Dolenio 750 Mg Film-Coated Tablets
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOLENIO 500 mg AND 750 mg FILM-COATED TABLETS GLUCOSAMINE SULPHATE
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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 signs of illness are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Dolenio is and what it is used for
2. What you need to know before you take Dolenio
3. How to take Dolenio
4. Possible side effects
5. How to store Dolenio
6. Contents of the pack and other information
1. WHAT DOLENIO IS AND WHAT IT IS USED FOR
Dolenio belongs to the group of other anti-inflammatory and anti-rheumatic agents, nonsteroids.
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 in adults.
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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOLENIO
Do not take Dolenio
- 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 ingredient, glucosamine, is extracted from shellfish.
Dolenio must not be used in children and adolescents under 18 years of age.
Warnings and precautions
Glucosamine is not indicated for the treatment of acute pain.
Talk to your doctor or pharmacist before taking Dolenio. Particularly, tell your doctor:
• if you suffer of diabetes mellitus or have impaired glucose tolerance. It is recommended to control 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 control your cholesterol before the start of treatment, since hypercholesterolemia has been observed in a few cases in patients treated with glucosamine.
• if you suffer from asthma. Treatment with glucosamine can worsen your asthma symptoms.
• if you have reduced kidney or liver function, since no studies with glucosamine have been performed in this patient group.
Children and adolescents
Dolenio should not be used in children and adolescents under 18 years of age.
Other medicines and Dolenio
Please 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 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.
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.
Pregnancy
Dolenio should not be used during pregnancy.
Breast-feeding
The use of Dolenio during breast-feeding is not recommended.
Driving and using machines
If you experience dizziness or drowsiness after you start taking Dolenio, you should not drive or operate machinery.
Dolenio contains sodium
Each Dolenio 750 mg film-coated tablet contains 3.287 mmol (75.610 mg) of sodium Each Dolenio 500 mg film-coated tablet contains 2.240 mmol (51.538 mg) of sodium Please take into consideration if you are on a controlled sodium diet.
3. HOW TO TAKE DOLENIO
Always take this medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
Dolenio 750 mg:
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;
Dolenio 500 mg:
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;
Older people
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.
For oral use. The tablets should be swallowed together with some water or other liquid with or without meal.
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.
If you take more Dolenio than you should
If you have taken too many Dolenio tablets, stop taking glucosamine and consult your doctor or go to a hospital.
Signs and symptoms of overdose with glucosamine might include headache, dizziness, confusion, joint pain, nausea, vomiting, diarrhoea or constipation.
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 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 Dolenio and see your doctor immediately or go to a hospital 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 (may affect up to 1 in 10 people): Headache, tiredness, nausea, abdominal pain, indigestion, diarrhoea, constipation.
Uncommon side effects (may affect up to 1 in 100 people): 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.
Reporting of side effects
If you get any side effects, talk to your doctor or, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard. By reporting side effect you can help provide more information on the safety of this medicine.
5. HOW TO STORE DOLENIO
Keep this medicine out of the sight and reacht of children.
Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date (EXP) refers to the last day of that month.
This medicine 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 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,
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 750 mg is a white to off white, ovalshaped, bi-convex film-coated tablets without breakline.
Dolenio 500 mg is a white to off white, ovalshaped, bi-convex film-coated tablets without breakline.
Pack-sizes:
Dolenio 750 mg: 60, 120, 180 film coated tablets in Alu/PVC/PVDC Blister packs Dolenio 500 mg 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
DOLENIO 750 mg:
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
Central-Pharma Limited Caxton Road Bedford MK41 0XZ
Marketing authorisation holder
DOLENIO 500 mg:
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
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 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