Flector EP - Plaster

Flector EP - Plaster is suitable for the external treatment of painful musculoskeletal complaints.

Application

1. WHAT IS FLECTOR EP - PLEAD AND WHAT IS IT USED FOR?

Flector EP - PLEAD is suitable for the external treatment of painful musculoskeletal complaints. The active ingredient diclofenac-epolamine is absorbed well through the skin and reaches the affected tissues directly, where it has an analgesic, anti-inflammatory and decongestant effect.

If you do not feel better or even worse, consult your doctor.

Application:
For external, local treatment of
- pain caused by muscle tension (including lumbago)
- pain and swelling after blunt injuries and sports injuries(such as sprains, strains, bruises)

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How is it applied?

WHAT IS FLECTOR EP - PLEASANT AND WHAT IS IT USED FOR?

Flector EP - Plaster is suitable for the external treatment of painful musculoskeletal complaints. The active substance contained, diclofenac-epolamine, is well absorbed through the skin and reaches the affected tissues directly, where it exerts its analgesic, anti-inflammatory and decongestant effect.

If you do not feel better or even worse, consult your doctor.

Application:
For external, local treatment of
-pain caused by muscle tension (including lumbago).pain and swelling after blunt injuries and sports injuries (e.g. sprains, strains, bruises)

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What should you pay attention to before taking it?

What SHOULD YOU TAKE INTO ACCOUNT BEFORE USING FLECTOR EP - PLEASANT ?
Flector EP - Patch must not be used,
- if you are allergic to diclofenac-epolamine or any of the other ingredients mentioned in section 6. other ingredients of this medicine mentioned in section 6.
- in case of known hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
- from the beginning of the 6th month of pregnancy and on the breast of breast-feeding mothers.
- on injured skin of any kind: weeping dermatosis (pathological skin changes), eczema, infected injuries, burns or wounds. - in patients with active ulceration of the digestive tract (peptic ulcer).
- in children and adolescents under 16 years of age.

Warnings and precautions
Please talk to your doctor or pharmacist before using Flector EP - Patch.If Flector EP Patch is used on large areas of skin and for long periods of time, the possibility of systemic side effects cannot be excluded. The use of Flector EP patches on large areas of skin and over a long period of time is therefore not recommended.

The patch should only be applied to intact, uninjured skin and should not be applied to skin wounds or open injuries.

Avoid contact with eyes and mucous membranes.

Do not apply Flector EP - Patch with a tight-fitting dressing (occlusive dressing).

If a rash occurs after applying the patch, you must stop treatment immediately and consult a doctor.

Avoid strong sun exposure (or solarium) to reduce the risk of a photosensitivity reaction.

Do not use Flector EP - Patch at the same time as other medicines containing diclofenac or other medicines from the group of non-steroidal painkillers and anti-inflammatories, whether applied topically or ingested.

Use Flector EP - Patch with caution if you have kidney, heart or liver dysfunction or have suffered from an ulcer in the digestive tract (peptic ulcer) or intestinal inflammation or have had a tendency to bleed (haemorhagic diathesis).

Medicines from the group of non-steroidal painkillers and anti-inflammatory drugs should be used with caution in elderly people as they are more prone to side effects.

Use Flector EP - Patch with caution if you have asthma, conditions associated with chronic cough, sputum and breathlessness (obstructive airway diseases), hay fever or nasal polyps.

Use of Flector EP - Patch with other medicines
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or do not intend to take/use any other medicines.

When the patch is used as directed, no interactions have been reported so far.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor for advice before using this medicine.

Pregnancy:
As there is insufficient experience of use in pregnant women, Flector EP - patches should not be used during the first 5 months of pregnancy for safety reasons.

Use in the last third of pregnancy (last 3 months) could lead to a developmental disorder of the circulatory system and/or kidney dysfunction in the unborn child and, during birth, to increased bleeding in the mother and child and to a delay/prolongation of the birth process.
Therefore, Flector EP - Patch must not be used from the beginning of the 6th month of pregnancy.

Lactation:
As with other medicines from the group of non-steroidal painkillers and anti-inflammatory drugs, the active substance of Flector EP Patch, diclofenac-epolamine, passes into breast milk in small amounts. However, no effects on the infant are expected at the therapeutic doses of Flector EP patches. Due to the lack of controlled studies in breastfeeding women, the preparation may only be used during breastfeeding on the advice of a doctor. In this case, Flector EP Patch must not be used on the breasts of breastfeeding mothers or on large areas of skin or for a prolonged period of time.

Driving and ability to operate machinery
When Flector EP - Patch is used as directed, no effects on driving ability or ability to operate machinery are expected.

Flector EP - Patches contain methyl 4-hydroxybenzoate (E218), propyl 4-hydroxybenzoate (E216) and propylene glycol
Methyl 4-hydroxybenzoate (E218) and propyl 4-hydroxybenzoate (E216) may cause allergic reactions, including delayed reactions. Propylene glycol may cause skin irritation.

How should the medicine be taken?

HOW TO USE FLECTOR EP - PLASTER?

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults and adolescents aged 16 and over:
Place 1 patch on the area to be treated 1 - 2 times daily (in the morning or evening) and press on well. The patch is self-adhesive.

Children and adolescents under 16 years of age:
There are insufficient data on efficacy and tolerability in children and adolescents under 16 years of age (see also section 2).

Older persons:
Flector EP patches should be used with caution in older persons as they are more prone to side effects (see section 2).

Patients with renal or hepatic impairment:
For use in patients with renal or hepatic impairment, see section 2.

How to use:
Flector EP - Patch is intended for use on the skin.

Cut the pouch along the mark and remove one patch.
Pull off the clear protective film and place the patch with the adhesive surface on the painful area, press firmly and allow to adhere to the skin.
Seal the pouch tightly after each removal (pressure seal).

No special precautions are required on the affected skin area before applying the patch.
Apply the patch to the most painful area.

The patch should only be applied to intact, uninjured skin and should not be worn while showering or bathing.

Simultaneous application of multiple patches is not recommended.

The patch should be used whole.

The duration of treatment should not exceed 14 days.
If your symptoms worsen or do not improve, you must consult a doctor in any case.

In adolescents aged 16 years and over, the patient / parents are advised to consult a doctor if the medicine is needed for more than 7 days to treat pain or if the symptoms worsen.

If you have used a larger amount of Flector EP - Patch than you should
There has been no experience of an overdose of Flector EP - Patch.

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

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What are the possible side effects?

HOW TO STORE FLECTOR EP - PLASTER?

Do not store above 25°C.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and pouch after "EXP". The expiry date refers to the last day of the month indicated.

After the first opening of the sachet, the patches must be used within 3 months.

Reseal the bag after removing a plaster.

Special instructions for storage

5. HOW TO STORE FLECTOR EP - PLASTER?

Do not store above 25°C.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and pouch after "use by". The expiry date refers to the last day of the month indicated.

After opening the pouch for the first time, use the patches within 3 months.

Reseal the pouch after removing a patch.

Special notes on the content

PACK CONTENT AND FURTHER INFORMATION

What Flector EP - Patch contains

- The active ingredient is:
180 mg diclofenac-epolamine (EP) per patch.

- The other ingredients are:
Gelatin, povidone, sorbitol solution 70%, white clay, titanium dioxide (E171), propylene glycol, methyl 4-hydroxybenzoate (E218), propyl 4-hydroxybenzoate (E216) , sodium edetate (.2H2O), tartaric acid, carmellose sodium, sodium polyacrylate, dihydroxyaluminium glycinate, 1,3-butanediol, polysorbate 80, fragrance (Dalin PH), purified water, polyester cloth, propylene film.

What Flector EP - Patch looks like and contents of the pack
Gel-impregnated patch for application to the skin (patch containing active substance) in
a resealable sachet of composite film.

Pack sizes:
2 pieces
5 pieces
10 pieces

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