Palladone SR 16 mg Prolonged-release Capsules

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Hydromorphone hydrochloride

Disponibil de la:

Mundipharma Pharmaceuticals Limited

Codul ATC:

N02AA; N02AA03

INN (nume internaţional):

Hydromorphone hydrochloride

Dozare:

16 milligram(s)

Forma farmaceutică:

Prolonged-release capsule, hard

Tip de prescriptie medicala:

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

Zonă Terapeutică:

Natural opium alkaloids; hydromorphone

Statutul autorizaţiei:

Marketed

Data de autorizare:

1993-03-02

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_PALLADONE_
_® _
_SR_ 2 MG, 4 MG, 8 MG, 16 MG AND 24 MG PROLONGED-RELEASE CAPSULES,
HARD
Hydromorphone hydrochloride
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 side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What
_PALLADONE SR _
is and what it is used for
2.
What you need to know before you take
_PALLADONE SR_
3.
How to take
_PALLADONE SR_
4.
Possible side effects
5.
How to store
_PALLADONE SR _
6.
Contents of the pack and other information
1.
WHAT _PALLADONE SR_ IS AND WHAT IT IS USED FOR
These capsules have been prescribed for you to relieve severe pain
over a period of 12 hours. They contain
the active ingredient hydromorphone which is a strong analgesic
(‘painkiller’) that belongs to a group of
medicines called opioids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE_ PALLADONE SR_
DO NOT TAKE _PALLADONE SR _IF YOU:
•
are allergic (hypersensitive) to hydromorphone or any of the other
ingredients of the capsules (see
section 6 ‘Further Information’);
•
have breathing problems, such as severe chronic obstructive airways
disease, respiratory depression or
severe asthma. Symptoms may include breathlessness, coughing or
breathing more slowly and weakly
than expected;
•
have a sudden severe pain in your abdomen (acute abdomen);
•
have a condition where the bowel does not work properly (paralytic
ileus);
•
are taking a type of medicine known as a monoamine oxidase inhibitor
(examples include tranylcypromine,
phenelzine, isocarboxazid, moclobemide and linezolid), or you have
taken this type

Caracteristicilor produsului

Health Products Regulatory Authority
04 September 2023
CRN00CST8
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Palladone SR 16 mg Prolonged-release Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release capsule, hard, contains hydromorphone
hydrochloride 16 mg equivalent to 14.24 mg hydromorphone.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release Capsule, hard (Prolonged-release Capsule)
Gelatin capsules with clear uncoloured bodies and opaque brown caps
marked HCR16 containing white to off-white spherical
pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of severe pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and adolescents over 12 years:
Palladone SR capsules should be administered at 12-hourly intervals.
The dosage is dependent upon the severity of the pain
and the patient's previous history of analgesic requirements. 4 mg of
hydromorphone hydrochloride has an analgesic efficacy
equivalent to 30 mg of morphine sulphate given orally. 2 mg, 4 mg, 8
mg, 16 mg and 24 mg capsules are available.
Treatment should normally be started at a dosage of 4 mg prolonged
release hydromorphone hydrochloride 12-hourly.
Increasing severity of pain will require an increased dosage of
hydromorphone hydrochloride prolonged release products
alone or in combination with immediate release hydromorphone product
to achieve the desired relief.
Patients who are not currently receiving opioids should be titrated
with immediate release hydromorphone hydrochloride
initially, prior to changing to Palladone SR capsules.
Transferring patients between oral and parental hydromorphone:
Switching patients from parenteral hydromorphone to oral hydromorphone
should be guided by the sensitivity of the
individual patient. The oral starting dose should not be overestimated
(for oral bioavailability see section 5.2).
Paediatric population
Not recommended for use in children under 12 years.
Elderly
As with adults, the el