Patient leaflet - Glucosamine 625 mg effervescent tablets
1. WHAT GLUCOSAMINE IS AND WHAT IT IS USED FOR
Glucosamine can improve mobility and relieve pain in the knee.
You can use Glucosamine for the relief of symptoms in mild to moderate osteoarthritis of the knee. Glucosamine is not suitable for treatment of acute pain.
If your doctor has prescribed Glucosamine for a different use, always follow your doctor’s advice.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLUCOSAMINE
Do not take Glucosamine
- 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 the active substance is extracted from shellfish.
Warnings and precautions
Talk to your doctor or pharmacist before taking Glucosamine if you:
- suffer from diseases related to the heart and blood vessels(cardiovascular), as your cholesterol levels in the blood may increase during your treatment with glucosamine.
- suffer from diabetes. Increased monitoring and control of your blood sugar levels may be necessary when you start your treatment with glucosamine.
- have asthma, as the symptoms of asthma may worsen after starting treatment with glucosamine.
- have any other diseases of the joints (other than osteoarthritis) as this may require a different avenue of treatment.
You should always inform your doctor about your treatment with Glucosamine prior to undertaking any medical laboratory test, as treatment with Glucosamine may alter the test results.
Children and adolescents
This medicine should not be used in children and adolescents below the age of 18 due to the lack of data on safety and efficacy.
Other medicines and Glucosamine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is particularly important to tell your doctor or pharmacist if you are taking:
- some types of medicines used to prevent blood clotting (e.g. warfarin, dicoumarol, phenprocoumon, acenocoumarol and fluindione). The effect of these medicines may be stronger when used with glucosamine. Patients treated with such combinations should therefore be monitored extra carefully when initiating or ending glucosamine therapy.
- antibiotics (tetracyclines).
Care should be taken when taking Glucosamine as there is limited knowledge on Glucosamine and its possible effects when taken in combination with other medicines. If in doubt always check with your doctor or pharmacist to ensure whether the combination is safe.
Glucosamine with food and drink
You can take Glucosamine with or without food.
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.
Glucosamine should not be used during pregnancy.
The use of Glucosamine is not recommended during breast-feeding.
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 following the intake of Glucosamine, you should not drive or operate machinery.
Glucosamine contains sorbitol (E420) and sodium
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) 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 (or your child) take or receive this medicine.
This medicine contains 320mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 16% of the recommended maximum daily dietary intake of sodium for an adult.
3. HOW TO TAKE GLUCOSAMINE
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
You should dissolve one effervescent tablet in at least 100 ml (1/2 glass) of water before intake.
Dosage:
Adults (including the elderly)
1 effervescent tablet of 625 mg taken twice daily, or 1 effervescent tablet of 1250 mg taken once daily.
Duration of treatment
Relief of symptoms (particularly pain relief) may not be experienced until after several weeks of treatment. In some cases it may take even longer. If you do not experience relief of the pain after 2-3 months, you should talk to your doctor or pharmacist about continued treatment with Glucosamine.
Children and adolescents
Glucosamine should not be used in children and adolescents below 18 years of age.
Those with impaired kidney and liver function
It may be necessary to reduce the dose. Follow your doctor’s advice.
If you take more Glucosamine than you should
If you have taken more Glucosamine than you should, you may experience headache, vertigo, disorientation, pain in joints, nausea, vomiting or diarrhoea, although it is possible you may not experience any symptoms. In any case, contact your doctor or a hospital emergency unit.
If you forget to take Glucosamine
If you forget to take a dose, take one as soon as you remember. If it is almost time for you to take your next dose, then skip the dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Glucosamine
Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the medicine, your condition 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.
You should stop taking Glucosamine and tell your doctor immediately or go to the nearest hospital immediately if you experience any of the following symptoms as these symptoms may indicate you are suffering a severe allergic reaction to this medicine:
- swelling of the face, tongue, throat
- difficulty in swallowing or breathing
- rash or hives.
The following side effects have been reported:
Common (may affect up to 1 in 10 people): Headache, tiredness, nausea, abdominal pain, indigestion, diarrhoea, constipation.
Uncommon (may affect up to 1 in 100 people): Rash, itching and flushing of the skin
Not known (frequency cannot be estimated from the available data):
Vomiting, urticaria, dizziness, swelling of the feet or ankles, angioedema. Aggravation of pre-existing asthma, blood glucose control worsened in diabetic patients.
Elevated cholesterol levels have been also reported. It is not possible to determine whether these events were directly related to Glucosamine.
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 doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 GLUCOSAMINE
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 package. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 Glucosamine contains
The active substance is glucosamine as glucosamine hydrochloride. Each 625mg tablet contains 625mg glucosamine. Each 1250mg tablet contains 1250mg glucosamine.
The other ingredients are anhydrous citric acid, sodium hydrogen carbonate (see section 2), anhydrous sodium carbonate (see section 2), sorbitol (see section 2), acesulfame potassium, leucine, lemon flavour.
What Glucosamine looks like and contents of the pack
Appearance
Glucosamine effervescent tablets are round, white to almost white tablets with lemon flavour.
Pack sizes
Glucosamine 625 mg effervescent tablets:
PP tubes:
10 effervescent tablets (1x10)
15 effervescent tablets (1x15)
30 effervescent tablets (2x15)
90 effervescent tablets (6x15)
20 effervescent tablets (1x20)
40 effervescent tablets (2x20)
60 effervescent tablets (3x20)
Strips:
60 effervescent tablets
Glucosamine 1250 mg effervescent tablets:
PP tubes:
20 effervescent tablets (2x10)
15 effervescent tablets (1x15)
30 effervescent tablets (2x15)
90 effervescent tablets (6x15)
20 effervescent tablets (1x20)
40 effervescent tablets (2x20)
60 effervescent tablets (3x20)
Strips:
30 effervescent tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Medley Pharma Ltd
Unit 2A, Olympic Way
Sefton Business Park
Liverpool
L30 1RD