CYMBALTA Hard gastro-resistant capsule (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Cymbalta 30 mg hard gastro-resistant capsules. Cymbalta 60 mg hard gastro-resistant capsules.
2. Qualitative and quantitative composition
Cymbalta 30 mg Each capsule contains 30 mg of duloxetine (as hydrochloride). <u>Excipient(s) with known effect:</u> Each capsule may contain up to 56 mg sucrose. Cymbalta 60 mg Each capsule contains 60 ...
3. Pharmaceutical form
Hard gastro-resistant capsule. <u>Cymbalta 30 mg:</u> Opaque white body, imprinted with 30 mg and an opaque blue cap, imprinted with 9543. <u>Cymbalta 60 mg:</u> Opaque green body, imprinted with 60 mg ...
4.1. Therapeutic indications
Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Cymbalta is indicated in adults. For further information see section ...
4.2. Posology and method of administration
Posology Major depressive disorder The starting and recommended maintenance dose is 60 mg once daily with or without food. Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day have been ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant use of Cymbalta with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated ...
4.4. Special warnings and precautions for use
Mania and seizures Cymbalta should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures. Mydriasis Mydriasis has been reported in association with ...
4.5. Interaction with other medicinal products and other forms of interaction
Monoamine oxidase inhibitors (MAOIs) Due to the risk of serotonin syndrome, duloxetine should not be used in combination with non-selective irreversible monoamine oxidase inhibitors (MAOIs), or within ...
4.6. Fertility, pregnancy and lactation
Fertility In animal studies, duloxetine had no effect on male fertility, and effects in females were only evident at doses that caused maternal toxicity. Pregnancy Studies in animals have shown reproductive ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Cymbalta may be associated with sedation and dizziness. Patients should be instructed that if they experience sedation ...
4.8. Undesirable effects
a. Summary of the safety profile The most commonly reported adverse reactions in patients treated with Cymbalta were nausea, headache, dry mouth, somnolence, and dizziness. However, the majority of common ...
4.9. Overdose
Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 5400 mg were reported. Some fatalities have occurred, primarily with mixed overdoses, but also with duloxetine ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other antidepressants <b>ATC code:</b> N06AX21 Mechanism of action Duloxetine is a combined serotonin (5-HT) and noradrenaline (NA) reuptake inhibitor. It weakly inhibits ...
5.2. Pharmacokinetic properties
Duloxetine is administered as a single enantiomer. Duloxetine is extensively metabolised by oxidative enzymes (CYP1A2 and the polymorphic CYP2D6), followed by conjugation. The pharmacokinetics of duloxetine ...
5.3. Preclinical safety data
Duloxetine was not genotoxic in a standard battery of tests and was not carcinogenic in rats. Multinucleated cells were seen in the liver in the absence of other histopathological changes in the rat carcinogenicity ...
6.1. List of excipients
<u>Capsule content:</u> Hypromellose Hypromellose acetate succinate Sucrose Sugar spheres Talc Titanium dioxide (E171) Triethyl citrate <u>Capsule shell:</u> <em>Cymbalta 30 mg</em> Gelatin Sodium lauryl ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store in the original package in order to protect from moisture. Do not store above 30ºC.
6.5. Nature and contents of container
Polyvinylchloride (PVC), polyethylene (PE), and polychlorotrifluoroethylene (PCTFE) blister sealed with an aluminium foil. <u>Cymbalta 30 mg:</u> Cymbalta 30 mg is available in packs of 7, 28 and 98 hard ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
8. Marketing authorization number(s)
EU/1/04/296/001 EU/1/04/296/002 EU/1/04/296/003 EU/1/04/296/004 EU/1/04/296/005 EU/1/04/296/006 EU/1/04/296/007 EU/1/04/296/008 EU/1/04/296/009
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 17 December 2004 Date of latest renewal: 24 June 2009
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