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Glusartel 1500mg Powder For Oral Solution

Document: leaflet MAH BRAND_PL 18219-0010 change

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Package Leaflet: Information for the user

Glusartel 1500 mg

powder for oral solution

(Glucosamine sulphate)


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 further questions, please ask your doctor or your pharmacist.

-    This medicine has been prescribed for you personally and you should 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


In this leaflet:

1.    What Glusartel is and what it is used for

2.    Before you take Glusartel

3.    How to take Glusartel

4.    Possible side effects

5.    How to store Glusartel

6.    Further Information


1. What Glusartel is and what it is used for


Glusartel contains glucosamine sulphate which belongs to a group of medicines called non-steroidal anti-inflammatory and anti-rheumatic agents.

Glusartel is used to relieve symptoms of mild to moderate osteoarthritis of the knee.


2. Before you take Glusartel

Do not take Glusartel:

-    if you are allergic (hypersensitive) to glucosamine or to any of the other ingredients (listed in section 6)

-    if you are allergic (hypersensitive) to shellfish, as glucosamine is manufactured from shellfish

-    if you suffer from phenylketonuria, as Glusartel contains aspartame, a source of phenylalanine.

Take special care with Glusartel Tell your doctor or pharmacist:

-    if you suffer from impaired glucose tolerance. More frequent controls of your blood glucose level may be necessary when starting the treatment with Glusartel

-    if you have liver and/or kidney problems

-    if you suffer from asthma. When starting on Glusartel, your asthma may get worse.

Important information about some of the ingredients of Glusartel

-    This medicine contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

-    One sachet contains 6.6 mmol (151 mg) sodium. If you have to follow a low-sodium diet, you should take this into account.

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.


Tell your doctor before taking Glusartel if you are taking any of the following:

-    medicines to thin the blood (anticoagulants such as warfarin or acenocoumarol)

-    tetracycline antibiotics.

Pregnancy and breast-feeding

Glusartel should not be used during pregnancy.

The use of Glusartel is not recommended during breast-feeding period.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

If you experience dizziness or drowsiness while taking Glusartel, you should not drive or operate machinery.


3. Howto take Glusartel


Always take Glusartel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults including the elderly

The dose is 1 sachet (1500 mg glucosamine sulphate) daily.

Dissolve the powder from the sachet in a glass of water (250 ml) and drink.

Glucosamine is not used for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may not be experienced until after some weeks of treatment or sometimes even longer.

If your symptoms do not get better after 2-3 months, consult your doctor or pharmacist, as you may need to consider other treatment.



4. Possible side effects


5. Howto store Glusartel


Children and adolescents

Glusartel should not be used in children and adolescents below the age of 18 years.

If you take more Glusartel than you should

If you have taken more Glusartel than you should, you must consult your doctor or a hospital.

If you forget to take Glusartel

Take the dose as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Glusartel

Your symptoms may re-occur.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Glusartel can cause side effects, although not everybody gets them.

Stop taking the solution and contact your doctor or go to the casualty department of your nearest hospital IMMEDIATELY if you have any of the following:

-    swelling of the lips, face, tongue or throat

-    difficulty swallowing or breathing

-    skin rash or hives.

The symptoms above may mean that you are having a serious allergic reaction to this medicine.

The following side effects have been reported:

Common side effects (occurring in less than 1 in every 10 patients):

-    stomach pain, indigestion, diarrhoea, constipation, nausea, flatulence

-    headache, sleepiness or drowsiness, tiredness.

Uncommon side effects (occurring in less than 1 in every 100 patients):

-    rash, itching, patchy inflammation of the skin.

Other side effects:

Allergic reaction, dizziness, visual disturbances, hair loss and hypercholesterolemia (increased cholesterol levels in blood) have also been reported occasionally.

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

Keep out of the reach and sight of children.

Do not use Glusartel after the expiry date which is stated on the carton/container or on sachets.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. The measures will help to protect the environment.

6. Further Information

What Glusartel contains

The active substance is Glucosamine sulphate. 1 sachet contains 1884 mg glucosamine sulphate sodium chloride, corresponding to 1500 mg glucosamine sulphate or 1178 mg glucosamine.

The other ingredients are:

Aspartame, Sorbitol, Citric acid anhydrous, Macrogol 4000.

What Glusartel looks like and content of the pack

Glusartel is a white, crystalline, odourless powder contained in single-dose sachets.

Each carton contains 4 (medical samples),

30 or 90 sachets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

ROTTAPHARM Ltd.

Damastown Industrial Park Mulhuddart, Dublin 15 - Ireland Distributed by

HFA Healthcare Limited, Solihull, B91 1NF, UK For medical information queries please call 0844 335 8270 Manufacturer ROTTAPHARM Ltd.

Damastown Industrial Park Mulhuddart, Dublin 15 - Ireland Or    |

Sigmar Italia S.p.A    §

Via Sombrero, 11 -24011 Alme - Italy    o

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Leaflet approved: December 2011    T,