PEROFEN Coated / Film-coated tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Perofen 400 mg coated tablets. Perofen 400 mg film-coated tablets.

2. Qualitative and quantitative composition

Perofen 400 mg coated tablets: Each tablet contains 400 mg ibuprofen. Perofen 400 mg film-coated tablets: Each tablet contains 400 mg ibuprofen. Excipient(s) with known effect: Perofen 400 mg coated ...

3. Pharmaceutical form

Perofen 400 mg coated tablets: Coated tablet. Perofen 400 mg film-coated tablets: Film-coated tablet. Perofen 400 mg coated tablets: Pink, round, sugar-coated tablets. Perofen 400 mg film-coated tablets: ...

4.1. Therapeutic indications

Adults, elderly and children over 12 years Perofen 400 mg coated tablets and Perofen 400 mg film-coated tablets are indicated for symptomatic relief of non-serious arthritic conditions, back pain, rheumatic ...

4.2. Posology and method of administration

For oral administration and short-term use only. Adults, the elderly and children and adolescents between 12 and 18 years Undesirable effects may be minimised by using the lowest effective dose for the ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioderma or urticaria) ...

4.4. 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 GI and cardiovascular risks below). Masking of symptoms of underlying ...

4.5. Interaction with other medicinal products and other forms of interaction

Ibuprofen (like other NSAIDs) should be avoided in combination with: Aspirin (acetylsalicylic acid): Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended ...

4.6. Fertility, pregnancy and lactation

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

4.7. Effects on ability to drive and use machines

None expected at recommended dose and duration of therapy.

4.8. Undesirable effects

Adverse events which have been associated with Ibuprofen are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon ...

4.9. Overdose

In children ingestion of more than 400 mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours. Symptoms Most patients who have ingested ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: antiinflammatory and antirheumatic products, antiinflammatory and antirheumatic products, non-steroids ATC code: M01AE01 Ibuprofen is a propionic acid derivative ...

5.2. Pharmacokinetic properties

Ibuprofen is well absorbed from the gastrointestinal tract. Ibuprofen is extensively bound to plasma proteins. Perofen 400 mg coated tables and Perofen 400 mg film-coated tablets consist of ibuprofen 400 ...

5.3. Preclinical safety data

No relevant information, additional to that contained elsewhere in the SPC.

6.1. List of excipients

Core: Perofen 400 mg coated tablets and Perofen 400 mg film-coated tablets: Cellulose, microcrystalline Sodium starch glycolate (type A) Starch, pregelatinised Silica, colloidal anhydrous Talc ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25ºC. Protect from light and moisture.

6.5. Nature and contents of container

Perofen 400 mg coated tablets: PVC/Aluminium blisters. Pack-sizes of 20, 100 and 1000 tablets. PP containers with PE closure. Pack-size of 1000 tablets. Perofen 400 mg film-coated tablets: ...

6.6. Special precautions for disposal and other handling

Not applicable.

7. Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

8. Marketing authorization number(s)

Perofen 400 mg coated tablets: 8595 Perofen 400 mg film-coated tablets: 8597

9. Date of first authorization / renewal of the authorization

Perofen 400 mg coated tablets: Date of first authorization: 11 January 1983 Date of latest renewal: 02 November 2009 Perofen 400 mg film-coated tablets: Date of first authorization: 11 January ...

10. Date of revision of the text

04/06/2021

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