PARACODIN Oral drops, solution (2020)
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Περιεχόμενα
1. Name of the medicinal product
Paracodin 10 mg/g Oral Drops, Solution
2. Qualitative and quantitative composition
Each drop contains 0.5 mg of dihydrocodeine hydrorhodanide. 1 g of Paracodin drops (=20 drops) contains 10 mg of dihydrocodeine hydrorhodanide. <u>Excipients:</u> benzoic acid (E201) 2mg per 20-drop dose. ...
3. Pharmaceutical form
Oral drops, solution. Clear, brown solution.
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:</u> 14-20 drops taken up to three times daily. <u>Children (aged 6-12 years):</u> 6-12 drops taken 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 should not be given during an attack of asthma and it should be administered with care to persons liable to such attacks. Paracodin Drops ...
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
The mean lethal dose (LD50) of dihydrocodeine hydrogen tartrate was determined on mice and rats after oral and intraperitoneal administration. The following 24-hour values, related to the base, were obtained: ...
6.1. List of excipients
Purified water Benzoic acid (E210) Glycerol (85 per cent) Saccharin sodium Sodium chloride Caramel (E150) Thyme flavour Eucalyptus flavour
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Do not store above 30°C. Store in the original package in order to protect from light.
6.5. Nature and contents of container
Amber glass bottle (type III) with polyethylene dropper and polypropylene screw cap containing 15 gof solution.
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)
PA1235/004/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 04 October 1991 Date of last renewal: 04 October 2006
10. Date of revision of the text
August 2020
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