Document: Comfora film-coated tablet ENG PL change

• Comfora film-coated tablet PL
• Comfora film-coated tablet OTC PL
• Comfora film-coated tablet ENG PL
• Comfora film-coated tablet OTC ENG PL

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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

6. Contents of the pack and other information

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.

Do not use Comfora

- if you are allergic to glucosamineor 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

• 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.

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.

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.

What Comfora looks like and contents of the pack

The tablets are yellow and oblong (length 19.6 mm, width 9.1 mm).

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