1.NAME OF THE MEDICINAL PRODUCT
Glucosamine sulphate 1500mg Film-coated tablets.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains

glucosamine sulfate sodium chloride USP        1884mg  
(equivalent to 1500 mg of glucosamine sulfate) or 1178mg glucosamine.
Excipient: Sodium 151 mg.
For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, oval shaped, bi-convex film coated tablets with breakline on one side.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications
Relief of symptoms in mild to moderate osteoarthritis of the knee.

4.2  Posology and method of administration
Adults
One tablet daily

The recommended dose is 1178 mg of Glucosamine (1500 mg Glucosamine sulphate) to be taken once daily with a glass of water.
This quantity corresponds to:
1 tablet of Glucosamine sulphate 1178 mg, once daily
Other strengths can be available and the corresponding dosages is:
2 tablets of Glucosamine sulphate 589 mg to be taken together or 3 tablets of Glucosamine sulphate 393 mg to be taken together, once daily.

Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may not be experienced until after several weeks of treatment and in some cases even longer. If no relief of symptoms is experienced after 2-3 months, continued treatment with glucosamine should be reevaluated.

Tablets can be taken with or without food.

Additional information on special populations:
Elders:
No specific studies have been performed in the elderly, but according to clinical experience dosage adjustment is not required when treating otherwise healthy, elderly patients.

Children and adolescents:
Glucosamine sulphate is not recommended for use in children and adolescents below the age of 18 years, due to lack of data on safety and efficacy.

Impaired renal and/or liver function:
In patients with impaired renal and/or liver function no dose recommendations can be given, since no studies have been performed with this group.

4.3 Contraindications
Glucosamine sulphate must not be used in patients who are allergic to shellfish as the active ingredient is obtained from shellfish.

Hypersensitivity to the active substance or to any of the excipients.
Children under 2 years of age.

4.4 Special Warnings and precautions for use
A doctor should be consulted to rule out the presence of joint disease for which other treatment should be considered.

In patients with impaired glucose tolerance, monitoring of the blood glucose levels and, where relevant, insulin requirements is recommended before start of treatment and periodically during treatment.

In patients with known risk factor for cardiovascular disease, monitoring of the blood lipid levels is recommended, since hypercholesterolemia has been reported in a few cases in patients treated with glucosamine.

A report on exacerbated asthma symptoms triggered after initiation of glucosamine therapy has been described (symptoms resolved after withdrawal of glucosamine). Asthmatic patients starting on glucosamine should therefore be aware of potential worsening of asthma symptoms.

This medicinal product contains 6.52 mmol (or 151 mg) of sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

4.5 Interaction with other medicinal products and other forms of interaction
Increased effect of coumarin anticoagulants (e.g. warfarin) during concomitant treatment with glucosamine has been reported. Patients treated with coumarin anticoagulants should therefore be monitored closely when initiating or ending glucosamine therapy.

Concurrent treatment with glucosamine may increase the absorption and serum concentrations of tetracyclines, but the clinical relevance of this interaction is probably limited.

Due to limited documentation on potential drug interactions with glucosamine, one should generally be aware of altered response or concentration of concurrently used medical products.

4.6 Fertility, Pregnancy and lactation
Pregnancy:
There are inadequate data concerning the use of glucosamine in pregnant women. From animal studies only insufficient data are available. Glucosamine should not be used during pregnancy.

Breast feeding:
There is no data available on the excretion of glucosamine in breastmilk. The use of glucosamine during breast feeding is therefore not recommended as there is no data on the safety of the child.

4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive or use machines have been performed.

If dizziness or drowsiness is experienced, car driving and the operating of machinery is not recommended.

4.8 Undesirable Effects
The most common adverse reactions associated with treatment with glucosamine are nausea, abdominal pain, indigestion, constipation, and diarrhoea. In addition, headache, tiredness, rash, itching, and flushing have been reported. The reported adverse reactions are usually mild and transitory.

In the table below, all causality adverse events are listed by system organ class and frequency (very common ≥1/10; common ≥1/100 to <1/10 to 1/1000 to <1/100, rare ≥1/10,000 to <1/1000; very rare <1/10000; not known (cannot be estimated from the available data)).

MedDRA System Organ ClassCommon (>1/100 to <1/10)Uncommon (>1/1000 to
<1/100)
Not known (cannot be estimated from the available data)
Nervous system disordersHeadache Tiredness Dizziness
Respiratory, thoracic and mediastinal disordersAsthma / Asthma aggravated
Gastrointestinal disordersNausea Abdominal pain Indigestion Diarrhoea ConstipationVomiting
Skin and subcutaneous tissue disordersRash Itching FlushingAngioedema Urticaria
Metabolism and nutrition disordersDiabetes mellitus inadequate control Hypercholesterolaemia
General disorders and administration site conditionsOedema / Peripheral oedema

Cases of Hypercholesterolemia, Asthma, aggravated and Diabetes mellitus inadequate control have been reported, but causality has not been established.

Glucosamine sulphate may cause Hepatic enzyme elevation and rarely jaundice.

Patients with Diabetes mellitus
Blood glucose control worsened in patients with diabetes mellitus. Frequency not known.

4.9 Overdose
Signs and symptoms of accidental or intentional overdose with glucosamine might include headache, dizziness, disorientation, arthralgia, nausea, vomiting, diarrhoea or constipation.

In case of overdose, treatment with glucosamine should be discontinued and standard supportive measures should be adopted as required.

In clinical trials one of five healthy young subjects experienced headache following infusion of glucosamin up to 30g.

In addition, one case of overdose has been reported in a 12-year old female who took orally 28 g of glucosamine hydrochloride. She developed arthralgia, vomiting and disorientation. The patient fully recovered.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other antiinflammatory and antirheumatic agents, non-steroids.

Glucosamine is an endogenous substance, a normal constituent of the polysaccharide chains of cartilage matrix and synovial fluid glucosaminoglycans. In vitro and in vivo studies have shown glucosamine stimulates the synthesis of physiological glycosaminoglycans and proteoglycans by chondrocytes and of hyaluronic acid by synoviocytes.

The mechanism of action of glucosamine is unknown. The period to onset of response cannot be assessed.

5.2 Pharmacokinetic properties
Glucosamine is a relatively small molecule (molecular mass 179), which is easily dissolved in water and soluble in hydrophilic organic solvents.

The available information on the pharmacokinetics of glucosamine is limited. The absolute bioavailability is unknown. The distribution volume is approximately 5 litres and the half-life after intravenous administration is approximately 2 hours. Approximately 38 % of an intravenous dose is excreted unchanged in the urine.

The ADME (absorption, distribution, metabolism and excretion) profile for Glucosamine sulphate in man has not been completely elucidated.

5.3 Preclinical safety data
D-glucosamine has low acute toxicity.
Animal experimental data relating to toxicity during repeated administration, reproduction toxicity, mutagenicity or carcinogenicity is lacking for glucosamine. Results from in vitro or in vivo studies in animals have shown that glucosamine reduces insulin secretion and induces insulin resistance, probably via glucokinase inhibition in the beta cells. The clinical relevance is unknown.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Core tablet
Povidone K30
Macrogol 4000
Magnesium Stearate

Coating material
Hypromellose
Titanium Dioxide (E171)
Talc
Propylene glycol
Polysorbate 80

6.2 Incompatibilities
Not applicable.

6.3  Shelf life
36 months.

6.4 Special precautions for storage
This medicinal product does not require any special storage conditions

6.5 Nature and contents of container
HDPE bottle with HDPE screw cap.
Alu/PVC/PVDC Blister packs
Pack-sizes:
20, 30, 60 and 90 film-coated tablets in HDPE bottle with HDPE screw cap.
4, 10, 20, 30, 45, 60, 90 film-coated tablets in Alu/PVC/PVDC Blister pack.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling
No special requirements.

7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Glucosamine sulphate 1500mg Film-coated tablets

Package leaflet: Information for the patient

Glucosamine sulphate 1500mg Film-coated tablets.

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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

What is in this leaflet
1. What  Glucosamine sulfate tablets is and what it is used for
2. Before you are given Glucosamine sulfate tablets
3. How you will be given  Glucosamine sulfate tablets
4. Possible side effects
5. How Glucosamine sulfate tablets is stored
6. Further Information

1. What Glucosamine sulfate tablets is and what it is used for
Glucosamine sulfate tablets belong to a group of medicines called other anti-inflammatory and anti-rheumatic agents, non steroids. Glucosamine sulfate tablets are used for the relief of symptoms of mild to moderate osteoarthritis of the knee.

Osteoarthritis is a type of joint degeneration that generates symptoms such as stiffness (after sleep or long rest) and pain at motion (e.g. when climbing the stairs or walking along uneven surfaces).

2. Before you are given Glucosamine sulfate tablets
DO NOT TAKE Glucosamine sulfate tablets
− If you are allergic to Glucosamine or to any of the other ingredients of this medicine (listed in section)
− Shellfish, since Glucosamine sulfate tablets are manufactured from shellfish.

TAKE SPECIAL CARE with Glucosamine sulfate tablets if you
– Suffer from impaired glucose tolerance. More frequent controls of your blood glucose levels may be necessary when starting treatment with Glucosamine sulfate tablets
– Have kidney or liver dysfunction, since no studies have been performed in such patients dose recommendations cannot be given.
– Have a known risk factor for heart (cardiovascular) disease, since high cholesterol (hypercholesterolemia) has been observed in a few cases in patients treated with Glucosamine sulfate tablets.
– Suffer with asthma. When starting on Glucosamine sulfate tablets, you should be aware of potential worsening of symptoms.
– If you have joint swelling, warmth and redness, joint painfulness, persistent joint stiffness, pain at rest, pain in more than one joint, increased body temperature and decrease in body weight because they can be symptoms of more serious diseases such as rheumatoid arthritis, systemic lupus, gout, tumours.

Talk to your doctor before using Glucosamine sulfate tablets if any of the above mentioned applies to you.

Other medicines and Glucosamine
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Caution should be exercised if Glucosamine sulfate tablets have to be combined with other medicines, especially with:
− Warfarin (a medicine used to thin the blood) or similar type of products (anticoagulants used to prevent blood-clotting). The effect of the anticoagulant may be intensified in association with glucosamine. Patients treated with such combinations should therefore be monitored extra carefully when initiating or ending glucosamine therapy.
− Medicines for diabetes, your doctor may wish to monitor your blood sugar levels closely while you are taking Glucosamine sulfate tablets
− Tetracycline (an antibiotic effective against a wide range of bacterial infections).

Please contact your doctor or pharmacist for medical advice before using Glucosamine sulfate tablets if you use any of the above mentioned medicines.

Glucosamine sulfate tablets with food and drink
You can take Glucosamine sulfate tablets with or without food.

Pregnancy and breast-feeding Glucosamine sulfate tablets should not be used during pregnancy. The use of Glucosamine sulfate tablets during breast-feeding is not recommended. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. If you experience dizziness or drowsiness from Glucosamine sulfate tablets, you should not drive or operate machinery.

Important information about some of the ingredients of Glucosamine sulfate tablets
This medicinal product contains 152 mg sodium per tablet. This should be taken into consideration by patients on a controlled sodium diet. Glucosamine sulfate tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Glucosamine sulfate tablets contain soya lecithin. Do not
use this product if you are allergic to soya or peanuts.

3. How you will be given Glucosamine sulfate tablets
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

One Glucosamine sulfate tablet should be taken once daily. The tablets should be swallowed whole with water.

Glucosamine sulfate tablets are not indicated for the treatment of acute painful symptoms (rapid onset of brief severe pain). Relief of symptoms (especially pain relief) may not be experienced until after several weeks of treatment and in some cases even longer. If no relief of symptoms is experienced after 2-3 months, continued treatment with Glucosamine sulfate tablets should be re-evaluated and medical advice sought.

Children and adolescents
Glucosamine sulfate tablets are not recommended for use in children and adolescents below the age of 18, due to lack of data on safety and efficacy.

Elderly
No dosage adjustment is required when treating otherwise healthy elderly patients, however your doctor will decide your dose.

Patients with impaired renal and/or liver function
No dose recommendations can be given, since no studies have been performed.

If you take more Glucosamine sulfate tablets than you should
If you have taken large quantities you must consult your doctor or a hospital.
In case of an overdose you may experience symptoms such as:
− headache
− dizziness
− disorientation
− joint pain
− feeling sick (nausea) or being sick (vomiting)
− diarrhoea or constipation.

If you forget to take Glucosamine sulfate tablets
Do not take a double dose to make up for a forgotten dose.

If you stop using Glucosamine sulfate tablets
Your symptoms may reoccur. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

You should stop taking Glucosamine sulfate tablets and see your doctor immediately if you experience symptoms such as: swollen face, tongue and/or pharynx and/or difficulty to swallow or hives together with difficulties to breathe (angioedema).

The following side effects have been reported:
Common side-effects (in less than 1 in 10 patients but in more than 1 out of 100 patients treated)
− Headache
− Tiredness
− Nausea
− Abdominal pain
− Indigestion
− Diarrhoea
− Constipation
− Wind (flatulence)

Uncommon side-effects (in less than 1 in 100 patients but more than 1 in 1000 patients treated)
− Rash
− Itching
− Flushing

Unknown frequency
− Allergic reaction
− Visual disturbance
− Hair loss (alopecia)
− Dizziness
− Swelling of the feet or ankles
− Vomiting
− Diabetes mellitus inadequate control
− Asthma or aggravation of pre-existing asthma
− Increased liver enzymes (hepatic enzyme elevation)
− Yellow discoloration of the skin (jaundice)

Elevated cholesterol levels have been also reported. It is not possible to determine whether these events were directly related to Glucosamine sulfate tablets

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How Glucosamine sulfate tablets is stored
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date stated on the label and carton after EXP:. The expiry date refers to the last day of that month.
After first opening of the tablet container the product should be used within 6 months.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Further information

What Glucosamine sulfate tablets contains
− The active substance is glucosamine sulfate.
Each tablet contains
glucosamine sulfate sodium chloride USP        1884mg  
(equivalent to 1500 mg of glucosamine sulfate) or 1178mg glucosamine.
− The other ingredients are Tablet: Microcrystalline cellulose 101, Microcrystalline cellulose 102, lactose monohydrate, pregelatinised maize starch, crospovidone, stearic acid, Poly(vinyl) alcohol, Coating: titanium dioxide (E171), talc (E553b), Lecithin soya (E322), macrogol 3350.

What Glucosamine sulfate tablets looks like and contents of the pack
Glucosamine sulfate 1500 mg tablets are off-white, oblong, film-coated tablets.
The tablets are available in two types of packaging.
Cartons containing PVdC coated PVC/Al blisters
Pack Size: 7,10,14,20,21,28,30, 56,60,84,90, 168,180 film-coated tablets
or
Cartons containing HDPE containers fitted with a tamper-evident HDPE screw cap. Pack Size: 7,10,14,20,21,28,30, 56,60,84,90, 168,180 film-coated tablets
Not all pack sizes may be marketed.

7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com