PACKAGE LEAFLET: INFORMATION FOR THE USER

Glucosamine 625 mg & 1250 mg effervescent tablets

Glucosamine

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Glucosamine carefully to get the best results from it.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    You must contact a doctor if your symptoms worsen or do not improve after 2-3 months.

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

In this leaflet:

1.    What Glucosamine is and what it is used for

2.    Before you take Glucosamine

3.    How to take Glucosamine

4.    Possible side effects

5.    How to store Glucosamine

6.    Further information

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.    BEFORE YOU TAKE GLUCOSAMINE Do not take Glucosamine

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

-    if you are allergic (hypersensitive) to shellfish, as the active substance is extracted from shellfish.

Take special care with Glucosamine

You should contact your doctor, to exclude that you have no other diseases of the joints, other than osteoarthritis, that may require other avenues of treatment.

Before taking Glucosamine, tell your doctor 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.

•    are in treatment with other medicines.

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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, medicines bought abroad, herbal medicines, strong vitamins and minerals and food supplements.

Tell your doctor before taking Glucosamine, if you are taking

•    blood thinning medicine (warfarin)

•    medicine after transplantation (cyclosporin)

•    antibiotics (tetracycline).

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.

Taking Glucosamine with food and drink You can take Glucosamine with or without food.

Pregnancy and breast-feeding

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

Glucosamine should not be used during pregnancy.

Breast-feeding

There is no information available about the safety of this medicine during breastfeeding. It is not known if glucosamine passes into breast milk. Glucosamine should not be used 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.

Important information about some of the ingredients of Glucosamine

Glucosamine contains sorbitol (E420). 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 contains 13.9 mmol (320 mg) sodium per tablet. This will need to be taken under consideration if you are on a sodium controlled diet.

3.    HOW TO TAKE GLUCOSAMINE

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

You should dissolve one effervescent tablet in at least 100 ml (% glass) of water before intake

Dosage:

Adults

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.

Elderly

It is not necessary to reduce the dose. Follow your doctor's advice.

Children and adolescents

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

Those with Impaired kidney and liver function

Itmaybenecessarytoreducethedose.FoNowyourdoctor'sadvice.

If you take more Glucosamine effervescent tablets than you should

If you have taken more Glucosamine than that stated in this leaflet or more than your doctor has prescribed and you are feelingunwell. You must contact your doctor, or a hospital emergency unit. Bring along and present the package of this medicine

Signs and symptoms of accidental or intentional overdose with glucosamine might include: headache, dizziness, disorientation, joint pain, nausea, vomiting, diarrhoea or constipation.

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.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Glucosamine may cause side effects, although not everybody gets them.

You should stop taking Glucosamine and see your doctor immediately if you develop the following symptoms such as: swelling of the face , tongue and/or throat. Have difficulty swallowing or hives together with difficulty breathing (angioedema).

The following side effects have been reported:

Common side effects (affects 1 to 10 users in 100): Headache, tiredness, nausea, abdominal pain, indigestion, diarrhoea, constipation.

Uncommon side effects (affects 1 to 10 users in 1,000): Rash, itching and flushing of the skin

Frequency not known (cannot be estimated from available data)

Vomiting, urticaria, dizziness, swelling oft 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.

Glucosamine may cause hepatic enzyme elevation and rarely jaundice.

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.

By reporting side effects you can help provide information on the safety of this medicine.

5.    HOW TO STORE GLUCOSAMINE

Keep out of the reach and sight of children.

Do not use Glucosamine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.

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

6. FURTHER INFORMATION What Glucosamine contains

•    Active substance: Glucosamine as glucosamine hydrochloride

•    Other ingredients: Anhydrous citric acid, sodium hydrogen carbonate, anhydrous sodium carbonate, sorbitol, 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

This leaflet was last revised June 2015 394/02