ALMIRAL 100MG SUPPOSITORIES

Country: Malasja

Lingwa: Ingliż

Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredjent attiv:

DICLOFENAC SODIUM

Disponibbli minn:

KOMEDIC SDN BHD

INN (Isem Internazzjonali):

DICLOFENAC SODIUM

Unitajiet fil-pakkett:

10Pieces Pieces; 100Pieces Pieces

Manifatturat minn:

MEDOCHEMIE LTD (COGOLS FACILITY)

Fuljett ta 'informazzjoni

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ALMIRAL SUPPOSITORIES
Diclofenac Sodium (100mg)
1
WHAT IS IN THIS LEAFLET
1.
What Almiral Suppositories is used
for
2.
How Almiral Suppositories works
3.
Before
you
use
Almiral
Suppositories
4.
How to use Almiral Suppositories
5.
While you are using it
6.
Side effects
7.
Storage
and
disposal
of
Almiral
Suppositories
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT ALMIRAL SUPPOSITORIES IS USED
FOR
Almiral
Suppositories
relieve
pain,
reduce swelling and ease inflammation
in
conditions
affecting
the
joints,
muscles and tendons.
HOW ALMIRAL SUPPOSITORIES WORKS
Almiral
Suppositories
contains
diclofenac sodium which belongs to a
group of medicines called non-steroidal
anti-inflammatory
drugs
(NSAIDs).
NSAIDS
relieves
the
symptoms
of
inflammation, such as pain and swelling,
by
blocking
the
production
of
the
molecules (prostaglandins) responsible
for pain and inflammation.
BEFORE YOU USE ALMIRAL SUPPOSITORIES
_- When you must not use it _
Do not use Almiral Suppositories if you:
-
are
allergic
to
diclofenac
sodium,
aspirin, ibuprofen, other NSAID, or
any of the other ingredients of this
medicine (listed in section 6). Signs
of a hypersensitivity reaction include
swelling
of
the
face
and
mouth
(angioedema),
breathing
problems,
runny nose, skin rash or any other
allergic type reaction.
-
have ulcer in stomach or digestive
tract.
-
have had stomach or bowel problems
after you have taken other NSAIDs.
-
have severe heart, kidney or liver
failure.
-
have
any
heart
problem
or
blood
vessel blockage
have or have had problems with your
blood circulation (peripheral arterial
disease).
-
are more than six months pregnant.
-
have rectal inflammation.
_ _
Tell your doctor if you recently had or
you are going to have a surgery of the
stomach
or
intestinal
tract
before
receiving/taking/using
Almiral
Suppositories, as Almiral Suppositories
can sometimes worsen wound healing in
your gut after surgery.
_Pregnancy and Lactation _
If you are

Karatteristiċi tal-prodott

1
ALMIRAL – PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Almiral 100mg suppositories
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Almiral suppositories contain 100 mg of Diclofenac sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suppositories
Almiral suppositories are white, smooth, homogenous, torpedo-shaped
suppositories, for rectal administration.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of:
•
rheumatoid arthritis,
•
osteoarthritis,
•
ankylosing spondylitis
Almiral suppositories are not indicated for use in children.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
One suppository daily usually administered at night. In more severe
cases combined therapy with tablets is
recommended. The daily dose should not exceed 150mg.
As a general recommendation, the dose should be individually adjusted.
Adverse effects may be minimized by
using the lowest effective dose for the shortest duration necessary to
control symptoms (see section 4.4).
ESTABLISHED CARDIOVASCULAR DISEASE OR SIGNIFICANT CARDIOVASCULAR RISK
FACTORS
Treatment with diclofenac is generally not recommended in patients
with established cardiovascular disease
(congestive heart failure, established ischemic heart disease,
peripheral arterial disease) or uncontrolled
hypertension, or significant risk factors for cardiovascular disease
(e.g. hypertension, hyperlipidaemia, diabetes
mellitus and smoking) should be treated with diclofenac only after
careful consideration and only at doses
≤100mg daily if treated for more than 4 weeks (see section 4.4).
Method of administration
Not to be taken by mouth, as per rectal administration only. The
suppositories should be inserted well into the
rectum. It is recommended to insert the suppositories after passing
stools.
4.3.
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
•
Active, gastric or intestinal ulcer, bleeding or perforation.
•
History of gastrointestinal bleeding or perforation, rel