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Dolenio 500 Mg Film-Coated Tablets

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5.    HOW TO STORE DOLENIO

Keep out of the reach and sight of children.

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

This medicinal product does not require any special storage conditions.

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 Dolenio contains

. The active substance is glucosamine sulphate

Each Dolenio 500 mg tablet contains 628.2 mg of Glucosamine sulphate sodium chloride equivalent to 500 mg Glucosamine sulphate or 393 mg glucosamine,

- The other ingredients are Core tablet:

Povidone K30, Macrogol 4000, Magnesium Stearate Coating material:

Hypromellose, Titanium Dioxide (E171), Talc, Propylene glycol, Polysorbate 80.

What Dolenio looks like and contents of the pack

Dolenio 500 mg is a white to off white, ovalshaped, bi-convex film-coated tablets without breakline.

Pack-sizes:

90, 180, 270 film coated tablets in Alu/PVC/PVDC Blister packs Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing authorisation holder

Blue Bio Pharmaceuticals Ltd.

5th Floor, Beaux Lane House, Mercer Street Lower Dublin 2, Ireland

Manufacturer

Jemo-Pharm A/S Hasselvej 1, DK-4780 Stege Denmark

<This medicinal product (Dolenio 500 mg) is authorised in the Member States of the EEA under the following names:>

Denmark: Dolenio

France: Dolenio 393 mg, comprime pellicule United Kingdom: Dolenio 500 mg Film-coated tablets This leaflet was last approved in {01/2012}.

Dolenio'

500 mg film-coated tablets

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 any further questions, ask your doctor or pharmacist

. 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

. 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 Dolenio is and what it is used for

2.    Before you take Dolenio

3.    How to take Dolenio

4.    Possible side effects

5.    How to store Dolenio

6.    Further information

1.    WHAT DOLENIO IS AND WHAT IT IS USED FOR

Dolenio belongs to the group of other anti-inflammatory and anti- rheumatic agents, non-steroids.

Glucosamine is a substance naturally occurring in the human body and necessary for joint fluid and cartilage.

Dolenio tablet is a medical product used for the relief of symptoms in mild to moderate osteoarthritis of the knee.

Osteoarthritis is a type of joint degeneration for which symptoms are:

Stiffness (after sleep or long rest), pain on motion (e.g. when climbing the stairs or walking along uneven surfaces), which is relieved at rest.

2.    BEFORE YOU TAKE DOLENIO Do not take Dolenio

. if you are allergic (hypersensitive) to glucosamine or any of the other ingredients of Dolenio

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

Dolenio must not be used in children under 2 years of age

Take special care with Dolenio

Consult your doctor before taking Dolenio:

. if you suffer of diabetes mellitus or have impaired glucose tolerance. It is recommended to ensure control of your blood sugar before the start of treatment and during the treatment

. if you have a known risk factor for cardiovascular disease (e.g. hypertension, diabetes mellitus, hypercholesterolemia or if you smoke). It is recommended to ensure control of your cholesterol before the start of treatment, since hypercholesterolemia has been observed in a few cases in patients treated with glucosamine

r

. if you have reduced kidney or liver function, since no studies with glucosamine have been performed in this patient group

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.

It is particularly important to tell your doctor or pharmacist if you are taking any of the following medicines:

. tetracyclines (antibacterials used against infection)

. warfarin or similar types of products (anticoagulants used to prevent blood-clotting). The effect of the anticoagulant may be intensified when taken with glucosamine. Patients treated with such combinations should therefore be monitored extra carefully when initiating or ending glucosamine therapy.

Taking Dolenio with food and drink

The tablets should be swallowed with some liquid, and can be taken with or without food.

Pregnancy and breast-feeding Pregnancy

Ask your doctor or pharmacist for information, before you take any kind of medicine.

Dolenio should not be used during pregnancy.

Breast-feeding

Ask your doctor or pharmacist for information, before you take any kind of medicine.

The use of Dolenio during breast-feeding is not recommended. 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 after you start taking Dolenio, you should not drive or operate machinery.

Important information about some ingredients of Dolenio

Each Dolenio 500 mg film-coated tablet contains 2.240mmol (51.538 mg) of sodium

Please take into consideration if you are on a controlled sodium diet.

3. HOW TO TAKE DOLENIO

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

Adults

The recommended dose is 1178 mg of Glucosamine (1500 mg Glucosamine sulphate) to be taken once daily with a glass of water.

This corresponds to:

Dolenio 500 mg - 3 tablets to be taken together,once daily

When other strengths are available, the corresponding dosage is:

Dolenio 1500 mg - 1 tablet

Dolenio 750 mg - 2 tablets to be taken together, once daily. Elderly

No dosage adjustment is required.

Patients with impaired renal and/or liver function

No dose recommendations can be given, since no studies have been performed.

Children and adolescents

Dolenio should not be used in children and adolescents under 18 years of age.

Glucosamine is not indicated for the treatment of acute pain. Relief of symptoms (especially pain relief) may not be experienced until after several weeks of treatment and in some cases even longer. If you do not experience relief of symptoms after 2-3 months, please tell your doctor or pharmacist, since continued treatment with Dolenio should be re-evaluated.

For oral use. The tablets should be swallowed together with some water or other liquid with or without meal.

If you take more Dolenio than you should

If you have taken too many Dolenio tablets, consult your doctor or hospital.

Signs and symptoms of overdose with glucosamine might include headache, dizziness, confusion, joint pain, nausea, vomiting, diarrhoea or constipation. Stop taking glucosamine at the first signs of overdose.

If you forget to take Dolenio

You should not take a double dose to make up for a forgotten dose.

If you stop taking Dolenio

Your symptoms may reoccur if you stop taking Dolenio.

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

4. POSSIBLE SIDE EFFECTS

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

You should stop taking Dolenio and see your doctor immediately if you experience symptoms such as:

Swollen face, tongue and/or throat and/or difficulty to swallow or hives together with difficulties in 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.

Frequency not known (can not be estimated from available data)

Vomiting, raised itchy rash (hives), dizziness, swelling of the feet or ankles, swelling of face or mouth causing difficulty in breathing, aggravation of pre-existing asthma and blood glucose control becoming worse in diabetic patients.

Elevated cholesterol levels have also been reported. It is not possible to determine whether these events were directly related to Dolenio.

Dolenio 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.

5.    HOW TO STORE DOLENIO

Keep out of the reach and sight of children.

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

This medicinal product does not require any special storage conditions.

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 Dolenio contains

. The active substance is glucosamine sulphate

Each Dolenio 500 mg tablet contains 628.2 mg of Glucosamine sulphate sodium chloride equivalent to 500 mg Glucosamine sulphate or 393 mg glucosamine,

- The other ingredients are Core tablet:

Povidone K30, Macrogol 4000, Magnesium Stearate Coating material:

Hypromellose, Titanium Dioxide (E171), Talc, Propylene glycol, Polysorbate 80.

What Dolenio looks like and contents of the pack

Dolenio 500 mg is a white to off white, ovalshaped, bi-convex film-coated tablets without breakline.

Pack-sizes:

90, 180, 270 film coated tablets in Alu/PVC/PVDC Blister packs Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing authorisation holder

Blue Bio Pharmaceuticals Ltd.

5th Floor, Beaux Lane House, Mercer Street Lower Dublin 2, Ireland

Manufacturer

Central-Pharma Limited Caxton Road, Bedford Mk410XZ

<This medicinal product (Dolenio 500 mg) is authorised in the Member States of the EEA under the following names:>

Denmark: Dolenio

France: Dolenio 393 mg, comprime pellicule United Kingdom: Dolenio 500 mg Film-coated tablets This leaflet was last approved in {01/2012}.

Dolenio'

500 mg film-coated tablets

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 any further questions, ask your doctor or pharmacist

. 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

. 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 Dolenio is and what it is used for

2.    Before you take Dolenio

3.    How to take Dolenio

4.    Possible side effects

5.    How to store Dolenio

6.    Further information

1.    WHAT DOLENIO IS AND WHAT IT IS USED FOR

Dolenio belongs to the group of other anti-inflammatory and anti- rheumatic agents, non-steroids.

Glucosamine is a substance naturally occurring in the human body and necessary for joint fluid and cartilage.

Dolenio tablet is a medical product used for the relief of symptoms in mild to moderate osteoarthritis of the knee.

Osteoarthritis is a type of joint degeneration for which symptoms are:

Stiffness (after sleep or long rest), pain on motion (e.g. when climbing the stairs or walking along uneven surfaces), which is relieved at rest.

2.    BEFORE YOU TAKE DOLENIO Do not take Dolenio

. if you are allergic (hypersensitive) to glucosamine or any of the other ingredients of Dolenio

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

Dolenio must not be used in children under 2 years of age

Take special care with Dolenio

Consult your doctor before taking Dolenio:

. if you suffer of diabetes mellitus or have impaired glucose tolerance. It is recommended to ensure control of your blood sugar before the start of treatment and during the treatment

. if you have a known risk factor for cardiovascular disease (e.g. hypertension, diabetes mellitus, hypercholesterolemia or if you smoke). It is recommended to ensure control of your cholesterol before the start of treatment, since hypercholesterolemia has been observed in a few cases in patients treated with glucosamine

r

. if you have reduced kidney or liver function, since no studies with glucosamine have been performed in this patient group

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.

It is particularly important to tell your doctor or pharmacist if you are taking any of the following medicines:

. tetracyclines (antibacterials used against infection)

. warfarin or similar types of products (anticoagulants used to prevent blood-clotting). The effect of the anticoagulant may be intensified when taken with glucosamine. Patients treated with such combinations should therefore be monitored extra carefully when initiating or ending glucosamine therapy.

Taking Dolenio with food and drink

The tablets should be swallowed with some liquid, and can be taken with or without food.

Pregnancy and breast-feeding Pregnancy

Ask your doctor or pharmacist for information, before you take any kind of medicine.

Dolenio should not be used during pregnancy.

Breast-feeding

Ask your doctor or pharmacist for information, before you take any kind of medicine.

The use of Dolenio during breast-feeding is not recommended. 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 after you start taking Dolenio, you should not drive or operate machinery.

Important information about some ingredients of Dolenio

Each Dolenio 500 mg film-coated tablet contains 2.240mmol (51.538 mg) of sodium

Please take into consideration if you are on a controlled sodium diet.

3. HOW TO TAKE DOLENIO

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

Adults

The recommended dose is 1178 mg of Glucosamine (1500 mg Glucosamine sulphate) to be taken once daily with a glass of water.

This corresponds to:

Dolenio 500 mg - 3 tablets to be taken together,once daily

When other strengths are available, the corresponding dosage is:

Dolenio 1500 mg - 1 tablet

Dolenio 750 mg - 2 tablets to be taken together, once daily. Elderly

No dosage adjustment is required.

Patients with impaired renal and/or liver function

No dose recommendations can be given, since no studies have been performed.

Children and adolescents

Dolenio should not be used in children and adolescents under 18 years of age.

Glucosamine is not indicated for the treatment of acute pain. Relief of symptoms (especially pain relief) may not be experienced until after several weeks of treatment and in some cases even longer. If you do not experience relief of symptoms after 2-3 months, please tell your doctor or pharmacist, since continued treatment with Dolenio should be re-evaluated.

For oral use. The tablets should be swallowed together with some water or other liquid with or without meal.

If you take more Dolenio than you should

If you have taken too many Dolenio tablets, consult your doctor or hospital.

Signs and symptoms of overdose with glucosamine might include headache, dizziness, confusion, joint pain, nausea, vomiting, diarrhoea or constipation. Stop taking glucosamine at the first signs of overdose.

If you forget to take Dolenio

You should not take a double dose to make up for a forgotten dose.

If you stop taking Dolenio

Your symptoms may reoccur if you stop taking Dolenio.

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

4. POSSIBLE SIDE EFFECTS

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

You should stop taking Dolenio and see your doctor immediately if you experience symptoms such as:

Swollen face, tongue and/or throat and/or difficulty to swallow or hives together with difficulties in 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.

Frequency not known (can not be estimated from available data)

Vomiting, raised itchy rash (hives), dizziness, swelling of the feet or ankles, swelling of face or mouth causing difficulty in breathing, aggravation of pre-existing asthma and blood glucose control becoming worse in diabetic patients.

Elevated cholesterol levels have also been reported. It is not possible to determine whether these events were directly related to Dolenio.

Dolenio 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.