Tendofirm
1.0 GENERIC NAME
Collagen (Type I, II, V, X), Mucopolysaccharides, Chondroitin Sulfate & Hyaluronic Acid Capsules
2.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
3.0 DOSAGE FORM AND STRENGTH
Capsule
4.0 CLINICAL PARTICULARS
4.1 Therapeutic indication
Stimulates joint health recovery and flexibility.
4.2 Posology and method of administration
2 capsules once or twice daily on empty stomach or as directed by a Healthcare Professional.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in the formulation.
4.4 Special warnings and precautions for use
Chondroitin sulfate may increase the anticoagulant activities of Warfarin. Don't take chondroitin if you are taking warfarin. Precaution: This Product is consumed by adults only and not recommended for pregnant women, lactating mothers and children below 5 years of age. Supportive therapy for cartilage and joint health.
4.5 Drugs interactions
No known drug-drug interaction
4.6 Use in special populations
Pregnancy & Lactation, usage in pediatrics
Precaution: This product is consumed by adults only and not recommended for pregnant women, lactating mothers and children below 5 years of age. Safety and efficacy in children has not been established.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8 Undesirable effects
- Tendofirm is a nutritional supplement and it is generally regarded as safe for oral consumption in adults.
- In clinical studies, hydrolyzed Collagen produced no skin irritation, sensitization, or indication of phototoxicity
4.9 Overdose
No cases of overdose have been reported.
5.0 PHARMACOLOGICAL PROPERTIES
5.1 Mechanism of Action
Tendofirm offers a multifaceted approach to the management of degenerative joint diseases, hypothesized to provide benefits like rebuilding, strengthening of cartilage, strengthening of tendons, fortification of ligaments and improved viscosity of synovial fluid.
5.2 Pharmacodynamic properties
Collagen is composed of amino acids responsible for the growth, repair and maintenance of various tissues. Collagen is a major component in forming ligaments, tendons, muscles and cartilage. As one increase in age, it is difficult to manufacture sufficient amounts of collagen, this may lead to arthritis and age related joint pain. Collagen promotes structural recovery from injurious strains of the muscle, tendons, ligaments and cartilage. Collagen is required to mend and restore connective tissue aiding muscle strengthening and better joint mobility. Hyaluronic acid increases viscosity of synovial fluid. Chondroitin Sulphate provides tensile strength of cartilage, tendons and ligaments. Mucopolysaccharides also known as Glycosaminoglycans (GAGs)— primarily function to support the most important structural proteins: collagen and elastin. Glycosaminoglycans are used in the body as a lubricant for joints, for supporting connective tissues such as cartilage and tendons, and may even help assist with weight loss. Recent research shows that GAGs don’t lubricate joints as originally thought, but instead reduce cartilage deterioration and inflammation. GAGs also work as the “building blocks” of new joint cartilage, which makes them extra beneficial for managing osteoarthritis or degenerative joint disease.
5.3 Pharmacokinetic properties
In experimental studies, it has been demonstrated that orally administered collagen hydrolysate is thoroughly absorbed by the intestines and circulated in the blood stream, reaching a maximal plasma concentration in 6 h, at which point < 10% of collagen hydrolysate remains in the gastrointestinal tract. These studies also revealed that collagen hydrolysate is not completely broken down by the digestive system, but that a variety of collagen fragments, including up to 10% high molecular form collagen fragments that range from 1 to ≈10 kD, are absorbed following oral administration of collagen hydrolysate, with some individual variability. In experiments with radiolabelled collagen hydrolysate, it has been shown that a significant amount of collagen hydrolysate-derived peptides reach cartilage tissue within 12 h after administration ( p < 0.05 compared with control animals). Hyaluronic acid (HA) is a component that is particularly abundant in the synovial fluid. HA is not absorbed into the body as a high-molecular-weight polymer after ingestion. A test using intestinal epithelia model cells (Caco-2 cells) revealed that HA with a MW exceeding 1 × 105 is rarely absorbed. On the contrary, the amount of HA absorbed by Caco-2 cells increases as the MW of HA decreases to 7 × 104, 2×104, or 5×103. Kurihara et al. reported that HA is decomposed into 2–6-membered polysaccharides by enteric bacteria, and these polysaccharides are partially absorbed into the body by the small intestine. Following the decomposition of HA by enteric bacteria to a low MW form, free polysaccharides are known to migrate into the joints and other tissues. Lactobacillus and Bifidobacterium have been reported as examples of enteric bacteria that play a critical role in HA absorption. The approximate half-life of chondroitin sulfate and its derivative metabolites is 15 hours. Chondroitin sulfate is excreted in the urine as intact polymers and as partial degradation products. Mucopolysaccharides may help reduce collagen breakdown in the body, and protect cartilage inside joints as well. It may also work to reduce inflammation in the body, which is one of the primary causes of joint pain and cartilage breakdown in individuals living with osteoarthritis. It also works as the “building blocks” of new joint cartilage, which makes them extra beneficial for managing osteoarthritis or degenerative joint disease.
6.0 NONCLINICAL PROPERTIES
6.1 Animal Toxicology or Pharmacology
No known animal toxicology data
7.0 DESCRIPTION
The product Tendofirm is a blend of collagen type I, type II type V and type X; Hyaluronic acid, chondroitin sulphate and mucopolysaccharides.
8.0 Pharmaceutical particulars
8.1 Incompatibilities
Not applicable
8.2 Shelf-life
Best Before Twenty-Four Months (24) From The Date of Manufacture.
8.3 Packaging information
Net Quantity: 1 x 15 N Capsules
8.4 Storage and handing instructions
Store in a dry, well-ventilated place at a temperature not exceeding 30°C. Protect from light & moisture. Keep out of reach of children.
9.0 Patient Counselling Information
It is NUTRACEUTICAL product.
Not for medicinal use
This product is not intended to diagnose, treat, cure or prevent any disease. Not to exceed the stated recommended daily dose. Precaution: This Product is consumed by adults only and not recommended for pregnant women, lactating mothers and children below 5 years of age. Supportive therapy for cartilage and joint health.
12.0 Date of revision
04.07.2024
About leaflet
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What TENDOFIRM® is and what it is used for
2. What you need to know before you take TENDOFIRM®
3. How to take TENDOFIRM®
4. Possible side effects
5. How to store TENDOFIRM®
6. Contents of the pack and other information
1. What TENDOFIRM® is and what it is used for
TENDOFIRM® contains collagen, chondroitin sulfate, hyaluronic acid, mucopolysaccharides. It is a nutritional supplement obtained from sternum (breast bone) of birds and the shell membrane of the eggs. It is a blend of various products which are helpful in maintaining good health of joints, cartilages and joint cavities and it also helps in relieving pain and swelling of various joints. It also helps in speedy recovery of the joints and reforms the damaged cartilage and joint fluids to its normal state. Tendofirm provides 4 important types of collagen which serve as building blocks of the cartilages of joints. Chondroitin sulfate, hyaluronic acid and mucopolysaccharides present in the combination protects the cartilage from degradation and wear and tear. While lysozyme, ovotransferrin and sialic acid act as anti-inflammatory agents and helps to relieve joint pain and swelling. TENDOFIRM® provides significant pain and symptom relief. It also causes improvement in walking distance in patients with osteoarthritis. Overall, it helps in reducing pain and stiffness of joints and improves joint mobility.
2. What you need to know before you take TENDOFIRM®.
Do not take TENDOFIRM® if:
You are allergic to the active substance or to any of the excipients in the formulation. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat and tongue.
Do not take this medicine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking TENDOFIRM®.
Warnings and precautions
Talk to your doctor or pharmacist before taking TENDOFIRM® if: Chondroitin sulfate may increase the anticoagulant activities of Warfarin. Don't take chondroitin if you are taking warfarin. Precaution: This Product is consumed by adults only and not recommended for pregnant women, lactating mothers and children below 5 years of age.
Other medicines and TENDOFIRM®
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because TENDOFIRM® can affect the way some other medicines work. Also, some medicines can affect the way TENDOFIRM® works. Till date no drug-drug interactions are reported.
Pregnancy and breast-feeding
Precaution: This product is consumed by adults only and not recommended for pregnant women, lactating mothers and children below 5 years of age. Safety and efficacy in children has not been established.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. No effect anticipated.
3. How to take TENDOFIRM®.
The recommended dose for Adults, Elderly: It is a nutritional supplement available in the form of hard gelatin capsules. Two capsules once or twice daily, should be consumed orally on empty stomach with a glass of drinking water or it should be used as directed by healthcare professional.
If you take more TENDOFIRM® than you should
If you have too much of this medicine, talk to your doctor straight away.
If you forget to take TENDOFIRM®
If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking TENDOFIRM®
Do not stop taking this medicine without talking to your doctor. You should not stop taking TENDOFIRM® just because you feel better. This is because the condition may come back or get worse again. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Tendofirm is a nutritional supplement and it is generally regarded as safe for oral consumption in adults. However, like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor straight away or go to the nearest hospital casualty department if you notice any of the following serious side effects – you may need urgent medical treatment:
- You have an allergic reaction. The signs may include: a rash, joint pain, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
- In clinical studies, hydrolyzed Collagen produced no skin irritation, sensitization, or indication of phototoxicity
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly: Website: www.zuventus.co.in and click the tab “Safety Reporting” located on the top of the home page. https://www.zuventus.co.in/drug-safety-reporting By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store TENDOFIRM®
Store in a dry, well-ventilated place at a temperature not exceeding 30°C. Protect from light & moisture. Keep out of reach of children.
6. Contents of the pack and other information
Packaging information
Net Quantity: 1 x 15 N Capsules
Marketing Authorisation Holder
Zuventus Healthcare Limited
Zuventus House Plot No. Y2, CTS No: 358/A2,
near Nahur Railway Station,off Raycon IT Park Road,
Nahur West, Mumbai, Maharashtra 400078