Loratadine-zdorovya

INSTRUCTION FOR MEDICAL USE of the medicinal product Arthiphlex (ARTIPHLEX)

Composition:

Active ingredients: glucosamine, ibuprofen, allantoin;

1 g of the preparation contains glucosamine hydrochloride 30 mg, ibuprofen 30 mg, allantoin 10 mg;

Excipients: glyceryl monostearate, mineral oil, isopropyl myristate, cetyl stearyl alcohol, polyethylene glycol stearate, polysorbate 80, ethanol 96%, methylparaben (E 218), propylparaben (E 216), menthol, methylpyrrolidinone, sodium metabisulfite (E 223), purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: white homogeneous cream with a specific odor.

Pharmacotherapeutic group. Other agents used in musculoskeletal disorders. ATC code M09AX.

Pharmacological properties.

Pharmacodynamics. A combined three-component drug for the treatment of musculoskeletal disorders. It contains glucosamine hydrochloride, ibuprofen, and allantoin.

Due to its combined composition, the drug exerts chondroprotective, analgesic, anti-inflammatory, anti-exudative, membrane-protective, and antioxidant effects.

Glucosamine hydrochloride – a low-molecular-weight mucopolysaccharide that stimulates regeneration of the joint capsule and articular cartilage, and also inhibits the degradation processes of cartilage tissue. It improves the synthesis of intra-articular fluid, which acts as a lubricant, enhancing joint gliding. Glucosamine hydrochloride increases chondrocyte resistance to the action of pro-inflammatory cytokines and activates metabolic processes in the joint matrix, thus promoting the formation of a stable joint. It enhances cartilage elasticity and resistance to compression, which are essential for counteracting physical stress. Glucosamine hydrochloride has a moderate anti-inflammatory effect and thus enhances the action of ibuprofen.

Ibuprofen exerts analgesic and anti-inflammatory effects.

The analgesic effect of ibuprofen is associated with reduced intensity of inflammation, decreased production, and attenuation of specific pain mediators (algesogenic bradykinin). It alleviates pain syndrome, including arthralgia at rest and during movement, reduces morning stiffness and joint swelling, and promotes increased range of motion.

Allantoin – a plant-derived preparation from medicinal comfrey (Symphytum officinale).

It has anti-inflammatory properties, reduces pain sensations, and stimulates regenerative processes in bone tissue.

Methylpyrrolidone is a transdermal agent that facilitates the penetration of active ingredients of the cream through the skin into joint tissues.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications. Treatment of musculoskeletal disorders accompanied by signs of inflammation, swelling and pain, degenerative-dystrophic changes in joint and spinal cartilage, reduced joint mobility (osteoarthrosis, arthropathies, intervertebral osteochondrosis).

Contraindications.

• Hypersensitivity to any component of the drug;
• Dermatoses, weeping eczema;
• Asthma, or if NSAIDs may provoke an asthma attack;
• Third trimester of pregnancy.

Interaction with other medicinal products and other types of interactions. No negative drug interactions have been established when the combined preparation – cream with ibuprofen – is used with other medicinal products included in standard treatment regimens. Caffeine enhances the analgesic effect of ibuprofen. Ibuprofen may reduce the diuretic effect of furosemide. When used concomitantly with acetylsalicylic acid or other NSAIDs, the risk of adverse effects increases. Glucosamine exhibits synergistic action with chondroitin and other chondroprotective agents.

Special precautions for use

Do not apply the cream on open wounds or allow contact with mucous membranes.

Use with caution in patients with concomitant kidney disease.

Do not exceed the recommended dose or duration of treatment. Prolonged use may lead to adverse effects of ibuprofen.

The product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis); methylparaben (E 218) and propylparaben (E 216), which may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding. There are no clinical data on the use of topical ibuprofen-containing medicinal products during pregnancy. Even though systemic exposure is lower compared to oral administration, it is unknown whether the systemic exposure to ibuprofen achieved after topical application may be harmful to the embryo/fetus. During the first and second trimesters of pregnancy, ibuprofen should not be used without strong medical justification. If used, the dose should be as low as possible and the duration of treatment as short as possible.

Systemic use of prostaglandin synthetase inhibitors, including ibuprofen, during the third trimester of pregnancy may cause cardiovascular and renal toxicity in the fetus. At the end of pregnancy, prolonged bleeding may occur in both mother and child, and labor may be delayed. Therefore, ibuprofen is contraindicated during the last trimester of pregnancy (see section "Contraindications").

There is no experience with the use of the product during breastfeeding; therefore, the use of this medicinal product is not recommended during this period.

Ability to influence reaction speed when driving or operating machinery. The product does not affect the ability to drive or operate machinery.

Dosage and Administration.

Apply the cream 2–3 times daily to the affected skin area and rub in for 2–3 minutes. Treatment duration: 2 weeks.

Children. For use in children aged 12 years and older.

Overdose. No data available.

Side effects.

No significant adverse effects were identified during clinical trials; however, there is a possibility of adverse reactions associated with the ibuprofen-containing product affecting the skin, gastrointestinal tract, and urinary system.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. Cream in tubes of 20 g, 40 g, or 100 g per box.

Availability. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address and place of business. 22 Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.