DIFENE Modified‑release capsule (2016)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Difene Dual Release. 100 mg modified‑release capsule, hard. Diclofenac sodium.
2. Qualitative and quantitative composition
Each modified‑release capsule, hard contains 100 mg diclofenac sodium (25 mg diclofenac sodium in gastroresistant form, 75 mg diclofenac sodium in prolonged‑release form). For a full list of excipients, ...
3. Pharmaceutical form
Modified‑release capsule, hard. Hard gelatine capsule, size 1, with a blue opaque capsule cap and colourless transparent body and white print D100M, filled with white to cream-coloured pellets.
4.1. Therapeutic indications
Symptomatic treatment of pain and inflammation in: Acute arthritis (including attacks of gout) Chronic arthritis, including rheumatoid arthritis (chronic polyarthritis) Ankylosing spondylitis (Bechterew ...
4.2. Posology and method of administration
Dosage The dose of diclofenac depends on the severity of the condition. The recommended dose range for adults lies between 50 and 100 mg diclofenac sodium per day. <b>Age</b> <b>Single dose: Number of ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; Known past reactions of bronchospasm, asthma, rhinitis or urticaria after taking acetylsalicylic acid or other ...
4.4. Special warnings and precautions for use
Gastrointestinal safety The administration of Difene Dual Release 100mg associated with NSAIDs, including selective cyclo‑oxygenase‑2 inhibitors, should be avoided. Undesirable effects can be reduced by ...
4.5. Interaction with other medicinal products and other forms of interaction
Other NSAIDs including salicylates Taking several NSAIDs concurrently can raise the risk of gastrointestinal ulcers and bleeding because of a synergistic effect. The concomitant administration of diclofenac ...
4.6. Fertility, pregnancy and lactation
Pregnancy The inhibition of prostaglandin synthesis can have a negative effect on the pregnancy and/or embryo/foetal development. Data from epidemiological studies indicate an increased risk of miscarriage ...
4.7. Effects on ability to drive and use machines
As undesirable effects on the central nervous system like fatigue and dizziness can occur when Difene Dual Release 100mgis used, especially at high dosage, in isolated cases the reaction time can be altered ...
4.8. Undesirable effects
The following categories are used as a basis for evaluating undesirable effects: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); ...
4.9. Overdose
Symptoms of overdose Symptoms of overdose can be central nervous system disorders, such as headache, dizziness, drowsiness and loss of consciousness (in children, also myoclonic seizures), and abdominal ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Non‑steroidal anti‑inflammatory and anti‑rheumatic agents; Acetic acid derivatives and related substances <b>ATC code:</b> M01AB05 Diclofenac is a non‑steroidal anti‑inflammatory/anti‑rheumatic ...
5.2. Pharmacokinetic properties
After oral administration of the usual gastroresistant pharmaceutical forms diclofenac is fully absorbed distal to the stomach. Maximum plasma levels are attained, depending on the duration of the passage ...
5.3. Preclinical safety data
Non‑clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and reproduction toxicity, which ...
6.1. List of excipients
Talc, Microcrystalline cellulose, Povidone K 25, Colloidal anhydrous silica, Propylene glycol, Ammonio methacrylate copolymer (type A), Ammonio methacrylate copolymer (type B), Methacrylic acid ethyl acrylate ...
6.2. Incompatibilities
None known to date.
6.3. Shelf life
he shelf life is 4 years. This medicinal product should not be used after the expiry date.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from moisture.
6.5. Nature and contents of container
Blister packs of PVC/PVDC foil and aluminium foil. Original pack of 10, 20, 50, 100 modified‑release capsules, hard. Hospital pack of 500 (10 50) modified‑release capsules, hard.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Medililink Pharmaceuticals Ltd, 30 Armenias Street, 2003 Strovolos, Nicosia, Cyprus, Tel.: +357 22319282, Fax: +357 22319290
8. Marketing authorization number(s)
19430
9. Date of first authorization / renewal of the authorization
05 December 2002
10. Date of revision of the text
May 2016
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