MOMENDOL 12CPS MOLLI 220MG

MOMENDOL 220 MG CAPSULE MOLLI

active ingredients

Each soft capsule contains: Active ingredient: Naprossene sodium 220 mg (equal to naprossene 200 mg) Excipients with known effects: sorbitol and sodium. For the full list of excipients see paragraph 6.1

Excellent

Content of the capsule: Macrogol 600, lactic acid, purified water. Cap coating: Gelatin, Sorbitol/ Special Glicerol (50:50), Brilliant Blue (E133), Lecithin, Medium Chain Triglycerides.

Therapeutic indications

Syntomatic treatment of short duration of mild and moderate pains such as muscle and joint pain, headache, toothache and menstrual pain. Momendol can also be used in the treatment of fever.

Contraindications

• • anti-inflammatory drugs and anti-inflammatory drugs. • children and teenagers under 16.

Population

Population Adults and teenagers over 16 years 1 soft capsule every 8-12 hours. If necessary, a better effect can be obtained by starting, on the first day, with 2 soft capsules followed by 1 soft capsule after 8-12 hours. Do not exceed 3 soft capsules in 24 hours. Seniors and patients with kidney failure Senior patients and patients with mild or moderate kidney failure should not exceed 2 soft capsules in 24 hours. (See paragraph 4.3 and paragraph 4.4). Do not use for more than 7 days for pain and for more than 3 days for fever. Patients should be informed to consult a doctor if pain and fever persist or worsen. Method of administration Momendol must be taken with a glass of water preferably after a meal.

Conservation

Store in the original container to protect the product from moisture.

Warnings

Undesirable effects can be minimized with the use of the minimum effective dose for the shortest possible duration of treatment needed to control symptoms (see below paragraphs on gastrointestinal and cardiovascular risks). Clinical studies and epidemiological data suggest that the use of coxib and some NSAIDs (especially high doses and long-term treatments) may be associated with a modest increase in the risk of arterial thrombotic events (p.es. infarction of myocardial or stroke). Although some data suggest that the use of naprossene (1000 mg/die) may be associated with a lower risk, some risks may not be excluded. There is no sufficient data on the effects of doses of naprossene from 220 to 660 mg per day to reach precise conclusions on possible trombotic risks. There is a close correlation between dose and appearance of serious side effects at gastrointestinal level. Therefore, the effective minimum dosage should always be used. Senior patients, who generally have some degree of impairment of kidney, liver and heart functions, are most exposed to the risk of undesirable effects related to the use of NSAIDs, especially hemorrhages and gastrointestinal perforations that may be fatal. These patients must begin treatment with the lowest dose available. Concurrent use of protective agents (misoprostol or protonic pump inhibitors) must be considered for these patients. Prolonged use of NSAIDs in the elderly is not recommended. Before starting treatment with Momendol Cautisus is required before starting treatment in patients with positive anamnesiums for non-serious hypertension and/or heart failure since retention of fluids, hypertension and edema were found in association with NSAIDs. Diuresis and kidney function should be well monitored, especially in the elderly, in patients treated with diuretics, or as a result of increased surgical interventions that involve hypovolemia. Particular caution is recommended in patients with previous gastrointestinal diseases or non-grainful liver failure, especially elderly. The use of the medicine must be avoided in cases of gastrointestinal pain. Concurrent use of protective agents (misoprostol or protonic pump inhibitors) must be considered in elderly patients, in patients with non-gravious gastrointestinal diseases and for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see below and paragraph 4.5). It is recommended caution in the treatment in regular consumers of high doses of alcohol, as at risk of gastric bleeding. The use of Momendol must be avoided in conjunction with NSAIDs including selective COX-2 inhibitors. During treatment with Momendol If visual disturbances arise treatment with Momendol must be suspended. Severe skin reactions some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see paragraph 4.8). In the early stages of therapy patients seem to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Momendol must be stopped at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Naprossene, like any other NSAID, can mask the symptoms of concomitant infectious diseases. In isolated cases it was reported, in temporal connection with the use of NSAIDs, an exacerbation of infectious inflammations (e.g. the development of necrotizer bundles). Durant treatment with all NSAIDs, at any time, with or without symptoms of notice or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration and perforation, which may be fatal. Patients with problems of gastric tolerability, especially elderly, must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. Caute should be lent to patients taking concomitant drugs that could increase the risk of ulceration or hemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-aggregating agents such as aspirin (see paragraph 4.5). When you experience bleeding or gastrointestinal ulceration in patients taking Momendol treatment should be suspended. Naprossene inhibits piastrinic aggregation and can prolong bleeding time. Patients with clotting alterations or medications that interfere with hemostasis should be carefully monitored while taking Momendol. With regard to associations with other drugs that require caution, see paragraph 4.5 “Interaction with other medicines and other forms of interaction”. Momendol soft capsules contains: • Sorbitol: the sorbitol is a source of fructose. If your doctor told you that you (or the child) are intolerant to some sugars, or if you have a diagnosis of hereditary intolerance to fructose, a rare genetic disease for which patients fail to transform fructose, speak to the doctor before you (or the child) take this medicine. • Sodium: This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially “without sodium”.

Interactions

Contraindicated associations Antiagulants Naprossene can increase the effect of anticoagulants, such as cumarinic anticoagulants (e.g. warfarin, dicumarol) because it extends protrombine time and reduces pyastrinic aggregation, increasing the risk of gastrointestinal hemorrhage (see paragraphs 4.3 and 4.4). Unrecommended associations Non-steroidal anti-inflammatory drugs (NS) or corticosteroids The administration of naprossene with other non-steroidal anti-inflammatory drugs (NSAID) or corticosteroids is not recommended as it increases the risk of gastro-duodenal ulcers and bleeding (see paragraph 4.4). Litio The combination of naprossene and lithium should be avoided; when necessary, strict monitoring of lithium plasma levels and adjustment of the dosage is recommended. Increased lithium levels can induce nausea, polydipsia, polyuria, tremors and confusion. Selective serotonin reuptake inhibitors (SSRIs) Concurrent use of serotonin reuptake selective anti-aggregants and inhibitors (SSRIs) increases the risk of gastrointestinal hemorrhage (see paragraph 4.4). Acetylsalicylic acid Clinical pharmacodynamics data show that the concomitant use of naprossene for more than one consecutive day may inhibit the effect of acetylsalicylic acid at low doses on pyasternic activity and this inhibition may persist for a few days after the interruption of treatment with naprossene. The clinical relevance of this interaction is not known. Ciclosporin Prostaglandin synthesis inhibitors such as naprossene, due to their effect on renal prostaglandins, can cause an increase in nephrotoxicity of cyclosporin. Tacrolimus The contemporary intake of non-steroidal anti-inflammatory drugs and tacrolimus can determine acute renal failure. Metotress A serious increase in the toxicity of methorate has also been observed in the case of therapy combined with naproxins. It is not clear the mechanism of this interaction, which can be due to the reduction of rhenal clearance of the methorate. Associations to be used with precaution Derivati idantoinici e sulfamidici Due to the high bonding of naprossene with plasma proteins, caution is recommended in the treatment of idantoinic or sulfamidic derivatives. Sulfaniluree It is important to take into account the possibility of augmenting the effects of the ties of sulfaniluree (oral antidiabetics) due to the inhibition of plasma proteins. Furosemide and horn diuretics Concurrent use with furosemide can lead to a reduction in the natriuretic effect of diuretics.Beta-blockers Momendol’s association with betabloccants can reduce their antihypertensive effect. Probenecid Concurrent intake of probenecid increases plasma levels of naprossene and significantly extends plasma half-life. Tiazide diuretics, ACE inhibitors and Angiotensin II antagonists NSAIDs can reduce the effect of thiazide diuretics and other antihypertensive drugs. In some patients with impaired kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function) co-administration of an inhibitor ACE or an angiotensin II antagonist and agents inhibiting the cyclo-oxidase system can lead to further deterioration of kidney function, which includes a possible acute kidney failure, generally reversible. Patients should be properly hydrated and should be taken into account the monitoring of kidney function after the start of concomitant therapy, especially in elderly patients. Digoxin Concurrent intake of Momendol with digoxin can alter the serum levels of the latter. Laboratory exams Naproxins can alter bleeding time (which can be increased up to 4 days after the therapy break), creatinine clearance (can decrease), atathemia and blood levels of creatinine and potassium (can increase), liver function tests (can be observed increased transamines). Naproxins can induce false positives in the determination of the urinary values of 17-chetosteroid and can interfere with the urinary determinations of 5-hydroxy-hyndolacetic acid. Naprossene therapy should be interrupted at least 72 hours prior to the execution of cortico-surrenalic function tests.

Effects

Like other NSAIDs, naprossene can induce the following side effects. The most commonly observed side effects are gastrointestinal. Clinical studies and epidemiological data suggest that the use of coxib and some NSAIDs (especially high doses and long-term treatments) may be associated with a modest increase in the risk of arterial thrombotic events (p.es. myocardial infarction or stroke) (see paragraph 4.4). Peptic ulcers, perforation or gastrointestinal hemorrhage may occur, sometimes fatal, especially in the elderly (see paragraph 4.4). After administration of Momendol were reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, ematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4). Less frequently gastritis were observed. Bollose reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rarely). In association with the treatment with the NSAIDs were reported edema, hypertension and heart failure. As with other NSAIDs, allergic reactions of anaphylactic or anaphylactic type may occur in patients with or without a previous exposure to drugs belonging to this class. The characteristic symptoms of an anaphylactic reaction are: severe and sudden hypotension, acceleration or slowing of the heartbeat, tiredness or unusual weakness, anxiety, agitation, loss of knowledge, difficulty breathing or swallowing, itching, hives with or without angioedema, redness of the skin, nausea, vomiting, abdominal cramps, diarrhea. The following table lists the side effects, using the following frequency values scales: very common (>1/10); common (>1/100, 1/1000, 1/10.000, Classification for systems and organs Frequency category Emolinfopoietic system pathologies Very rare: aplastic or hemolytic anemia, heosinophilia, thrombocytopenia, leukopenia, granulocytopenia as agranulocytosis Immune system disorders Not common: allergic reactions (including facial edema and angioedema). Psychiatric disorders Not common: sleep disorder, excitement Very rare: depression, difficulty in concentration Disorders of metabolism and nutrition Raro: hyperglycemia, hypoglycemia Diseases of the nervous system City: headache, drowsiness, dizziness, dizziness Not common: sopore, insomnia Very rare: symil-meningitis reaction aseptic meningitis in patients with autoimmune diseases, cognitive disorders, convulsions Pathologies of the eye Not common: view disorders Very rare: corneal opacity, papillite, retrobulb optic neuritis, papyledema Ear and labyrinth pathologies Not common: tinnitus, hearing disorders Very rare: decrease of hearing Heart disease Very rare: in conjunction with the treatment with the NSAIDs were observed tachycardia, edema, hypertension and heart failure Vascular diseases Not common: ecchimo Very rare: vasculitis Respiratory, chest and mediastinic pathologies Very rare: dispnea, asthma, eosinophilic pneumonia, alveolites Gastrointestinal diseases City: nausea, dyspepsia, vomiting, pyrosis, gastralgia, flatulence Not common: diarrhea, constipation Raro: peptic ulcer, perforation or gastrointestinal bleeding, sometimes fatal; especially in the elderly, there may be ematogenesis, ulcerative stomatitis, a worsening of the colitis and Crohn's disease (see paragraph 4.4) Very rare: colitis, stomatitis, pancreatis, aftous ulcers, esophagitis. Less frequently was observed Notable: gastritis Hepatobiliary diseases Very rare: jaundice, hepatitis (including fatal cases), reduced liver function Pathologies of skin and subcutaneous tissue Not common: skin rash/hardened Very rare: photosensitivity including late skin porphyria (“pseudoporfiria”) or bollous epidermolysis, alopecia, bladder eczema, including Stevens-Johnson syndrome and toxic epidermal necrolysis, multiform erythema, nodosa erythema, fixed erythema, lichen planus, pustole, lupus erythema Musculoskeletal and connective tissue disorders Raro: mialgia, muscle weakness Kidney and urinary pathologies Not common: reduced renal function Raro: glomerulonefrite Very rare: interstitial nephritis, papillar necrosis, nephrosic syndrome, nephritic syndrome, kidney failure, nephropathy, hematuria, proteinuria Systemic pathologies and conditions for administration Not common: bruises, edema (including peripheral edema) Raro: pyresia Very rare: thirst, malaise Diagnostic tests Very rare: increased blood pressure, increased serum creatinine, alteration of liver function tests, hyperkaliemia Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

As signs of overdose may occur thorax, heartburn, diarrhea, nausea, vomiting, abdominal pain, dizziness, disorientation, gastric hemorrhage, drowsiness, increased blood levels of sodium, metabolic acidosis, seizures, alterations of liver function, hypoprotrombinemia, kidney dysfunction, apnea. In case of ingestion/administration of a strong amount of product, accidental or voluntary, the doctor must implement the normal measures required in these cases. It is recommended to empty the stomach and the usual support measures. The prompt administration of an adequate amount of activated carbon can reduce the absorption of the medicinal product.

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: • cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); • kidney dysfunction, which can progress in kidney failure with oligo-idroamnios; the mother and the newborn, at the end of pregnancy, to: • possible prolongation of the bleeding time, and anti-aggregating effect that can also be necessary at very low doses; • inhibition of uterine contractions resulting in delay or extension of labor, Consequently, Momendol is contraindicated during pregnancy (see paragraph 4.3).

Food

Since NSAIDs are excreted in breast milk, the medicinal product is contraindicated during breastfeeding (see paragraph 4.3).

Fertility

There are some evidence that drugs that inhibit the synthesis of prostaglandins and cyclooxygenases could cause female fertility problems through an effect on ovulation. This is reversible if you stop treatment.

The use of Momendol, as of any drug inhibitor of the synthesis of prostaglandins and cyclooxygenase is not recommended in women who intend to begin a pregnancy.

The administration of Momendol should be suspended in women who have fertility problems or who are subject to fertility surveys.

Source: Farmadati