PENTASA Suppository (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Pentasa 1g Suppositories.

Qualitative and quantitative composition

Each suppository contains mesalazine 1g. For the full list of excipients, see section 6.1.

Pharmaceutical form

Suppository. White to tan, spotted, oblong suppository.

Therapeutic indications

For the treatment of ulcerative proctitis.

Posology and method of administration

Adults Active treatment: 1 g mesalazine twice daily for two to four weeks. Maintenance treatment: 1-2 g mesalazine daily. Paediatric population There is little experience with only limited ...

Contraindications

Hypersensitivity to mesalazine, any of the excipients listed in section 6.1, or salicylates. Severe liver and/or renal impairment.

Special warnings and precautions for use

Most patients who are intolerant or hypersensitive to sulphasalazine are able to take Pentasa without risk of similar reactions. However, caution is recommended when treating patients allergic to sulphasalazine ...

Interaction with other medicinal products and other forms of interaction

Combination therapy with Pentasa and azathioprine, or 6-mercaptopurine or thioguanine have in several studies shown a higher frequency of myelosuppressive effects, and an interaction seems to exist, however, ...

Fertility, pregnancy and lactation

Pentasa should be used with caution during pregnancy and lactation and only if the potential benefit outweighs the possible hazards in the opinion of the physician. The underlying condition itself (Inflammatory ...

Effects on ability to drive and use machines

Treatment with Pentasa is unlikely to affect the ability to drive and/or use machines.

Undesirable effects

The most frequent adverse reactions seen in clinical trials are diarrhoea, nausea, abdominal pain, headache, vomiting and rash. Hypersensitivity reactions and drug fever may occasionally occur. Following ...

Overdose

Acute experience in animals Single oral doses of mesalazine of up to 5 g/kg in pigs or a single intravenous dose of mesalazine at 920 mg/kg in rats were not lethal. Human experience There is limited clinical ...

Pharmacodynamic properties

Pharmacotherapeutic group: Intestinal anti-inflammatory agents ATC Code: A07EC02 Mechanism of action and pharmacodynamic effects It has been established that mesalazine is the active component ...

Pharmacokinetic properties

General characteristics of the active substance Disposition and local availability The therapeutic activity of mesalazine most likely depends on a local contact of the drug with the diseased area of the ...

Preclinical safety data

Toxic renal effects have been demonstrated in all species tested. Rat and monkey dosages and plasma concentrations at the No Observed Adverse Effect Levels (NOAELs) exceed those used in humans by a factor ...

List of excipients

Povidone Macrogol 6000 Magnesium stearate Talc

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from light.

Nature and contents of container

Each suppository is individually packed in double aluminium foil and presented in cartons of 28 suppositories.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Ferring Ireland Ltd, United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland

Marketing authorization number(s)

PA1009/006/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 21 December 1992 Date of last renewal: 21 December 2007

Date of revision of the text

April 2021

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