Palladone 1.3mg 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:

1.3mg

Farmacevtska oblika:

Oral capsule

Pot uporabe:

Oral

Razred:

Schedule 2 (CD)

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 04070200; GTIN: 5012854073555

Navodilo za uporabo

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 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 severe pain in your abdomen;
•
have liver problems;
•
have a condition whe

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Palladone 1.3mg Capsules
2
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each capsule contains hydromorphone hydrochloride 1.3 mg.
Excipient with known effect:
Each capsule contains 39.35 mg of lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
Hard gelatin capsule with opaque orange, body and clear uncoloured
cap,
marked HNR 1.3.
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 pa