PARACODIN Syrup (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Paracodin 0.20% w/w Syrup.
2. Qualitative and quantitative composition
Dihydrocodeine hydrogen tartrate 12.1 mg per 5 ml (0.20% w/w).
Excipients:
Sucrose 2424.2 mg per 5 ml (40 % w/w) benzoic acid (E210) 12.1mg per 5ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Syrup.
Clear, colourless or faintly yellow liquid with a cherry flavour.
4.1. Therapeutic indications
Paracodin is indicated in the management of non-productive cough.
4.2. Posology and method of administration
For oral administration.
Adults:
5 to 10 ml up to three times daily.
Children (aged 6 to 12 years):
2.5 to 5 ml 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 in...
4.4. Special warnings and precautions for use
Diabetics are reminded that one 5 ml-spoon of Paracodin Syrup contains 2424.2mg of sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucras...
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 receivin...
4.6. Fertility, pregnancy and lactation
All the narcotic analgesics are able to traverse the placenta and are also excreted in 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 may induce drowsiness. Patients receiving Paracodin Syrup should not drive or operate machinery if affected.
4.8. Undesirable effects
At the usual recommended doses the most frequent side effects are nausea and constipation and less frequently headache and dizziness.
Psychiatric disorders
Confusion, euphoria
Nervous system disord...
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 ...
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 coug...
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...
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, we...
6.1. List of excipients
Purified water
Benzoic acid (E210)
Glycerol 85%
Sucrose
Cherry flavour
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
5 years.Do not store above 25°C. Do not refrigerate or freeze.
Store in the original package in order to protect from light.
6.5. Nature and contents of container
Brown glass (type III) bottle with polyethylene flow restrictor and polypropylene screw cap.
Each bottle contains 100g Paracodin Syrup.
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)
PA1235/004/002
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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