COSTI Tablet (2019)
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Περιεχόμενα
1. Name of the medicinal product
Costi 10mg, tablets.
2. Qualitative and quantitative composition
Each tablet contains 10mg of domperidone. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. Pink round flat scored, embossed MC tablets, for oral administration.
4.1. Therapeutic indications
For the relief of the symptoms of nausea and vomiting.
4.2. Posology and method of administration
Posology Costi should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting. Adults and adolescents (12 years of age and older and weighing 35 kg or more) ...
4.3. Contraindications
Domperidone is contraindicated in the following situations: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Prolactin-releasing pituitary tumour (prolactinoma). ...
4.4. Special warnings and precautions for use
Costi should only be taken according to the above posology (See section 4.2). Patients who find they have post-prandial symptoms that persist, and are having to take domperidone continuously for more than ...
4.5. Interaction with other medicinal products and other forms of interaction
The main metabolic pathway of domperidone is through CYP3A4. <em>In vitro</em> data suggest that the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels ...
4.6. Pregnancy and lactation
Pregnancy There are limited post-marketing data on the use of domperidone in pregnant women. Therefore, Costi should only be used during pregnancy when justified by the anticipated therapeutic benefit. ...
4.7. Effects on ability to drive and use machines
Costi has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
The safety of domperidone was evaluated in 1275 patients with dyspepsia, gastro-oesophageal reflux disorder (GERD), Irritable Bowel Syndrome (IBS), nausea and vomiting or other related conditions in 31 ...
4.9. Overdose
Symptoms Overdose has been reported primarily in infants and children. Symptoms of overdosage may include agitation, altered consciousness, convulsion, disorientation, somnolence and extrapyramidal reactions. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Propulsives <b>ATC Code:</b> A03FA03 Domperidone is a dopamine antagonist with anti-emetic properties. Domperidone does not readily cross the blood-brain barrier. In domperidone ...
5.2. Pharmacokinetic properties
Absorption Domperidone is rapidly absorbed after oral administration, with peak plasma concentrations occurring at approximately 1 hr after dosing. The C<sub>max</sub> and AUC values of domperidone increased ...
5.3. Preclinical safety data
Electrophysiological <em>in vitro</em> and <em>in vivo</em> studies indicate an overall moderate risk of domperidone to prolong the QTc interval in humans. In <em>in vitro</em> experiments on isolated ...
6.1. List of excipients
Costi tablets also contain pregelatinised maize starch, microcrystalline cellulose, sodium starch glycollate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate and erythosine sodium. ...
6.2. Incompatibilities
None known.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C, in the original package, in order to protect from light and moisture.
6.5. Nature and contents of container
Packs of 30 tablets are available. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
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)
9119
9. Date of first authorization / renewal of the authorization
21/10/83
10. Date of revision of the text
13/05/2019
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