CINNARON Tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Cinnaron 25 mg tablets.
2. Qualitative and quantitative composition
Each tablet contains 25 mg cinnarizine. <u>Excipients with known effect:</u> Each tablet contains 138 mg lactose monohydrate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. White, round, flat, scored tablets with Remedicas logo on one side. The tablet can be divided into equal doses.
4.1. Therapeutic indications
Cinnaron is indicated for: the maintenance therapy for symptoms of labyrinthine disorders, including vertigo, dizziness, tinnitus, nystagmus, nausea and vomiting. the prophylaxis of motion sickness. the ...
4.2. Posology and method of administration
Posology Adults and children over the age of 12 Cerebral circulatory disorders: 1 tablet three times daily. Peripheral circulatory disorders: 2-3 tablets three times daily. Disorders of balance: 1 tablet ...
4.3. Contraindications
Cinnaron should not be given to patients with known hypersensitivity to cinnarizine or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Cinnaron has not been found to reduce blood pressure significantly. However, the drug should be used with reasonable caution in hypotensive patients. As with other antihistamines, Cinnaron may cause epigastric ...
4.5. Interaction with other medicinal products and other forms of interaction
Alcohol/CNS depressants/Tricyclic Antidepressants Concurrent use of may potentiate the sedative effects of either these drugs or of Cinnaron. Diagnostic Interference Because of its antihistamine effect, ...
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 Acute cinnarizine overdoses have been reported with doses ranging from 90 to 2,250 mg. The most commonly reported signs and symptoms associated with overdose of cinnarizine include: alterations ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other nervous system drugs, antivertigo preparations <b>ATC code:</b> N07CA02 Cinnarizines actions in the treatment of peripheral vascular disease are due to its anti-vasoconstrictor ...
5.2. Pharmacokinetic properties
Absorption The peak plasma levels of cinnarizine are obtained 1 to 3 hours after intake. Distribution The plasma protein binding of cinnarizine is 91%. Metabolism Cinnarizine is extensively metabolised ...
5.3. Preclinical safety data
Nonclinical safety studies showed that effects were observed only after chronic exposures from approximately 5 to 72 times, on a mg/kg basis when compared to the maximum recommended human dose of 225 mg/day, ...
6.1. List of excipients
Povidone Cellulose, microcrystalline Lactose monohydrate Sodium starch glycolate (Type A) Silica, colloidal anhydrous Magnesium stearate Talc Maize starch
6.2. Incompatibilities
None known.
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 50 and 500 tablets. PP containers with PE closures. Pack sizes of 50, 500 and 1000 tablets. 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)
8557
9. Date of first authorization / renewal of the authorization
Date of first authorization: 20 November 1982 Date of latest renewal: 20 March 2009
10. Date of revision of the text
21/02/2019
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