BEFORE USING, CAREFULLY READ THE INFORMATION CONTAINED IN THE EXPLANATORY LEAFLET
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.

 

MOMENDOL
220 mg film-coated tablets
Sodium naproxen



COMPOSITION
Each tablet contains:
Active ingredient: naproxen mg 200 (equivalent to sodium naproxen 220 mg)
Excipients
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

PHARMACEUTICAL FORM
Momendol is marketed in the form of white, round and biconvex film-coated tablets.
Each packaging contains 12 film-coated tablets.

WHAT IT IS
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.

MARKETING AUTHORIZATION HOLDER
Aziende Chimiche Riunite Angelini Francesco - ACRAF S.p.A., Viale Amelia 70, 00181 Rome, Italy

MANUFACTURER AND FINAL INSPECTOR
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22
60131 Ancona, Italy

WHEN 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.

WHEN 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.

WHEN 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.

HOW 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.

PRECAUTIONS FOR USE

  • There is 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.
  • Owing 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”.
  • Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not use the medicinal product.

MEDICATIONS 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.

Combinations 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.

Consult your physician or pharmacist if you are using other medicinal products.

IT 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 time.
  • If pain or fever persist, new symptoms develop or the sore area turns red/swollen, consult the doctor.
  • As 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.

NOTES 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.

HOW TO USE THIS MEDICINAL PRODUCT
How much
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 physician.

When and how long
Do not use for more than 7 days for treatment of pain and for over 3 days for fever.
Consult your doctor if the problem is repeated or has been recently showing changes in characters.

Which way
Take the medicinal product preferably after a meal.
Swallow the film-coated tablets whole with water or any other drink.

WHAT 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, convulsions.
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.

UNDESIRABLE EFFECTS
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, flatulence.
Nervous system: headache, sleepiness, dizziness.
Uncommon (>1/1000, <1/100)
Gastrointestinal tract: diarrhea, constipation.
Nervous system: sleep disturbances, excitation, visual disorders, tinnitus, hearing disturbances.
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 and perforation.
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.

Observance of directions contained in the explanatory leaflet reduces the risk of undesirable effects.
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).

SHELF LIFE AND STORAGE
Warning: do not use the medication after the expiry date reported on the packaging.
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.

REVISION OF THE EXPLANATORY LEAFLET, AIFA DECREE: June 2005.

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