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SPC, UK: IBUPROFEN 400mg Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Ibuprofen 400 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 400 mg ibuprofen. Excipient with known effect: each tablet contains 47 mg lactose. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. Ibuprofen 400 mg film-coated tablets: pink coloured, round, approximately 13 mm in diameter, biconvex film coated tablets debossed with DK on one side and plain on other side.

Therapeutic indications

In adults and children over 12 years (>40 kg): Short term treatment of fever and pain of mild to moderate intensity, including dysmenorrhea. Long term symptomatic treatment of pain and inflammation in ...

Posology and method of administration

Posology The treatment should start with the lowest dose anticipated to be effective, which can subsequently be adjusted, depending on the therapeutic response and any undesirable effects. In long-term ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active gastric or duodenal ulcer or a history of recurrent gastrointestinal ulcer/bleeding (two or more clear ...

Special warnings and precautions for use

General precautions Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and gastrointestinal and cardiovascular ...

Interaction with other medicinal products and other forms of interaction

The following combinations with Ibuprofen should be avoided The dicumarol group: NSAIDs may increase the effect of anticoagulants such as warfarin Experimental studies show that ibuprofen reinforces the ...

Fertility, pregnancy and lactation

Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac ...

Effects on ability to drive and use machines

Following treatment with ibuprofen, the reaction time of certain patients may be affected. This should be taken into account where increased vigilance is required. Undesirable effects such as dizziness, ...

Undesirable effects

The undesirable effects are mainly associated with the pharmacological effect of ibuprofen on prostaglandin synthesis. The most common effects are dyspepsia and diarrhoea, which are estimated to occur ...

Overdose

Toxicity Risk of symptoms at doses >80–100 mg/kg. At doses >200 mg/kg there is a risk of severe symptoms, though with considerable variations between individuals. A dose of 560 mg/kg in a child aged 15 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, nonsteroids; propionic acid derivatives ATC code: M01AE01 Mechanism of action Ibuprofen belongs to the group of non-steroidal anti-inflammatory ...

Pharmacokinetic properties

Absorption Ibuprofen is rapidly absorbed from the gastrointestinal tract with a bioavailability of 80-90%. Peak serum concentrations occur one to two hours after administration. If administered with food, ...

Preclinical safety data

There are no preclinical data of relevance for the safety assessment, apart from what has already been taken into account in this summary of product characteristics.

List of excipients

Tablet Core: Lactose monohydrate Maize starch Croscarmellose sodium Colloidal anhydrous Silica Microcrystalline cellulose Magnesium stearate Tablet Coating: Hypromellose Triacetin Titanium dioxide (E171) ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 5 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

PVC Aluminium blisters or PVC/PVdC – Aluminium Blisters Pack sizes: 10, 12, 14, 20, 21, 24, 28, 30, 40, 42, 48, 50, 60, 84, 100 or 500 film-coated tablets in carton. Not all pack sizes may be marketed. ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Marketing authorization number(s)

PL 20075/0436

Date of first authorization / renewal of the authorization

05/08/2016

Date of revision of the text

16/03/2018

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