Palladone SR 24mg 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:

24mg

Farmacevtska oblika:

Modified-release capsule

Pot uporabe:

Oral

Razred:

Schedule 2 (CD)

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 04070200; GTIN: 5012854073524

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
_PALLADONE® SR_ 2 MG, 4 MG, 8 MG, 16 MG AND 24 MG PROLONGED-RELEASE
CAPSULES
Hydromorphone hydrochloride
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 SR_ capsules are and what they are used for
2. What you need to know before you take _PALLADONE SR_ capsules
3. How to take _PALLADONE SR_ capsules
4. Possible side effects
5. How to store _PALLADONE SR_ capsules
6. Contents of the pack and other information
1. WHAT _PALLADONE SR_ 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 SR_ CAPSULES
DO NOT TAKE _PALLADONE SR_ 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 incl

Lastnosti izdelka

OBJECT 1
PALLADONE SR CAPSULES 24 MG
Summary of Product Characteristics Updated 25-Nov-2020 | Napp
Pharmaceuticals Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
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6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
_PALLADONE SR_ 2 mg, 4 mg, 8 mg, 16 mg, 24 mg prolonged-release
Capsules
2. Qualitative and quantitative composition
Each capsule contains hydromorphone hydrochloride 2 mg, 4 mg, 8 mg, 16
mg, 24 mg.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged release capsule.
Hard gelatin capsule containing spherical prolonged release pellets.
The 2 mg capsules are yellow/white capsules marked HCR2
The 4 mg capsules are pale blue/clear capsules marked HCR4
The 8 mg capsules are pink/clear capsules marked HCR8
The 16 mg capsules are brown/clear capsules marked HCR16
The 24 mg capsules are dark blue/clear capsules marked HCR24
4. Clinical particulars
4.1 Therapeutic indications
For the relief of severe pain in cancer.
_PALLADONE SR_ capsules are indicated in adults and children aged