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DOLENIO 750 MG FILM-COATED TABLETS

Active substance(s): GLUCOSAMINE SULPHATE SODIUM CHLORIDE

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5. How to store Dolenio
Keep this medicine out of the sight and reach 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,
– 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:
Dolenio 750 mg: 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
Nordia Pharmaceutical Company Aps
Damvejen 13,
Hillerod, 3400
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, comprimé pelliculé
United Kingdom: Dolenio 750 mg Film-coated tablets
This leaflet was last revised in 08/‌2015

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Dolenio

®

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 ,pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.
What is 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, 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
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

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

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.

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;

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.

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