CINNARON Hard capsule (2019)
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Περιεχόμενα
1. Name of the medicinal product
Cinnaron 75 mg hard capsules.
2. Qualitative and quantitative composition
Each hard capsule containscinnarizine 75 mg. <u>Excipients with known effect:</u> Each hard capsule contains 48.7 mg lactose monohydrate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsules. Orange/yellow capsules.
4.1. Therapeutic indications
<u>Cerebral circulatory disorders:</u> Prophylaxis from migraine. <u>Disorders of balance:</u> Vertigo. <u>Peripheral circulatory disorders:</u> Raynauds phenomenon. Probably effective in peripheral ...
4.2. Posology and method of administration
Posology Adults <u>Cerebral circulatory disorders:</u> 1 capsule once daily. <u>Disorders of balance:</u> 1 capsule once daily. <u>Peripheral circulatory disorders:</u> 2-3 capsules once daily. The maximum ...
4.3. Contraindications
Cinnaron should not be given to patients with known hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
As with other antihistamines, Cinnaron may cause epigastric distress; taking it after meals may diminish gastric irritation. In patients with Parkinsons disease, Cinnaron should only be given if the advantages ...
4.5. Interaction with other medicinal products and other forms of interaction
Alcohol, CNS depressants and tricyclic antidepressants Concurrent use with alcohol, CNS depressants or tricyclic antidepressants may potentiate the sedative effects of either these drugs or of Cinnaron. ...
4.6. Pregnancy and lactation
Pregnancy Although in animal studies, cinnarizine has shown no teratogenic effects, as with all drugs, Cinnaron should be used during pregnancy only if the therapeutic benefits justify the potential risks ...
4.7. Effects on ability to drive and use machines
Since somnolence may occur, especially at the start of treatment, caution should be taken during activities such as driving or operating machinery.
4.8. Undesirable effects
The safety of cinnarizine was evaluated in 372 cinnarizine-treated subjects who participated in 7 placebo-controlled trials for the indications peripheral circulatory disorders, cerebral circulatory disorders, ...
4.9. Overdose
Symptoms and signs The signs and symptoms are mainly due to the anticholinergic (similar to atropine) effect of cinnarizine. Acute overdoses have been reported with cinnarizine in doses ranging from 90 ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other nervous system drugs, anti-vertigo preparations <b>ATC code:</b> N07CA02 Cinnarizine inhibits contractions of vascular smooth muscle cells, by blocking calcium channels. ...
5.2. Pharmacokinetic properties
Absorption Maximum absorption levels of cinnarizine reached 1 to 3 hours after intake. Distribution The binding of cinnarizine to plasma proteins is 91%. Biotransformation Cinnarizine is extensively metabolised ...
5.3. Preclinical safety data
The LD<sub>50</sub> values of single dose in various animal models showed a wide range of security on a mg/kg base compared to the maximum recommended human dose (MRHD) of 225 mg/day or 4.5 mg/kg based ...
6.1. List of excipients
<u>Capsule content:</u> Sodium starch glycolate (Type A) Lactose monohydrate Maize starch Povidone Silica colloidal anhydrous Magnesium stearate Talc <u>Capsule body:</u> Quinoline yellow (E104) Erythrosine ...
6.2. Incompatibilities
None.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C. Protect from light and moisture.
6.5. Nature and contents of container
PVC/Aluminium blisters. Pack sizes of 20 and 1000 hard capsules. PP containers with PE closures. Pack size of 1000 hard capsules. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
11726
9. Date of first authorization / renewal of the authorization
Date of first authorization: 01 July 1988 Date of latest renewal: 20 November 2009
10. Date of revision of the text
22/02/2019
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