140 mg medicinal patch
contains diclofenac sodium
1. What Flector is and what it is used for
Flector belongs to a group of medicines called non-steroidal anti-inflammatory drugs ( NSAIDs ). NSAIDs relieve pain and inflammation.
Flector is used for local treatment of pain at the tennis elbow, golf elbow ( epicondylitis ), and ankle sprain.
2. What you need to know before using Flector
Do not use Flector
- if you are allergic (hypersensitive) to diclofenac, acetylsalicylic acid, or other NSAIDs.
- if you are allergic to any of the other ingredients of Flector (listed in section 6).
- from the sixth month of pregnancy.
- if you have ongoing stomach ulcers.
- if you have damaged skin, including exuding or infected areas, eczema, burns, or wounds in the treatment area.
- if you are a child or adolescent younger than 16 years.
Talk to your doctor or pharmacist if any of the above apply to you.
Warnings and cautions
Talk to your doctor or pharmacist before using Flector
- if you have heart disease,
- if you have kidney disease,
- if you have liver disease,
- if you have had stomach ulcers before,
- if you have any inflammatory bowel disease such as Crohn’s disease or ulcerative colitis or if you are prone to stomach bleeding,
- if you have asthma,
- if you have difficulty breathing, a rash, or runny nose after taking acetylsalicylic acid or other NSAIDs,
- if you are taking diclofenac or other NSAIDs in oral form (by mouth) or topical form (on the skin),
- whether you regularly sunbathe solarium or solarium outdoors. Avoid direct sunlight and tanning beds on the treated area during the treatment and at least two weeks after the end of the treatment.
- If you are older, you can get side effects more easily.
Children and young people
Flector should not be used in children and adolescents under 16 years of age.
Other drugs and Flector
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If Flector is used correctly, the risk of exposure to other medicines is very small.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnant women should not use Flector during the last three months of pregnancy, as it may harm the unborn baby and cause problems during childbirth. The use of Flector should be avoided by women who are planning to become pregnant or are pregnant. Treatment during the first six months of pregnancy should only take place after a doctor’s prescription and the dose should be kept as low as possible and the treatment time should be as short as possible.
Breast-feeding
Flector should only be used during breast-feeding if prescribed by a doctor as small amounts of diclofenac pass into breast milk. Flector should not be applied directly to the breasts if you are breastfeeding, nor too large areas of skin or for a long time.
Driving and using machines
Flector does not affect the ability to drive or use machines.
Flector contains:
- preservatives called parahydroxybenzoates which may cause an allergic reaction (possibly delayed).
- and propylene glycol which may cause skin irritation.
3. How to use Flector
Always use this medicine exactly as described in this leaflet or as directed by your pharmacist. If you are not sure, talk to a pharmacist.
Adults and adolescents 16 years and older
Number of patches
- Tennis or golf elbow
- Put on a patch in the morning
- Remove the patch in the evening and apply a new one
- Remove the patch in the morning repeat these steps for a maximum of 14 days.
- Ankle sprain
- Apply one patch per day
- Remove the patch the next day and apply a new one. Repeat these steps for a maximum of 3 days.
Remember: Ankle sprains usually improve within 3 days and elbow pain within 14 days. You must contact a doctor if the symptoms worsen or do not improve within 14 days with tennis elbow and golf elbow or 3 days with an ankle sprain.
Use for children and adolescents (under 16 years)
Flector is not recommended for children and adolescents under 16 years of age. There are only insufficient data on efficacy and safety in children and adolescents under 16 years of age (see also Do not use Flector).
For adolescents 16 years and older, who need pain treatment longer than 7 days or whose symptoms worsen, it is recommended that the patient/parents contact a doctor.
Instructions for use :
- Cut the top of the resealable envelope. Remove a patch and reseal the envelope carefully using the slide seal.
- Note the date the envelope was opened at the intended location.
- Remove the protective plastic film from the adhesive layer of the patch.
- Apply a patch on the painful or swollen area. If necessary, the patch can be held in place with the help of an elastic mesh or thin tape. This can be bought at pharmacies.
- Do not cover the patch with any other material.
- The patch must not be used on damaged or infected skin, on wounds, or open injuries. The patch should not be used during the bath or shower.
- Be careful not to get the gel in your eyes, nose, mouth, genitals, or at the anal opening. Rinse with water if gel comes in contact with these areas.
- The patch should not be cut in half.
If you forget to use Flector
Do not take another patch to compensate for a missed dose. Apply the next patch as planned.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Flector can cause side effects, although not everybody gets them.
Some less common and very rare side effects may be serious
Contact a doctor immediately and stop using the patch if you notice any of the following signs of an allergy:
- Swelling of the lips, eyes, or tongue, shortness of breath, or asthma attack which is signs of a severe allergic reaction (may affect up to 1 in 10,000 users),
- Skin rash, stinging, or burning sensation on the area where the patch has been applied (may affect up to 1 in 100 people).
Other side effects that may occur are usually mild, transient, and harmless (if you are worried, talk to your doctor or pharmacist).
Common side effects are (may affect up to 1 in 10):
- Itching
Less common side effects are (may affect up to 1 in 100):
- Rash
- Reddening of the skin
- Small dark purple/dark red dots under the skin
Rare side effects are (may affect up to 1 in 1000):
- Dry, scaly, skin
- Swelling at the site where the patch was placed.
Very rare side effects are (may affect up to 1 in 10 000 users):
- Skin rash aggravated by sunlight.
Because Flector is applied to the skin, over the affected area, the risk of side effects such as stomach upset including pain, indigestion, or signs of bleeding in the stomach or intestines is lower than for diclofenac taken by mouth. However, if Flector is not used correctly, these side effects may occur.
5. How to store Flector
Keep this medicine out of the sight and reach of children.
Used before the expiry date which is stated after “EXP.” on the envelope or carton. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Use within 3 months after opening the envelope. Be sure to reseal the patch envelope after each patch is removed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is diclofenac sodium. Each patch contains a total of 180 mg of diclofenac polamine corresponding to 140 mg of diclofenac sodium (1% w / w).
- The other ingredients are gelatin, povidone (K90), sorbitol, kaolin, titanium dioxide (E171), propylene glycol, methyl parahydroxybenzoate (E218), propyl parhydroxybenzoate (E216), disodium edetate (E385), tartaric acid, aluminum glycolide acrylate, Karyl glycosylate; polysorbate 80, perfume (propylene glycol, benzyl salicylate, phenyl ethyl alcohol, alpha-amyl cinnamaldehyde, hydroxy citronellal, phenethylphenyl acetate, cinnamon acetate, benzyl acetate, terpineol, cinnamon alcohol, cyclamen aldehyde) and purified water and polyhydric ester.
What the medicine looks like and the contents of the pack
Each medical patch contains a white to pale yellow gel that is spread in an even layer on gauze and has a transparent plastic film that protects the adhesive layer.
The resealable envelopes contain 2 or 5 patches.
Flector medical patch contains packs of 2, 5, 10, or 14 patches per carton.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
IBSA Farmaceutici Italia SrI – Via Martiri di Cefalonia, 2 – 26900 Lodi – Italien
Manufacturer
Altergon Italia, Zona Industriale, 83040 Morra De Sanctis (Av), Italy
This medicinal product is authorized under the European Economic Area under the names:
| Cyprus, France, Ireland | Flector Tissugel |
| Poland | Flector Patch |
| Germany | DICLOFENAC IBSA Pharmaceuticals |