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Drug Regulatory Affairs Novartis Pharma AG
GALVUS
®
(vildagliptin) EUCREAS
®
(vildagliptin/metformin)
50 mg Tablets 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
EU Succinct Statement Basic Succinct Statement
GALVUS
®
Important note: Before prescribing, consult full prescribing
Note: Before prescribing, please consult full prescribing
information.
information.
Presentation: Vildagliptin/Metformin hydrochloride. Film-coated tablets:
Presentation: Vildagliptin. Tablets: 50 mg.
50 mg/850 mg, 50 mg/1 000 mg.
Indications: Treatment of type 2 diabetes mellitus as dual oral therapy
Indications: Treatment of type 2 diabetes mellitus patients who are
in combination with i) metformin, in patients with insufficient glycaemic
unable to achieve sufficient glycaemic control at their maximally
control despite maximal tolerated dose of monotherapy with metformin,
tolerated dose of oral metformin alone or who are already treated with
ii) a sulphonylurea (SU) in patients with insufficient glycaemic control
the combination of vildagliptin and metformin as separate tablets.
despite maximal tolerated dose of a sulphonylurea and for whom
Dosage: Do not exceed the maximum recommended daily dose of
metformin is inappropriate due to contraindications or intolerance, iii) a
vildagliptin (100 mg). Eucreas may be initiated at either the 50 mg/850
thiazolidinedione (TZD) in patients with insufficient glycaemic control
mg or 50 mg/1000 mg tablet strength twice daily. The recommended
and for whom the use of a thiazolidinedione is appropriate.
daily dose is 100 mg vildagliptin plus 2000 mg metformin hydrochloride.
Dosage: The recommended daily dose is 100 mg (in two divided doses
Patients receiving vildagliptin and metformin from separate tablets may
of 50 mg) in dual combination with metformin or a TZD ; 50 mg daily in
be switched to Eucreas. Eucreas is not recommended in elderly (>75
dual combination with a SU. Galvus is not recommended in paediatric
years) and paediatric patients.
patients.
Contraindications: Known hypersensitivity to vildagliptin or metformin
Contraindications: Hypersensitivity to vildagliptin or to any of the
hydrochloride or to any of the excipients ♦ Renal disease or renal
excipients.
dysfunction ♦ Acute or chronic metabolic acidosis including diabetic
Precautions/Warnings: Should not be used in patients with type 1
ketoacidosis with or without coma ♦ Acute or chronic disease which may
cause tissue hypoxia, such as: cardiac or respiratory failure, recent
diabetes or for the treatment of diabetic ketoacidosis ♦ Not
myocardial infarction, shock ♦ Hepatic impairment ♦ Acute alcohol
recommended in moderate to severe renal impairment, or in patients
intoxication, alcoholism ♦ Lactation.
with End Stage Renal Disease on haemodialysis ♦ should not be used
in patients with hepatic impairment including patients with a pre-
Precautions/Warnings: Should not be used in patients with type 1
treatment ALT or AST>3X the upper limit of normal. Liver function tests
diabetes ♦ Risk of lactic acidosis ♦ Monitoring of renal function ♦
(LFT) to be performed prior to treatment initiation, at three-month
Caution with concomitant use of medications that may affect renal
intervals during the first year and periodically thereafter. Withdrawal of
function or metformin hydrochloride disposition ♦ Should not be used in
therapy with Galvus recommended if an increase in AST or ALT of 3X
patients with hepatic impairment including patients with a pre-treatment
upper limit normal or greater persist, or if patients develop jaundice or
ALT or AST >3x the upper limit of normal. Liver function tests (LFT) to
other signs suggestive of liver dysfunction. Following withdrawal of
be performed prior to treatment initiation, at three-month intervals during
treatment with Galvus and LFT normalisation, treatment with Galvus
the first year and periodically thereafter. Withdrawal of therapy with
should not be reinitiated ♦ Use with caution in patients with congestive
Eucreas recommended if an increase in AST or ALT 3x upper limit of
heart failure (CHF) of New York Heart Association (NYHA) functional
normal or greater persist, or if patients develop jaundice or other signs
class I-II; not recommended in patients with CHF NYHA Class III-IV ♦ In
suggestive of liver dysfunction. Following withdrawal of treatment with
keeping with routine care of the diabetic patient, monitoring of skin
Eucreas and LFT normalisation, treatment with Eucreas should not be
disorders such as blistering and ulceration is recommended ♦ Contains
reinitiated ♦ Use with caution in patients with congestive heart failure
lactose.
(CHF) of New York Heart Association (NYHA) functional class I-II; not
Pregnancy: Should not be used.
recommended in patients with CHF NYHA Class III-IV ♦ Contraindicated
in patients with heart failure ♦ In keeping with routine care of the
Breast-feeding: Should not be used.
diabetic patient, monitoring of skin disorders such as blistering and
Interactions: Vildagliptin has a low potential for drug interactions. No
ulceration, is recommended ♦ Should be temporarily discontinued in
clinically relevant interactions with other oral antidiabetics
patients undergoing radiologic studies involving intravascular
(glibenclamide, pioglitazone, metformin), amlodipine, digoxin, ramipril,
administration of iodinated contrast materials ♦ Temporary
simvastatin, valsartan or warfarin were observed after co-administration
discontinuation in patients undergoing surgical procedure.
with vildagliptin. As with other oral antidiabetic medicinal products the Pregnancy: Should not be used.
hypoglycaemic effect of vildagliptin may be reduced by certain active
Lactation: Should not be used.
substances, including thiazides, corticosteroids, thyroid products and
sympathomimetics.
Interactions: Interactions with Vildagliptin - Low potential for drug
Adverse reactions: Rare cases of angioedema. Rare cases of hepatic
interactions. No clinically relevant interactions with other oral
antidiabetics (glibenclamide, pioglitazone, metformin), amlodipine,
dysfunction (including hepatitis). ♦ Combination with metformin -
digoxin, ramipril, simvastatin, valsartan or warfarin were observed after
common: headache, tremor, dizziness, nausea, hypoglycemia –
co-administration with vildagliptin. As with other oral antidiabetic
uncommon: fatigue ♦ Combination with a sulphonylurea - common:
medicinal products, the hypoglycaemic effect of vildagliptin may be
headache, hypoglycaemia, tremor, dizziness, asthenia – uncommon:
reduced by certain active substances, including thiazides,
constipation – very rare: nasopharyngitis ♦ Combination with a
corticosteroids, thyroid products and sympathomimetics. Interactions
thiazolidinedione - common: weight increase, oedema peripheral -
with Metformin hydrochloride - Combinations not recommended: Alcohol,
uncommon: headache, hypoglycaemia, asthenia ♦ Monotherapy –
cationic drugs, iodinated contrast media - Combinations requiring
common: dizziness – uncommon: headache, hypoglycaemia, oedema
precautions for use: Glucocorticoids, beta-2-agonists, diuretics and ACE
peripheral, constipation, arthralgia – very rare: nasopharyngitis, upper
inhibitors.
respiratory tract infection. ♦ Post-marketing experience: urticaria
Packs and prices
Adverse reactions: Vildagliptin: Rare cases of angioedema. Rare
: Country specific.
cases of hepatic dysfunction (including hepatitis) ♦ Combination with
Legal classification: Country specific.
metformin – Common: headache, hypoglycemia, tremor, dizziness,
nausea – Uncommon: fatigue ♦ Monotherapy – Common: dizziness –
Uncommon: headache, hypoglycemia, constipation, arthralgia, oedema
peripheral – Very rare: nasopharyngitis, upper respiratory tract infection.
Metformin monotherapy: Very common: nausea, vomiting, diarrhoea,
abdominal pain and loss of appetite - Common: metallic taste – Very
rare: decrease of vitamin B
12
absorption and lactic acidosis, liver function
test abnormalities or hepatitis, skin reactions such as erythema, pruritus
and urticaria. Post marketing experience: urticaria
Packs and prices: Country specific.
Legal classification: Country specific.