Package Leaflet: Information for the User Glucosamine sulfate 1500 mg Film-Coated Tablets

Glucosamine Sulfate

What is in this leaflet:

1.    What Glucosamine sulfate tablets are and what they are used for

2.    What you need to know before you take Glucosamine sulfate tablets

3.    How to take Glucosamine sulfate tablets

4.    Possible side effects

5.    How to store Glucosamine sulfate tablets

6.    Contents of the pack and other information

1.    What Glucosamine sulfate tablets are and what they are 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.    What you need to know before you take 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 to take 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. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Glucosamine sulfate tablets

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.

Contents of the pack and other information

What Glucosamine sulfate tablets contain

-    The active substance is glucosamine sulfate. Each tablet contains 1884 mg of glucosamine sulfate sodium chloride (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 look 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.

Marketing authorisation holder

CF Pharma Ltd., The Racecourse, Danesfort, Kilkenny, Ireland Manufacturers

Chanelle Medical, Loughrea, Co.Galway, Ireland.

Millmount Healthcare Ltd. Block 7, CityNorth Business Campus, Stamullen, County Meath Ireland

Walmark a.s, Oldrichovice 44, 739 61 Trinec, Czech Republic.

This leaflet was last revised in: 10/2014