Moment 200

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

IBUPROFEN

Dostupno od:

A. C. R. A. F. SpA (Aziende Chimiche Riunite Angelini Francesco) Viale Amelia 70, Rome 00181, Italy

ATC koda:

M01AE01

INN (International ime):

IBUPROFEN 20 % (W/V)

Farmaceutski oblik:

ORAL DROPS, SOLUTION

Sastav:

IBUPROFEN 20 % (W/V)

Tip recepta:

OTC

Područje terapije:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Status autorizacije:

Withdrawn

Datum autorizacije:

2006-03-15

Uputa o lijeku

1
_ _
_BEFORE_
_ _
_USE _
READ CAREFULLY ALL THE INFORMATION CONTAINED ON THE
PACKAGE INSERT
This is a SELF-MEDICATION drug you can use to treat mild,
transient disorders that can be easily recognised and solved
without
consulting
a
physician.
You
can
purchase
this
medication without prescription. However, it should be taken
correctly
to
ensure
its
efficacy
and
minimise
undesirable
effects. For more information and advice, please consult the
pharmacist. See a physician if the disorder does not go away
after a short treatment period.
MOMENT 200, 20% ORAL DROPS SOLUTION
IBUPROFEN
COMPOSITION
100 ml of solution contains:
Active ingredient: ibuprofen g 20
Excipients:
saccharose,
glycerol,
potassium
hydroxide,
pyridoxine
hydrochloride,
anhydrous
sodium
sulfite,
polysorbate
20,
methyl
p-hydroxybenzoate,
sodium
citrate
dihydrate, sodium saccharine, sodium edetate, mint flavour,
elder flavour, erythrosine (E127), purified water.
2
PHARMACEUTICAL FORM
Moment 200 is marketed in the form of 20% solution for oral
use.
Each packaging contains 1 bottle of 12.5 ml of solution, with
dropper applicator
WHAT IT IS
Moment 200 is included in the analgesic antiinflammatory
group, that is inflammation and pain-relieving medications.
MARKETING AUTHORIZATION HOLDER
Aziende Chimiche Riunite Angelini Francesco
ACRAF S.p.A., Viale Amelia 70, 00181 Rome
MANUFACTURER
A.C.R.A.F.
S.p.A.,
Via
Vecchia
del
Pinocchio,
22-60131
Ancona
WHEN IT SHOULD BE USED
Pain
of
various
origin
and
nature
(headache,
toothache,
neuralgia, osteo-articular and muscular pain, menstrual pain).
Adjuvant in the symptomatic treatment of febrile states and flu.
WHEN IT SHOULD NOT TO BE USED
•
Hypersensitivity
towards
the
constituents
or
strictly
correlated chemical substances and other antirheumatics
(e.g. acetylsalicylic acid).
•
Children under 12 years
3
•
Pregnancy and breastfeeding (refer to “_How to behave in _
_pregnancy and breastfeeding_).
•
Severe
or
active
gastroduodenal
ulcer
or
other
gastric
diseases.
•
Severe liver or kidney disorders.
WHEN IT CAN

Svojstava lijeka

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Moment 200, 20% oral drops solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml of solution contains:
Active ingredient: ibuprofen g 20
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
Drops. 20% solution for oral use.
4.
CLINICAL PARTICULARS
4.1 T
HERAPEUTIC
I
NDICATIONS
Pain of various origin and nature (headache, toothache,
neuralgia, osteo-articular and muscular pain, menstrual
pain). Adjuvant in the symptomatic treatment of febrile
states and flu.
4.2 P
OSOLOGY AND METHOD OF ADMINISTRATION
Drops: adults and children over 12 years: 25-50 drops, 2-
3 times a day (25 drops = Ibuprofen 200 mg).
Do not exceed the dosage of 50 drops 3 times a day.
2
Do not exceed the recommended doses. Elderly patients
in particular should follow the minimum dosage mentioned
above.
Take the medicinal product on a full stomach.
4.3 C
ONTRAINDICATIONS
Do not administer to children under 12, during pregnancy
and breast feeding.
Hypersensitivity
towards
the
constituents
or
other
antirheumatics (acetylsalicylic acid, etc).
Severe or active gastroduodenal ulcer or other gastric
diseases.
Severe liver or kidney disorders.
4.4 S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
In asthmatic patients, the product shall be taken with
caution only on medical advice.
The product contains saccharose, bear this in mind in case
of diabetes or low-calory diets, and _sodium sulphite_, this
substance
may
cause
allergic
reactions
and
severe
asthma attacks in sensitive subjects and particularly in
asthmatic patients. _ The product contains 5.4% ethylic _
_alcohol. Each dose (50 drops) contains up to 0.08744 of _
_ethylic alcohol. Subjects with liver diseases, alcoholism, _
_epilepsy, _
_cerebral _
_traumas _
_or _
_diseases, _
_children _
_and _
_pregnant women, must be cautious. The product may _
_increase or alter the effect of other medicines._
3
As
with
all
medications
inhibiting
the
synthesis
of
prostaglandins and cyclo-oxygenase, use of Moment 200
is not recommended in women plann