Teraflex^® Ultra (Capsules) Instructions for Use

Marketing Authorization Holder

BAYER, JSC (Russia)

Manufactured By

VTF, LLC (Russia)

Contact Information

BAYER AG (Germany)

Dosage Form

Teraflex® Ultra

Capsules: 60 or 120 pcs.

Dosage Form, Packaging, and Product Composition

Capsules with a mass of 875 mg.

Composition: Glucosamine hydrochloride, Chondroitin sulfate sodium; gelatin capsule (gelatin, colorant: titanium dioxide); ginger root extract, vitamin premix (native type II collagen (Collavant^® n2), Nicotinamide, carrier: microcrystalline cellulose; Calcium pantothenate, Pyridoxine hydrochloride, Riboflavin, Thiamine hydrochloride, Cyanocobalamin), Ascorbic acid; carrier: microcrystalline cellulose; anti-caking agents: amorphous silicon dioxide, magnesium salt of stearic acid (magnesium stearate).

¹ % of the recommended daily intake level according to TR TS 022/2011 “Food products regarding their labeling”;
² % of the adequate daily intake level according to the EurAsEC “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)”;
* does not exceed the upper permissible intake level.

Nutritional value (4 caps.): proteins – 0.468 g.
Energy value (4 caps.): 1.9 kcal/8 kJ.

10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (12) – cardboard packs.

Therapeutic Category

Dietary supplement for supporting musculoskeletal function

Properties

Ultra of the Teraflex^® trademark (t.m.) dietary supplement (DS) helps reduce the feeling of pain and restore healthy structure, flexibility, and mobility of joints and the spine. The improved Teraflex^® formula is specially designed for a comprehensive intensive effect on degenerative-dystrophic processes in joint and spine tissues that develop with aging and inflammation.

Ultra t.m. Teraflex^® dietary supplement is a combination of the chondroprotectors chondroitin and glucosamine – the most important structural components of joint cartilage tissue, enhanced with the following ingredients:

• Undenatured (native) type II collagen (Collavant^® n2 (is a trademark licensed by Bioiberica, S.A.U.) – at the immune level, helps prevent the destruction of the body’s own cartilage collagen and stimulates the natural renewal of joint cartilage tissue;
• Gingerol – has a natural analgesic and anti-inflammatory effect;
• B vitamins – enhance the chondroprotective action of glucosamine and chondroitin;
• Vitamin C – promotes the synthesis of the body’s own collagen.

This combination of substances contributes to:

• Intensive restoration of joint cartilage tissue;
• Renewal of the body’s own collagen in joint tissues;
• Reduction of inflammation and pain in the joints.

Can be used to correct the diet as a dietary supplement – an additional source of chondroitin, glucosamine, B vitamins, and vitamin C for various degenerative-dystrophic changes and joint diseases (osteoarthritis and osteochondrosis).

Not a medicinal product.

Properties of the components

Glucosamine and Chondroitin sulfate are contained in proven effective dosages and in combination exhibit synergy, complementing and enhancing each other’s beneficial effects on the symptoms of osteoarthritis (joint discomfort, pain, stiffness, etc.). Glucosamine and Chondroitin sulfate stimulate restorative processes in the joint cartilage tissue, which undergoes wear under the influence of physical exertion, age-related changes, and degenerative-dystrophic processes in osteoarthritis and osteochondrosis.

Glucosamine is necessary for the synthesis of chondroitin and hyaluronic acid, stimulates the synthesis of type II collagen, and has an anti-inflammatory effect.

Chondroitin sulfate has an analgesic and anti-inflammatory effect, promotes active cartilage regeneration, and reduces the need for NSAID use.

When used together, chondroitin and Glucosamine are more effective than separately, particularly in terms of their influence on the synthesis of joint cartilage components, recovery processes, and the symptoms of osteoarthritis.

Undenatured collagen (native) type II (Collavant^® n2) due to its unique mechanism of action, helps reduce joint pain, improve mobility, and prevent inflammation of joint tissues.

Type II collagen is the main protein of the joint connective tissue that forms its structure. In osteoarthritis, age-related, or degenerative-dystrophic changes, the body’s own cartilage collagen is destroyed. Collagen fragments are recognized by the body as foreign and activate immune cells, which release substances that cause inflammation. Inflammation enhances the destruction of collagen and other structures of the joint cartilage tissue. Thus, a vicious circle is formed, leading to progression and further gradual destruction of the cartilage and all tissues of the joint.

Undenatured (native) type II collagen (Collavant^® n2) is collagen with a preserved natural (native) structure and a unique mechanism of action aimed at suppressing the immune-inflammatory response.

Native collagen, unlike ordinary dietary collagen, is protected from destruction by stomach acid and digestive enzymes, so it reaches the intestine unchanged, where it exhibits its activity. Sections of the native collagen molecule interact with cells of the lymphoid tissue in the intestine, which release special signaling molecules that ultimately suppress the pathological immune response to the body’s own cartilage collagen and inflammation. Thus, native collagen prevents further progression of cartilage tissue destruction and stimulates joint regeneration.

Gingerol (active component of ginger extract) has an analgesic and anti-inflammatory effect by inhibiting the formation and action of many pro-inflammatory substances.

Unlike NSAIDs, gingerol is a natural and safe analgesic, which is why it can be taken in long courses to achieve a long-term analgesic effect. Experimental studies have shown that the analgesic effect of gingerol is comparable to NSAIDs, and it also increases the production of protective factors of the gastric mucosa and reduces the damaging effect of NSAIDs.

Vitamin C is necessary for the synthesis of the body’s own collagen and preservation of the elasticity of ligaments, tendons, and other structures of the connective tissue of joints and the spine; promotes the renewal of cartilage tissue; has anti-inflammatory and antioxidant effects; is necessary for the normalization of metabolic processes in joint tissues. Numerous studies have established a relationship between insufficient vitamin C intake and loss of cartilage tissue.

B vitamins enhance the chondroprotective action of glucosamine and chondroitin. Deficiency of B vitamins is associated with the development of joint pathology.

Scope of Application

Of the Teraflex^® Ultra product

• As a dietary supplement – a source of chondroitin sulfate and glucosamine, an additional source of vitamins C, B₁, B₂, B₃/PP, B₅, B₆, B₁₂, containing Gingerols.

ICD codes

Dosage Regimen

Adults – 2 capsules 2 times/day, during or after meals.

The duration of administration is at least 2 months. If necessary, the course can be repeated.

Contraindications

• Individual intolerance to the components;
• Pregnancy;
• Breastfeeding period;
• Concomitant use of warfarin and other coumarin anticoagulants.

Before using the dietary supplement, it is recommended to consult a doctor.

Use during pregnancy and lactation

Contraindicated for use during pregnancy and breastfeeding.

Dispensing Status

Places of sale are determined by the national legislation of the member states of the Eurasian Economic Union.

Storage Conditions

The product should be stored in the original packaging in a place inaccessible to children at a temperature not exceeding 25°C (77°F) and relative ambient air humidity not more than 65%.

Shelf Life

Shelf life – 2 years.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.