The Pharmaceutical Journal
Vol 280 No 7494 p331
22 March 2008

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Products

Accessing SPCs
The summaries of product characteristics and patient information leaflets for medicines licensed in the UK are available online

New medicines
• Galvus
Prescription Products
• Eucreas
Discontinued products
• Trinordiol
Supply issues
• Goldshield products
Products miscellany
• Ensure Plus Savoury

New medicines

Galvus

Composition: Vildagliptin.

Presentation: Tablet.

Action: Dipeptidyl-peptidase-4 (DPP-4) inhibitor.

Indications: Dual therapy for the treatment of type 2 diabetes in combination with: metformin, in patients with insufficient glycaemic control despite maximal dosing of metformin as monotherapy; with a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance; or with a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate.

Dosage: When used in combination with metformin or a thiazolidinedione the recommended dose is 50mg twice a day. When used in combination with a sulphonylurea the recommended dose is 50mg each morning. Galvus can be taken with or without food.

Precautions: Doses higher than 100mg daily are not recommended.

Safety and efficacy of Galvus as triple therapy in combination with both metformin and a thiazolidinedione, or with both metformin and a sulphonylurea, have not been established.

Galvus is not a substitute for insulin in type 2 diabetes and should not be used to treat type 1 diabetes or diabetic ketoacidosis.

No dose adjustment is required for patients with mild renal impairment, but Galvus is not recommended for patients with moderate or severe renal impairment or for haemodialysis patients with end-stage renal disease.

Galvus should not be used for patients with hepatic impairment.

Liver function should be checked before initiating treatment, every three months during the first year of treatment and periodically thereafter.

Monitoring for signs of skin disorders, such as blistering or ulceration, is recommended.

For patients with congestive heart failure, Galvus should be used with caution or not be used depending on the severity of heart failure.

Galvus should not be used during pregnancy because of a lack of data.

Side effects: Common (>=1/100, <1/10) with metformin: tremor, headache, dizziness, nausea; with sulphonylurea: tremor, headache, dizziness, asthenia; with thiazolidinedione: weight increase, peripheral oedema.

Legal category: POM.

Net price: 56 x 50mg, £31.76.

Contact details: Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Surrey GU16 7SR (tel 01276 692255).

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Prescription Products

Eucreas
Eucreas (vildagliptin/metformin hydrochloride) film-coated tablets 50/850mg and 50/1,000mg are now available from Novartis.

Net price: 60 (both strengths), £31.76
Legal category: POM

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Discontinued products

Trinordiol
Wyeth has discontinued Trinordiol (levonorgestrel/ethinylestradiol 50/30µg, 75/40µg and 125/30µg) tablets, 3 x 21 packs.

Medical information on 0845 367 0098.

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Supply issues

Goldshield products
The following Goldshield products are available again after being out of stock:

• Aureocort (triamcinolone acetonide, chlortetracycline hydrochloride) ointment 15g
• Eltroxin (levothyroxine sodium) tablets 28 x 50µg
• Fentazin (perphenazine) tablets 100 x 2mg and 100 x 4mg
• Macrodantin (nitrofurantoin) capsules 30 x 50mg
• Trasidrex (oxprenolol hydrocholoride/cyclopenthiazide) tablets 28 x 160mg/250µg

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Products miscellany

Ensure Plus Savoury
Ensure Plus Savoury (Abbott) chicken flavour and mushroom flavour products have been relaunched as a 250ml can. The formulation is the same as that available previously in Tetrapak.

Net price: 250ml, £2.22.

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