Paracodin 0.20% w/w Syrup

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Dihydrocodeine tartrate

Dostępny od:

Teofarma S.R.L.

Kod ATC:

N02AA; N02AA08

INN (International Nazwa):

Dihydrocodeine tartrate

Dawkowanie:

0.2 percent weight/weight

Forma farmaceutyczna:

Syrup

Typ recepty:

Product subject to prescription which may not be renewed (A)

Dziedzina terapeutyczna:

Natural opium alkaloids; dihydrocodeine

Status autoryzacji:

Marketed

Data autoryzacji:

1991-10-04

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACODIN® 0.20% W/W SYRUP
(DIHYDROCODEINE HYDROGEN TARTRATE)
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 Syrup is and what it is used for
2. What you need to know before you take Paracodin Syrup
3. How to take Paracodin Syrup
4. Possible side effects
5. How to store Paracodin Syrup
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 SYRUP IS AND WHAT IT IS USED FOR
Paracodin
Syrup
is
for
oral
administration.
The
active
ingredient
in
Paracodin
Syrup
is
dihydrocodeine hydrogen tartrate. Paracodin Syrup belongs to a group
of medicines called cough
suppressants. Paracodin is used to treat a dry (non-productive) cough.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACODIN SYRUP
DO NOT TAKE PARACODIN SYRUP IF YOU:
•
are allergic to dihydrocodeine hydrogen tartrate 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 any head injuries or 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) group, or hav

Charakterystyka produktu

Health Products Regulatory Authority
12 August 2020
CRN009SHY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
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 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: 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 injuries and condition in
which intracerebralpressure is elevated (at high doses), hypotension
and hypovolaemia.
Do not give Paracodin to children below the age of 6 years.
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
sucrase-isomaltase insufficiency should not take this
medicine.
This medicine contains 12.1mg benzoic acid (E210) in each 5ml dose
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.
Dosage should be reduced in the elderly, in hypothyroidism, in chronic
hepatic disease and in renal insufficiency.
Health Products Regulatory Authority
12 August 2020
CRN009SHY
Page 2 of 5
Prolonged regular use, except under medical supervision, may lead to
physical and psychological dependence (addiction)