The Pharmaceutical Journal
Vol 269 No 7208 p130
27 July 2002

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Products

SPC changes
• Yasmin tablets
• Primolut N tablets
• Angettes 75 tablets
• Dutonin tablets
Discontinued products
• Mexitil PL Perlongets
• Chloramphenicol eye-drops
Supply problems
• Leucomax
• Naftidrofuryl capsules
Counter medicines
• Simple Eye ointment
Products miscellany
• Abbott products

Recall Adsorbed diphtheria and tetanus vaccine

SPC changes

Yasmin tablets

The summary of product characteristics for Yasmin (drospirenone 3mg, ethinylestradiol 30µg) tablets has been updated (Schering Health Care). The information on vascular disorders under the special warnings and precautions for use section states that the incidence of venous thromboembolism (VTE) in users of oral contraceptives with low oestrogen content (<50µg ethinyl-estradiol) ranges from about 20 to 40 cases per 100,000 women-years, (but this risk estimate varies according to the progestogen) compared with five to 10 cases per 100,000 women-years for non-users. It is not yet known how Yasmin tablets influence the risk of VTE compared with other oral contraceptives. See SPC.

Primolut N tablets

The summary of product characteristics for Primolut N (norethisterone) tablets has been updated (Schering Health Care). The undesirable effects section states that various skin disorders have rarely been recorded with doses of 15mg daily. See SPC.

Angettes 75 tablets

The summary of product characteristics for Angettes 75 (aspirin) tablets has been updated (Bristol-Myers Squibb Pharmaceuticals). The wording of the indication now reads: "For the secondary prevention of thrombotic cerebrovascular or cardiovascular disease and following bypass surgery. The advice of a doctor should be sought before commencing therapy for the first time." See SPC.

Dutonin tablets

The summary of product characteristics for Dutonin (nefazodone hydrochloride) tablets has been updated in terms of information on hepatic impairment (Bristol-Myers Squibb Pharmaceuticals). The posology and method of administration section states: "In general, treatment with nefazodone should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases." Nefazodone is contraindicated in patients in whom the drug has previously been withdrawn because of liver injury. Nefazodone should be withdrawn from any patient who develops signs and symptoms of liver injury during treatment. See SPC.

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Discontinued products

Mexitil PL Perlongets

Mexitil PL Perlongets (mexiletine hydrochloride) will be discontinued from 11 October (Boehringer Ingelheim). Mexitil 50mg and 200mg capsules and Mexitil 250mg/10ml ampoules remain available. Further information can be obtained from the company's medical information department (tel 01344 741261).

Chloramphenicol eye-drops

Chloramphenicol eye-drops, pack size 10ml, have been discontinued (Alpharma).

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Supply problems

Leucomax

Stocks of Leucomax (molgramostim) 150µg and 300µg vials have been exhausted and stocks of Leucomax 400µg vials are expected to be exhausted by September. Supplies are expected to resume in October (Novartis Pharmaceuticals).

Naftidrofuryl capsules

Naftidrofuryl oxalate 100mg capsules, pack size 84, are back in stock (Alpharma).

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Counter medicines

Simple Eye ointment

Simple Eye ointment (yellow soft paraffin 80 per cent, liquid paraffin 10 per cent and wool fat 10 per cent) pack size 4g, has been launched (Dominion Pharma); net price, £2.67. Legal category: pharmacy medicine.

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Products miscellany

Abbott products

The following two liquid feeds have been launched in banana flavour (Abbott Laboratories):

• Paediasure Plus tetrapak; net price, 27 £62.10

• Paediasure Fibre tetrapak; net price, 27 £55.50

Both products are approved by the Advisory Committee on Borderline Substances.

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