Pardelprin MR 75mg capsules

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Indometacin

可用日期:

Actavis UK Ltd

ATC代码:

M01AB01

INN（国际名称）:

Indometacin

剂量:

75mg

药物剂型:

Modified-release capsule

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 10010100; GTIN: 5012617005038

资料单张

PARDELPRIN MR 75MG CAPSULES
Indometacin modified release capsules
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

If any of the side effects gets serious or if you notice any side
effects not listed in this leaflet,
please tell 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 symptoms are the same as yours.
IN THIS LEAFLET:
1.
WHAT PARDELPRIN MR CAPSULES ARE AND WHAT THEY ARE USED FOR
2.
BEFORE YOU USE PARDELPRIN MR CAPSULES
3.
HOW TO USE PARDELPRIN MR CAPSULES
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PARDELPRIN MR CAPSULES
6.
FURTHER INFORMATION
1.
WHAT PARDELPRIN MR CAPSULES ARE AND WHAT THEY ARE USED FOR
Pardelprin MR capsules belong to a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
These medicines are pain killers which reduce swelling.
Pardelprin MR capsules are for:

inflammatory diseases of the joints such as rheumatoid arthritis,
osteoarthritis and degenerative hip disease

disorders occurring around a joint such as inflammation of:
-
fluid surrounding a joint (bursitis)
-
tendons (tendinitis)
-
a joint membrane (synovitis)
-
the lining of a tendon (tenosynovitis)
-
the capsule surrounding a joint (capsulitis)

pain and stiffness in the backbone (ankylosing spondylitis)

sprains and strains (acute muscle and bone disorders)

lower back pain

pain and swelling following muscle or bone surgery

period pain.
2.
BEFORE YOU TAKE
PARDELPRIN MR
CAPSULES
DO NOT TAKE PARDELPRIN MR CAPSULES IF YOU:

are in the
LAST THREE MONTHS OF PREGNANCY

are
ALLERGIC (HYPERSENSITIVE) TO INDOMETACIN
or any of the ingredients of Pardelprin MR capsules (see
section 6)

are
ALLERGIC (HYPERSENSITIVE) TO ASPIRIN, IBUPROFEN OR OTHER NSAIDS
or you have developed signs of
asthma (wheezing), runny nose, swelling of the face, lips, tongue or
thr

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pardelprin MR Capsules 75mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 75mg of Indometacin
3
PHARMACEUTICAL FORM
Dark blue (head) and clear (body) hard gelatin Size 2 capsules printed
“C” and
“IR” in grey
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indometacin has non-steroidal analgesic and anti-inflammatory
properties.
It is indicated for the following conditions:
•
active stages of rheumatoid arthritis, osteoarthritis, ankylosing
spondylitis,
degenerative joint disease of the hip, acute musculoskeletal disorders
and
low back pain
•
periarticular disorders such as bursitis, tendinitis, synovitis,
tenosynovitis
and capsulitis
•
inflammation, pain and oedema following orthopaedic procedures
•
treatment of pain and associated symptoms of primary dysmenorrhoea
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Method of Administration _
For oral administration
Pardelprin should always be given with food or milk to reduce the
chance of
gastro-intestinal disturbance.
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration necessary to control symptoms (see section 4.4).
_Adults_: One capsule once or twice daily, depending on patient needs
and
response.
_Dysmenorrhoea_: One capsule a day, starting with onset of cramps or
bleeding,
and continuing for as long as symptoms usually last.
_Elderly_: The elderly are at increased risk of the serious
consequences of
adverse reactions. If an NSAID is considered necessary, the lowest
effective
dose should be used and for the shortest possible duration. The
patient should
be monitored regularly for GI bleeding during NSAID therapy
_Children_:_ _Safety for use in children has not been established (see
Section 4.3).
4.3
CONTRAINDICATIONS
•
Hypersensitivity to indometacin or to any of the excipients.
•
NSAIDs are contraindicated in patients with angioneurotic oedema.
•
NSAIDs
are
contraindicated
in
patients
who
have
previously
shown