Patient leaflet - Glusartel 1500 mg powder for oral solution
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.
What you need to know before you take Glusartel
Do not take Glusartel:
- if you are allergic to glucosamine or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to shellfish, as glucosamine is manufactured from shellfish • if you suffer from phenylketonuria, as Glusartel contains aspartame, a source of phenylalanine.
- if you suffer from rare hereditary problems of fructose intolerance, as Glusartel contains sorbitol.
Warnings and precautions
Talk to your doctor or pharmacist before using Glusartel:
- 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. • if you suffer from concomitant diseases which may require another treatment. • if you are on a controlled sodium diet
Other medicines and Glusartel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Glusartel should not be used during pregnancy.
The use of Glusartel is not recommended during breast-feeding period.
Driving and using machines
Undesirable effects such as headache, tiredness, drowsiness, dizziness or visual disturbances (disorders of sight) are possible after taking this medicine. If affected, patients should not drive or operate machinery.
Glusartel contains aspartame, sorbitol and sodium
- This medicine contains 2.5 mg aspartame in each sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
This medicine contains 2029 mg sorbitol in each sachet. Sorbitol is a source of fructose.
If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take or receive this medicine
- This medicine contains 151 mg sodium (main component of cooking/table salt) in each sachet. This is equivalent to 7.6% of the recommended maximum daily dietary intake of sodium for an adult.
3. How to take Glusartel
Always take this medicine exactly as your doctor has told you. 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.
Use in 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
Symptoms are unlikely to arise after acute ingestion of this product. It is possible that nausea and vomiting or diarrhoea may occur.
If you have taken more Glusartel than you should, you must consult your doctor or a hospital.
If overdose occurs treatment should be discontinued, symptomatic and standard supportive measures should be adopted as required e.g. act to restore the hydroelectrolytic balance.
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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side-effects have been reported.
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 (may affect up to 1 in 10 people) :
- stomach pain,
- indigestion,
- diarrhoea,
- constipation,
- nausea,
- flatulence
- headache,
- sleepiness or drowsiness,
- tiredness.
Uncommon side effects (may affect up to 1 in 100 people):
- skin rash,
- itching,
- patchy inflammation of the skin.
- flushing (reddening of the skin).
Not known (frequency cannot be estimated from the available data)
- allergic reactions,
- insufficient control of diabetes
- dizziness,
- insomnia
- visual disturbances (disorders with your sight)
- asthma/asthma aggravated
- cardiac arrhythmias (abnormal heart rhythm) e.g. tachycardia (fast heartbeat) • vomiting
- angioedema (swelling of face, tongue or throat, breathing difficulty)
- urticaria (hives)
- oedema (fluid retention in your body)
- peripheral oedema (fluid retention in the limbs).
- elevated liver enzymes and jaundice (skin and whites of the eyes turn yellow) • blood glucose increased
- Increased blood pressure
- fluctuation in laboratory blood clotting test (INR).
Cases of hypercholesterolemia (increased cholesterol levels in blood) have been reported, but a causal link has not been demonstrated.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Glusartel
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton/container and on the sachets. The expiry date refers to the last day of that month.
Do not store above 30°C.
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 protect the environment.
6. Contents of the pack and other 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 contents 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
Mylan Products Ltd.,
Station Close, Potters Bar,
Hertfordshire, EN6 1TL, UK
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 Sombreno, 11 - 24011 Almè - Italy