MOMENDOL 220 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

NAPROXEN SODIUM

Available from:

Aziende Chimiche Riunite Angelini Francesco

ATC code:

M01AE02

INN (International Name):

NAPROXEN SODIUM

Dosage:

220 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Propionic acid derivatives

Authorization status:

Authorised

Authorization date:

2003-05-16

Patient Information leaflet

_RX_ 
_Due to the different legal status in different countries certain Rx  information
has been_ 
_added to the PL. The Rx information is marked in
grey shadings, If it is not indicated for_ 
_Rx  the grey shaded
parts will be deleted in the national version._ 

PACKAGE LEAFLET: INFORMATION FOR THE USER  
MOMENDOL, 220 MG FILM-COATED TABLETS 
NAPROXEN SODIUM 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START  TAKING
THIS MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU. 

Always take this medicine exactly as described in this leaflet or
as your doctor or pharmacist have 
told you  
Keep this leaflet. You may need to read it again. 
-  Ask your pharmacist if you need more information
or advice. 
-  If you get any side effects, talk to your doctor pharmacist.
This includes any possible side effects 
not listed in this leaflet. See section 4. 
-  You must talk to  a doctor if you do not feel better or
if you feel worse after 7 days for pain and 3 
days for the treatment of fever 

Read all of this leaflet carefully before you start taking this
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 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:  

_RX_ 
_Due to the different legal status in different countries certain Rx  information
has been_ 
_added to the PL. The Rx information is marked in
grey shadings, If it is not indicated for

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
Naproxen 200 mg (as Naproxen sodium 220 mg)
Excipient with known effect: 41,8 mg lactose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Momendol
is indicated in adults and adolescents above 16 years 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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.
Elderly/Renal impairment
In elderly and in patients with mild to moderate renal impairment
dosages should not exceed 2 film-coated tablets in 24
hours (see sections 4.3 and 4.4).
Paediatric population
Momendol
is contraindicated in children aged 12 years. (see section 4.3).
Method of administration
Momendol should be administered preferably after meal. Swallow
film-coated whole tablets with some water. 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,
or to any of the excipients listed in section 6.1 or other
chemically-related
substances.
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