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PJ Online homeThe Pharmaceutical Journal
Vol 275 No 7361 p161
6 August 2005

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Products

    New medicines Prescription Products SPC changes

Recall Lipitor and 3M Health Care inhalers


New medicines

Seractil
Composition: Dexibuprofen.
Presentation: Film-coated tablets.
Class: Anti-inflammatory and antirheumatic product.
Indications: Symptomatic treatment for the relief of pain and inflammation associated with osteoarthritis or other forms of mild to moderate pain such as muscular-skeletal pain or dental pain. Acute symptomatic treatment of pain during menstrual bleeding.
Dosage: 600 to 900mg daily, divided in up to three single doses. Maximum single dose 400mg.
Precautions: Care is recommended in conditions that predispose patients to the gastrointestinal adverse effects of NSAIDs, and in elderly patients. In the rare instances where gastrointestinal bleeding or ulceration occurs, dexibuprofen should be discontinued immediately. In the treatment of patients with heart failure, hypertension, renal or hepatic disease, especially during concomitant diuretic treatment, the risk of fluid retention and a deterioration in renal function must be taken into account. See SPC.
Contraindications: Include patients in whom substances with a similar action precipitate attacks of asthma, bronchospasm, acute rhinitis or cause nasal polyps, urticaria or angioneurotic oedema. Patients with gastrointestinal ulcers, bleeding disorders, Crohn’s disease, active ulcerative colitis, heart failure, severe renal dysfunction or severely impaired hepatic function. See SPC.
Side effects: Most common are gastrointestinal. See SPC.
Legal category: POM.
Net price: 300mg 60 £9.47, 400mg 60 £9.97.
Contact details: Genus Pharmaceuticals, Benham Valence, Newbury, Berkshire RG20 8LU. Telephone 01635 568 400.

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Prescription Products

Humulin M3
Humulin M3 (biphasic isophane insulin;Lilly) pre-filled injection pen 100IU/ml will be available from 22 August. Net price, 5 pens, £27.22. Legal category: POM.

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SPC changes

Cymbalta
Cymbalta (duloxetine hydrochloride; Lilly) is now additionally indicated for the treatment of diabetic peripheral neuropathic pain in adults. The starting and recommended maintenance dose is 60mg daily. The summary of product characteristics states that some patients who respond insufficiently to 60mg may benefit from a higher dose. Response should be evaluated after two months of treatment and the therapeutic benefit should be reassessed at least every three months. See SPC.

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