Dolenio

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Dolenio, 1178 mg, coated tablets

Glucosamine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Dolenio and what is it used for
• 2. Important information before taking 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 is Dolenio and what is it used for

Dolenio belongs to a group of non-steroidal anti-inflammatory and pain-relieving medicines.
Dolenio, available in tablet form, is used to reduce the symptoms of mild to moderate knee osteoarthritis.

2. Important information before taking Dolenio

When not to 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 substance of the medicine, glucosamine, is produced from shellfish;
• if you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby.

Do not use Dolenio in children under 2 years of age and it is not recommended for use in children and adolescents under 18 years of age.

Warnings and precautions

Before starting to take Dolenio, discuss it with your doctor:

• if you have been diagnosed with glucose intolerance. After starting glucosamine treatment, more frequent blood glucose level checks may be necessary;
• if you have been diagnosed with risk factors for heart and blood vessel diseases (e.g. high blood pressure, diabetes, high cholesterol or if you smoke). It is recommended to check your cholesterol level before starting treatment;
• if you have asthma. Glucosamine treatment may worsen asthma symptoms;
• if you have reduced kidney or liver function.

Children and adolescents

Do not use Dolenio in children under 2 years of age and it is not recommended for use in children and adolescents under 18 years of age.

Dolenio and other medicines

Tell your doctor about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take.
It is especially important to tell your doctor or pharmacist if you are taking any of the following medicines:

• anticoagulant medicines (used to prevent blood clotting), such as warfarin, whose effect may be enhanced when taken with glucosamine.
• tetracyclines (antibacterial medicines used in infections).

Dolenio with food and drink

Swallow the tablets with a small amount of liquid and can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Dolenio during pregnancy.

Breastfeeding

Do not use Dolenio during breastfeeding.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines. If you experience dizziness or drowsiness while taking Dolenio, do not drive or operate machinery.

Important information about some of the ingredients of Dolenio

One tablet contains 6.52 mmol (151 mg) of sodium, which should be taken into account in patients controlling their sodium intake.

3. How to take Dolenio

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Adults

The recommended dose is 1 tablet (1178 mg of glucosamine) per day for adults.

The elderly

No dose adjustment is necessary.

Patients with kidney and/or liver impairment

No dosage recommendations can be provided as no studies have been conducted.
Take the medicine orally. Swallow the tablets with a small amount of water or other liquid and can be taken with or without food.
Glucosamine is not indicated for the treatment of acute pain symptoms. Symptoms may not subside (especially pain) for several weeks of treatment, and in some cases, even longer. If symptoms do not subside after 2-3 months, tell your doctor or pharmacist, as a re-evaluation of further treatment is necessary.

Overdose of Dolenio

If you have taken too many Dolenio tablets, stop taking Dolenio and any other products containing glucosamine, contact your doctor or go to the hospital.
Subjective and objective symptoms of glucosamine overdose may include headache, dizziness, disorientation, joint pain, nausea, vomiting, diarrhea, and constipation.

Missed dose of Dolenio

Do not take a double dose to make up for a forgotten dose.

Stopping Dolenio treatment

Consult your doctor before stopping treatment, as changing treatment may cause a relapse of symptoms.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dolenio can cause side effects, although not everybody gets them.
You should call emergency services or go to the hospital and stop taking Dolenio if you experience symptoms such as: swelling of the face, tongue, and/or throat, and/or difficulty swallowing, or hives associated with difficulty breathing (anaphylactic edema).
The following side effects have been reported:
Common side effects(occurring in 1 to 10 patients): headache, feeling tired, nausea, abdominal pain, indigestion, diarrhea, constipation.
Uncommon side effects(occurring in 1 to 100 patients): rash, itching, and sudden redness of the skin.
Frequency not known(frequency cannot be estimated from the available data): vomiting, hives, swelling of the feet or ankles, anaphylactic edema. Exacerbation of pre-existing asthma, worsening of blood sugar control in diabetic patients. Increased cholesterol levels have also been reported.
Dolenio may cause increased liver enzyme activity and rarely jaundice.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your or or .
Side effects can be reported directly to the "national reporting system" listed in Annex V*. By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

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 packaging after "EXP". The expiry date refers to the last day of that month.
There are no special storage requirements.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dolenio contains

• The active substance is glucosamine. One coated tablet contains 1884.60 mg of glucosamine sulfate sodium chloride, equivalent to 1500 mg of glucosamine sulfate or 1178 mg of glucosamine.
• The other ingredients are: CorePovidone K30 Macrogol 4000 Magnesium stearate CoatingHypromellose Titanium dioxide (E 171) Talc Propylene glycol Polysorbate 80

What Dolenio looks like and contents of the pack

Dolenio are white or almost white, oval, biconvex, film-coated tablets with a score line on one side. The score line is to facilitate breaking the tablet to make it easier to swallow, and not to divide it into two equal doses.
Pack sizes: 30 or 90 film-coated tablets in an HDPE bottle with an HDPE cap or 4, 20, 30, 60, and 90 film-coated tablets in Al/PVC/PVDC blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Blue Bio Pharmaceuticals Limited, 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
United Kingdom
Wasdell Packaging Limited
Unit 6-8, Euroway Industrial Estate,
Blagrove, Swindon, Wiltshire,
SN5 8YW,
United Kingdom

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:

Austria: Tavimin 1500 mg Filmtabletten
Belgium: Dolenio 1178 mg Filmomhulde tabletten
Bulgaria: Bonartos 1178 мг филмирани таблетки
Czech Republic: Bayflex 1178 mg
Cyprus: Dolenio
Germany: Dolenio 1178 Filmtabletten
Denmark: Dolenio
Estonia: Dolenio
France: Dolenio 1178 mg, comprimé pelliculé
Greece: Dolenio
Hungary: Dolenio 1500 mg filmtabletta
Iceland: Dolenio
Ireland: Dolenio 1178 mg Film-coated tablets
Lithuania: Dolenio 1178 mg plėvele dengtos tabletės
Luxembourg: Dolenio 1178 mg, comprimé pelliculé
Latvia: Dolenio 1178 mg apvalkotās tablets
Malta: Dolenio
Netherlands: Dolenio 1178 mg Filmomhulde tablet
Norway: Dolenio
Poland: Dolenio
Portugal: Dolenio
Romania: Slideflex
Sweden: Dolenio 1178 mg filmdragerade tabletter
Slovenia: Dolenio 1178 mg
Slovakia: Dolenio 1178 mg filmsko obložene tablete
United Kingdom: Dolenio 1500 Film coated tablets
Date of last revision of the leaflet:11/2016