USING, CAREFULLY READ THE INFORMATION CONTAINED IN THE EXPLANATORY
This is a SELF-TREATMENT medicinal product, which can be used in
case of mild and transitory ailments easy to be identified and solved
with no need for medical help. Though purchasable without prescription,
it is to be correctly used in order to ensure efficacy and reduce
side effects. For better information and advice, consult a pharmacist.
If the problem should persist after a short period of treatment,
advise with your physician.
220 mg film-coated tablets
Each tablet contains:
Active ingredient: naproxen mg 200 (equivalent to sodium naproxen
Core: lactose monohydrate - maize starch – microcrystalline
cellulose - povidone (K25) – carboxymethyl starch - anhydrous colloidal
silica – magnesium stearate.
Film-coating: hypromellose - macrogol 400 - titanium dioxide
(E 171) – talcum
Momendol is marketed in the form of white, round and biconvex film-coated
Each packaging contains 12 film-coated tablets.
Momendol is included in the analgesic anti inflammatory-anti- rheumatic
non steroid group, therefore medicines that fight pain, inflammation and
fever and are useful in the symptomatic treatment of rheumatic pathologies.
Aziende Chimiche Riunite Angelini Francesco - ACRAF S.p.A., Viale Amelia
70, 00181 Rome, Italy
AND FINAL INSPECTOR
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22
60131 Ancona, Italy
IT SHOULD BE USED
Momendol should be used for symptomatic short-term treatment of mild and
moderate pain as muscular and articular pain (e.g. back ache, stiff neck)
headache, toothache, menstrual pain.
Momendol may also be used in the treatment of fever.
IT SHOULD NOT BE USED
In cases of hypersensitivity towards the active ingredient and any
of the excipients or other strictly correlated chemical substances.
Naproxen is contraindicated in patients with allergic emergences,
such as asthma, urticaria, rhinitis, nasal polyps, angioedema and
anaphylactic or anaphylactoid reactions induced by acetylsalicylic
acid, analgesic agents, non steroidal antiinflammatory drugs (NSAIDs)
and/or antirheumatic drugs, owing to the possible cross sensitivity.
Naproxen is contraindicated in patients with history of gastrointestinal
hemorrhage, active peptic or duodenal ulceration, intestinal chronic
inflammatory diseases (ulcerative colitis, Crohn’s disease),
severe hepatic failure, severe uncompensated heart failure, severe
renal failure (creatinine clearance <30ml/min), angioedema, during
acute care with diuretic agents, in subjects with hemorrhage in progress
and at risk of hemorrhage during therapy with anticoagulant agents
(See the“ Medications and food able to alter the effect of the
drug” and “ It is important to know that” paragraph)
Pregnancy, starting from the sixth month, and breatfeeding (See the
“What to do during pregnancy and breastfeeding” paragraph)
Contraindicated in children under 12.
IT SHOULD ONLY BE USED ON MEDICAL ADVICE
During the first five months of pregnancy (See the “What to do
during pregnancy and breastfeeding” paragraph)
Children between 12 and 15.
Medical advice should also be sought where the disorders above have developed
in the past.
TO BEHAVE IN PREGNANCY AND BREASTFEEDING
As all NSAIDs, Momendol should not be used starting from the sixth month
of pregnancy and during breastfeeding.
As all NSAIDs, during the first five months of pregnancy, Momendol should
only be used where necessary and after consulting the physician and assessing
with him the individual risk/benefit ratio. If you suspect or wish to
plan a pregnancy, consult the physician.
a close correlation between the dose and the appearance of severe
undesirable gastrointestinal effects. Therefore, it should always
be used the minimal effective dose.
The treatment of hypertensive patients or patients with impaired heart
or kidney functions calls for special caution (prostaglandin-inhibiting
drugs may cause fluid retention and kidney failure, particularly in
patients with impaired kidney function).
Diuresis and renal function should be monitored with special attention
in elderly patients, in patients with chronic congestive heart failure
or chronic kidney failure and in patients under diuretic treatment,
following major surgery involving hypovolemia.
- In patients
with severe heart failure, such condition may grow worse.
Special caution is recommended in patients with history of gastrointestinal
diseases or hepatic impairment and in patients with in-progress or
past allergic occurrences, as in these subjects the product may cause
bronchospasm, asthma or other allergic events.
- If visual
disorders develop, the treatment with Momendol should be discontinued.
- As all
NSAIDs, naproxen may mask symptoms of concomitant infectious diseases.
In isolated cases, exacerbation of infection-related inflammations
(such as development of necrotizing fascitis) has been reported within
use of NSAIDs.
Elderly patients, where renal, hepatic and cardiac functions commonly
show somehow impaired, are more exposed to the risk of developing
undesirable effects correlated to use of NSAIDs. Prolonged use of
NSAIDs is not recommended in the elderly.
Naproxen inhibits platelet aggregation and can prolong the bleeding
time. Patients with altered coagulation or under treatment with hemostasis-affecting
medications should be closely monitored during treatment with Momendol.
to risk of stomach bleeding, caution is recommended in patients who
regularly drink high doses of alcohol.
- The product
should not be used in cases of gastrointestinal pain.
- As regards
caution required by combinations with other medicinal products, see
“Medications and food able to alter the effect of the drug”.
with rare hereditary problems of galactose intolerance, Lapp lactase
deficiency or glucose-galactose malabsorption should not use the medicinal
AND FOOD ABLE TO ALTER THE EFFECT OF THE DRUG
Combinations not recommended
Combinations of naproxen and corticosteroids or other non-steroidal
antiinflammatory drugs (NSAIDs) is contraindicated as it causes an
increased risk of gastrointestinal ulceration or bleeding.
As it prolongs prothrombin time and reduces platelet aggregation,
Naproxen strengthens the anticoagulant effect of cumarinic anticoagulants
(such as warfarin, dicumarol).
Combinations of naproxen and lithium should be avoided: where they
are necessary, close monitoring of lithium plasma levels and dosage
adjustment are recommended.
to be used with caution
Caution is recommended in concomitant treatment with hydantoin or
sulpha drugs, owing to naproxen high binding with plasma proteins.
Special caution is also recommended in patients being treated with
cyclosporins, tacrolimus, sulfonylureas, loop diuretics, methotrexate,
beta-blockers, ACE-inhibitors, probenecid, thiazides and digoxin.
Naproxen can alter bleeding time (which may show increased up to 4
days since discontinuation of treatment), creatinine clearance (possible
reduction), nitremia and creatinine and potassium hematic levels (possible
increase), and hepatic function tests (possible increase in transaminases).
Naproxen may cause false positive results in the assessment of 17-ketosteroid
urinary values and can affect the 5-hydroxy-indoleacetic acid urinary
assessment. The naproxen treatment should be discontinued 72 hours
at least before carrying out corticosuprarenal function tests.
your physician or pharmacist if you are using other medicinal products.
IS IMPORTANT TO KNOW THAT
In asthmatic patients, the product is usually contraindicated.
If undesirable effects correlated to analgesic or antiarthritic treatments
have occurred in the past, the product is usually contraindicated.
Naproxen inhibits the platelet aggregation and can prolong the bleeding
If pain or fever persist, new symptoms develop or the sore area turns
red/swollen, consult the doctor.
a rule, the product does not affect the ability to drive and use machines.
However, should they experience drowsiness, dizziness and/or depression,
subjects who perform activities requiring vigilance should use caution.
The product is included in a group of drugs (NSAIDs) that may cause
fertility problems in women. This effect is reversible on discontinuation
of the treatment.
OF HEALTH EDUCATION
More o less frequently, during our every-day life, all of us happen to
experience a number of pains, of various origins and nature: muscle-skeleton
pain, headache, menstrual pain, toothache, etc.
One of the main uses of analgesic, anti-inflammatory, anti-rheumatic non-steroidal
self-medication drugs is the treatment of occasional muscle-skeleton pains
(not chronic), for which dosages as usually prescribed by doctors would
imply a less favourable risk/benefit rate.
The occasional muscle-skeleton pains are acute affections which generally
affect the back (lumbago, sciatica), the inguinal area, the neck (wryneck),
or a top limb (cervical-brachial neuralgia). All these acute pains may
suddenly arise after a strain (as the lifting of a heavy weight) associated
to a torsion of the body or after a fall, or after a chill or due to a
lengthy incorrect position. In lumbago or sciatica, the pain initially
localised in the lower part of the back may spread to the nape of the
neck, to the thigh, to the calf and to the foot. Should the pain persist
or the area concerned turn diffusely swollen, consult a physician.
TO USE THIS MEDICINAL PRODUCT
Adults and patients over 16: 1 film-coated tablet every 8-12 hours.
It is possible to obtain increased benefit starting the therapy with 2
film-coated tablets, followed by 1 film-coated tablet after 8-12 hours.
Elderly and patients with mild or moderate renal insufficiency should
not exceed 2 film-coated tablets in the 24 hours (ref. to “When
it should not be used” and “Precautions for use”).
Warning: do not exceed the prescribed dose unless recommended by your
and how long
Do not use for more than 7 days for treatment of pain and for over 3 days
Consult your doctor if the problem is repeated or has been recently showing
changes in characters.
Take the medicinal product preferably after a meal.
Swallow the film-coated tablets whole with water or any other drink.
TO DO IN CASE OF OVERDOSING
Overdose signs may be numbness, heartburn, diarrhoea, nausea, vomiting,
sleepiness, increase of the hematic levels of sodium, metabolic acidosis,
If you have accidentally or voluntarily swallowed an excess dose of Momendol,
inform the doctor so that the measures usually required in these cases
can be implemented. Take this explanatory leaflet with you.
Gastric depletion and usual supportive therapy are recommended.
The prompt administration of an adequate quantity of active carbon (active
carbon is a medicine: if necessary ask your pharmacist) may reduce the
absorption of the product.
As with other analgesic, anti-inflammatory, anti-rheumatic non-steroidal
drugs (NSAIDs), naproxen may induce the following side effects:
Common (> 1/100, <1/10)
Gastrointestinal tract: nausea, dyspepsia, vomiting, heartburn, gastralgia,
Nervous system: headache, sleepiness, dizziness.
Uncommon (>1/1000, <1/100)
Gastrointestinal tract: diarrhea, constipation.
Nervous system: sleep disturbances, excitation, visual disorders, tinnitus,
Others: allergic reactions (including facial edema and angioedema), shivering,
cutaneous reaction/pruritus, edema (including peripheral edema), ecchymosis,
impaired renal function.
Rare (> 1/10000, <1/1000)
Gastrointestinal tract: gastrointestinal ulcer, gastrointestinal bleeding
Very rare (<1/10000) including isolated cases:
Gastrointestinal tract: colitis, stomatitis.
Hepato-biliary system: jaundice, hepatitis, altered hepatic function.
Hemato-lymphatic system: aplastic or hemolytic anemia, increased blood
pressure, thrombocytopenia, granulocytopenia.
Thoracic and respiratory system: dyspnea, asthma.
Others: photosensitivity, alopecia, vesicular rash, tachycardia, aseptic
meningitis-like symptoms in patients with autoimmune diseases.
As with other analgesic, anti-inflammatory, anti-rheumatic non-steroidal
drugs (NSAIDs), anaphylactic or anaphylactoid allergic reactions may take
place in patients with or without prior experience of this class of medicines.
The characteristic symptoms of an anaphylactic reaction are: severe and
sudden hypotension, increased or decreased heart beat, unusual weakness
or tiredness, anxiety, restlessness, unconsciousness, difficulty in breathing
or swallowing, pruritus, ourticaria with or without angiodema, reddening
of the skin, nausea, vomiting, cramp like abdominal pain, diarrhea.
When these undesirable effects occur, it is advisable for you to consult
your physician or your pharmacist.
of directions contained in the explanatory leaflet reduces the risk of
It is important that undesirable effects not listed in this explanatory
leaflet are reported in to your doctor or pharmacist.
Ask for and fill in the undesirable effects report from available at the
pharmacy (B form).
LIFE AND STORAGE
Warning: do not use the medication after the expiry date reported on the
Keep the product out of the reach of children.
Keep box and explanatory leaflet, so that information concerning the drug
is available all the time.
OF THE EXPLANATORY LEAFLET, AIFA DECREE: June 2005.