Paracodin 10 mg/g Oral Drops, Solution
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
13-08-2020
Summary of Product characteristics
(SPC)
13-08-2020
Active ingredient:
Dihydrocodeine hydrorhodanide
Available from:
Teofarma S.R.L.
ATC code:
N02AA; N02AA08
INN (International Name):
Dihydrocodeine hydrorhodanide
Dosage:
10 milligram(s)/gram
Pharmaceutical form:
Oral drops, solution
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Natural opium alkaloids; dihydrocodeine
Authorization status:
Marketed
Authorization date:
1991-10-04
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACODIN® 10 MG/G ORAL DROPS, SOLUTION
(DIHYDROCODEINE HYDRORHODANIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
- them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
- side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
:
1. What Paracodin Drops are and what they are used for
2. What you need to know before you take Paracodin Drops
3. How to take Paracodin Drops
4. Possible side effects
5. How to store Paracodin Drops
6. Contents of the pack and other information
The information in this leaflet applies to both adults and children
who have been prescribed
the medicine.
1. WHAT PARACODIN DROPS ARE AND WHAT THEY ARE USED FOR
Paracodin Drops are for oral administration.
The active substance in Paracodin Drops is dihydrocodeine
hydrorhodanide.
Paracodin Drops belongs to a group of medicines called cough
suppressants. Paracodin Drops are
used to treat a dry (non-productive) cough.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACODIN DROPS
DO NOT TAKE PARACODIN DROPS IF YOU:
•
are allergic to dihydrocodeine hydrorhodanide or to any of the
ingredients in this medicine
(see section 6)
•
suffer from breathing difficulties such as asthma
•
have addiction problems
•
suffer from confusion
•
have head injuries and are suffering from raised intracerebral
pressure (an increase in the
pressure of the fluid around the brain)
•
are suffering from hypotension (low blood pressure)
•
are suffering from a disorder of the blood called hypovolaemia
(decrease in the volume of
circulating blood in the body).
•
are taking an antidepressant of the mono-amine oxidase inhibitor
(MAOI) g
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
12 August 2020
CRN009SHY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
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.
Excipients: benzoic acid (E201) 2mg per 20-drop dose For full list of
excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution.
Clear, brown solution.
4 CLINICAL PARTICULARS
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: 14-20 drops taken up to three times daily.
Children (aged 6-12 years): 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 and conditions
in which intracerebral pressure is elevated (at high doses),
hypotension and hypovolaemia.
Do not give Paracodin to children below the age of 6 years.
Do not give to patients who are receiving monoamine oxidase inhibitors
or who have received these within the previous 14
days.
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 CONTAINS BENZOIC ACID
This medicine contains 2 mg benzoic acid in each 20-drop dose
Dosage should be reduced in the elderly, in hypothyroidism, in chronic
hepatic disease and in renal insufficiency. Prolonged
regular use, except under medical supervision, may lead to physical
and psychological dependence
(addiction) and result in withdrawal symptoms such as restlessness and
irritability, once the drug is stopped.
Patients with pre-existing s
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