PARACODIN Tablet (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Paracodin 10 mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains 10 mg Dihydrocodeine Hydrogen Tartrate. <u>Excipients with known effect:</u> Each tablet also includes Lactose monohydrate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. Round, off white biplane tablets, with a score line on one side and a star with three rays on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide ...
4.1. Therapeutic indications
Paracodin is indicated in the management of non-productive cough.
4.2. Posology and method of administration
For oral administration. <u>Adults and children over the age of 12 years:</u> The usual dose is 10 to 30 mg up to three times daily.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Opiate addiction, mental clouding, disturbances of the breathing centre and respiratory function, head injuries ...
4.4. Special warnings and precautions for use
As dihydrocodeine may bring about histamine release, Paracodin Tablets should not be given during an attack of asthma and should be administered with due care to persons liable to such attacks. Dosage ...
4.5. Interaction with other medicinal products and other forms of interaction
As with all other drugs acting on the central nervous system, the consumption of alcohol should be avoided under Paracodin therapy. Paracodin should not be administered to patients who are receiving monoamine ...
4.6. Fertility, pregnancy and lactation
All narcotic analgesics can cross the placenta and are also excreted in breast milk. They should not be used during pregnancy or lactation unless considered essential by the physician.
4.7. Effects on ability to drive and use machines
Paracodin Tablets may induce drowsiness. Patients receiving Paracodin Tablets should not drive or operate machinery unless it has been shown not to affect physical or mental ability.
4.8. Undesirable effects
At the usual recommended doses the most frequent side effects are nausea and constipation and less frequently headache and dizziness. <u>Psychiatric disorders:</u> Confusion, euphoria. <u>Nervous system ...
4.9. Overdose
In the case of overdosage conservative management is recommended. Severe respiratory depression can be treated with naloxone hydrochloride 0.4 to 2 mg subcutaneously, repeated as required at 2 or 3 minute ...
5.1. Pharmacodynamic properties
Paracodin is a centrally-acting anti-tussive. Dihydrocodeine works on the cough centre to lessen the incidence and intensity of coughing fits. Dihydrocodeine inhibits troublesome, unproductive cough but ...
5.2. Pharmacokinetic properties
Dihydrocodeine is readily absorbed after oral administration, has a duration of action of 4 to 6 hours, is extensively metabolised in the liver and is excreted mainly via the kidney. The biological availability ...
5.3. Preclinical safety data
Not applicable.
6.1. List of excipients
Lactose monohydrate Microcrystalline cellulose (E460) Sodium starch glycolate Magnesium stearate (E572)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Keep blister in the outer carton.
6.5. Nature and contents of container
Aluminium/PVC foil blister strips containing 20 tablets.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Teofarma S.R.L., Valle Salimbene (PV), Via F. LLI Cervi, 8 CAP 27010, Italy
8. Marketing authorization number(s)
PA1235/004/003
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 01 April 1978 Date of last renewal: 01 April 2008
10. Date of revision of the text
August 2020
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
