Glucosamine Navamedic

Document: Glucosamine Navamedic tablet ENG PL change

Package leaflet: Information for the user

Glucosamine Navamedic 625 mg tablets

Glucosamine

Note: grey-shading corresponds to the OTC-information

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 further questions, please ask your doctor or your 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 x months.

In this leaflet:

1. What Glucosamine Navamedic is and what it is used for

2. What you need to know before you take Glucosamine Navamedic

3. How to take Glucosamine Navamedic

4. Possible side effects

5 How to store Glucosamine Navamedic

6. Content of the pack and other information

1. What Glucosamine Navamedic is and what it is used for

Glucosamine Navamedic belongs to the group of medicines called anti-inflammatory and anti-rheumatic agents, non-steroids.

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

2. What you need to know before you take Glucosamine Navamedic

Do not take Glucosamine Navamedic if you:

are allergic to glucosamine or to any of the other ingredients of this medicine (listed in section 6).
are allergic (hypersensitive) to shellfish, since glucosamine is manufactured from shellfish.

Warnings and precautions

Talk to your doctor or pharmacist before taking Glucosamine Navamedic if you:

suffer from impaired glucose tolerance. More frequent controls of your blood glucose levels may be necessary when starting treatment with Glucosamine Navamedic.
have a known risk factor for cardiovascular (heart) disease, since an abnormally high level of cholesterol in the blood has been observed in a few patients treated with Glucosamine Navamedic.
suffer from asthma. When starting on Glucosamine Navamedic, you should be aware of potential worsening of symptoms.

Glucosamine Navamedic should not be used in children and adolescents below the age of 18 years.

Other medicines and Glucosamine Navamedic

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

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

warfarin
tetracycline

Increased effect of coumarin anticoagulants (e.g. warfarin) 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.

Please contact your doctor for medical advice.

Glucosamine Navamedic with food, drink and alcohol

You can take the tablets with or without food and they should be swallowed together with some water or other suitable liquid.

Pregnancy, breast-feeding and fertility

Glucosamine Navamedic should not be used during pregnancy.

The use of Glucosamine Navamedic during breastfeeding is not recommended.

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.

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 from the tablets, you should not drive or operate machinery.

3. How to take Glucosamine Navamedic

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

Dosage

The recommended starting dose is 2 tablets (1250 mg of glucosamine) once daily, taken orally.

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 Glucosamine Navamedic should be re-evaluated.

Glucosamine Navamedic should not be used for a longer period than x month without contact with a doctor.

For oral use.

The tablets should be swallowed together with some water or other suitable liquid.

If you take more Glucosamine Navamedic 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 Glucosamine Navamedic

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 Glucosamine Navamedic as scheduled.

If you stop taking Glucosamine Navamedic

Your symptoms may reoccur.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

You should stop taking Glucosamine Navamedic 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

The following side effects have also been reported:

Common (may affect up to 1 in 10 people)

headache, tiredness, feeling sick, abdominal pain, indigestion, diarrhoea, constipation.

Uncommon (may affect up to 1 in 100 people)

rash, itching, flushing.

Not known (frequency cannot be estimated from the available data): hives, swelling/swelling of ankles, legs and feet, dizziness, vomiting (being sick), blood glucose control worsened in patients with diabetes mellitus. Hepatic enzyme elevation and jaundice.

Reportingof side effects

If you getany side effects, talk to your doctor or pharmacist.This includes any possible side effectsnot 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.

5. How to store Glucosamine Navamedic

Keep out of the sight and reach of children.

Do not use Glucosamine Navamedic after the expiry date which is stated on the blister/carton or tablet container after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Bottle:

Keep the bottle tightly closed. Store in the original package in order to protect from moisture.

Blister:

Store in the original package in order to protect from moisture.

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 to protect the environment.

6. Content of the pack and other information

What Glucosamine Navamedic contains

The active substance is glucosamine. Each tablet contains 750 mg glucosamine hydrochloride equivalent to 625 mg of glucosamine.
The other ingredients are microcrystalline cellulose, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose (L-HPC) and magnesium stearate.

What Glucosamine Navamedic looks like and content of the pack

Glucosamine Navamedic is a white to light beige, oval tablet of 10x18.75 mm marked with “G” on one side and a score line on the other side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

PVC/PVDC-aluminium blisters packed in paper cartons.
Pack-sizes of 20, 40, 60 or 180 tablets.

HDPE tablet container with a silica gel desiccant in Tyvek bags.
Pack-sizes of 60 or 180 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturers: Haupt Pharma Wülfing GmbH, Bethelner Landstr. 18, 31028 Gronau, Germany

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

Germany	Doppelherz Glucosaminhydrochlorid 750 mg Tabletten
Sweden	Glucosamine Navamedic

This leaflet was last revised in: 2015-12-14

Detailed information on this medicine is available on the web site of {MS/Agency}: