Ketoprofen Vramed - instructions for use, doses, side effects, contraindications

Excipients: ethanol (96%) 35.00 g, carbomer 940 2.00 g, propylene glycol 3.00 g, diethanolamine 1.30 g, benzalkonium chloride 0.10 g, orange flowers synthetic oil 0.05 g, lavender oil 0.10 g g, disodium edetate 0.05 g, macrogol 400 5.00 g, purified water 50.90 g.

Description:

Colorless, clear or slightly opalescent gel with the smell of essential oils and ethyl alcohol.

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

ATX: & nbsp

M.02.A.A.10 Ketoprofen

Pharmacodynamics:

Ketoprofen is a non-steroidal anti-inflammatory drug. It has an anti-inflammatory and analgesic effect. Its pharmacological action ketoprofen It exerts by suppressing the synthesis of prostaglandins by inhibiting cyclooxygenase (COX-1 and COX-2).

Pharmacokinetics:

When topical application is absorbed slowly, almost does not cumulate. Bioavailability of the gel is about 5%.

Metabolized by conjugation with glucuronic acid.Active metabolites are not formed.

Indications:

Acute and chronic inflammatory diseases of the musculoskeletal system (rheumatoid arthritis, spondylitis, arthrosis, osteochondrosis); uncomplicated injuries of the musculoskeletal system (including sports, dislocations, sprains or ruptures of ligaments and tendons, bruises, post-traumatic pains).

Contraindications:

- Hypersensitivity to ketoprofen or any of the excipients;

- presence in the anamnesis of any photosensitivity reaction;

- known hypersensitivity reactions, such as asthma symptoms, allergic rhinitis caused by ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or other NSAIDs;

- presence in the anamnesis of a skin reaction to ketoprofen, tiaprofenic acid, fenofibrate, sunscreen or perfume;

- sunlight, indirect sunlight, inclusive and UV rays of the solarium;

- exudative dermatoses, eczema, skin ulcers and infected skin lesions or cracks, burns;

- the last trimester of pregnancy; breast-feeding;

- children under 15 years of age.

Carefully:

Despite the fact that systemic effects are minimal, ketoprofen gel should be used cautiously in patients with severe liver and kidney disease, bronchial asthma or bronchospasm, severe cardiovascular diseases and erosive-ulcerative lesions of the gastrointestinal tract.

During treatment and for 2 weeks after the use of the drug should avoid exposure to sunlight, indirect sunlight, including UV rays of the solarium.

Pregnancy and lactation:

Pregnancy: no special studies have been conducted during pregnancy, so the appointment of ketoprofen gel is not recommended for pregnant women, unless the potential benefit to the mother exceeds the risk to the fetus. Do not use in the last trimester of pregnancy.

Breast-feeding: when applied topically, traces of ketoprofen in breast milk are found. Due to the lack of sufficient safety data for the infant, it is recommended that breastfeeding be discontinued in the treatment of ketoprofen gel.

Dosing and Administration:

Mode of application: For external use only. The gel is applied gently, rubbing into the skin over the affected area with light massage movements for several minutes.

Adults and adolescents over 15 years of age: The gel is applied a thin layer on the skin over the affected area once or twice a day. The daily dose should not exceed 15 g (7.5 g correspond to about 14 cm gel).

Duration of treatment: not more than 7 days.

Children under 15 years of age: experience of topical application in children under 15 years of age is limited, so its use is not recommended for this age group.

Side effects:

The described side effects are presented for MedDRA, classified by organs and systems and by their frequency. Depending on the frequency, side effects can be very frequent (affect more than 1 per 10 patients), frequent (occur in less than 1 per 100 patients), infrequent (affect 1 per 1000 patients), infrequent (affect 1 to 10 patients per 10000), very rare (affecting less than 1 per 10,000 patients), with unknown frequency (can not be estimated from the available data).

From the immune system. Very rarely: anaphylactic reactions, hypersensitivity reactions.

From the digestive system. Very rarely: peptic ulcer disease, gastrointestinal bleeding, diarrhea.

From the skin and subcutaneous fat. Sometimes: erythema, itching, eczema. Rarely: photosensitivity reactions, bullous or flickenous rash. Very rarely: contact dermatitis, burning sensation, angioedema.

From the genitourinary system. Very rarely, the increase in renal failure.

Other side effects anti-inflammatory drugs depend on the penetrating ability of the active substance through the skin and thus on the amount of gel applied, the area of the treated surface, the integrity of the skin, the duration of application and the presence / absence of sealed clothing. Ketoprofen can cause asthma attacks in patients with hypersensitivity to acetylsalicylic acid or its derivative.

Older patients are more prone to side effects when using NSAIDs.

Overdose:

There is no evidence of an overdose of ketoprofen when applied topically to the skin.

Interaction:

With topical application, resorption of ketoprofen is minimal, as a result of which clinically significant plasma concentrations are not observed.It is unlikely to interact with other drugs of systemic use. Despite this, caution should be given to patients taking drugs that increase the risk of gastrointestinal complications (corticosteroids, anticoagulants, antiaggregants, selective serotonin reuptake inhibitors).

Special instructions:

Ketoprofen gel should not be applied to damaged skin, mucous membranes, anal or genital areas. When used, an occlusive dressing is not used.

After applying the product, wash hands immediately.

Treatment should be stopped immediately if any skin reaction occurs, including reactions with simultaneous use of agents containing octocrylene. Octocrylene is one of the auxiliaries of some cosmetic and hygiene products, such as shampoos, shaving aids, shower gels and baths, skin creams, lipsticks, anti-wrinkle creams, make-up products, hair sprays.

Skin areas treated with gel, during treatment and for 2 weeks after use, should not be exposed to direct sunlight or ultraviolet radiation,to avoid the risk of photosensitivity. It is recommended to protect the treated areas of the skin, covering them with clothing.

Ketoprofen gel contains as an auxiliary substance ethanol. If used frequently, it can cause irritation and dry skin.

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

Data on the effect of Ketoprofen gel on the ability to drive and machinery are absent.

Form release / dosage:

Gel for external use 2.5%.

Packaging:

For 40 g of the drug in aluminum membrane tubes, with an internal lacquer coating, corked with polyethylene caps.

Each tube, together with instructions for use, is placed in a cardboard pack.

Storage conditions:

In the original packaging at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Shelf life after first opening of tuba: 6 months.

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

After opening the tube and applying the drug, the tube is tightly closed and Store under the above conditions.

Terms of leave from pharmacies:On prescription

Registration number:П N015515 / 01

Date of registration:01.07.2009 / 12.10.2017

Expiration Date:Unlimited

The owner of the registration certificate:Sopharma, AOSopharma, AO Bulgaria

Manufacturer: & nbsp

SOPHARMA, AD Bulgaria

Representation: & nbspSOFARMA SA SOFARMA SA Bulgaria

Information update date: & nbsp06.01.2018

Illustrated instructions

Instructions

Ketoprofen Vramed (Ketoprofen Vramed)