Dolenio 1500 Mg Film Coated Tablets
Out of date information, search anotherwaste. Askyour pharmacist how to dispose of medicines no longer
required. These measureswill help to protecttheenvironment.
6. FURTHER INFORMATION WhatDolenio contains
. The active substance is glucosamine. One tablet contains
1884.60 mg of Glucosamine sulphate sodium chloride equivalent to 1500 mg Glucosamine sulphate or 1178 mg glucosamine
The other ingredients are
Core tablet
Povidone K30 Macrogol 4000 Magnesium Stearate
Coatingmaterial
Hypromellose Titanium Dioxide (E171)
Talc
Propylene glycol Polysorbate 80
What Dolenio looks like and contents ofthe pack
Dolenio is a white to off white, oval shaped, bi-convex film-coated tablet with break line on one side.
The score line is only to facilitate breaking for ease of swallowing and notto divide into equal doses.
Pack-sizes: 20,30,60 or 90 film-coated tablets in a HDPE bottles with HDPEscrew cap.
4, 10, 20, 30, 45, 60, 90 film coated tablets in Alu/PVC/PVDC blister packs.
Not all pack sizes may be marketed.
MarketingAuthorisation Holder
Blue Bio Pharmaceuticals Ltd.,
5th Floor, Beaux Lane House,
Mercer Street Lower,
Dublin 2, Ireland
Manufacturer
Wasdell Packaging Limited,
Units 6-8,
Euroway Industrial Estate,
Blagrove, Swindon, Wiltshire,
Sn5 8YW, United Kingdom.
This leafletwas lastapproved in {11/2012}.
Dolenio'
Glucosamine Sulphate 1500mg
Film Coated Tablets
Read all of this leaflet carefully before you start taking this medicine.
. Keep this leaflet. You may need to read it again.
. Ifyouhaveanyfurther questions, askyour 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.
Inthisleaflet:
1. What Dolenio is and what it is used for
2. Beforeyou take Dolenio
3. Howto take Dolenio
4. Possible side effects
5. Howto store Dolenio
6. Further information
1. WHAT DOLENIO ISANDWHAT IT IS USED FOR
Dolenio belongs to the group of other antiinflammatory and antirheumaticagents, non-steroids.
Glucosamine is a substance naturally occurring in the human body and necessaryforjointfluid and cartilage.
Dolenio tablet is a medical product used for the relief of symptoms in mild to moderate osteoarthritis ofthe knee.
Osteoarthritis is a type of joint degeneration which symptoms are: stiffness (after sleep or long rest), pain at motion (e.g. when climbing the stairs or walking along uneven surfaces), which relieves at a rest.
2. BEFOREYOUTAKEDOLENIO DonottakeDolenio
. 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
Consultyour doctor beforetakingDolenio.
. If you suffer of diabetes mellitus or have impaired glucose tolerance. It is recommended to make control your glycaemia before start of treatment and with regular intervals during the treatment.
. If you suffer from asthma. The treatment by glucosamine can worsenofasthma symptoms.
. If you have reduced kidney or liver function, since no studies with glucosamine have been performed in this patient group.
Taking othermedicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained withoutaprescription.
It is particularlyimportant to tell yourdoctor or pharmacist if you are takingany of the following medicines:
. Tetracyclines (antibacterials usedagainstinfection)
. Warfarin or similar type of products (anticoagulants used to prevent blood-clotting). The effect of the anticoagulant may be intensified in association with glucosamine. Patients treated with such combinations should therefore be monitored extra carefullywheninitiatingorendingglucosamine therapy
Taking Doleniowith food and drink
The tablets should be swallowed with some liquid, and can be taken withorwithoutfood.
Pregnancy and breast-feeding Pregnancy
Askyour doctor or pharmacistfor information, before you take any kind of medicine.
Dolenio should not be used during pregnancy.
Breast-feeding
Askyour doctor or pharmacistfor 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
One tablet contains 6.52 mmol (151 mg) of sodium. Please take into consideration if you are on a controlled sodium diet.
3. HOWTOTAKEDOLENIO
Always take Dolenio exactly as your doctor has told you. You should check with your doctor or pharmacist ifyouarenotsure.
Adults
The recommended dose is 1178 mg of Glucosamine to be taken once daily with a glass ofwater.
This corresponds to:
Dolenio 1500 mg-1 tablet
When other strengths are available, the corresponding dosage is: Dolenio 589 mg - 2 tablets to be taken together,once daily.
Dolenio 393 mg - 3 tablets to be taken together,once daily.
Elderly
No dosage adjustment is required.
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 orwithout 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 signs of overdose.
IfyouforgettotakeDolenio
You should not take a double dose to make up for aforgotten dose. If you stoptaking 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. POSSIBLESIDEEFFECTS
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 pharynx and/or difficulty to swallow or hives together with difficulties to breathe (angioedema).
Thefollowing 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 1to 10 users in 1,000): Rash, itching andflushing.
Frequency not known (can not be estimated from 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 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. HOWTOSTOREDOLENIO
Keep out of the reach and sightof 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 .
6. FURTHER INFORMATION WhatDolenio contains
. The active substance is glucosamine. One tablet contains
1884.60 mg of Glucosamine sulphate sodium chloride equivalent to 1500 mg Glucosamine sulphate or 1178 mg glucosamine
The other ingredients are
Core tablet
Povidone K30 Macrogol 4000 Magnesium Stearate
Coatingmaterial
Hypromellose Titanium Dioxide (E171)
Talc
Propylene glycol Polysorbate 80
What Dolenio looks like and contents ofthe pack
Dolenio is a white to off white, oval shaped, bi-convex film-coated tablet with break line on one side.
The score line is only to facilitate breaking for ease of swallowing and notto divide into equal doses.
Pack-sizes: 20,30,60 or 90 film-coated tablets in a HDPE bottles with HDPEscrew cap.
4, 10, 20, 30, 45, 60, 90 film coated tablets in Alu/PVC/PVDC blister packs.
Not all pack sizes may be marketed.
MarketingAuthorisation 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 leafletwas lastapproved in {11/2012}.
Dolenio'
Glucosamine Sulphate 1500mg
Film Coated Tablets
Read all of this leaflet carefully before you start taking this medicine.
. Keep this leaflet. You may need to read it again.
. Ifyouhaveanyfurther questions, askyour 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.
Inthisleaflet:
1. What Dolenio is and what it is used for
2. Beforeyou take Dolenio
3. Howto take Dolenio
4. Possible side effects
5. Howto store Dolenio
6. Further information
1. WHAT DOLENIO ISANDWHAT IT IS USED FOR
Dolenio belongs to the group of other antiinflammatory and antirheumaticagents, non-steroids.
Glucosamine is a substance naturally occurring in the human body and necessaryforjointfluid and cartilage.
Dolenio tablet is a medical product used for the relief of symptoms in mild to moderate osteoarthritis ofthe knee.
Osteoarthritis is a type of joint degeneration which symptoms are: stiffness (after sleep or long rest), pain at motion (e.g. when climbing the stairs or walking along uneven surfaces), which relieves at a rest.
2. BEFOREYOUTAKEDOLENIO DonottakeDolenio
. 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
Consultyour doctor beforetakingDolenio.
. If you suffer of diabetes mellitus or have impaired glucose tolerance. It is recommended to make control your glycaemia before start of treatment and with regular intervals during the treatment.
L
. If you suffer from asthma. The treatment by glucosamine can worsenofasthma symptoms.
. If you have reduced kidney or liver function, since no studies with glucosamine have been performed inthis patient group.
Taking othermedicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained withoutaprescription.
It is particularlyimportant to tell yourdoctor or pharmacist if you are takingany of the following medicines:
. Tetracyclines (antibacterials usedagainstinfection)
. Warfarin or similar type of products (anticoagulants used to prevent blood-clotting). The effect of the anticoagulant may be intensified in association with glucosamine. Patients treated with such combinations should therefore be monitored extra carefullywheninitiatingorendingglucosamine therapy
Taking Doleniowith food and drink
The tablets should be swallowed with some liquid, and can be taken withorwithoutfood.
Pregnancy and breast-feeding Pregnancy
Askyour doctor or pharmacistfor information, before you take any kind of medicine.
Dolenio should not be used during pregnancy.
Breast-feeding
Askyour doctor or pharmacistfor 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
One tablet contains 6.52 mmol (151 mg) of sodium. Please take into consideration if you are on a controlled sodium diet.
3. HOWTOTAKEDOLENIO
Always take Dolenio exactly as your doctor has told you. You should check with your doctor or pharmacist ifyouarenotsure.
Adults
The recommended dose is 1178 mg of Glucosamine to be taken once daily with a glass ofwater.
This corresponds to:
Dolenio 1500 mg-1 tablet
When other strengths are available, the corresponding dosage is: Dolenio 589 mg - 2 tablets to be taken together,once daily.
Dolenio 393 mg - 3 tablets to be taken together,once daily.
Elderly
No dosage adjustment is required.
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 orwithout 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 signs of overdose.
IfyouforgettotakeDolenio
You should not take a double dose to make up for aforgotten dose. If you stoptaking 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. POSSIBLESIDEEFFECTS
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 pharynx and/or difficulty to swallow or hives together with difficulties to breathe (angioedema).
Thefollowing 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 1to 10 users in 1,000): Rash, itching andflushing.
Frequency not known (can not be estimated from 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 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. HOWTOSTOREDOLENIO
Keep out of the reach and sightof 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 .
6. FURTHER INFORMATION WhatDolenio contains
. The active substance is glucosamine. One tablet contains
1884.60 mg of Glucosamine sulphate sodium chloride equivalent to 1500 mg Glucosamine sulphate or 1178 mg glucosamine
The other ingredients are
Core tablet
Povidone K30 Macrogol 4000 Magnesium Stearate
Coatingmaterial
Hypromellose Titanium Dioxide (E171)
Talc
Propylene glycol Polysorbate 80
What Dolenio looks like and contents ofthe pack
Dolenio is a white to off white, oval shaped, bi-convex film-coated tablet with break line on one side.
The score line is only to facilitate breaking for ease of swallowing and notto divide into equal doses.
Pack-sizes: 20,30,60 or 90 film-coated tablets in a HDPE bottles with HDPEscrew cap.
4, 10, 20, 30, 45, 60, 90 film coated tablets in Alu/PVC/PVDC blister packs.
Not all pack sizes may be marketed.
MarketingAuthorisation Holder
Blue Bio Pharmaceuticals Ltd.,
5th Floor, Beaux Lane House,
Mercer Street Lower,
Dublin 2, Ireland
Manufacturer
Jemo-PharmA/S,
Hasselvej1,
DK-4780 Stege,
Denmark
This leafletwas lastapproved in {11/2012}.
Dolenio'
Glucosamine Sulphate 1500mg
Film Coated Tablets
Read all of this leaflet carefully before you start taking this medicine.
. Keep this leaflet. You may need to read it again.
. Ifyouhaveanyfurther questions, askyour 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.
Inthisleaflet:
1. What Dolenio is and what it is used for
2. Beforeyou take Dolenio
3. Howto take Dolenio
4. Possible side effects
5. Howto store Dolenio
6. Further information
1. WHAT DOLENIO ISANDWHAT IT IS USED FOR
Dolenio belongs to the group of other antiinflammatory and antirheumaticagents, non-steroids.
Glucosamine is a substance naturally occurring in the human body and necessaryforjointfluid and cartilage.
Dolenio tablet is a medical product used for the relief of symptoms in mild to moderate osteoarthritis ofthe knee.
Osteoarthritis is a type of joint degeneration which symptoms are: stiffness (after sleep or long rest), pain at motion (e.g. when climbing the stairs or walking along uneven surfaces), which relieves at a rest.
2. BEFOREYOUTAKEDOLENIO DonottakeDolenio
. 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
Consultyour doctor beforetakingDolenio.
. If you suffer of diabetes mellitus or have impaired glucose tolerance. It is recommended to make control your glycaemia before start of treatment and with regular intervals during the treatment.
L
. If you suffer from asthma. The treatment by glucosamine can worsenofasthma symptoms.
. If you have reduced kidney or liver function, since no studies with glucosamine have been performed inthis patient group.
Taking othermedicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained withoutaprescription.
It is particularlyimportant to tell yourdoctor or pharmacist if you are takingany of the following medicines:
. Tetracyclines (antibacterials usedagainstinfection)
. Warfarin or similar type of products (anticoagulants used to prevent blood-clotting). The effect of the anticoagulant may be intensified in association with glucosamine. Patients treated with such combinations should therefore be monitored extra carefullywheninitiatingorendingglucosamine therapy
Taking Doleniowith food and drink
The tablets should be swallowed with some liquid, and can be taken withorwithoutfood.
Pregnancy and breast-feeding Pregnancy
Askyour doctor or pharmacistfor information, before you take any kind of medicine.
Dolenio should not be used during pregnancy.
Breast-feeding
Askyour doctor or pharmacistfor 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
One tablet contains 6.52 mmol (151 mg) of sodium. Please take into consideration if you are on a controlled sodium diet.
3. HOWTOTAKEDOLENIO
Always take Dolenio exactly as your doctor has told you. You should check with your doctor or pharmacist ifyouarenotsure.
Adults
The recommended dose is 1178 mg of Glucosamine to be taken once daily with a glass ofwater.
This corresponds to:
Dolenio 1500 mg-1 tablet
When other strengths are available, the corresponding dosage is: Dolenio 589 mg - 2 tablets to be taken together,once daily.
Dolenio 393 mg - 3 tablets to be taken together,once daily.
Elderly
No dosage adjustment is required.
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 orwithout 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 signs of overdose.
IfyouforgettotakeDolenio
You should not take a double dose to make up for aforgotten dose. If you stoptaking 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. POSSIBLESIDEEFFECTS
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 pharynx and/or difficulty to swallow or hives together with difficulties to breathe (angioedema).
Thefollowing 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 1to 10 users in 1,000): Rash, itching andflushing.
Frequency not known (can not be estimated from 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 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. HOWTOSTOREDOLENIO
Keep out of the reach and sightof 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 .
Patientswithimpairedrenaland/orliver function
No dose recommendations can be given, since no studies have
been performed.
Medicines should not be disposed of via wastewater or household