Document: OSAFLEX 1178 mg powder for oral solution, sachet ENG PL change

• OSAFLEX powder for oral solution, sachet PL
• OSAFLEX 1178 mg powder for oral solution, sachet ENG PL

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Package Leaflet: Information for the user

Osaflex 1178 mg powder for oral solution, sachet

Glucosamine

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 only. 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.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

- Keep this leaflet. You may need to read it again.

- Ask your pharmacist if you need more information or advice.

- 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.

You must talk to a doctor if you do not feel better or if you feel worse after 30 days.

What is in this leaflet:

2. What you need to know before you take Osaflex

3. How to take Osaflex

4. Possible side effects

5. How to store Osaflex

6. Contents of the pack and other information

1. What Osaflex is and what it is used for

Osaflex contains glucosamine which belongs to a group of medicines called other anti-inflammatory and anti-rheumatic agents, non steroids.

Osaflex is used for the relief of symptoms in mild to moderate osteoarthritis of the knee.

2. What you need to know beforeyou take Osaflex

Do not take Osaflex:

- if youare allergicto glucosamineor to any of the other ingredients of this medicine (listed in section 6).

- if you are allergicto shellfish, since glucosamine is manufactured from shellfish.

Warnings and precautions

Talk to your doctor or pharmacist before using this medicine if you:

- suffer from diabetes mellitusor have impaired glucose tolerance. More frequent controls of your blood glucose levels may be necessary when starting the treatment with Osaflex.

- suffer from asthma. When starting on Osaflex, you should be aware of potential worsening of symptoms.

You should stop taking Osaflex and see your doctor immediately if you experience symptoms of angioedema, such as: swollen face, tongue and/or pharynx and/or difficulty to swallow or hives together with difficulties to breathe

Other medicines and Osaflex

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines.

Caution should be exercised if Osaflex has to be combined with other medicines, especially:

- warfarin (medicine to thin the blood, anticoagulant).

- tetracycline (antibiotic).

An increased effect of coumarin anticoagulants (e.g. warfarin or similar drugs) 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.

Non-steroidal anti-inflammatory drugs (NSAIDs) can be administered together with glucosamine sulfate.

Osaflex with food and drink

Osaflex should be taken at meals.

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.

Osaflex should not be used during pregnancy.

Osaflex should not be used during breast-feeding.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. If you experience dizziness or drowsiness while taking Osaflex, you should not drive or operate machinery.

Osaflex contains aspartame, sodium and sorbitol.

• Aspartame (E951) is a source of phenylalanine, which may be harmful for people with phenylketonuria.

• Sorbitol (E420): If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

• This medicinal product contains 6.6 mmol (151 mg) sodium, which should be taken into consideration by patients on a controlled sodium diet.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The usual dose is one sachet (1178 mg of glucosamine) once daily, taken orally at meals.

Dissolve the powder from the sachet in a glass of water (250 ml) and drink.

Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may not be experienced until after several weeks of treatment and in some cases even longer. If no relief of symptoms is experienced after 2-3 months, continued treatment with Osaflex should be re-evaluated.

Use in children and adolescents

Use of Osaflex is not recommended in children and adolescents below the age of 18.

If you take more Osaflex than you should

If you have taken large quantities, you must consult your doctor or a hospital. Signs and symptoms of overdose with glucosamine might include headache, dizziness, confusion, joint pain, feeling sick, vomiting (being sick), diarrhoea or constipation. Stop taking glucosamine at signs of overdose.

If you forget to take Osaflex

Do not take a double dose to make up for a forgotten dose. If it is almost time for your next dose, skip the forgotten dose and carry on taking Osaflex as scheduled.

If you stop taking Osaflex

Please tell your doctor, a change in your treatment might be required. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Osaflex and immediately contact a doctor if you experience symptoms of angioedema, such as: swelling of the face, tongue and/or throat and/or difficulties to swallow, hives and difficulties to breath.

Common (may effect up to 1 in 10 people):

• Headache,

• Somnolence, Tiredness

• Nausea, Abdominal pain, Indigestion, Diarrhoea, Constipation, Flatulence

Uncommon (may effect up to people):

Not known (frequency cannot be estimated from the available data):

• Allergic reaction (hypersensitivity)

• Swelling/swelling of ankles, legs and feet

• Diabetes inadequate control

• Dizziness

• Asthma/ Asthma aggrevated

• Vomiting (being sick)

• International normalized ratio (INR) fluctuation and hepatic enzyme elevation

• jaundice

Cases of hypercholesterolaemia have been reported, but a causal link has not been demonstrated.

Reporting ofside effects

If youget any side effects, talk to your doctor or pharmacist. This includesany possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 carton and on the sachets after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw any medicines you no longer use. These measures will help to protect the environment.

What Osaflex contains

• The active substance is glucosamine. Each sachet contains 1884 mg mixture of glucosamine hydrochloride and anhydrous sodium sulphate, corresponding to 1500 mg glucosamine sulphate or 1178 mg glucosamine.

• The other ingredients are aspartame (E951), sorbitol (E420), citric acid anhydrous, macrogol 4000.

What Osaflex looks like and content of the pack

Osaflex is a white, crystalline powder for oral solution.

Each carton contains 30 or 90 sachets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

To be completed nationally

Manufacturer

To be completed nationally

ROTTAPHARM Ltd

Damastown Indusstrial Park

Mulhuddart, Dublin 15

Ireland

or

Sigmar Italia S.p.A.

Via Sombreno 11

24011 Almè

Italy

This medicinal product is authorized in the Member States of the EEA under the following names:

Sweden: OSAFLEX

France: OSAFLEXAN

This leaflet was last revised in 2016 10 26.