REMETHAN Gastro-resistant tablet (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Remethan 25 mg gastro-resistant tablets. Remethan 50 mg gastro-resistant tablets.
2. Qualitative and quantitative composition
Remethan 25 mg gastro-resistant tablets: Each gastro-resistant tablet contains 25 mg diclofenac sodium. Remethan 50 mg gastro-resistant tablets: Each gastro-resistant tablet contains 50 mg diclofenac sodium. ...
3. Pharmaceutical form
<u>Remethan 25 mg & 50 mg:</u> Gastro-resistant tablet. Yellow, round, enteric-coated tablets.
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
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use). Posology <b> ...
4.3. Contraindications
Hypersensitivity to the diclofenac sodium 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 minimized by using the minimum effective dose for the shortest duration necessary to control symptoms (see section 4.2 Posology and method of administration and GI and ...
4.5. Interaction with other medicinal products and other forms of interaction
The following interactions include those observed with diclofenac sodium. <u>Lithium:</u> If used concomitantly, diclofenac sodium may increase plasma concentrations of lithium. Monitoring of the serum ...
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 or ...
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 operating machinery. ...
4.8. Undesirable effects
Adverse reactions are ranked under the 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 (≥1/10,000, ...
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 bleeding, diarrhoea, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antiinflammatory and antirheumatic products; antiinflammatory and antirheumatic products, non-steroids <b>ATC code:</b> M01AB05 Mechanism of action Diclofenac Sodium is ...
5.2. Pharmacokinetic properties
Absorption Absorption is complete but onset is delayed until passage through the stomach, which may be affected by food which delays stomach emptying. The mean peak plasma diclofenac concentration reached ...
5.3. Preclinical safety data
None stated.
6.1. List of excipients
Remethan 25 mg & 50 mg gastro-resistant tablets <u>Core:</u> Povidone Lactose monohydrate Maize starch Cellulose, microcrystalline Starch, pregelatinised Silica, colloidal anhydrous Magnesium stearate ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C, protected from light and moisture.
6.5. Nature and contents of container
<u>Remethan 25 mg gastro-resistant tablets:</u> PVC-PE-PVDC/Aluminium blisters. Pack sizes of 30, 100 and 1000 tablets. PP containers with PE closure. Pack sizes of 100 and 1000 tablets. <u>Remethan 50 ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
Remethan 25 mg gastro-resistant tablets: 10334 Remethan 50 mg gastro-resistant tablets: 19633
9. Date of first authorization / renewal of the authorization
<u>Remethan 25 mg gastro-resistant tablets:</u> Date of first authorization: 02 December 1985 Date of latest renewal: 04 September 2012 <u>Remethan 50 mg gastro-resistant tablets:</u> Date of first authorization: ...
10. Date of revision of the text
19/08/2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
