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SPC, UK: Seractil 400mg Film-Coated Tablets (2004)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Genus Pharmaceuticals
Διεύθυνση :
Park View House, 65 London Road, Newbury, Berkshire, RG14 1JN
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Περιεχόμενα

Name of the medicinal product

Seractil! 400 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 400 mg of dexibuprofen. For excipients, see 6.1.

Pharmaceutical form

Film-coated tablet. White, oblong, both-sided scored film-coated tablet.

Therapeutic indications

Symptomatic treatment for the relief of pain and inflammation associated with osteoarthritis. Acute symptomatic treatment of pain during menstrual bleeding (primary dysmenorrhoea). Symptomatic treatment ...

Posology and method of administration

The dosage should be adjusted to the severity of the disorder and the complaints of the patient. During chronic administration, the dosage should be adjusted to the lowest maintenance dose that provides ...

Contraindications

Dexibuprofen must not be administered in the following cases: Patients previously sensitive to dexibuprofen, to any other NSAID, or to any of the excipients of the product. Patients in whom substances ...

Special warnings and precautions for use

Care is recommended in conditions that predispose patients to the gastrointestinal adverse effects of NSAIDs such as dexibuprofen, including existing gastrointestinal disorders, previous gastric or duodenal ...

Interaction with other medicinal products and other forms of interaction

The information in this section is based upon previous experience with racemic ibuprofen and other NSAIDs. In general, NSAIDs should be used with caution with other drugs that can increase the risk of ...

Pregnancy and lactation

Pregnancy For dexibuprofen, no clinical data on exposed pregnancies are available. Animal studies with ibuprofen and other NSAIDs have shown reproductive toxicity (see 5.3 Preclinical Safety Data). Inhibition ...

Effects on ability to drive and use machines

During treatment with dexibuprofen the patients reaction capacity may be reduced when dizziness or fatigue appear as side effects. This should be taken into consideration when increased alertness is required, ...

Undesirable effects

Clinical experience has shown that the risk of undesirable effects induced by dexibuprofen is comparable to that of racemic ibuprofen. The most common adverse events are gastrointestinal in nature. It ...

Overdose

Dexibuprofen has a low acute toxicity and patients have survived after single doses as high as 54 g of racemic ibuprofen. Most overdoses have been asymptomatic. There is a risk of symptoms at doses >80-100 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids, propionic acid derivatives ATC code: M01AE14 Dexibuprofen (= S(+)-ibuprofen) is considered to be the pharmacologically ...

Pharmacokinetic properties

Dexibuprofen is absorbed primarily from the small intestine. After metabolic transformation in the liver (hydroxylation, carboxylation), the pharmacologically inactive metabolites are completely excreted, ...

Preclinical safety data

Bridging studies on single and repeated dose toxicity, reproduction toxicity and mutagenicity have shown that the toxicological profile of dexibuprofen is comparable to that of racemic ibuprofen. Racemic ...

List of excipients

Tablet core: Hypromellose Microcrystalline cellulose Carmellose calcium Colloidal anhydrous silica Talc Film-coating material: Hypromellose Titanium dioxide (E171) Glycerol triacetate Talc Macrogol 6000 ...

Incompatibilities

Not applicable.

Shelf life

3 years (PVC/PVDC/aluminium blisters). 18 months (PE jars).

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

10, 20, 30, 50, 60, 90, 100, 100x1 and 500x1 film-coated tablets in PVC/PVDC/aluminium blisters. 150 film-coated tablets in PE jars with dosing hole and hinged closure. Not all pack sizes may be marketed. ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Gebro Pharma GmbH, A-6391, Fieberbrunn, Austria

Marketing authorization number(s)

PL 04536/0007

Date of first authorization / renewal of the authorization

31 October 2000

Date of revision of the text

April 2004

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