Palladone SR 2 mg prolonged release capsules, hard

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Hydromorphone hydrochloride

Доступна с:

Mundipharma Pharmaceuticals Limited

код АТС:

N02AA; N02AA03

ИНН (Международная Имя):

Hydromorphone hydrochloride

дозировка:

2 milligram(s)

Фармацевтическая форма:

Prolonged-release capsule, hard

Тип рецепта:

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

Терапевтические области:

Natural opium alkaloids; hydromorphone

Статус Авторизация:

Marketed

Дата Авторизация:

1995-12-07

тонкая брошюра

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_PALLADONE_
_® _
_SR_ 2 MG-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 of medicine in the last
two weeks.
If y

Характеристики продукта

Health Products Regulatory Authority
04 September 2023
CRN00CST8
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Palladone SR 2 mg prolonged release capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Palladone SR 2 mg capsules contain hydromorphone hydrochloride 2 mg
equivalent to 1.78 mg hydromorphone.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release capsule, hard. (prolonged release capsule)
Palladone SR 2 mg capsules are gelatin capsules with opaque white
bodies and opaque yellow caps marked HCR2 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:
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.
Patients with renal and hepatic impairment
These patien