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DOLENIO 750 MG FILM-COATED TABLETS

Active substance(s): GLUCOSAMINE SULPHATE SODIUM CHLORIDE

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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

EEA under the following names:>
Denmark: Dolenio
France: Dolenio 589 mg, comprimé pelliculé
United Kingdom: Dolenio 750 mg Film-coated tablets
EEA under the following names:>
Denmark: Dolenio
France: Dolenio 393 mg, comprimé pelliculé
United Kingdom: Dolenio 500 mg Film-coated tablets
This leaflet was last revised in 06/2015.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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