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Glusartel 1500mg Powder For Oral Solution

Document: leaflet MAH BRAND_PLPI 21828-0467 change

PACKAGE LEAFLET: INFORMATION FOR THE USER Glusartel® 1500mg powder for oral solution

(glucosamine sulphate sodium chloride)

Your medicine is available using the name Glusartel 1500mg powder for oral solution but will be referred to as Glusartel throughout this leaflet.

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 6.6mmol (151mg) 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.

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.

4.    Possible side effects

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.

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 at: 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 Glusartel

Keep out of the sight and reach 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.

Store in the original package.

If the medicine appears to be discoloured or shows any other signs of deterioration, please return to your pharmacist who will advise you. 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.

PO M


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. How to 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 (1500mg glucosamine sulphate) daily.

Dissolve the powder from the sachet in a glass of water (250ml) 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. Page 1 of 2

6. Further Information What Glusartel contains

The active substance is glucosamine sulphate.

Each sachet contains 1884mg glucosamine sulphate sodium chloride, equivalent to 1500mg glucosamine sulphate or 1178mg glucosamine.

Also contains: sorbitol (E420), citric acid, aspartame (E951) and 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 30 or 90 sachets.

Manufacturer

Manufactured by: ROTTAPHARM, Ltd., Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL No: 21828/0467

Leaflet issue and revision date (Ref): 18.02.15

Glusartel® is a registered trademark of Rottapharm Ltd.

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