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FEMINAX ULTRA is a brand name for Naproxen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indicated for the treatment of primary dysmenorrhoea in women aged 15 to 50 years.
Verbatim from this product's MHRA label. Tap a section to expand.
For oral administration. To be taken preferably with or after food swallowed whole with water.
Adolescents (post puberty) and adult females between the ages of 15 and 50:
On the first day 2 tablets (500 mg) should be taken initially and then one tablet (250 mg) after 6 to 8 hours if needed. On the second and third day, if needed, one tablet (250mg) should be taken every 6 to 8 hours. Not more than 3 tablets to be taken per day.
The maximum duration of continuous treatment in any one cycle (period) is 3 days.
Gastro-intestinal: the most commonly-observed adverse events are gastrointestinal in nature. 4). 4 - Special warnings and precautions for use) have been reported following administration. Less frequently, gastritis has been observed.
Hypersensitivity:
Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritis, urticaria, purpura, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis, erythema multiforme and Stevens-Johnson Syndrome).
Cardiovascular:
Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment. 4). Eosinophilic pneumonitis and aseptic meningitis have also been reported.
Other adverse events reported less commonly include:
Renal: Nephrotoxicity in various forms, including glomerular nephritis, interstitial nephritis, nephrotic syndrome, haematuria and renal failure.
Hepatic:
Abnormal liver function, hepatitis and jaundice.
Neurological and special senses:
Visual disturbances, optic neuritis, headaches, paraesthesia, depression, confusion, hallucinations, tinnitus, hearing impairment, vertigo, dizziness, convulsions, insomnia, inability to concentrate, cognitive dysfunction, malaise, fatigue and drowsiness.
Haematological:
Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia, hyperkalaemia and haemolytic anaemia.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see warnings on GI and cardiovascular risks below). Cardiovascular and cerebrovascular effects Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.
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 (for example myocardial infaction or stroke).
Although data suggest that the use of naproxen (1000mg daily) may be associated with a lower risk, some risk cannot be excluded. There are insufficient data regarding the effects of low dose naproxen 250mg – 750mg daily to draw firm conclusions on possible thrombotic risks.
Gastrointestinal effects GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events. Although naproxen is usually well tolerated, there have been reported incidences of gastro-intestinal bleeding.
Therefore, patients with a history of gastro- intestinal disease should not take naproxen without being closely monitored by their doctor. Patients with a history of GI toxicity should report any unusual abdominal symptoms. 5). If GI bleeding or ulceration occurs in patients receiving the product, the treatment should be withdrawn.
Serious gastro-intestinal adverse reactions may occur at any time in patients on therapy with non-steroidal anti-inflammatory drugs. The duration of therapy does not seem to change the risk of occurrence. Studies to date have not identified any subset of patients not at risk of developing peptic ulcer and bleeding.
Naproxen is contra-indicated in patients with a history of, or active peptic ulceration and active gastrointestinal bleeding. Naproxen is contra-indicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Naproxen is contra-indicated for patients with known hypersensitivity to naproxen, naproxen sodium formulations or any of the excipients. Naproxen should not be given to patients in whom aspirin or other non-steroidal anti-inflammatory/analgesic drugs induce the syndrome of asthma, rhinitis or urticaria.
Naproxen should not be given to patients with severe heart failure.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Naproxen in United Kingdom.
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Dermatological:
Photosensitivity, alopecia. Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare).
However, elderly and debilitated patients tolerate gastro-intestinal ulceration or bleeding less well than others. Most of the serious gastro-intestinal events associated with non-steroidal anti-inflammatory drugs occurred in this patient population.
8). The anti-inflammatory and antipyretic activities of Naproxen may reduce inflammation and fever, thereby diminishing their utility as diagnostic signs. In patients with a history of bronchial asthma or allergic disease, administration of naproxen may elicit bronchospasm.
Naproxen decreases platelet aggregation and prolongs bleeding time. The use of NSAIDs may result in a deterioration of renal function. Patients with impaired renal function, or cardiac impairment should only use naproxen with great caution and under their doctor’s supervision who will monitor serum creatinine and/or creatinine clearance.
When the baseline creatinine clearance is less than 20 ml/min naproxen is not recommended. When renal blood flow is compromised, patients should have renal function assessed before and during naproxen therapy. A reduction in daily dosage should be considered to avoid the possibility of excessive accumulation of naproxen metabolites in these patients.
Patients with impaired liver function should only take naproxen under the supervision of their doctor. When liver function is impaired, the plasma concentration of unbound naproxen is increased. The significance of this is unknown but caution is advised when high doses are required.
Haematological Patients who have coagulation disorders or patients who are receiving drug therapy that interferes with haemostasis should be carefully observed if naproxen-containing products are administered. g. dicoumarol derivatives) can be at increased risk of bleeding if given naproxen- containing products.
Anaphylactic (anaphylactoid) reactions In susceptible individuals hypersensitivity reactions may occur. Anaphylactic (anaphylactoid) reactions may occur both in patients with and without a history of hypersensitivity or exposure to aspirin, other non-steroidal anti-inflammatory drugs or naproxen-containing products.
g. asthma), rhinitis and nasal polyps. Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome. 8). The product should be discontinued at the first appearance of skin rash, mucosal lesion, or any other sign of hypersensitivity.
Steroids Patients taking steroids should not take naproxen except under the supervision of their doctor. If steroid dosage is eliminated or reduced during therapy, the steroid dosage should be reduced slowly and the patients must be observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of arthritis.
Ocular effects Studies have not shown any changes in the eye attributable to naproxen administration. Rarely, adverse ocular disorders including papillitis, retrobulbar optic neuritis and papilledema, have been reported in users of NSAIDs including naproxen, although a cause-and-effect relationship cannot be established; accordingly, patients who develop visual disturbances during treatment with […]