Indorem 100 Suppositories

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

INDOMETACIN

Dostopno od:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

Koda artikla:

M01AB01

INN (mednarodno ime):

INDOMETACIN 100 mg

Farmacevtska oblika:

SUPPOSITORY

Sestava:

INDOMETACIN 100 mg

Tip zastaranja:

POM

Terapevtsko območje:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Status dovoljenje:

Withdrawn

Datum dovoljenje:

2006-11-03

Navodilo za uporabo

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
INDOREM 100 MG SUPPOSITORIES
Indometacin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THE
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 your 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.
WHAT IS IN THIS LEAFLET
1.
What Indorem is and what it is used for
2.
What you need to know before you take Indorem
3.
How to take Indorem
4.
Possible side effects
5.
How to store Indorem
6.
Contents of the pack and other information
1.
WHAT INDOREM IS AND WHAT IT IS USED FOR
Indorem suppositories contain the active ingredient indometacin.
This belongs to a group of medicines known as ‘non-steroidal
anti-inflammatory agents’ or
NSAIDs. These work by reducing the body’s ability to produce
inflammation, which may
cause pain and discomfort.
Your doctor has prescribed Indorem for you because you are suffering
from one of the
following:
- rheumatoid arthritis (disease mainly of the joints).
-
osteoarthritis (disease of the joints).
-
ankylosing spondylitis (a form of arthritis which mainly affects the
back).
-
pain, inflammation, and swelling following orthopaedic surgery.
-
musculoskeletal disorders (muscles and bone disorders).
-
period pain.
-
low back pain.
-
disease of the hip joint.
-
acute gouty arthritis (a form of arthritis in which crystals build up
in the joints).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDOREM
DO NOT TAKE INDOREM:
-
if you are allergic to indometacin or any of the other ingredients of
this medicine (listed
Page 2 of 6
in section 6) (for example, if you have experienced breathing
difficulties, skin rashes
which look like nettle rash, or a runny nose)

Lastnosti izdelka

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Indorem 100 mg suppositories
_ _
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 100 mg indometacin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suppository.
Off-white, torpedo shaped suppositories.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Non-steroidal anti-inflammatory agent indicated for the active stages
of rheumatoid arthritis,
osteoarthritis, ankylosing spondylitis, acute musculoskeletal
disorders, degenerative joint
disease of the hip, low-back pain, and acute gouty arthritis.
Also indicated in inflammation, pain and oedema following orthopaedic
procedures; and the
treatment of pain and associated symptoms of primary dysmenorrhoea.
Indorem Suppositories may be used where night pain and morning
stiffness are prominent.
One suppository at bedtime will frequently give relief from pain and
stiffness for 13 to 16
hours after administration.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage of Indorem should be carefully adjusted to suit the needs
of the individual patient.
_Adult dosage for suppositories_: One suppository to be inserted once
or twice a day. One
should be used at bedtime. If another is necessary, it should be used
in the morning.
_Use in the elderly_: Indorem should be used with particular care in
older patients who are more
prone to adverse reactions.
Method of administration
Rectal use.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Page 2 of 9
A history of peptic ulcer or active peptic ulcer; a recurrent history
of gastro-intestinal lesions;
in
patients
who
have
nasal
polyps
associated
with
angioneurotic
oedema,
who
show
sensitivity to indomethacin or any of the ingredients in this product,
or who have experienced
acute asthmatic attacks, urticaria or rhinitis as a result of therapy
with aspirin or other non-
steroidal anti-inflammatory drugs.
Safety for use in children has n