Flotter - instructions for use, dose, side effects, contraindications

Excipients: gelatin 0.280 g, povidone-K90 0.280 g, sorbitol 5.600 g, kaolin 0.420 g, titanium dioxide 0.070 g, propylene glycol 0.420 g, methyl parahydroxybenzoate 0.014 g, propyl parahydroxybenzoate 0.007 g, disodium edetate 0.017 g, tartaric acid 0.070 g, carmellose sodium 0.420 g, sodium polyacrylate 0.560 g, aluminum glycinate 0.042 g, butylene glycol 1,400 g, polysorbate 80 0.028 g, Dalin flavor (propylene glycol, benzyl salicylate, phenylethanol, alpha amylcinnamic aldehyde, hydroxycitronellal, phenylethyl phenyl acetate, cinnamyl acetate, benzyl acetate, terpineol, cinnamol, cyclemene aldehyde) 0.0028 grams of water and purified to 14.0 g;

Substrate: non-woven polyester substrate 1.5 g;

Protective film: polypropylene film 0.4 g.

Description:

A rectangular patch on a white non-woven substrate with a plaster mass ranging from white to light yellow with a weak odor, covered with a removable protective film.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:

Diclofenac is a non-steroidal anti-inflammatory drug that exerts a pronounced analgesic and anti-inflammatory effect. Inhibiting cyclooxygenase I and II type, inhibits the synthesis of prostaglandins.

When applying the patch, the active substance penetrates through the skin into the lower tissues, where it manifests its activity, facilitating acute and chronic inflammatory conditions.

Pharmacokinetics:

Suction.

The concentration of diclofenac in plasma in the equilibrium state is characterized by the concentrations of the plateau after the application of the plaster (t_max in the range 2-12hours); FROM_m_Oh mean = 17.4 ± 13.5 ng / ml; T_m_Oh mean = 5.4 ± 3.7 hours.

Distribution. Up to 99% of the absorbed diclofenac binds to plasma proteins, mainly albumin.

Metabolism. Diclofenac is mainly metabolized in the liver, where it undergoes glucuronidation and sulfation.

Excretion. Most of the diclofenac and its metabolites are excreted in the urine.

Indications:

For local symptomatic treatment of gonarthrosis.

Traumatologically caused inflammation of tendons, ligaments, muscles and joints (as a result of damage to joint ligaments, overstrain, bruises and injuries).

Pain syndrome and inflammatory diseases of the musculoskeletal system (arthritis, periarthritis, bursitis, tendenitis, tendovaginitis, myositis).

Contraindications:

Hypersensitivity to diclofenac or other components of the drug; pregnancy (III trimester), the period of breastfeeding; children's age (up to 15 years); violation of the integrity of the skin (open wounds, abrasions, cuts, burns); wetting dermatoses, eczema; complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses with intolerance to acetylsalicylic acid or other NSAIDs (including in history), propensity to bleed.

Carefully:

Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe violations of liver and kidney function, chronic heart failure, bronchial asthma, elderly age, pregnancy (I and II trimester).

Pregnancy and lactation:

Due to the lack of data on use in pregnant women, use in I and II trimesters is possible only after consulting a doctor.

The drug is contraindicated in the III trimester of pregnancy in connection with the possibility of premature closure of the arterial duct of the fetus, a decrease in the tone of the uterus and an increased risk of bleeding.

Due to the lack of data on the penetration of diclofenac epolamine into breast milk, the drug is not recommended for use in the period of breastfeeding.

Dosing and Administration:

Outwardly.

The plaster is applied to the skin over the focus of pain and inflammation 2 times a day, in the morning and in the evening.

The duration of treatment depends on the indications and severity of the symptoms, but should not exceed 14 days without consulting a doctor.

The use of the drug for the treatment of knee osteoarthritis is recommended only in the symptomatic stage of the disease. In 2 weeks from the beginning of therapy it is recommended to evaluate the feasibility of further use of the drug.

Directions for use:

Cut the envelope with the patches on the dotted line. Take out one patch and gently close the envelope. Remove the protective film from the surface of the patch and attach it to the painful area until completely adherent. If necessary, the patch can be fixed with an elastic mesh bandage or fabric mesh.

Use the whole band-aid.

Side effects:

Classification of incidence of adverse reactions: Often - ≥1/10, often - ≥1 / 100, but <1/10, infrequently - ≥1 / 1000, but <H \ 00, rarely - ≥1 / 10'000, but <1/1000, rarely - <1/10'000.

Complications of a general nature and reaction at the site of administration

Often: itching in patients with hypersensitivity.

Infrequently: erythema and / or skin rash in patients with increased sensitivity.

Rarely: hypersensitivity reactions (for example, urticaria, asthma, Quinck edema in patients with acetylsalicylic acid intolerance or some excipients, especially in patients suffering from asthma (endogenous) or chronic urticaria).

With prolonged use of the Flector patch on skin areas of considerable size, it is not possible to completely exclude any systemic side effect.

Overdose:

No cases of overdose have been documented.

If, as a result of improper use of the drug Flector patch or as a result of unintentional overdose (for example, in children), significant systemic side effects will manifest, it is necessary to carry out preventive measures provided for intoxication with nonsteroidal anti-inflammatory drugs.

Interaction:

Clinically significant interaction with other drugs has not been established.

Special instructions:

The drug should be applied only to intact skin.Avoid contact with eyes and mucous membranes. Do not use with occlusive dressings.

To avoid manifestations of hypersensitivity and photosensitivity, during treatment it is recommended to avoid exposure to the skin of sunlight.

Effect on the ability to drive transp. cf. and fur:

The drug does not affect the ability to drive vehicles and mechanisms.

Form release / dosage:Plaster 1%.

Packaging:

2 of the patch in a sealed envelope having self-closing device (clasp). 1 envelope with plasters in a cardboard bundle together with instructions for use and a fabric mesh or without it.

5 patches in a sealed envelope that has a self-closing device (clasp). 1 or 2 envelopes with plasters in a cardboard bundle together with instructions for use and a fabric mesh or without it.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children!

Shelf life:

3 years.

After the first opening of the envelope: no more than 3 months.

The drug should not be used after the expiry date indicated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-004517

Date of registration:31.10.2017

Expiration Date:31.10.2022

The owner of the registration certificate:IBSA Institute Biokimik S.A.IBSA Institute Biokimik S.A. Switzerland

Manufacturer: & nbsp

ALTERGON ITALIA, Srl. [Morra de Sanctis] Italy

Representation: & nbspIBSA Institute Biokimik S.A.IBSA Institute Biokimik S.A.Switzerland

Information update date: & nbsp21.11.2017

Illustrated instructions

Instructions

The Flector (Flector)