Palladone 1.3 mg 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:

1.3 milligram(s)

Forma farmaceutică:

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:

1995-12-07

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
_PALLADONE_
_® _
1.3 MG AND 2.6 MG 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 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 _
is and what it is used for
2.
What you need to know before you take
_PALLADONE_
3.
How to take
_PALLADONE_
4.
Possible side effects
5.
How to store
_PALLADONE_
6.
Contents of the pack and other information
1.
WHAT _PALLADONE_ IS AND WHAT IT IS USED FOR
These capsules have been prescribed for you to relieve severe pain.
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_
DO NOT TAKE _PALLADONE_ 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 of medicine in the last
two weeks.
WARNINGS AND PRECAUTIONS
Before treatment with these capsu

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 1.3 mg capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Palladone 1.3 mg capsules contain hydromorphone hydrochloride 1.30 mg
equivalent to 1.16 mg hydromorphone.
Excipients with known effect:
Each Palladone 1.3 mg capsule contains 39.35 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard(capsule).
Palladonecapsules 1.3 mg are gelatin capsules with clear uncoloured
caps and opaque orange bodies, containing white to
off-white spherical pellets. The capsule is marked HNR 1.3.
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:
The dosage is dependent upon the severity of the pain and the
patient's previous history of analgesic requirements. 1.3 mg of
hydromorphone hydrochloride has an efficacy equivalent to 10 mg of
morphine sulphate given orally. 1.3 mg and 2.6 mg
capsules are available. Treatment should normally be started at a
dosage of 1.3 mg or 2.6 mg hydromorphone hydrochloride 4
hourly. Increasing severity of pain will require increased dosage of
hydromorphone using 1.3 mg and 2.6 mg capsules alone or
in combination with prolonged release hydromorphone products to
achieve the desired relief.
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).
Elderly
As with adults, the elderly should be dose-titrated with
_PALLADONE_capsules in order to achieve adequate analgesia. It should
be noted however, that the elderly may require a lower dosage than
adults to achieve adequate analgesia.
Paediatric population
Not recommended for use in children under 12 years.
Pat