Itami 140 mg medicated plaster

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Diclofenac sodium

זמין מ:

Fidia Farmaceutici S.p.A.

קוד ATC:

M02AA; M02AA15

INN (שם בינלאומי):

Diclofenac sodium

כמות:

140 milligram(s)

טופס פרצבטיות:

Medicated plaster

סוג מרשם:

Product subject to prescription which may be renewed (B)

איזור תרפויטי:

Antiinflammatory preparations, non-steroids for topical use; diclofenac

מצב אישור:

Marketed

תאריך אישור:

2017-11-10

עלון מידע

WHAT IS IN THIS LEAFLET
1.
What Itami is and what it is used for
2.
What you need to know before you use Itami
3.
How to use Itami
4.
Possible side effects
5.
How to store Itami
6.
Contents of the pack and other information
1. WHAT ITAMI IS AND WHAT IT IS USED FOR
Itami is a medicine that relieves pain. It belongs to
a
group
of
medicines
known
as
non-steroidal
anti-
inflammatory drugs (NSAIDs).
Itami is used for the local symptomatic and short term
treatment (max. 7 days) of pain associated with acute
strains, sprains or bruises on the arms and legs as a
result of injuries in adolescents from 16 years of age and
adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
ITAMI
DO NOT USE ITAMI
-
if you are ALLERGIC to DICLOFENAC or any of the OTHER
INGREDIENTS of this medicine (listed in section 6);
-
if you are ALLERGIC to any OTHER NON-STEROIDAL ANTI-
INFLAMMATORY DRUG (NSAID, e.g. acetylsalicylic acid
or ibuprofen);
-
if you have EVER DEVELOPED ASTHMA ATTACKS, HIVES
or SWELLING AND IRRITATION INSIDE THE NOSE after
taking acetylsalicylic acid or any other NSAID;
-
if
you
are
suffering
from
an
active
STOMACH
OR
DUODENAL ULCER;
-
ON INJURED SKIN (e.g. skin abrasions, cuts, burns),
INFECTED
SKIN
OR
SKIN
AFFECTED
BY
EXUDATIVE
DERMATITIS OR ECZEMA.
-
if you are in the last three months of pregnancy;
-
if you are a child or an adolescent younger than
16 years of age.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING
ITAMI
•
if you suffer or have previously suffered from bronchial
asthma or allergies; you may experience a bronchial
muscle cramp (bronchospasm), which makes breathing
difficult.
•
if you NOTICE A SKIN RASH that develops after applying
the medicated plaster. If this happens, immediately
remove the medicated plaster and stop the treatment.
•
if you suffer from disorders of the KIDNEYS, HEART or
LIVER, or have previously suffered from a STOMACH OR
INTESTINAL ULCER or INTESTINAL INFLAMMATION or a
TENDENCY TO BLEEDING.
Side effects can be reduced by using the lowest effective
dose for the shor

מאפייני מוצר

Health Products Regulatory Authority
06 March 2024
CRN00DS5P
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Itami 140 mg medicated plaster
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each medicated plaster contains diclofenac as 140 mg diclofenac
sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated plaster
White 10x14 cm sized self-adhesive plaster made of non-woven fabric on
one and paper on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Local symptomatic and short term treatment (max. 7 days) of pain in
acute strains, sprains or bruises of the extremities
following blunt trauma in adolescents from 16 years of age and adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ _
_Adults and adolescents from 16 years of age_
One medicated plaster should be applied to the painful area twice
daily, in the morning and in the evening. The maximum daily
dose is 2 medicated plasters, even if there is more than one injured
area to be treated. Therefore, only one painful area can be
treated at a time.
_Duration of use_
Itami is for short-term treatment.
The duration of use should not exceed 7 days. The therapeutic benefit
of longer use has not been established.
Itami is to be used for the shortest duration necessary to control
symptoms.
_Elderly patients and patients with renal or hepatic impairment_
This medicinal product should be used with caution in elderly patients
who are more prone to adverse events (see also section
4.4).
In treatment of elderly and patients with renal or hepatic impairment
see section 4.4.
_Paediatric population_
The safety and efficacy of Itami in children and adolescents under 16
years of age has not been established (see also section
4.3).
In adolescents aged 16 years and over, if this medicinal product is
required for more than 7 days for pain relief or if the
symptoms worsen, the patient/parents of the adolescent is/are advised
to consult a doctor.
METHOD OF ADMINISTRATION
Cutaneous use.
Health Products Reg