LEVOMED Tablet (2017)
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Περιεχόμενα
1. Name of the medicinal product
Levomed 100/10 mg tablets. Levomed 100/25 mg tablets. Levomed 250/25 mg tablets.
2. Qualitative and quantitative composition
Levomed 100/10mg tablets: Each tablet contains 100mg Levodopa and 10mg Carbidopa. Levomed 100/25mg tablets: Each tablet contains 100mg Levodopa and 25mg Carbidopa. Levomed 250/25mg tablets: Each tablet ...
3. Pharmaceutical form
Tablet. <u>Levomed 250/25 mg tablets:</u> blue, round, flat, scored tablets. <u>Levomed 100/25 mg tablets:</u> yellow, round flat, scored tablets. <u>Levomed 100/10mg tablets:</u> blue, round, flat, scored ...
4.1. Therapeutic indications
Antiparkinsonian agent. For treatment of Parkinsons disease and syndrome. Levomed is useful in relieving many of the symptoms of parkinsonism, particularly rigidity and bradykinesia. It is frequently helpful ...
4.2. Posology and method of administration
Method of administration To be taken orally. Posology The optimum daily dosage of Levomed must be determined by careful titration in each patient. Levomed Tablets are available as: Levomed 100/10 mg tablets ...
4.3. Contraindications
Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with Levomed. These inhibitors must be discontinued at least two weeks before starting Levomed. Levomed may be administered concomitantly ...
4.4. Special warnings and precautions for use
Levomed is not recommended for the treatment of drug-induced extrapyramidal reactions. Levomed should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, ...
4.5. Interaction with other medicinal products and other forms of interaction
Caution should be exercised when the following drugs are administered concomitantly with Levomed. Antihypertensive agents Symptomatic postural hypotension has occurred when Levomed is added to the treatment ...
4.6. Fertility, pregnancy and lactation
Pregnancy Although the effects of Levomed on human pregnancy are unknown, both levodopa and combinations of carbidopa and levodopa have caused visceral and skeletal malformations in rabbits. Therefore, ...
4.7. Effects on ability to drive and use machines
No data are known about the effect on the ability to drive. If side effects such as dizziness or somnolence occur, they may affect the ability to drive and to operate machinery. Patients being treated ...
4.8. Undesirable effects
Side effects that occur frequently with Levomed are those due to the central neuropharmacological activity of dopamine. These reactions can usually be diminished by dosage reduction. The most common are ...
4.9. Overdose
Treatment Management of acute overdosage with Levomed is basically the same as management of acute overdosage with levodopa; however pyridoxine is not effective in reversing the actions of Levomed. ECG ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Dopa and dopa derivatives, levodopa and decarboxylase inhibitor <b>ATC Code:</b> N04BA02 Levodopa is a precursor of dopamine, and is given as replacement therapy in Parkinson ...
5.2. Pharmacokinetic properties
Following oral dosing levodopa, in the absence of decarboxylase inhibitor, is rapidly but variably absorbed from the gastrointestinal tract. It has a plasma half-life of about 1 hour and is mainly converted ...
5.3. Preclinical safety data
Levomed is well established in medical use. Preclinical data is broadly consistent with clinical experience (For reproductive toxicity, see section 4.6).
6.1. List of excipients
Levomed 250/25 mg tablets: Pregelatinised starch, microcrystalline cellulose, powdered cellulose, Blue Lake E132, povidone K25, magnesium stearate. Levomed 100/25 mg tablets: Pregelatinised starch, microcrystalline ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 30°C in the original package, in order to protect from light.
6.5. Nature and contents of container
PVC/AL blister packs 100 tablets. Levomed 250/25mg tablets are also marketed in PVC/AL blister packs of 30. Levomed 100/25mg tablets are also marketed in PVC/AL blister packs of 10, 50. Not all pack sizes ...
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
Levomed 10/100mg tablets: 19853 Levomed 25/100mg tablets: 19837 Levomed 25/250mg tablets: 19836
9. Date of first authorization / renewal of the authorization
Levomed 10/100 mg tablets: 19.12.2005 / 14.05.2013 Levomed 25/100 mg tablets: 19.12.2005 / 14.05.2013 Levomed 25/250 mg tablets: 19.12.2005
10. Date of revision of the text
09/2017
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