Fastum gel 2,5% 100 g — Made in Poland — Free Delivery

(Fastum gel 2,5%)
Fastum gel 2,5% 100 g — Made in Poland — Free Delivery
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Berlin-Chemie Brand: Berlin-Chemie
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Description Fastum gel 2,5% 100 g — Made in Poland — Free Delivery

Pharmacodynamics

The mechanism of action of the preparation is associated with inhibition of prostaglandin synthesis. Ketoprofen has analgesic and anti-inflammatory effects. Ketoprofen, penetrating the skin, reaches the focus of inflammation, making it possible to local treatment of lesions (joints, tendons, ligaments and muscles), accompanied by pain.

Pharmacokinetics

When applied topically, ketoprofen penetrates into the focus of inflammation through the skin, the absorption of ketoprofen from the focus of inflammation occurs extremely slowly (the bioavailability of the gel is about 5%). After using ketoprofen at a dose of 50-150 mg, the concentration in the blood plasma after 5-8 hours is 0.08-0.15 μg / ml. Practically does not accumulate in the body. The half-life is 1-3 hours. The connection with blood plasma proteins is 60-90%. It is excreted mainly through the kidneys in the form of glucuronide; approximately 90% of the administered dose is eliminated within 24 hours.

Indications for use

- pain of traumatic origin (injuries, bruises, sprains of ligaments and muscles);
- tension and stiffness of the neck muscles;
- lumbago (pain in the lumbosacral spine);
- muscle and osteoarticular pain of rheumatic origin.

Contraindications

- hypersensitivity to ketoprofen or other components of the preparation, tiaprofenic acid, fenofibrate, acetylsalicylic acid or other NSAIDs (a history of asthma symptoms, urticaria or rhinitis caused by taking preparations);
- a history of increased sensitivity of the skin to the effects of solar radiation (photosensitivity);
- a history of skin allergies to ketoprofen, tiaprofenic acid, fenofibrate, sunscreens or perfumes;
- exposure to the sun on the treated areas, including indirect sunlight and a tanning bed during the course of application of the preparation  and 2 weeks after application, pathological changes in the skin, such as acne, eczema, infected abrasions, wounds (at the site of application of the gel);
- children under 12 years of age (efficacy and safety have not been studied);
- the third trimester of pregnancy.
Carefully
- dysfunction of the liver and kidneys;
- heart failure;
- old age (elderly patients are more susceptible to adverse reactions when using non-steroidal anti-inflammatory preparations).
Application during pregnancy and during breastfeeding
In the first and second trimester of pregnancy
In a study on mice and rats, no teratogenic or embryotoxic effects of the preparation were detected. A small embryotoxic effect was noted in a rabbit study, probably related to maternal toxicity.
Since there have been no studies of the safety of ketoprofen in pregnant women, its use in the first and second trimester of pregnancy should be avoided.
In the third trimester of pregnancy
All inhibitors of prostaglandin synthesis, including ketoprofen, cause toxic damage to the cardiopulmonary system and fetal kidneys. At the end of pregnancy, both the mother and the baby may have a longer bleeding time. In this regard, ketoprofen is contraindicated in the third trimester of pregnancy.
Breast-feeding
There are no data on the penetration of ketoprofen into mother's milk. Ketoprofen is not recommended for use in nursing mothers.

Method of administration and dosage

For external use.
A strip of gel 5-10 cm long is applied with a thin layer to the affected area or skin over the focus of inflammation 1-3 times a day and rubbed lightly.
It is possible to use the preparation Fastum® in combination with physiotherapy (phonophoresis and iontophoresis).

Side effect

Possible side effects of Fastum® are given in decreasing 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
Uncommon: erythema, pruritus, eczema, burning sensation;
Rarely: photosensitivity, bullous dermatitis, urticaria;
Very rare: contact dermatitis, angioedema.
From the gastrointestinal tract
Very rare: peptic ulcer, gastrointestinal bleeding, diarrhea.
From the immune system
Very rare: anaphylactic reactions, hypersensitivity reactions.
From the urinary system
Very rare: renal failure or worsening of existing renal failure.

Overdose

The extremely low systemic absorption of the active substance of the preparation when applied externally makes an overdose unlikely.
In case of accidental ingestion of large amounts of the preparation, systemic side effects may occur. Treatment should be symptomatic, as with an overdose of oral NSAIDs.
Interaction with other medicinal products
With external application of ketoprofen in the form of a gel, it is possible to enhance the action of preparations that cause photosensitization. No other interactions have been identified. However, patients taking coumarin anticoagulants are advised to regularly monitor the International Normalized Ratio (INR).

Special instructions

Do not apply the gel to damaged (including open wounds) and inflamed skin!
Avoid contact of the gel with mucous membranes and eyes (risk of irritation of the conjunctiva).
It is recommended to wash your hands thoroughly after each use of the preparation. Do not use as a hermetic bandage. The recommended duration of treatment should not be exceeded, since with an increase in the time of application, the risk of developing contact dermatitis and photosensitization reactions increases.
To avoid any manifestations of hypersensitivity or photosensitization, exposure to direct sunlight (including visiting a solarium) should be avoided during treatment and within two weeks after using the preparation, it is recommended to cover the treated areas with clothing.
Patients with renal, heart or hepatic insufficiency should be careful when using Fastum®; reported isolated cases of systemic side effects associated with kidney damage.
The preparation should be discontinued in case of any skin reaction, including reactions with the simultaneous application of sunscreen or other cosmetic products containing octocrylene organic sunscreen filter to the skin. With external use of the preparation in large quantities, the development of systemic side effects (hypersensitivity, bronchial asthma, disorders of the gastrointestinal tract and kidneys) is possible. Local skin reactions have been reported that could subsequently extend beyond the site of application. Rare events include cases of more pronounced reactions, such as bullous or phlyctenular eczema, which can spread and become generalized.
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 (therefore, the maximum recommended duration of the course of treatment should not be exceeded).
Avoid exposure of the treated areas to sunlight or UV rays during the treatment period and for two weeks after treatment.
Patients with asthma combined with chronic rhinitis, chronic sinusitis, and / or nasal polyps have a higher risk of developing allergic reactions to aspirin and / or NSAIDs than other people.
Influence on the ability to drive vehicles and mechanisms
Fastum® does not affect the ability to drive vehicles and mechanisms.

Release form

Gel for external use, 2.5%.
30 g, 50 g or 100 g of the preparation in tubes, made of soft aluminum, coated from the inside with epoxyphenol varnish, with a screw-on cap-perforator (polyethylene / polypropylene).
1 tube with instructions for use of the preparation in a cardboard box.

Storage conditions

Store at a temperature not exceeding 30 ° C.
Keep the medicinal product out of the reach of children!

Tags: Fastum

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