Package leaflet: Information for the user
Comfora 595 mg film-coated tablet (tablet)
glucosamine
Read all of this leaflet carefully before you start using 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.
What is in this leaflet:
1.
What Comfora is and what it is used for
2.
What you need to know before you use Comfora
3.
How to use Comfora
4.
Possible side effects
5.
How to store Comfora
6.
Contents of the pack and other information
1.
What Comfora is and what it is used for
Comfora is used for alleviation of symptoms in mild to moderate degeneration of articular cartilage
(arthritis) of the knee.
Glucosamine is a substance that is naturally produced in the body and that is formed from glucose (a sugar
type). The body needs glucosamine to build larger molecules that exist in, for example, synovial fluid and
cartilage.
2.
What you need to know before you use Comfora
Do not use Comfora
if you are allergic to glucosamine or any of the other ingredients of this medicine (listed in section 6).
if you are allergic (hypersensitive) to shellfish, as the active substance glucosamine is extracted from
shellfish.
Warning and precautions
Talk to your doctor or pharmacist before using Comfora:
if you have diabetes, you should consult a doctor before using Comfora, and your blood sugar
levels may have to be checked more frequently during the initial period of the treatment.
if you are aware of having a known risk factor for cardiovascular disease, you should consult a doctor
before using Comfora, and your blood lipids may have to be checked.
if you have asthma, treatment with Comfora might worsen your asthmatic symptoms.
Comfora should not be used in children and adolescents below the age of 18 years.
You should stop taking Comfora and see your doctor immediately if you experience symptoms of
angioedema, such as:
 swollen face, tongue or throat
 difficulty to swallow
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
hives and difficulties to breath
Other medicines and Comfora
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Caution should be exercised if Comfora has to be combined with other medicines, especially medicines
which affect blood clotting (e.g. warfarin and acenocoumarol) and tetracyclines (an antibiotic). Please
contact your doctor for medical advice.
Increased effect of coumarin anticoagulants (e.g. warfarin and acenocoumarol) during concomitant
treatment with glucosamine has been reported. Patients treated with such combinations should therefore be
monitored extra carefully when initiating or ending glucosamine therapy.
Pregnancy and breast-feeding
Do not use Comfora if you are pregnant or if you are breast-feeding.
Driving and using machines
Comfora is not thought to affect the ability to drive a car or use machines, but drowsiness and headache are
common undesirable effects.
You alone are responsible to decide if you are in fit condition to drive a motor vehicle or perform other tasks
that demand increased concentration. Because of their effects or undesirable effects, one of the factors that
can reduce your ability to do these things safely is your use of medicines. Descriptions of these effects can
be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor,
nurse or pharmacist if you are unsure about anything.
Comfora contains potassium and Sunset yellow FCF
Comfora contains 130 mg potassium per tablet. Consult your doctor or pharmacist if you have impaired
renal function or if you are on a prescribed potassium-low diet.
The colorant Sunset yellow FCF (E110) may cause allergic reactions.
3.
How to use Comfora
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.
The usual initial dose is 1 tablet twice daily. Alternatively, the full dosage may be taken as a single dose
during the day. Once symptom relief has been achieved, the dosage may be reduced to 1 tablet daily.
Swallow the tablet with a glass of water.
If you take more Comfora than you should
If you have taken more Comfora than you should, or if children have been taking medicine by accident,
please contact your doctor, the hospital or Giftinformationscentralen (tel. 112) to get an opinion of the risk
and advice on action to be taken.
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.
If you forget to take Comfora
Do not take a double dose to make up for a forgotten dose.
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4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects
that have been reported have been mild and usually transient.
You should stop taking Comfora and see your doctor immediately if you experience symptoms of
angioedema, such as:
 swollen face, tongue or throat
 difficulty to swallow
 hives and difficulties to breath
Common (occur in more than 1 of 100 users): Headache, drowsiness, stomach pains, dyspepsia (discomfort
from the upper gastrointestinal tract, for example heartburn), diarrhoea, constipation, nausea.
Uncommon (occur in less than 1 of 100 users): Skin rash, pruritus (itching), erythema (skin redness).
Unknown frequency (can not be estimated from available data): Swelling of face, tongue or throat
(angioedema, see Warning and precautions), hives, oedema/oedema in ankles, legs and feet, asthma or
asthma deteriorated, dizziness, vomiting, blood glucose control worsened in patients with diabetes mellitus.
Increased liver enzyme values, jaundice.
In very rare cases increased levels of cholesterol in the blood have been reported.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the nationalreporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store Comfora
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the label after “Exp”. The expiry date refers
to the last day of that month.
Do not throw away any medicines via wastewater. 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 Comfora contains
The active substance is glucosamine. One film-coated tablet contains: glucosamine sulphate
potassium chloride corresponding to 595 mg glucosamine.
The excipients in the tablet core are: microcrystalline cellulose, povidone, crospovidone, magnesium
stearate.
The excipients in the film coating are: Opadry yellow, which consists of polyvinyl alcohol, titanium
dioxide (E 171), macrogol, talc, quinoline yellow aluminium lake (E 104), Sunset yellow FCF
aluminium lake (E110), yellow iron oxide (E 172).
What Comfora looks like and contents of the pack
The tablets are yellow and oblong (length 19.6 mm, width 9.1 mm).
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Plastic jar (polyethene) 60, 180 and 400 tablets.
PVC/PVDC/aluminium blister 60, 90 and 180 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Nordic Drugs AB, Box 300 35, 200 61 Limhamn, Sweden
E-mail: info@nordicdrugs.se
Manufacturer
QPharma AB, Box 590, 201 25 Malmö, Sweden
This leaflet was last approved in 25 June 2015
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