OxyContin 10mg modified-release tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Oxycodone hydrochloride

Inapatikana kutoka:

Napp Pharmaceuticals Ltd

ATC kanuni:

N02AA05

INN (Jina la Kimataifa):

Oxycodone hydrochloride

Kipimo:

10mg

Dawa fomu:

Modified-release tablet

Njia ya uendeshaji:

Oral

Darasa:

Schedule 2 (CD)

Dawa ya aina:

Caution - AMP level prescribing advised

Bidhaa muhtasari:

BNF: 04070200; GTIN: 5012854046108

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
_OXYCONTIN_
®
5 MG, 10 MG, 15 MG, 20 MG, 30 MG, 40 MG, 60 MG, 80 MG AND 120 MG
PROLONGED RELEASE
TABLETS
Oxycodone 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 possible side effects
not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1.
What _OXYCONTIN_ tablets are and what they are used for
2.
What you need to know before you take _OXYCONTIN_ tablets
3.
How to take _OXYCONTIN_ tablets
4.
Possible side effects
5.
How to store _OXYCONTIN_ tablets
6.
Contents of the pack and other information
_ _
1.
WHAT _OXYCONTIN_ TABLETS ARE AND WHAT THEY ARE USED FOR
These tablets have been prescribed for you by your doctor to relieve
moderate to severe pain over a period
of 12 hours. They contain the active ingredient oxycodone which
belongs to a group of medicines
called strong analgesics or ‘painkillers’.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE _OXYCONTIN_ TABLETS
DO NOT TAKE _OXYCONTIN_ TABLETS IF YOU:

are allergic (hypersensitive) to oxycodone, or any of the other
ingredients of the tablets (listed in
section 6’);

have breathing problems, such as severe chronic obstructive lung
disease, severe bronchial asthma
or severe respiratory depression. Your doctor will have told you if
you have any of these
conditions. Symptoms may include breathlessness, coughing or breathing
more slowly or weakly
than expected;

have a condition where the small bowel does not work properly
(paralytic ileus), your stomach
empties more slowly than it should (delayed gastric emptying) or you
have severe pain in your
abdomen;

have

Tabia za bidhaa

OBJECT 1
OXYCONTIN 5 MG PROLONGED RELEASE TABLETS
Summary of Product Characteristics Updated 30-May-2018 | Napp
Pharmaceuticals Limited
1. Name of the medicinal product
_OXYCONTIN_ 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 120
mg prolonged release tablets
2. Qualitative and quantitative composition
5 mg tablet contains 4.5 mg of oxycodone as 5 mg of oxycodone
hydrochloride
10 mg tablet contains 9.0 mg of oxycodone as 10 mg of oxycodone
hydrochloride
15 mg tablet contains 13.5 mg of oxycodone as 15 mg of oxycodone
hydrochloride
20 mg tablet contains 18.0 mg of oxycodone as 20 mg of oxycodone
hydrochloride
30 mg tablet contains 27 mg of oxycodone as 30 mg of oxycodone
hydrochloride
40 mg tablet contains 36.0 mg of oxycodone as 40 mg of oxycodone
hydrochloride
60 mg tablet contains 54 mg of oxycodone as 60 mg of oxycodone
hydrochloride
80 mg tablet contains 72.0 mg of oxycodone as 80 mg of oxycodone
hydrochloride
120 mg tablet contains 108 mg of oxycodone as 120 mg of oxycodone
hydrochloride
Excipient with known effect:
Contains lactose monohydrate.
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
Prolonged release round, convex tablet.
The 5 mg tablets are light blue, marked OC on one side and 5 on the
other.
The 10 mg tablets are white, marked OC on one side and 10 on the
other.
The 15 mg tablets are grey, marked OC on one side and 15 on the other.
The 20 mg tablets are pink, marked OC on one side and 20 on the other.
The 30 mg tablets are brown, marked OC on one side and 30 on the
other.
The 40 mg tablets are yellow, marked OC on one side and 40 on the
other.
The 60 mg tablets are red, marked OC on one side and 60 on the other.
The 80 mg tablets are green, marked OC on one side and 80 on the
other.
The 120 mg tablets are purple, marked OC on one side and 120 on the
other.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of moderate to severe pain in patients with cancer
and post-operative pain. For the
treatment of severe pain requiring the use of a strong