DICLOFLEX Prolonged-release tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
Dicloflex 75 mg SR.
2. Qualitative and quantitative composition
Diclofenac sodium 75 mg. <u>Excipients(s) with known effect:</u> Each tablet contains approximately 86 mg Sucrose. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet. Pink, round, biconvex tablet, marked DICL 75 on one side.
4.1. Therapeutic indications
Adults and elderly Relief of all grades of pain and inflammation in a wide range of conditions, including: arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, ...
4.2. Posology and method of administration
Posology Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). <u>Adults:</u> One tablet once or twice daily. ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active, gastric or intestinal ulcer, bleeding or perforation. History of gastrointestinal bleeding or perforation, ...
4.4. Special warnings and precautions for use
General 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 concomitant ...
4.5. Interaction with other medicinal products and other forms of interaction
The following interactions include those observed with diclofenac gastro-resistant tablets and/or other pharmaceutical forms of diclofenac. Lithium If used concomitantly, diclofenac may raise plasma concentrations ...
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
Patients who experience visual disturbances, dizziness, vertigo, somnolence central nervous system disturbances, drowsiness or fatigue while taking NSAIDs should refrain from driving or operate machinery. ...
4.8. Undesirable effects
Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common: (>1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare ...
4.9. Overdose
Symptoms There is no typical clinical picture resulting from diclofenac over dosage. Over dosage can cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal haemorrhage, diarrhoea, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Acetic acid derivatives and related substances <b>ATC code:</b> M01AB05 Mechanism of action Diclofenac sodium is a non-steroidal agent with marked analgesic/anti-inflammatory ...
5.2. Pharmacokinetic properties
After ingestion of the diclofenac slow release tablet, the active principle is slowly released into the gastrointestinal contents. Once released from the tablet, diclofenac is rapidly absorbed from the ...
5.3. Preclinical safety data
None stated.
6.1. List of excipients
<u>Granulating fluid:</u> Cetostearyl Alcohol <u>Core:</u> Colloidal Silicon Dioxide Compressible Sugar Talc Povidone Magnesium Stearate <u>Subcoat:</u> Copovidone Sucrose <u>Pigmented film coat:</u> ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
The tablets are presented in aluminium/PVC or PVDC-coated-PVC blisters, strips of which are contained within a printed cardboard carton. Cartons of 28 and 56 tablets. Not all pack sizes may be marketed. ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Dexcel-Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire NN11 8PB, UK
8. Marketing authorization number(s)
PL 14017/0009
9. Date of first authorization / renewal of the authorization
30 January 1997 / 18 February 2003
10. Date of revision of the text
21/04/2021
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