Paracodin 10 mg Tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Dihydrocodeine Hydrogen Tartrate

Disponible desde:

Teofarma S.R.L.

Código ATC:

N02AA; N02AA08

Designación común internacional (DCI):

Dihydrocodeine Hydrogen Tartrate

Dosis:

10 milligram(s)

formulario farmacéutico:

Tablet

tipo de receta:

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

Área terapéutica:

Natural opium alkaloids; dihydrocodeine

Estado de Autorización:

Marketed

Fecha de autorización:

1978-04-01

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACODIN® 10 MG TABLETS (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 Tablets are and what they are used for
2. What you need to know before you take Paracodin Tablets
3. How to take Paracodin Tablets
4. Possible side effects
5. How to store Paracodin Tablets
6. Contents of the pack and other information
1. WHAT PARACODIN TABLETS ARE AND WHAT THEY ARE USED FOR
PARACODIN TABLETS ARE FOR ORAL ADMINISTRATION.
The active ingredient in Paracodin 10mg tablets is dihydrocodeine
hydrogen tartrate. Paracodin
Tablets belongs to a group of medicines called cough suppressants.
Paracodin 10 mg tablets are
used to treat a dry (non-productive) cough.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACODIN
TABLETS
DO NOT TAKE PARACODIN TABLETS IF YOU:
•
are allergic to dihydrocodeine hydrogen tartrate or to any of the
ingredients in the tablets (see
section 6)
•
suffer from breathing difficulties such as asthma
•
have addiction problems
•
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 have
taken an MAOI during the last 14 days (MAOIs include phenelzine and
tranylcypromine).
Paracodin

Ficha técnica

Health Products Regulatory Authority
12 August 2020
CRN009SHY
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracodin 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg Dihydrocodeine Hydrogen Tartrate.
Excipients with known effect: 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 into equal doses.
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 and children over the age of 12 years: 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 and conditions
in which intracerebral pressure is elevated (at high doses),
hypotension, hypovolaemia.
Do not give Paracodin to children below the age of 12 years.
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 should be reduced in the elderly and in patients with
hypothyroidism, chronic hepatic disease or renal insufficiency.
Prolonged regular use of high dosage, 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 seizure disorders should be observed with
caution when prescribed this product.
Patients with rare hereditary