Flector Tissugel Heparin Medicated Patch for Sprains: Flector Tissugel Heparin is a medicated patch containing diclofenac and heparin. It helps reduce inflammation and pain associated with sprains, as well as reduce swelling.
For warnings, precautions, and contraindications, please refer to the package insert.
Topical symptomatic treatment of mild ankle sprains.
As a complementary treatment, we recommend usingPiasclédine, which is effective for osteoarthritis.
Each 10 cm x 14 cm medicated patch contains 14 g of gel containing 140 mg of diclofenac sodium in the form of diclofenac epolamine and 5,600 IU of heparin sodium.
100 g of gel contain 1 g of diclofenac sodium in the form of diclofenac epolamine and 40,000 IU of sodium heparin.
The other ingredients are :
Base:
Nonwoven polyester backing.
Adhesive layer (active gel) composed of: gelatin, povidone K 90, non-crystallizable sorbitol, heavy kaolin, titanium dioxide (E 171), propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), disodium edetate (E 385), tartaric acid, aluminum glycinate, sodium carmellose, sodium polyacrylate, 1,3-butylene glycol, polysorbate 80, Dalin PH fragrance (propylene glycol, benzyl salicylate, phenylethyl alcohol, alpha-amylcinnamic aldehyde, hydroxycitronellal, phenyl ethyl phenylacetate, cinnamyl acetate, benzyl acetate, terpineol, cinnamic alcohol, cyclamenaldehyde), purified water.
Protective film: polypropylene film
Contraindications:
Precautions for use:
The plaster must not come into contact with the eyes or mucous membranes, nor should it be applied to the eyes or mucous membranes.
Do not use under an occlusive dressing. However, for the treatment of sprains and strains, a compression bandage may be used.
If a skin rash develops after applying FLECTOR TISSUGEL HEPARINE, treatment must be discontinued immediately.
Concomitant use of medications containing diclofenac or other NSAIDs, whether applied topically or systemically, should be avoided.
Although the occurrence of systemic adverse effects is rare, FLECTOR TISSUGEL HEPARINE should be used with caution in patients with impaired cardiac, renal, or hepatic function, and in patients with a history of peptic ulcer, inflammatory bowel disease, or gastrointestinal bleeding. Nonsteroidal anti-inflammatory drugs (NSAIDs) should be used with particular caution in the elderly, who are more prone to adverse effects.
This medication contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. It may cause allergic reactions (which may be delayed). It also contains propylene glycol, which may cause skin irritation.
To reduce any risk of photosensitization, patients should be advised to avoid exposure to sunlight (sunlight or UV tanning beds).
3 medicated patches, 1 g/40,000 IU per 100 g, FLECTOR TISSUGEL HEPARIN.
What Is a Sprain?
A sprain is a stretching or tearing of a ligament. A ligament is a kind of cord that connects two bones to form a joint, thereby stabilizing it.
A simple stretch or tear is classified as a mild sprain, while a complete tear is classified as a severe sprain. In between, it is considered a moderate sprain (a significant stretch or one affecting more than one ligament, or a slightly more severe tear). The ankle is stabilized by an external ligament consisting of three bundles and the internal ligament. The most common sprain is mild and involves one of the bundles of the external ligament.
You must see a doctor
In the case of ankle sprains:
In the case of knee injuries:
In all cases, if there is complete functional impairment—that is, if you cannot use your upper or lower limb—and in the event of a large bruise.
Please note: Medications are not like other products. Read the medication guide carefully before ordering. Keep medications out of the reach of children. If symptoms persist, consult your doctor or pharmacist. Be aware of potential interactions with your current medications.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Last updated: 30/01/2014
Name of the medicinal product
FLECTOR TISSUGEL HEPARINE 1 g / 40 000 IU per 100 g, medicated plaster
Diclofenac sodium and heparin sodium
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist beyond 3 days, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT TISSUGEL FLUORINE HEPARIN 1 g / 40 000 IU per 100 g, medicated plaster AND WHAT IT IS USED FOR?
2. BEFORE YOU USE FLECTOR TISSUGEL HEPARINE 1 g / 40 000 IU per 100 g, medicated plaster?
3. HOW TO USE FLECTOR TISSUGEL HEPARINE 1 g / 40 000 IU per 100 g, medicated plaster?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE FLECTOR TISSUGEL HEPARINE 1 g / 40 000 IU per 100 g, medicated plaster?
6. ADDITIONAL INFORMATION
1. WHAT TISSUGEL FLUORINE HEPARIN 1 g / 40 000 IU per 100 g, medicated plaster AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
This medicinal product contains 2 active substances:
· diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It calms pain and reduces inflammation.
· the heparin used topically is an anti-inflammatory and an anti-edematous.
Therapeutic indications
FLECTOR TISSUGEL HEPARINE is used to treat locally the symptoms of a benign ankle sprain.
This medication is for adults only.
2. BEFORE YOU USE FLECTOR TISSUGEL HEPARINE 1 g / 40 000 IU per 100 g, medicated plaster?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use FLUTOR TISSUGEL HEPARINE 1 g / 40 000 IU per 100 g medicated plaster in the following cases:
· if you are allergic to any of the active ingredients (diclofenac or heparin), or to any of the other ingredients of this medication ( see Section 6. Additional Information ),
· if you have ever had an allergy to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs),
· if you have an injured skin, regardless of the lesion (eg oozing lesions, eczema, infected lesion, burn or wound),
· if you have an ulcer of the stomach or intestine,
· pregnant women from the 6th month of pregnancy,
· in a child.
IN CASE OF DOUBT, YOU MUST REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Take special care with FLECTOR TISSUGEL HEPARINE 1 g / 40 000 IU per 100 g, medicated plaster:
· Do not use this medicine on the eyes or mucous membranes (inside the nose, ears or other mucous membranes).
· Do not use the plaster under occlusive dressing.
If you notice a rash, immediately remove the plaster, stop treatment.
To avoid the risk of skin reaction when exposed to sunlight (photosensitization), it is preferable to avoid direct exposure to the sun or UV cabin during treatment.
If you are in any of the following situations, you should use this medication after your doctor has approved and supervised it:
· if you have a heart, kidney or liver disease,
· if you have ever had an ulcer or digestive bleeding,
· if you have an inflammatory bowel disease,
· if you are currently suffering from or have had asthma or have allergies to aspirin or other NSAIDs, use of this medication may lead to bronchial spasm (bronchospasm), which can cause breathe,
· elderly patients should use FLECTOR TISSUGEL HEPARINE with caution as they are particularly prone to adverse effects,
· this medicinal product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate and may cause allergic reactions. It also contains propylene glycol and can induce skin irritations.
Interaction with other medicines
Use of other medicines:
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
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FLECTOR TISSUGEL HEPARINE contains a non-steroidal anti-inflammatory drug (NSAID): diclofenac. Do not take this medication with other medicines containing diclofenac or other NSAIDs (medication for pain, fever, inflammation) irrespective of the method of administration (see oral, injectable or local application). Read the leaflet carefully for other medicines you are taking to ensure that diclofenac and / or non-steroidal anti-inflammatory drugs are not present. |
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
During the first and second trimesters of pregnancy, this medication can only be used on the advice of your doctor and in brief intake. Prolonged use of this medication is strongly discouraged.
From the beginning of the 6th month of pregnancy, you should IN NO EVENT taking this medicine because it affects your child can have serious consequences including cardiopulmonary and renal level, even with a single dose .
If you have taken this medicine while you were pregnant during or after the 6th month, talk to your obstetrician gynecologist so that you adapted monitoring is proposed.
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
If you are breast-feeding, you should not use FLECTOR TISSUGEL HEPARINE because it is not known whether the active substance (diclofenac epolamine) passes into breast milk.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines:
Although the occurrence of such effects is highly unlikely with the use of skin preparations such as FLECTOR TISSUGEL HEPARINE, patients who have experienced dizziness or other central nervous system disorders while taking NSAIDs, refrain from driving vehicles or using machinery.
List of excipients with known effect
Important information about some of the ingredients of FLECTOR TISSUGEL HEPARINE 1 g / 40 000 IU per 100 g, medicated plaster:
FLECTOR TISSUGEL HEPARINE contains propylene glycol which can induce skin irritation, as well as methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E 216), which can cause allergic reactions even after discontinuation of the treatment.
3. HOW TO USE FLECTOR TISSUGEL HEPARINE 1 g / 40 000 IU per 100 g, medicated plaster?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Always use FLECTOR TISSUGEL HEPARINE exactly as prescribed by your doctor or described in this leaflet. If in doubt, consult your doctor or pharmacist.
FLECTOR TISSUGEL HEPARINE is for adults only.
dosage
Apply a patch on the area to be treated once a day and keep it all day.
Administration mode
To be used exclusively in application on the skin.
1. Cut the envelope containing the patch (box of 2 and 5 medicated plasters) at the indicated place.
2. Remove the plaster and carefully close the envelope using the slide.
3. Remove the clear plastic sheet that protects the adhesive surface from the plaster.
4. Apply the adhesive surface of the patch on the joint or on the painful area. It can be held in place by an elastic net, if the area to be treated requires it.
Duration of the treatment
The recommended treatment time is 3 days.
The use of FLECTOR TISSUGEL HEPARINE should be as short as possible. Without improvement after 3 days, a doctor should be consulted.
If you feel that the effect of FLECTOR TISSUGEL HEPARINE is too strong or too weak, talk to your doctor or pharmacist.
Symptoms and Instructions for Overdose
If you used more than 1 g / 40,000 IU FLUORINE TISSUGEL HEPARINE per 100 g, medicated plaster that you should:
You should tell your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to use FLECTOR TISSUGEL HEPARINE 1 g / 40 000 IU per 100 g, medicated plaster:
Do not apply this medication twice to compensate for the application you have forgotten.
Continue your treatment normally.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all drugs, FLECTOR TISSUGEL HEPARINE 1 g / 40 000 IU per 100 g, medicated plaster is likely to have undesirable effects, although not everyone is subject to it.
Stop treatment immediately and tell your doctor if:
· allergic reactions (known as swelling of the throat or face, itching, difficulty breathing, sudden drop in blood pressure ...) or skin reactions after exposure to sun and UV.
The following adverse reactions have been reported:
· Infrequent effects (affecting 1 to 10 patients in 1,000): sleep disorders, gastroenteritis, skin lesions, pain in the extremities, musculoskeletal stiffness, itching, feeling of heat, hematoma.
· Frequent effects (affecting 1 to 10 patients in 100): redness of the skin.
Tell your doctor if:
· if you are using this medicine on a large area of your skin and for a long time. Indeed, one of the active substances (diclofenac) may pass through your bloodstream. Effects comparable to those of oral NSAIDs (capsule, tablet, etc.) may then occur (eg disorders of the stomach, kidneys ...)
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE FLECTOR TISSUGEL HEPARINE 1 g / 40 000 IU per 100 g, medicated plaster?
Keep out of the reach and sight of children.
Expiration date
Do not use FLOWOR TISSUGEL HEPARINE 1 g / 40 000 IU per 100 g, medicated plaster after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
Storage conditions
Store at a temperature not exceeding 25 ° C.
After 1 st opening of the sealed envelope: keep for a maximum of 6 months.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What contains FLECTOR TISSUGEL HEPARINE 1 g / 40 000 IU per 100 g, medicated plaster?
The active substances are:
Each medicinal plaster of 10 cm x 14 cm contains 14 g of gel containing 140 mg of sodium diclofenac in the form of diclofenac epolamine and 5600 IU of heparin sodium.
100 g of gel contain 1 g of sodium diclofenac in the form of diclofenac epolamine and 40,000 IU of heparin sodium.
The other components are:
Support:
Polyester nonwoven support.
Adhesive layer (gel active) composed of: gelatin, povidone K 90, non-crystallizable sorbitol, heavy kaolin, titanium dioxide (E 171), propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 385), tartaric acid, aluminum glycinate, sodium carmellose, sodium polyacrylate, 1,3-butylene glycol, polysorbate 80, Dalin PH perfume (propylene glycol, benzyl salicylate, phenylethyl alcohol, alpha amylcinnamic aldehyde, hydroxycitronellal, phenylethyl acetate, cinnamyl acetate, benzyl acetate, terpineol, cinnamyl alcohol, cyclamenaldehyde), purified water.
Protective film : polypropylene film.
Pharmaceutical form and content
What is FLECTOR TISSUGEL HEPARINE 1 g / 40 000 IU per 100 g, medicated plaster and contents of the pack?
This medication is in the form of a gel-impregnated medicated plaster. The plasters are packaged in a sealed envelope.
Boxes of 2, 3 or 5 plasters
Not all pack sizes may be marketed.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
LABORATOIRES GENEVRIER SA
ZI DES TROIS MOULINS - SOPHIA ANTIPOLIS PARK
280 GOA ROUTE
06600 ANTIBES
exploiting
LABORATOIRES GENEVRIER SA
ZI DES TROIS MOULINS - SOPHIA ANTIPOLIS PARK
280 GOA ROUTE
06600 ANTIBES
Maker
LABORATOIRES GENEVRIER SA
ZI DES TROIS MOULINS - SOPHIA ANTIPOLIS PARK
280 GOA ROUTE
06600 ANTIBES
or
altergon italia srl
zona industriale
83040 morra de sanctis
Italy
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
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Contact your pharmacist or doctor: If you need more information or advice. If you are not sure whether this medication is appropriate for you, in particular: If you are pregnant or nursing; If you have, besides what you want to treat with this medicine, another disease; If you are taking other medicines at the same time, even if they are sold without a prescription; If you have ever been allergic to a drug. If you experience any side effect while using this medicine. |
SANITARY EDUCATION COUNCILS
You have just sprained your ankle, you can use FLECTOR TISSUGEL HEPARINE to relieve your pain. But, you should consult your doctor:
· if you absolutely can not put yourself in support on the leg to take a few steps,
· if a hematoma (blue) appears within 24 hours to 48 hours,
· or if there is a considerable distortion or edema (swelling).
Your doctor will then decide whether or not you need to do an x-ray and orthopedic treatment (eg physiotherapy ...).
If you absolutely can not move or take a single step, you should consult your doctor immediately.
Anti-inflammatory of local action
diclofenac, heparin
. Presentations . Composition . Indications . Contraindications . Attention . Pregnancy and breastfeeding . Instructions for use and dosage . Tips . Side effects . Lexicon
FLECTOR TISSUGEL HEPARIN: medicinal plaster; box of 3.
Not refunded - Free price -
Laboratory Genévrier SA
| p plaster | |
| Diclofenac epolamine expressed as sodium diclofenac | 140mg |
| Heparin sodium | 5600 IU |
| parahydroxybenzoates | + |
Usual dosage:
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