allergic reactions (possibly delayed).
3. How to use Flectormed
Follow exactly the instructions for medication administration provided in this leaflet or as directed by your physician or pharmacist. If in doubt, consult your physician or pharmacist.
Adults and adolescents over 16 years of age
Apply one medicated patch per day for a maximum period of 7 days. You should consult a physician if you do not observe improvement within the recommended treatment duration, or if symptoms worsen.
This medicated patch must not be used in children or adolescents under 16 years of age, as there is insufficient data available regarding the safety and efficacy of this medicinal product.
Method of administration
Instructions for use for packs containing 2, 5, and 10 medicated patches:
- Cut the top of the resealable pouch containing the medicated patches along the dotted line.
- Remove one medicated patch and carefully reseal the closure by pressing the adhesive strip together.
- Remove the plastic backing that protects
the adhesive side of the medicated patch.
- Apply the medicated patch directly onto
the skin, over the painful or inflamed area.
Instructions for use for packs containing 7 medicated patches only:
- Cut the top of the sealed pouch along the
dotted line and remove the medicated patch.
- Remove the plastic backing that protects
the adhesive side of the medicated patch.
- Apply the medicated patch directly onto
the skin, over the painful or inflamed area.
If necessary, the patch may be secured in place using an open-mesh gauze dressing or the elastic mesh provided in the package, avoiding the use of occlusive bandages.
The medicated patch must only be applied to intact, undamaged skin, avoiding application over wounds or open lesions. The medicated patch should not be used during bathing or showering.
The medicated patch should be used as a whole and for the shortest possible treatment duration, in accordance with the instructions for use.
If you forget to use Flectormed
Do not use more than one medicated patch at the same time. If you need further information, contact your physician or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Some uncommon and very rare adverse effects could be serious
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 a severe allergic reaction.
- Burning or stinging at the site where the medicated patch has been applied.
In general, adverse effects are related to the application site.
Frequent adverse effects (affect between 1 and 10 out of every 100 users)
Skin reactions: skin rash, dermatitis, redness and inflammation of the skin, pruritus.
Other adverse effects
Uncommon, rare and very rare: skin rash with blister or vesicle formation, dry skin, allergic reaction also after exposure of the skin to sunlight or sunbed (photosensitivity), urticaria.
If medicated adhesive patches are used correctly, the risk of adverse effects is very low. However, if they are used for prolonged treatment periods or together with other medicines containing diclofenac, especially those taken orally, the risk of generalized adverse effects cannot be excluded.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Flectormed
Keep this medicine out of the sight and reach of children.
Store below 30 °C.
For packages containing 2, 5, and 10 medicated adhesive patches only: do not use more than 3 months after first opening the pouch. After removing each adhesive patch, ensure the pouch is properly resealed.
Do not use this medicine after the expiry date stated on the pouch and on the carton following EXP.
Do not dispose of unused adhesive patches in household waste. They must be disposed of in accordance with local regulations. Used adhesive patches must not be flushed down the toilet or disposed of via liquid waste systems.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be taken to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Flectormed
The active substance is diclofenac epolamine. Each medicated adhesive patch contains a total of 180 mg of diclofenac epolamine, equivalent to 140 mg of diclofenac sodium (1% w/w).
The other components are gelatin, povidone (K90), sodium heparin, liquid sorbitol, kaolin, titanium dioxide (E171), propylene glycol, methylparaben (E218), propylparaben (E216), disodium edetate (E385), tartaric acid, aluminum glycinate, sodium carmellose, sodium polyacrylate, 1,3-butylene glycol, polysorbate 80, fragrance (containing amyl cinnamaldehyde, amyl cinnamyl alcohol, benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnamaldehyde, cinnamyl alcohol, citronellol, d-Limonene, eugenol, farnesol, geraniol, hexyl cinnamaldehyde, hydroxycitronellal, isoeugenol, linalool, methyl heptine carbonate), purified water, and a non-woven polyester support.
Presentation of the product and contents of the pack
Each medicated adhesive patch consists of a paste ranging in colour from white to pale yellow, impregnated onto a dressing with a transparent, removable plastic backing that protects the adhesive layer.
The carton contains 2, 5, or 10 medicated adhesive patches in 1 or 2 resealable pouches, whereas the pack containing 7 medicated adhesive patches includes 7 sealed pouches, each containing one patch.
A tubular mesh is included.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia, 2
26900 Lodi, Italy
Manufacturer
Altergon Italia srl
Zona Industriale ASI
83040 Morra De Sanctis (Av), Italy
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Instituto Bioquímico Ibérico IBSA S.L.
Avenida Diagonal 605,
8th Floor, Local 1,
08028 Barcelona (Spain)
This medicinal product is authorised in the following Member States of the European Economic Area under the following names:
Belgium Flalgo/Flectoflex
Czech Republic Flalgo
Hungary Flectorin
Italy Calminemed
Slovakia Flectopar
Spain Flectormed
Date of the most recent review of this leaflet: October 2023
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/