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GLUCOSAMINE SULFATE 750MG FILM-COATED TABLETS

Active substance(s): GLUCOSAMINE SULPHATE SODIUM CHLORIDE

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Package Leaflet: Information for the User
Glucosamine sulfate 750 mg Film-Coated Tablets
Glucosamine Sulfate
Read all of this leaflet carefully before you start taking this medicine.
− 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. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
− If any of the side effects get serious, or if you notice any side effect not listed in this
leaflet, please tell your doctor or pharmacist.

In this leaflet:
1.
What Glucosamine sulfate tablets are and what it is used for
2.
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.
Further information
1.
What Glucosamine sulfate tablets are 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 take Glucosamine sulfate tablets
DO NOT TAKE Glucosamine sulfate tablets
- If you are allergic (hypersensitive) to:
- Glucosamine or to any of the other ingredients of Glucosamine sulfate tablets (see
Section 6 “Further Information”)
- 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.
Consult a doctor before using Glucosamine sulfate tablets if any of the above mentioned
applies to you.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
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 (anticoagulents
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.
Taking 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 76 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 Glucosamine sulfate tablets 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 twice daily or two Glucosamine sulfate
tablets to 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, Glucosamine sulfate tablets 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 breath (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.
5.
How to store Glucosamine sulfate tablets
Keep out of the reach and sight 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 Glucosamine sulfate tablets 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.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6.
Further information
What Glucosamine sulfate tablets contain
The active substance is glucosamine sulfate. Each tablet contains 942 mg of glucosamine
sulfate sodium chloride (equivalent to 750 mg of glucosamine sulfate) or 589 mg
glucosamine.
The other ingredients are
Tablet: Microcrystalline cellulose 101, Microcrystalline cellulose 102, lactose monohydrate,
pregelatinised maize starch, crospovidone, stearic acid, poly(vinyl) alcoholhydrolysed.
Coating: titanium dioxide (E171), talc (E553b), Lecithin soya (E322), macrogol 3350.

What Glucosamine sulfate tablets look like and contents of the pack
Glucosamine sulfate 750 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: 8, 10, 12, 14, 20, 28, 30, 56, 60, 112, 120, 168, 180, 336, 360 film-coated tablets.
or
Cartons containing HDPE containers fitted with a tamper-evident HDPE screw cap.
Pack Size: 8, 10, 12, 14, 20, 28, 30, 56, 60, 112, 120, 168, 180, 336, 360 film-coated tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder
FMC Pharma Ltd

Unit 622, Northern Extension, Co.Waterford
Ireland

Manufacturers
Chanelle Medical, Loughrea, Co.Galway, Ireland.
Walmark a.s, Oldrichovice 44, 739 61 Trinec, Czech Republic.
Millmount Healthcare Ltd. Block 7, CityNorth Business Campus, Stamullen, County Meath
Ireland
mibe GmbH Arzneimittel, Münchener Straße 15, 06796 Brehna, Germany

This leaflet was last approved in:

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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