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NABUMETONE Film-coated tablet (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Nabumetone 500 mg Tablets.

Qualitative and quantitative composition

Nabumetone 500 mg. For a full list of excipients see section 6.1.

Pharmaceutical form

Film-coated tablet. Brown, capsule-shaped biconvex tablet marked NEO on one side NBU500 on the other.

Therapeutic indications

Nabumetone is a non-acidic non-steroidal anti-inflammatory agent which is a relatively weak inhibitor of prostaglandin synthesis. However, following absorption from the gastrointestinal tract it is rapidly ...

Posology and method of administration

For oral administration. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). 500 mg film-coated tablets should ...

Contraindications

Hypersensitivity to nabumetone or to any of the other excipients listed in section 6.1 NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, ...

Special warnings and precautions for use

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below). The use of Nabumetone ...

Interaction with other medicinal products and other forms of interaction

As the major circulating metabolite of Nabumetone 500mg Tablets is highly protein bound, patients receiving concurrent treatment with oral protein-bound anti- coagulants, eg. hydantoin anticonvulsants, ...

Fertility, pregnancy and lactation

Pregnancy There is no clinical trial experience with the use of nabumetone during human pregnancy. No teratogenic effects have been demonstrated in experiments with animals. High doses which were maternally ...

Effects on ability to drive and use machines

Dizziness, confusion, drowsiness, fatigue, visual disturbances or headaches are possible undesirable effects after taking NSAIDs, if affected, patients should not drive or operate machinery.

Undesirable effects

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) ...

Overdose

Symptoms Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting and occasionally ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other anti-inflammatory and anti-rheumatic agents, non steroids ATC code: M01AX01 Nabumetone contains an active substance 4-(6'-methoxy-2naphthyl)-2 butanone. Nabumetone is a ...

Pharmacokinetic properties

Although nabumetone is well absorbed from the GI tract (>80%), concentrations in the plasma are too small to be measured as extensive metabolism occurs during the first pass through the liver to the active ...

Preclinical safety data

No data of relevance which is additional to that already included in other sections of the SPC.

List of excipients

Maize starch Sodium starch glycollate (Type A) Povidone Sodium lauryl sulphate Colloidal silicon dioxide Magnesium stearate Film Coating: Hypromellose Titanium dioxide Talc Red iron oxide Glycerol triacetate ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 25°C. Store in the original package.

Nature and contents of container

Blisters of PVC/PVdC/aluminium. Pack sizes of 8, 56 and 100 tablets.

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT

Marketing authorization number(s)

PL 20417/0054

Date of first authorization / renewal of the authorization

8 January 2004/13 January 2012

Date of revision of the text

21/08/2018

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