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Instructions for medical use of
Theraflex® Advance
Trade name:
Theraflex® Advance
International nonproprietary name
None
Dosage form
Capsules
Composition
One capsules includes:
Active substance: glucosamine sulfate 250 mg, chondroitin sulfate (as chondroitin sodium sulfate) 200 mg, ibuprofen (as a mixture of ibuprofen 66 %) 100 mg;
Adjuvants: microcrystalline cellulose silicate, corn starch pre-gelatinized, stearic acid, sodium starch glycolate, crospovidone, magnesium stearate, polyvinylpyrrolidone, silicon dioxide.
Capsule composition: gelatin, titanium dioxide (E 171), varnish blue FD&C No. 1 (E133).
Description
Solid gelatin capsules, size No.0 in blue cover and white case bearing the notice "THERAFLEX ADVANCE". Capsule composition: white powder or white with a slight odor powder.
Pharmacotherapeutic group
Other drugs for the treatment of the musculoskeletal system diseases.
Code АТX М09АХ
Pharmacological properties
Chondroitin sulfate promotes to restore cartilage tissue, protects it from destruction and improves mobility of joints. It has an anti-inflammatory effect, reduces intensity of pain syndrome.
Glucosamine sulfate activates the synthesis of proteoglycans, hyaluronic, chondroitinase acids and other substances ingressed in the articular membranes, intra-articular fluid and cartilaginous tissues.
Ibuprofen provides fast analgesic, anti-inflammatory, antipyretic effect.
Theraflex Advance reduces stiffness and promotes increase in the volume of movements in the joints.
Indications
– to relieve pain syndrome during the acute phase of primary osteoarthrosis and osteoarthropathy;
– to treat other degenerative diseases of the joints of the extremities and intervertebral discs;
– to treat joint injuries.
Dosage and methods of use
Adults take 2 capsules 2-3 times a day after meals. To administer capsules orally, with a small amount of water. The duration of administration should not exceed 20 days. The maximal daily dose includes 12 capsules. After eliminating the pain syndrome, it is desirable to continue treatment with Theraflex capsules.
Adverse reaction
Possible reactions:
– nausea, abdominal pain, meteorism, diarrhea or constipation
– headache, sleep disorders, dizziness
– allergic reactions
All manifestations disappear after the drug withdrawal.
Contraindications
– increased individual sensitivity to any of the ingredients of the drug
– erosion and ulcerous lesions of the gastrointestinal tract during the acute phase
– diseases of the optic nerve
– dyshematopoiesis
– visible compromised liver or kidney function
– chronic impaired cardial function
– «aspirin asthma»
– phenylketonuria
– children under 18 y.o.
– pregnancy and lactation
Drug interaction
The drug improves the absorption of tetracyclines and reduces the absorption of penicillins and chloramphenicol. It reduces the effect of antihypertensive agents (angiotensin converting enzyme inhibitors, beta-adrenergic blocking agents, diuretics (furosemide, hypothyazide); it enhances the effect of antiaggregants, fibrinolytics, and coumarin anticoagulants (eg, warfarin), with simultaneous administration of these drugs may change the indices of coagulogram (INR) and increase the risk of bleeding.
Simultaneous use with non-steroidal anti-inflammatory drugs and glucocorticosteroids (NSAID, GCS) increases the risk of side effect by the gastrointestinal tract.
Special indications
Do not exceed the recommended dose and duration of administration.
Features of the effect upon the ability to drive the vehicle or potentially dangerous machinery.
It does not effect.
Overdosage
There is no description of overdosage for the drug. At overdose it is recommended to make gastric lavage, administration of activated carbon, hospitalization to the Toxicological Department.
Form of output and packing
It is packed in high-density polyethylene bottles with a screw-on lid per 60 capsules. The bottleneck is sealed with a protective membrane made of the combined material: aluminum foil paper, laminated with polyethylene. The protective film seals the bottle cap. A label made of self-adhesive paper is pasted on the bottle.
The enclosure of the cardboard box includes the bottle together with the instruction on medical use in the state and Russian languages.
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 indicated on the package.
Conditions for drug supply
Over the counter.
Name and country of the organization-manufacturer
Contract Pharmacal Corporation, 135 Adams Avenue,
Hauppauge, New York 11788, USA
Name and country of the Registration Certificate holder
Bayer Consumer Care AG, Switzerland
Name and country of the packaging company
Contract Pharmacal Corporation, USA
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: +7 727 244 70 01
e-mail: kz.claims@bayer.com