Description
Instructions for medical use of
Theraflex® Hondocream Forte
Trade name:
Theraflex® Hondocream Forte
International nonproprietary name
None
Dosage form
Cream for external use, 30 g
Composition
1 g of the cream contains
Active substance:chondroitin sodium sulfate 50 mg
meloxicam 10 mg;
Adjuvants: DMSO, propylene glycol, macrogol cetostearyl ether, cetostearyl alcohol [amount of cetyl and stearyl alcohol not more than 90 %, stearyl alcohol is not less than 40 %], liquid paraffin, petrolatum, imidurea, sodium disulfite, water.
Description
Cream color varies from light yellow with a greenish tinge to yellow with a greenish tinge of color, with the smell of dimethyl sulfoxide.
Pharmacotherapeutic group
Drugs for treatment of diseases of the musculoskeletal system. Other drugs for local treatment of the musculoskeletal system diseases. Other drugs.
Code ATCM02AХ10
Pharmacological properties
Pharmacokinetics
Not described.
Pharmacodynamics
Chondroitin sulfate – mucopolysaccharide, in the composition of D-glucuronic acid and N-acetyl-D-galactosamine. An important component of the extracellular matrix isthe most common mucopolysaccharide of the molecule of the specific proteoglycan nuclear protein of cartilage tissue. Due to the negative charge, chondroitin sulfate promotes retaining water molecules in the cartilage tissue, providing resistance to compression loads. It stimulates the synthesis of hyaluronic acid by synoviocytes, thereby supporting the synovial fluid viscosity. It effects upon the metabolic activity of chondrocytes, stimulating the production of the basic components of new cartilage tissue: collagen and proteoglycans. It is able to inhibit activity of leukocyte elastase and hyaluronidase, found in high concentrations in the synovial fluid of patients with rheumatic diseases. In studies, chondrocyte culture in vitro, the ability of chondroitin sulfate dose-dependent stimulate their proliferation was found.
Meloxicam is a non-steroidal anti-inflammatory agent; it has anti-inflammatory, analgesic effect. Meloxicam selectively inhibits cyclooxygenase 2, disrupts the arachidonic acid metabolism, it reduces the number of prostaglandins (mediators of pain and inflammation) in the focus of inflammation. Meloxicam is a chondroneutral drug; it effects upon cartilage tissue not negatively, it does not affect upon the proteoglycan synthesis by chondrocytes of articular cartilage.
Indications
It is used as a part of the complex therapy at degenerative-dystrophic diseases of the musculoskeletal system: osteoarthritis, osteochondrosis of the spine; other diseases of the joints, accompanied by pain syndrome.
Dosage and methods of use
For external use. A slip of cream with a length of 1 to 5 cm is lightly rubbed, 2-3 times a day. The required amount of the drug depends on the size of the painful area. After applying the drug, it is necessary to wash your hands thoroughly. The treatment course depends on the indications and the observed effect. The patient should consult a doctor after 2 weeks of use of the drug.
Adverse reaction
- hypersensitivity reactions (itching, redness, skin rash, urticaria, Quincke's edema);
- contact dermatitis, bullous dermatitis, pustular rashes;
- bronchospastic reactions, asthma (in predisposed patients after administration of nonsteroidal anti-inflammatory drugs, including meloxicam);
- response of photosensitization
- hypersensitivity to the components of the drug, as well as to other non-steroidal anti-inflammatory drugs;
- violation of the skin integrity in the area of the drug application;
- children under 12 years old;
- pregnancy and lactation.
If any adverse reactions occur, it is necessary to discontinue use of the drug and consult a doctor.
Contraindications
Drug interaction
Cases of interaction or incompatibility with other drugs are not described.
Special indications
The drug should be used with caution in patients having impaired renal and liver function, severe pathology of the gastrointestinal tract (peptic ulcer in the acute phase), severe pathology of the blood system, as well as elderly people. The skin must be intact for the drug use, avoiding contact with open wounds. You should not allow the drug to contact with the eyes and mucous membranes. You should consult Your doctor before joint use Theraflex® Chondrocream Forte cream with other non-steroidal anti-inflammatory drugs, as well as it is required to use the drug for more than 2 weeks. Adjuvants (dimethyl sulfoxide, propylene glycol, cetostearyl alcohols, stearyl) may cause skin irritation and/or contact dermatitis. Features of the drug effect upon the ability to drive a car or potentially dangerous mechanisms. It does not cause sedation, psychomotor disorders and does not effect upon the ability to drive or potentially dangerous mechanisms.
Overdosage
Extremely low systemic absorption of the drug active components at the external use makes overdose virtually impossible.
Form of output and packing
Per 30 g in aluminum or plastic laminate tubes.
Per 1 tube and the instruction on medical use in the state and Russian languages packed together in a cardboard package.
Storage conditions
Do not store above 25 °C.
Keep out of the reach of children!
Shelf live
2 years
Do not use after the expiration date.
Conditions for drug supply
Over the counter.
Manufacturer / packer
“NizhFarm” JSC,
7, Salganskaya Street,
603950, Nizhniy Novgorod,
Russian Federation
tel.: (831) 278-80-88
Fax.: (831) 430-72-28
Web.site: http://www.nizhpharm.ru
Name and country of the Registration Certificate holder
Bayer Consumer Care AG, Switzerland
Name, address and contact details of the organization in the territory of the Republic of Kazakhstan accepting claims (offers) from consumers concerning the drug quality:
«Bayer KAZ» LLP.
Timiryazev Street, 42, Pav. 15, office 301
050057 Almaty, Republic of Kazakhstan
Tel: +7 727 258 80 40
Fax.: +7 727 258 80 39
e-mail: kz.claims@bayer.com
Address of the organization receiving claims from consumers regarding the quality of products (goods) on the territory of the Republic of Kazakhstan and responsible for post-registration supervision over the drug safety:
«Bayer KAZ» LLP.
Timiryazev Street, 42, “Expo City” Business Center, Pav. 15
050057 Almaty, Republic of Kazakhstan
Tel: +7 701 715 78 46 – round the clock
Tel.: +7 727 258 80 40 (106) – during working hours
Fax.: +7 727 2588 039
e-mail: pv.centralasia@bayer.com
