PEPTOMET Film-coated tablet (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Peptomet 10 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains domperidone 10 mg. <u>Excipient(s) with known effect:</u> This product contains 60.9 mg lactose. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet. White, round, film-coated tablets.
4.1. Therapeutic indications
Peptomet is indicated for the relief of the symptoms of nausea and vomiting.
4.2. Posology and method of administration
Posology Peptomet should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting. Usually, the maximum treatment duration should not exceed one week. See ...
4.3. Contraindications
Peptomet is contraindicated in the following situations: known hypersensitivity to domperidone or any of the excipients listed in section 6.1. prolactin-releasing pituitary tumour (prolactinoma). in patients ...
4.4. Special warnings and precautions for use
Cardiovascular effects Domperidone has been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation ...
4.5. Interaction with other medicinal products and other forms of interaction
The main metabolic pathway of domperidone is through CYP3A4. In vitro data suggest that the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels of domperidone. ...
4.6. Pregnancy and lactation
Pregnancy There are limited post-marketing data on the use of domperidone in pregnant women. Therefore, Peptomet tablets should only be used during pregnancy when justified by the anticipated therapeutic ...
4.7. Effects on ability to drive and use machines
Peptomet has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
The safety of Peptomet was evaluated in clinical trials and in post-marketing experience. The clinical trials included 1275 patients with dyspepsia, gastro-oesophageal reflux disorder (GERD), Irritable ...
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> Drugs for functional gastrointestinal disorders, Propulsives <b>ATC code:</b> A03FA03 Domperidone is a dopamine antagonist with anti-emetic properties. Domperidone does ...
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 QT interval in humans. In in-vitro experiments on isolated cells transfected ...
6.1. List of excipients
<u>Core:</u> Cellulose, microcrystalline Lactose monohydrate Maize starch Povidone Sodium starch glycolate (type A) Silica, colloidal anhydrous Magnesium stearate Talc <u>Coating:</u> Hypromellose Macrogol ...
6.2. Incompatibilities
None.
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 30, 100 and 1000 film-coated 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)
19873
9. Date of first authorization / renewal of the authorization
Date of first authorization: 13 December 2005 Date of latest renewal: 04 April 2014
10. Date of revision of the text
18/1/2021
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