Momendol 220mg film-coated tablet

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NAPROXEN

Available from:

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

ATC code:

M01AE02

INN (International Name):

NAPROXEN 200 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

NAPROXEN 200 mg

Prescription type:

OTC

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2006-03-15

Patient Information leaflet

_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.
MOMENDOL, 220-MG FILM-COATED TABLETS
NAPROXEN SODIUM
COMPOSITION
Each tablet contains:
Active ingredient:
Naproxen 200 mg (as Naproxen sodium 220 mg)
Tablet core:
lactose
monohydrate,
maize
starch,
cellulose
microcrystalline,
povidone
(K25),
sodium starch glycollate, silica colloidal hydrated, magnesium
stearate.
Tablet film coating: hypromellose, macrogol 400, titanium dioxide (E
171), talc.
PRESENTATION
Momendol is a film-coated tablet white, round, biconvex
Each package contains 12 film-coated tablets
WHAT IT IS
Momendol is a non-steroidal analgesic-antinflammatory-antirheumatic
drug; this class of
medications acts against pain, inflammation, fever and it is useful in
the symptomatic treatment of
rheumatic diseases.
HOLDER OF THE MARKETING AUTHORISATION
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A., Viale
Amelia 70, 00181 Rome,
Italy.
MANUFACTURER
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona,
Italy.
WHY IT IS USED
Momendol is used for short-term symptomatic treatment of mild to
moderate pain such as joint and
muscle pain, headache, toothache and menstrual pain. Momendol may also
be useful in the relief of
fever.
WHEN IT SHOULD NOT BE USED
Hypersensitivity to the active substance, to any of the excipients or
other chemically related
substances.
Naproxen is contraindicated in patients suffering from allergic
manifestations such as asthma,
urticaria, rhinitis, nasal polyps, angioedema, anaphylactic or
anaphylactoid reactions induced by
acetylsalicylic ac

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Momendol 220 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Naproxen 200 mg (as Naproxen sodium 220 mg)
Excipient with known effect: 41,8 mg lactose and and 1 mmol (23mg) of
sodium
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
White, round, biconvex film-coated tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term symptomatic treatment of mild to moderate pain such as
joint and
muscle pain, headache, toothache and menstrual pain. Momendol may also
be
useful in the relief of fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and adolescents over age 16: 1 film-coated tablet every 8-12
hours.
On the first day, if needed, a better effect may be obtained by
starting with 2 film-
coated tablets followed by 1 film-coated tablet after 8-12 hours. Do
not exceed 3
film-coated tablets in 24 hours. In elderly and in patients with mild
to moderate
renal impairment dosages should not exceed 2 film-coated tablets in 24
hours (see
4.3,
_Contraindications _
and
_4.4 Special warnings and special precautions for use). _
Momendol should be administered preferably after meal. Do not take for
more than
7 days for pain and 3 days for the treatment of fever. Patients should
be advised to
consult their physician if pain or fever persist or worsen.
4.3
CONTRAINDICATIONS
Hypersensitivity
to
the
active
substance,
to
any
of
the
excipients
or
other
chemically-related substances.
Naproxen is contraindicated in patients suffering from allergic
manifestations such
as
asthma,
urticaria,
rhinitis,
nasal
polyps,
angioedema,
anaphylactic
or
anaphylactoid reactions induced by acetylsalicylic acid, analgesics,
NSAIDs and
anti-rheumatic medicinal products due to possible cross-sensitivity.
Naproxen is
contraindicated in patients with previous gastro-intestinal bleeding,
active peptic
ulcer, chronic inflammatory bowel diseases (ulcerative colitis,
Crohn's disease),
severe liv