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

Excipients: carbomer 940 1.50 g, ethanol 96% 40.00 ml, non-saline oil 0.05 g, lavender oil * 0.05 g, trolamine (triethanolamine) 2.80 g, water purified to 100.00 g.

* Lavender oil of hybrid ("Lavandin").

Description:Colorless, almost transparent gel of viscous consistency, with a pleasant smell.

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

ATX: & nbsp

M.02.A.A.10 Ketoprofen

Pharmacodynamics:

The mechanism of action of the drug is associated with the inhibition of the synthesis of prostaglandins. Ketoprofen has analgesic and anti-inflammatory effect. Ketoprofen, penetrating through the skin, reaches the focus of inflammation, thus providing the opportunity for local treatment of lesions (joints, tendons, ligaments and muscles) accompanied by pain syndrome.

Pharmacokinetics:

With local application penetrates into the focus of inflammation through the skin, the absorption of ketoprofen from the focus of inflammation is extremely slow (bioavailability of the gel - about 5%).After application in a dose of 50-150 mg of ketoprofen, the concentration in the blood plasma after 5-8 hours is 0.08-0.15 μg / ml. Practically does not cumulate in the body. The elimination half-life is 1-3 hours. Linkage to blood plasma proteins is 60-90%. It is excreted primarily through the kidneys in the form of glucuronide.

Indications:

- Pain of traumatic origin (bruises, sprains, ligaments and muscles);

- tension and stiffness of the neck muscles;

- Lumbago (pain in the lumbosacral spine);

- muscular and osteoarticular pain of rheumatic origin (eg, osteoarthritis).

Contraindications:

- Individual hypersensitivity to ketoprofen or other components of the drug, acetylsalicylic acid or other NSAIDs (indication in anamnesis for bronchospasm, hives, or

rhinitis caused by the intake of acetylsalicylic acid); tiaprofenic acid and fenofibrate;

- increased sensitivity of the skin to the effects of solar radiation (photosensitization) in the anamnesis;

- a skin allergy in the anamnesis on ketoprofen, tiaprofenic acid, fenofibrate, sunscreen products or perfumes;

- exposure of the sun to the treated areas, including the solarium during the course of the drug and 2 weeks after.

- wet dermatoses, eczema, infected abrasions, wounds (at the site of application of the gel);

- Children under 12 years of age (efficacy and safety not studied);

- pregnancy and lactation.

Carefully:

- Severe renal insufficiency;

- elderly age.

Pregnancy and lactation:

The drug Fastum® is contraindicated in pregnancy and during breastfeeding.

Dosing and Administration:

For external use.

When using tuba: a strip of gel length of 5-10 cm is applied a thin layer on the affected area or skin over the focus of inflammation 1-2 times a day and lightly rub.

When using a container with a dispenser (dispenser): press twice on the dome of the dispenser or on the base before the appearance of the gel. It is recommended to keep the dispenser in a horizontal position. Apply a thin layer of gel on the affected area or skin over the focus of inflammation 1-2 times a day and lightly rub. The amount of gel applied depends on the size of the treated area. It is possible to use the preparation Fastum ® in combination with physiotherapy (phonophoresis and iontophoresis). The course of treatment is 10 days.

Side effects:

Possible side effects are given in the descending frequency of occurrence: very often (≥ 10%), often (≥ 1%, <10%), infrequently (≥ 0,1%, <1%), rarely (≥ 0.01%, <0.1%), very rarely (<0.01%)

From the skin: infrequently - erythema, itching, eczema; rarely - photosensitivity, bullous dermatitis, urticaria; very rarely - contact dermatitis, angioedema.

From the gastrointestinal tract: very rarely - peptic ulcer, bleeding, diarrhea.

From the immune system: very rarely - anaphylactic reactions, hypersensitivity reactions.

From the urinary system: very rarely - aggravation of renal failure.

Overdose:

Extremely low systemic absorption of active components of the drug with external application makes an overdose almost impossible.

If you randomly ingest large amounts of the drug may manifest systemic side effects. Treatment should be symptomatic.

Interaction:

With external application of ketoprofen in the form of a gel, it is possible to enhance the effect of drugs that cause photosensitivity. Other interactions are not established.However, patients taking anticoagulants of the coumarin series are advised to conduct regular monitoring of the international normalized relationship (INR).

Special instructions:

Do not apply to damaged (including open wounds) and inflamed skin.

Avoid contact with eyes (danger of irritation of the conjunctiva).

It is recommended to wash hands thoroughly after applying the drug.

Do not use in the form of hermetic bandages. Do not use in conjunction with hermetic clothing.

Long-term use of topical agents can lead to increased sensitivity or local irritation. In order to avoid any manifestations of hypersensitivity or photosensitivity, direct sunlight should be avoided (including a visit to the solarium) during the treatment period and within two weeks after application of the drug and it is recommended to cover the treated areas with clothing.

Patients with severe renal, cardiac or liver failure should be careful with the use of the drug Fastum ®.

It should stop using the drug in case of any skin reaction,including reactions with the simultaneous application of sunscreen or other cosmetic products containing an organic sunscreen octocrylene on the skin.

When using the drug in large quantities, it is possible, in very rare cases, the development of systemic side effects (hypersensitivity, bronchial asthma, disorders of the gastrointestinal tract, aggravation of the course of renal failure).

The risk of systemic side effects increases depending on the amount of gel applied, the area of the treated skin area, the condition of the skin, the duration of treatment.

Avoid sunlight or UV rays, including the solarium, on the treated areas during the treatment period and within two weeks after treatment.

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

The drug Fastum® does not affect the ability to drive vehicles and work requiring increased concentration of attention.

Form release / dosage:

Gel for external use, 2.5%.

Packaging:

For 30 g, 50 g or 100 g of the drug in tubes, of soft aluminum, covered from the inside with epoxy phenolic varnish,with a screw cap-perforator (polyethylene / polypropylene) or 100 g of the drug in a polypropylene container with a dispenser (dispenser).

For 1 tube or 1 dispenser together with instructions for use in a cardboard pack.

Storage conditions:

Store at a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N012306 / 01

Date of registration:21.12.2010

The owner of the registration certificate:A.Menarini Industry Pharmaceuticals Riunite S.L.A.Menarini Industry Pharmaceuticals Riunite S.L. Italy

Manufacturer: & nbsp

A.MENARINI Manufacturing Logistics and Servicer Italy

Representation: & nbspBERLIN-CHEMI / MENARINI PHARMA GmbH BERLIN-CHEMI / MENARINI PHARMA GmbH Germany

Information update date: & nbsp28.04.2012

Illustrated instructions

Instructions

Fastum® (Fastum®)