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GLUCOSAMINE SULFATE 750 MG FILM COATED TABLETS

Active substance(s): GLUCOSAMINE SULPHATE

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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 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 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 any of the other ingredients of this medicine
(listed in section 6)
− 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 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 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 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, 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 <,> . 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.
6.

Contents of the pack and other 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
CF Pharma Ltd.,The Racecourse, Danesfort, Kilkenny, 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
This leaflet was last updated in: 10/2014

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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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