Palladone 2.6mg capsules

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Hydromorphone hydrochloride

Dostopno od:

Napp Pharmaceuticals Ltd

Koda artikla:

N02AA03

INN (mednarodno ime):

Hydromorphone hydrochloride

Odmerek:

2.6mg

Farmacevtska oblika:

Oral capsule

Pot uporabe:

Oral

Razred:

Schedule 2 (CD)

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 04070200; GTIN: 5012854073586

Navodilo za uporabo

7360-11
THIS MEDICINE CONTAINS HYDROMORPHONE WHICH
IS AN OPIOID, WHICH CAN CAUSE ADDICTION. YOU
CAN GET WITHDRAWAL SYMPTOMS IF YOU STOP
TAKING IT SUDDENLY.
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.
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. See section 4.
IN THIS LEAFLET:
1.
What
_PALLADONE_
capsules are and what they
are used for
2.
What you need to know before you take
_PALLADONE_
capsules
3.
How to take
_PALLADONE_
capsules
4.
Possible side effects
5.
How to store
_PALLADONE_
capsules
6.
Contents of the pack and other information
1. WHAT _PALLADONE_ CAPSULES ARE AND WHAT
THEY ARE USED FOR
This medicine has been prescribed for you
for the relief of severe pain. It contains
hydromorphone, which belongs to a class
of medicines called opioids, which are ‘pain
relievers’. The medicine has been prescribed
for you and should not be given to anyone
else. Opioids can cause addiction and you may
get withdrawal symptoms if you stop taking it
suddenly. Your doctor should have explained
how long you will be taking it for and when it is
appropriate to stop, how to do this safely.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
_PALLADONE_ CAPSULES
DO NOT TAKE _PALLADONE_ CAPSULES IF YOU:
• are allergic to hydromorphone or to any of
the other ingredients of the capsules (listed in
section 6);
• have a condition where you breathe more
slowly or weakly than expected (respiratory
depression);
• have a severe pain in your abdomen;
• have liver problems;
• have a condition where the small bowel does
not work properly (paralytic ileus);
• are taking a type of medicine known as a
mono

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Palladone 2.6mg Capsules
2
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each capsule contains hydromorphone hydrochloride 2.6 mg.
Excipient with known effect:
Each capsule contains 78.70 mg of lactose.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsule, hard.
Hard, gelatin capsule with opaque red body and clear uncoloured cap
marked HNR 2.6
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of severe pain in cancer.
Palladone capsules are indicated in adults and children aged 12 years
and above.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Prior to starting treatment with opioids, a discussion should be held
with
patients to put in place a strategy for ending treatment with
hydromorphone in
order to minimise the risk of addiction and drug withdrawal syndrome
(see
section 4.4).
Transferring patients between oral and parenteral hydromorphone
The dose should be based on the following ratio: 3 mg of oral
hydromorphone is
equivalent to 1 mg of intravenously administered hydromorphone. It
must be
emphasised that this is a general guide to the dose required.
Inter-patient
variability requires that each patient is carefully titrated to the
appropriate dose.
Adults and children aged 12 years and above
_PALLADONE_ capsules should be used at 4 hourly intervals. The dosage
is
dependent upon the severity of the pain and the patient’s previous
history of
analgesic requirements. 1.3 mg of hydromorphone has an efficacy
approximately equivalent to 10 mg of morphine given orally. A patient
presenting with severe pain should normally be started on a dosage of
one
_PALLADONE_ capsule 4 hourly. Increasing severity of pain may require
increased
dosage of hydromorphone to achieve the desired relief.
Elderly and patients with renal impairment
The elderly and patients with renal impairment should be dose titrated
with
_PALLADONE_ capsules in order to achieve adequate analgesia. It should
be noted,
however, that these patients