ALMIRAL Gastro-resistant tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Almiral 25 mg gastro-resistant tablets. Almiral 50 mg gastro-resistant tablets.
2. Qualitative and quantitative composition
Almiral tablets contain either 25 mg or 50 mg of diclofenac sodium. <u>Excipients with known effect:</u> lactose, propylene glycol, sunset yellow (FCF) aluminium lake (E110), tartrazine aluminium lake ...
3. Pharmaceutical form
Gastro-resistant tablets. Almiral tablets are orange, round, convex, for oral administration.
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). Posology Adults 75-150mg daily in two or three divided ...
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. <u>Lithium:</u> If used concomitantly, diclofenac may increase ...
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, Nonsteroids <b>ATC code:</b> M01AB05 Mechanism of action Almiral contains diclofenac sodium which is a nonsteroidal agent ...
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
No further relevant information.
6.1. List of excipients
<u>Almiral tablets 25 mg:</u> Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Silica colloidal anhydrous Magnesium stearate Propylene glycol Talc Methacrylic acid copolymer (1:1) ...
6.2. Incompatibilities
None known.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Almiral tablets 25 mg and 50 mg should be stored below 25oC, in the original package.
6.5. Nature and contents of container
Almiral tablets 25 mg are presented in aluminium/polyvinylchloride blisters of ten tablets in packs of three or ten blisters. Almiral tablets 50 mg are presented in aluminium/polyvinylchloride blisters ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
Almiral 25mg tablets: 9918 Almiral 50mg tablets: 9919
9. Date of first authorization / renewal of the authorization
Almiral 25mg tablets: 06.03.1985/10.11.2011 Almiral 50mg tablets: 06.03.1985/15.07.2013
10. Date of revision of the text
05/08/2019
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