Momendol 12 capsules

Product Description

Tablets for mild to moderate pain.

Indications

Momendol is indicated in adults and adolescents over 16 years of age for the short-term symptomatic treatment of mild to moderate pain such as muscle and joint pain, headache, toothache, and menstrual pain. It can also be used as a pain reliever. can also be used in the treatment of fever.

Composition

Active ingredients
Naproxen 200 mg (corresponding to naproxen sodium 220 mg).

Excipients
Tablet core: lactose monohydrate, maize starch, microcrystalline cellulose, povidone (K25), sodium starch glycolate, colloidal anhydrous silica, magnesium stearate.
Film-coating: hypromellose, macrogol 400, titanium dioxide (E 171), talc.

Directions for use and Dosage

Adults and adolescents over 16 years: the recommended dose is 1 capsule every 8-12 hours.

For best results, start treatment with 2 capsules on the first day, and continue with 1 capsule after 8-12 hours. Do not exceed 3 capsules in 24 hours. For the elderly or those suffering from kidney disease (mild and moderate renal insufficiency), do not exceed 2 capsules in 24 hours.

Do not exceed the indicated dose without medical advice.

The medicine should preferably be taken on a full stomach (after breakfast, lunch, or dinner). Do not use Momendol for more than 7 days for pain and for more than 3 days for fever.

Consult your doctor if pain or fever persists or worsens. Swallow the capsule whole with water or another drink.

Warnings

Undesirable effects can be minimized by using the lowest effective dose for the longest duration of treatment. Dosage should be as short as necessary to control symptoms (see gastrointestinal and cardiovascular risks below). Clinical trial and epidemiological data suggest that use of coxibs and some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Although some data suggest that the use of naproxen (1000 mg/day) may be associated with a lower risk, some risks cannot be excluded. There are insufficient data on the effects of naproxen at low doses (600 mg/day) to draw definitive conclusions on possible thrombotic risks. There is a close correlation between dosage and the occurrence of severe gastrointestinal adverse effects. Therefore, the lowest effective dosage should always be used. Caution is advised (discuss with your doctor or pharmacist) before starting treatment in patients with a history of hypertension and/or heart failure, as fluid retention, hypertension, and edema have been reported in association with NSAID treatment. Diuresis and renal function must be carefully monitored, particularly in the elderly, in patients with chronic congestive heart failure or chronic renal failure, in patients treated with diuretics, or following major surgery resulting in hypovolemia.
In patients with severe heart failure, worsening of the condition may occur. Particular caution is advised in patients with a history of gastrointestinal disease or liver failure and in patients with current or previous allergic reactions, as in these subjects the product may cause bronchospasm, asthma, or other allergic reactions.
If visual disturbances occur, treatment with Momendol must be discontinued. Serious skin reactions, some of them fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at higher risk early in therapy, with the onset of the reaction occurring in most cases within the first month of treatment. Momendol should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Naproxen, like any other NSAID, may mask the symptoms of concomitant infectious diseases. In isolated cases, exacerbation of infectious inflammation has been reported in temporal connection with the use of NSAIDs (e.g., the development of necrotizing fasciitis). Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported at any time during treatment with all NSAIDs, with or without warning symptoms or a previous history of serious gastrointestinal events.
This medicine contains:

• Lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
• Sodium: This medicine contains 23 mg sodium per tablet, equivalent to 1.15% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Pregnancy and breastfeeding

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Results of epidemiological studies report an increased risk of miscarriage, cardiac malformation, and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality. Additionally, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimesters of pregnancy, naproxen should not be administered unless clearly necessary. If naproxen is used by a woman attempting to conceive, or during the first and second trimesters of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and newborn, at the end of pregnancy, to: possible prolongation of bleeding time, and an antiplatelet effect that may occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor. Therefore, naproxen is contraindicated during the third trimester of pregnancy. Since NSAIDs are excreted in breast milk, as a precautionary measure, their use is contraindicated during breastfeeding. There is some evidence that drugs that inhibit the synthesis of prostaglandins and cyclooxygenase may cause problems with female fertility by affecting ovulation. This effect is reversible upon discontinuation of treatment.

Storage

Store in the original package to protect from light and moisture.

Format

12 soft capsules of 220 mg.