Dolenio 750 Mg Film-Coated Tablets
Out of date information, search another5. 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 750 mg tablet contains 942.3 mg of Glucosamine sulphate sodium chloride equivalent to 750 mg Glucosamine sulphate or 589 mg of 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 750 mg is a white to off white, ovalshaped, bi-convex film-coated tablets without breakline.
Pack-sizes:
60, 120, 180 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 MK41 0XZ
<This medicinal product (Dolenio 750 mg) is authorised in the Member States of the EEA under the following names:>
Denmark: Dolenio
France: Dolenio 589 mg, comprime pellicule United Kingdom: Dolenio 750 mg Film-coated tablets This leaflet was last approved in {01/2012}.
Dolenio'
750 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
. 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 750 mg film-coated tablet contains 3.287 mmol (75.610 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 750 mg - 2 tablets to be taken together, once daily.
When other strengths are available, the corresponding dosage is:
Dolenio 1500 mg - 1 tablet
Dolenio 500 mg - 3 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 750 mg tablet contains 942.3 mg of Glucosamine sulphate sodium chloride equivalent to 750 mg Glucosamine sulphate or 589 mg of 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 750 mg is a white to off white, ovalshaped, bi-convex film-coated tablets without breakline.
Pack-sizes:
60, 120, 180 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 750 mg) is authorised in the Member States of the EEA under the following names:>
Denmark: Dolenio
France: Dolenio 589 mg, comprime pellicule United Kingdom: Dolenio 750 mg Film-coated tablets This leaflet was last approved in {01/2012}.
Dolenio'
750 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
. 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 750 mg film-coated tablet contains 3.287 mmol (75.610 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 750 mg - 2 tablets to be taken together, once daily.
When other strengths are available, the corresponding dosage is:
Dolenio 1500 mg - 1 tablet
Dolenio 500 mg - 3 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.