AKAMON Tablet (2014)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Akamon 1.5 mg tablets. Akamon 3 mg tablets.

2. Qualitative and quantitative composition

Akamon 1.5 mg tablets: Each tablet contains 1.5 mg bromazepam. Akamon 3mg tablets: Each tablet contains 3 mg bromazepam. Excipient(s) with known effect: 1.5mg tablets: lactose monohydrate (79.70mg/tablet) ...

3. Pharmaceutical form

Tablet. Akamon 1.5 mg tablets: Yellow, round, flat, scored embossed MC tablet Akamon 3 mg tablets: White, round, flat, scored tablet, embossed MC.

4.1. Therapeutic indications

Bromazepam is a pyridylbenzodiazepine compound with anxiolytic properties. It is indicated for short term therapy, usually not exceeding two to four weeks, as symptomatic treatment of severe, disabling ...

4.2. Posology and method of administration

The dosage should be individually titrated and optimized as should frequency of administration, on the basis of the individual response, severity of symptoms and any available history of precious response ...

4.3. Contraindications

Hypersensitivity to the active substance, other benzodiazepines, or to any of the excipients listed in section 6.1.or to any of the tablet ingredients. Akamon, is also contraindicated in patients with ...

4.4. Special warnings and precautions for use

Patients with chronic pulmonary insufficiency, hepatic impairment and renal impairment may require dosage reduction. Amnesia may occur. Akamon should not be used alone to treat anxiety associated with ...

4.5. Interaction with other medicinal products and other forms of interaction

Drugs Centrally acting drugs: Concomitant use with centrally acting drugs such as anaesthetics, analgesics, sedative antihistamines, antidepressants, hypnotics, neuroleptics and tranquillisers is likely ...

4.6. Pregnancy and lactation

Pregnancy Animal experimentation has not shown the drug to be free from hazard in pregnancy and there is inadequate evidence of safety in human pregnancy. Use in pregnancy is not recommended, especially ...

4.7. Effects on ability to drive and use machines

Like all medicaments of this type Akamon may modify patients performance at skilled tasks. Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive ...

4.8. Undesirable effects

The undesirable effects frequencies are defined by using the following convention: 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 ...

4.9. Overdose

Symptoms Intensification of therapeutic effects such as sedation, muscle weakness and profound sleep. In some cases it may be characterized by paradoxical reactions of excitation. High overdosage may result ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Anxiolytics Benzodiazepine derivatives ATC code: N05BA08 Bromazepam is a psychotropic substance of the pyridylbenzodiazepine class and has anxiolytic properties. ...

5.2. Pharmacokinetic properties

Absorbtion Bromazepam is rapidly absorbed from the gastro-intestinal tract. Peak plasma concentration are usually reached within two hours of oral administration of bromazepam. The absolute (versus iv ...

5.3. Preclinical safety data

No further information of relevance to the prescriber.

6.1. List of excipients

Akamon tablets 1.5 mg contain microcrystalline cellulose, lactose monohydrate, powdered cellulose, pregelatinised maize starch, croscarmellose sodium, tartazine lake (E102), colloidal anhydrous silica ...

6.2. Incompatibilities

None known.

6.3. Shelf life

60 months.

6.4. Special precautions for storage

Store below 25ºC in the original package, in order to protect form light.

6.5. Nature and contents of container

Akamon 1.5 mg tablets: Combination polyvinylchloride – aluminium blisters. Thirty (30), forty (40) or sixty (60) tablets are contained in a card carton. Akamon 3 mg tablets: Combination polyvinylchloride ...

6.6. Special precautions for disposal and other handling

Tablets are for oral administration only. No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

8. Marketing authorization number(s)

Akamon 1.5 mg tablets: 19858 Akamon 3 mg tablets: 9039

9. Date of first authorization / renewal of the authorization

Akamon tablets 1.5 mg tablets: 29/12/2005 Akamon tablets 3 mg tablets: 15/ 09 /83

10. Date of revision of the text

02/2014

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