Feminax Ultra tablets

Size – 9

Active ingredient: Naproxen 250mg

Feminax ultra is the first ever medicine containing the active ingredients Naproxen 250mg tablets to be made available from over the counter. Feminax Ultra is designed for the treatment of period pain (primary dysmenorrhoea) for women aged between 15 to 50 years.

It is estimated that 40-70% of women of reproductive age experience period pain during their menstrual cycles. For up to 10% of women period pain can interfere with their daily activities. In England, approximately 1 million naproxen prescritptions are issued every year.

Naproxen 250mg is a non-steroidal anti-inflammatory drug. It inhibits the synthesis of prostaglandins, which are thought to be responsible for the development of period pain. Clinical guidelines recommend OTC analgesics including NSAIDs for the treatment of primary dysmenorrhoea.

Main uses and Indications:

Feminax Ultra –Naproxen 250mg  is indicated for the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis), osteoarthrosis (degenerative arthritis), ankylosing spondylitis, acute gout, acute musculo-skeletal disorders (such as sprains and strains, direct trauma, lumbo-sacral pain, cervical spondylitis, tenosynovitis and fibrositis) and dysmenorrhoea.

Contra Indications:
Pregnancy
Active peptic ulceration
Hypersensitivity to naproxen or naproxen sodium formulations

Directions and Dosage:
Adults:
For rheumatoid arthritis, osteoarthrosis and ankylosing spondylitis, the starting dose and usual maintenance dose is 500 mg to 1 g per day taken in two doses at twelve hour intervals. Where 1g per day is needed, the suggested regimen is two Feminax ultra (Naproxen 250 mg) tablets twice daily.

In the following cases a loading dose of 750 mg or 1g per day for the acute phase is recommended:

a.	In patients reporting severe night-time pain and/or morning stiffness.
b.	In patients being switched to Feminax ultra (Naproxen 250 mg) from a high dose of another anti-rheumatic compound.
c.	In osteoarthrosis where pain is the predominant symptom.

For the patient who requires 750 mg per day and whose night-time pain and/or morning stiffness are most troublesome, 500 mg should be taken before retiring and 250 mg upon awakening. For the patient whose day-time pain and reduced mobility are most troublesome, 500 mg should be taken on awakening and 250 mg upon retiring.

In acute gout, the recommended dosage is 750 mg at once, and then 250 mg every eight hours until the attack has passed.

For the treatment of acute musculo-skeletal disorders, the recommended dose is 250 mg twice or thrice daily; most patients will require only seven days' treatment but some patients may require up to fourteen days' treatment.

In dysmenorrhoea the recommended regimen is 500 mg initially, followed by 250 mg every six to eight hours.

Precautions:

Do not overdose

Not recommended for children under 14 years.

Since the potential exists for cross-sensitivity reactions, Feminax ultra (Naproxen 250 mg) 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.

Side effects:

Gastro-intestinal:
The more frequent reactions are nausea, vomiting, abdominal discomfort, constipation and epigastric distress. More serious reactions which may occur are gastro-intestinal bleeding and peptic ulceration (sometimes with haemorrhage and perforation).

Dermatological/hypersensitivity:
Skin rashes, urticaria, angio-oedema. Anaphylactic reactions to naproxen and naproxen sodium formulations and eosinophilic pneumonitis may occur.

CNS: Headache, insomnia, inability to concentrate and cognitive dysfunction have been reported.

Haematological: Thrombocytopenia, granulocytopenia, aplastic anaemia and haemolytic anaemia may occur.

Other: Tinnitus, visual disturbances, hearing impairment, vertigo, mild peripheral oedema. Jaundice, fatal hepatitis, reversible renal failure, nephrotic syndrome, interstitial nephritis and ulcerative stomatitis have been reported.

Special Precautions:

Feminax ultra (Naproxen 250 mg) should be given under close supervision to patients with a history of gastro-intestinal disease.

Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease.

Feminax ultra (Naproxen 250 mg) decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined.

Mild peripheral oedema has been observed in a few patients receiving Feminax ultra (Naproxen 250 mg).

The use of Feminax ultra (Naproxen 250 mg) should be avoided in patients who are breast-feeding.

Use in patients with impaired renal function:

As naproxen is eliminated to a large extent (95%) by urinary excretion via glomerular filtration, it should be used with great caution in patients with impaired renal function. The monitoring of serum creatinine and/or creatinine clearance is advised in these patients. Feminax ultra (Naproxen 250 mg) is not recommended in patients having baseline creatinine clearance less than 20 ml/minute.

Use in patients with impaired liver function:
Chronic alcoholic liver disease and probably also other forms of cirrhosis reduce the total plasma concentration of naproxen but the plasma concentration of unbound naproxen is increased. Caution is advised and lower doses might be required when using Feminax ultra (Naproxen 250 mg) in patients with hepatic diseases.

Use in the elderly:

Although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised and lower doses might be required. For the effect of reduced elimination in the elderly, refer to the section - Use in patients with impaired renal function