LORANS Tablet (2017)
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Περιεχόμενα
1. Name of the medicinal product
Lorans 1mg tablets. Lorans 2mg tablets.
2. Qualitative and quantitative composition
Lorans 1mg tablets contain 1 mg of lorazepam. Lorans 2mg tablets contain 2 mg of lorazepam. <u>Excipient with known effect:</u> lactose monohydrate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. Lorans 1mg tablets are white, round, flat, scored tablets with diameter of 7 mm. Lorans tablet 1mg can be divided into equal doses. Lorans 2mg tablets are white, round, flat, scored tablets, embossed ...
4.1. Therapeutic indications
Lorans is indicated for the short term treatment of unacceptable disabling or distressful anxiety states including anxiety associated with psychosomatic, organic and psychotic illness, and the short term ...
4.2. Posology and method of administration
Posology Dosage and duration of therapy should be individualised. The lowest effective dose should be prescribed for the shortest time possible. The risk of withdrawal and rebound phenomena is greater ...
4.3. Contraindications
Hypersensitivity to the active substance, other benzodiazepines or to any of the excipients listed in section 6.1. Severe hepatic impairment. Severe respiratory insufficiency. Sleep apnoea syndrome. Myasthenia ...
4.4. Special warnings and precautions for use
Use of benzodiazepines, including lorazepam, may lead to potentially fatal respiratory depression. Severe anaphylactic/anaphylactoid reactions have been reported with the use of benzodiazepines. Cases ...
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant intake with alcohol is not recommended. The sedative effects may be enhanced when the product is used in combination with alcohol. This affects the ability to drive or use machines. The benzodiazepines, ...
4.6. Pregnancy and lactation
Pregnancy Benzodiazepines should not be used during pregnancy, especially during the first and last trimesters. Benzodiazepines may cause foetal damage when administered to pregnant women. In particular, ...
4.7. Effects on ability to drive and use machines
Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive or to use machines. If insufficient sleep occurs, the likelihood of impaired alertness ...
4.8. Undesirable effects
Adverse reactions, when they occur, are usually observed at the beginning of therapy and generally decrease in severity or disappear with continued use or upon decreasing the dose. The frequency of reporting ...
4.9. Overdose
Symptoms In the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. In postmarketing experience, overdose with lorazepam has occurred predominantly ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Benzodiazepine derivatives, Anxiolytics <b>ATC code:</b> N05BA06 Lorazepam is a short acting benzodiazepine with anxiolytic, sedative, hypnotic and muscle relaxant properties. ...
5.2. Pharmacokinetic properties
Lorazepam is almost completely absorbed from the gastrointestinal tract and peak serum levels are reached in 2 hours. It is metabolised by a simple one-step process to a pharmacologically inert glucuronide. ...
5.3. Preclinical safety data
Oesophageal dilation occurred in rats treated with lorazepam for more than one year at 6 mg/kg/day.
6.1. List of excipients
<u>Lorans 1mg and 2mg tablets also contain:</u> Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Magnesium stearate
6.2. Incompatibilities
No known incompatibilities.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C, in the original package.
6.5. Nature and contents of container
Lorans tablets (1mg and 2mg) are packed in aluminium foil-PVC film blisters. Packs containing 50 tablets, 100, 500 or 1000 tablets are available. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
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)
Lorans 1mg tablets: 7228 Lorans 2mg tablets: 7229
9. Date of first authorization / renewal of the authorization
Lorans 1mg tablets: 14.12.1979/22.12.2014 Lorans 2mg tablets: 14.12.1979/05.07.2013
10. Date of revision of the text
01/2017
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