Vipidia

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Vipidia 6.25 mg film-coated tablets 
Vipidia 12.5 mg film-coated tablets 
Vipidia 25 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Vipidia 6.25 mg film-coated tablets 
Each tablet contains alogliptin benzoate equivalent to 6.25 mg alogliptin. 
 
Vipidia 12.5 mg film-coated tablets 
Each tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin. 
 
Vipidia 25 mg film-coated tablets 
Each tablet contains alogliptin benzoate equivalent to 25 mg alogliptin. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet). 
 
Vipidia 6.25 mg film-coated tablets 
Light pink, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with 
“TAK” and “ALG-6.25” printed in grey ink on one side. 
 
Vipidia 12.5 mg film-coated tablets 
Yellow, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with 
“TAK” and “ALG-12.5” printed in grey ink on one side. 
 
Vipidia 25 mg film-coated tablets 
Light red, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with 
“TAK” and “ALG-25” printed in grey ink on one side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve 
glycaemic control in combination with other glucose lowering medicinal products including insulin, 
when these, together with diet and exercise, do not provide adequate glycaemic control (see 
sections 4.4, 4.5 and 5.1 for available data on different combinations). 
 
4.2 Posology and method of administration 
 
Posology 
 
For the different dose regimens, Vipidia is available in strengths of 25 mg, 12.5 mg and 6.25 mg 
film-coated tablets. 
 



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Adults (≥ 18 years old) 
The recommended dose of alogliptin is one tablet of 25 mg once daily as add-on therapy to metformin, 
a thiazolidinedione, a sulphonylurea, or insulin or as triple therapy with metformin and a 
thiazolidinedione or insulin. 
 
When alogliptin is used in combination with metformin and/or a thiazolidinedione, the dose of 
metformin and/or the thiazolidinedione should be maintained, and Vipidia administered 
concomitantly. 
 
When alogliptin is used in combination with a sulphonylurea or insulin, a lower dose of the 
sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4). 
 
Caution should be exercised when alogliptin is used in combination with metformin and a 
thiazolidinedione as an increased risk of hypoglycaemia has been observed with this triple therapy (see 
section 4.4). In case of hypoglycaemia, a lower dose of the thiazolidinedione or metformin may be 
considered. 
 
Special populations 
Elderly (≥ 65 years old) 
No dose adjustment is necessary based on age. However, dosing of alogliptin should be conservative 
in patients with advanced age due to the potential for decreased renal function in this population. 
 
Renal impairment 
For patients with mild renal impairment (creatinine clearance (CrCl) > 50 to ≤ 80 mL/min), no dose 
adjustment of alogliptin is necessary (see section 5.2). 
 
For patients with moderate renal impairment (CrCl ≥ 30 to ≤ 50 mL/min), one-half of the 
recommended dose of alogliptin should be administered (12.5 mg once daily; see section 5.2). 
 
For patients with severe renal impairment (CrCl < 30 mL/min) or end-stage renal disease requiring 
dialysis, one-quarter of the recommended dose of alogliptin should be administered (6.25 mg once 
daily). Alogliptin may be administered without regard to the timing of dialysis. Experience in patients 
requiring renal dialysis is limited. Alogliptin has not been studied in patients undergoing peritoneal 
dialysis (see sections 4.4 and 5.2). 
 
Appropriate assessment of renal function is recommended prior to initiation of treatment and 
periodically thereafter (see section 4.4). 
 
Hepatic impairment 
No dose adjustment is necessary for patients with mild to moderate hepatic impairment (Child-Pugh 
scores of 5 to 9). Alogliptin has not been studied in patients with severe hepatic impairment 
(Child-Pugh score > 9) and is, therefore, not recommended for use in such patients (see sections 4.4 
and 5.2). 
 
Paediatric population 
The safety and efficacy of Vipidia in children and adolescents < 18 years old have not been 
established. No data are available. 
 
Method of administration 
 
Oral use. 
 
Vipidia should be taken once daily with or without food. The tablets should be swallowed whole with 
water. 
 
If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be 
taken on the same day. 



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4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or history of a 
serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and 
angioedema, to any dipeptidyl-peptidase-4 (DPP-4) inhibitor (see sections 4.4 and 4.8).  
 
4.4 Special warnings and precautions for use 
 
General 
 
Vipidia should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic 
ketoacidosis. Vipidia is not a substitute for insulin in insulin-requiring patients. 
 
Use with other antihyperglycaemic medicinal products and hypoglycaemia 
 
Due to the increased risk of hypoglycaemia in combination with a sulphonylurea, insulin or 
combination therapy with thiazolidinedione plus metformin, a lower dose of these medicinal products 
may be considered to reduce the risk of hypoglycaemia when these medicinal products are used in 
combination with alogliptin (see section 4.2). 
 
Combinations not studied 
 
Alogliptin has not been studied in combination with sodium glucose co-transporter 2 (SGLT-2) 
inhibitors or glucagon like peptide 1 (GLP-1) analogues nor formally as triple therapy with metformin 
and a sulphonylurea. 
 
Renal impairment 
 
As there is a need for dose adjustment in patients with moderate or severe renal impairment, or 
end-stage renal disease requiring dialysis, appropriate assessment of renal function is recommended 
prior to initiation of alogliptin therapy and periodically thereafter (see section 4.2).  
 
Experience in patients requiring renal dialysis is limited. Alogliptin has not been studied in patients 
undergoing peritoneal dialysis (see sections 4.2 and 5.2). 
 
Hepatic impairment 
 
Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score > 9) and 
is, therefore, not recommended for use in such patients (see sections 4.2 and 5.2).  
 
Cardiac failure 
 
Experience of alogliptin use in clinical studies in patients with congestive heart failure of New York 
Heart Association (NYHA) functional class III and IV is limited and caution is warranted in these 
patients. 
 
Hypersensitivity reactions 
 
Hypersensitivity reactions, including anaphylactic reactions, angioedema and exfoliative skin 
conditions including Stevens-Johnson syndrome and erythema multiforme have been observed for 
DPP-4 inhibitors and have been spontaneously reported for alogliptin in the post-marketing setting. In 
clinical studies of alogliptin, anaphylactic reactions were reported with a low incidence.  
 



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Acute pancreatitis 
 
Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis. In a pooled 
analysis of the data from 13 studies, the overall rates of pancreatitis reports in patients treated with 
25 mg alogliptin, 12.5 mg alogliptin, active control or placebo were 2, 1, 1 or 0 events per 
1,000 patient years, respectively. In the cardiovascular outcomes study the rates of pancreatitis reports 
in patients treated with alogliptin or placebo were 3 or 2 events per 1,000 patient years, respectively. 
There have been spontaneously reported adverse reactions of acute pancreatitis in the post-marketing 
setting. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, 
severe abdominal pain, which may radiate to the back. If pancreatitis is suspected, Vipidia should be 
discontinued; if acute pancreatitis is confirmed, Vipidia should not be restarted. Caution should be 
exercised in patients with a history of pancreatitis. 
 
Hepatic effects 
 
Postmarketing reports of hepatic dysfunction including hepatic failure have been received. A causal 
relationship has not been established. Patients should be observed closely for possible liver 
abnormalities. Obtain liver function tests promptly in patients with symptoms suggestive of liver 
injury. If an abnormality is found and an alternative etiology is not established, consider 
discontinuation of alogliptin treatment. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Effects of other medicinal products on alogliptin 
 
Alogliptin is primarily excreted unchanged in the urine and metabolism by the cytochrome (CYP) 
P450 enzyme system is negligible (see section 5.2). Interactions with CYP inhibitors are thus not 
expected and have not been shown. 
 
Results from clinical interaction studies also demonstrate that there are no clinically relevant effects of 
gemfibrozil (a CYP2C8/9 inhibitor), fluconazole (a CYP2C9 inhibitor), ketoconazole (a CYP3A4 
inhibitor), cyclosporine (a p-glycoprotein inhibitor), voglibose (an alpha-glucosidase inhibitor), 
digoxin, metformin, cimetidine, pioglitazone or atorvastatin on the pharmacokinetics of alogliptin. 
 
Effects of alogliptin on other medicinal products 
 
In vitro studies suggest that alogliptin does not inhibit nor induce CYP 450 isoforms at concentrations 
achieved with the recommended dose of 25 mg alogliptin (see section 5.2). Interaction with substrates 
of CYP 450 isoforms are thus not expected and have not been shown. In studies in vitro, alogliptin 
was found to be neither a substrate nor an inhibitor of key transporters associated with disposition of 
the active substance in the kidney: organic anion transporter-1, organic anion transporter-3 or organic 
cationic transporter-2 (OCT2). Furthermore, clinical data do not suggest interaction with 
p-glycoprotein inhibitors or substrates.  
 
In clinical studies, alogliptin had no clinically relevant effect on the pharmacokinetics of caffeine, 
(R)-warfarin, pioglitazone, glyburide, tolbutamide, (S)-warfarin, dextromethorphan, atorvastatin, 
midazolam, an oral contraceptive (norethindrone and ethinyl oestradiol), digoxin, fexofenadine, 
metformin, or cimetidine, thus providing in vivo evidence of a low propensity to cause interaction with 
substrates of CYP1A2, CYP3A4, CYP2D6, CYP2C9, p-glycoprotein, and OCT2. 
 
In healthy subjects, alogliptin had no effect on prothrombin time or International Normalised Ratio 
(INR) when administered concomitantly with warfarin. 



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Combination with other anti-diabetic medicinal products 
 
Results from studies with metformin, pioglitazone (thiazolidinedione), voglibose (alpha-glucosidase 
inhibitor) and glyburide (sulphonylurea) have shown no clinically relevant pharmacokinetic 
interactions. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no data from the use of alogliptin in pregnant women. Animal studies do not indicate direct 
or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary 
measure, it is preferable to avoid the use of alogliptin during pregnancy. 
 
Breast-feeding 
 
It is unknown whether alogliptin is excreted in human milk. Animal studies have shown excretion of 
alogliptin in milk (see section 5.3). A risk to the suckling child cannot be excluded. 
 
A decision on whether to discontinue breast-feeding or to discontinue alogliptin therapy should be 
made taking into account the benefit of breast-feeding for the child and the benefit of alogliptin 
therapy for the woman. 
 
Fertility 
 
The effect of alogliptin on fertility in humans has not been studied. No adverse effects on fertility were 
observed in animal studies (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Vipidia has no or negligible influence on the ability to drive and use machines. However patients 
should be alerted to the risk of hypoglycaemia especially when combined with a sulphonylurea, 
insulin or combination therapy with thiazolidinedione plus metformin. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The information provided is based on a total of 9,405 patients with type 2 diabetes mellitus, including 
3,750 patients treated with 25 mg alogliptin and 2,476 patients treated with 12.5 mg alogliptin, who 
participated in one phase 2 or 12 phase 3 double-blind, placebo- or active-controlled clinical studies. 
In addition, a cardiovascular outcomes study with 5,380 patients with type 2 diabetes mellitus and a 
recent acute coronary syndrome event was conducted with 2,701 randomised to alogliptin and 
2,679 randomised to placebo. These studies evaluated the effects of alogliptin on glycaemic control 
and its safety as monotherapy, as initial combination therapy with metformin or a thiazolidinedione, 
and as add-on therapy to metformin, or a sulphonylurea, or a thiazolidinedione (with or without 
metformin or a sulphonylurea), or insulin (with or without metformin). 
 
In a pooled analysis of the data from 13 studies, the overall incidences of adverse events, serious 
adverse events and adverse events resulting in discontinuation of therapy were comparable in patients 
treated with 25 mg alogliptin, 12.5 mg alogliptin, active control or placebo. The most common adverse 
reaction in patients treated with 25 mg alogliptin was headache. 
 
The safety of alogliptin between the elderly (≥ 65 years old) and non-elderly (< 65 years old) was 
similar. 
 



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Tabulated list of adverse reactions 
 
The adverse reactions are listed by system organ class and frequency. Frequencies are defined as very 
common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to 
<1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data). 
 
In the pooled pivotal phase 3 controlled clinical studies of alogliptin as monotherapy and as add-on 
combination therapy involving 5,659 patients, the observed adverse reactions are listed below 
(Table 1). 
 
Table 1: Adverse reactions 
 
System organ class Frequency of adverse reactions 

Adverse reaction  
Infections and infestations  
upper respiratory tract infections common 
nasopharyngitis common 
Immune system disorders  
hypersensitivity not known 
Metabolism and nutrition disorders  
hypoglycaemia common 
Nervous system disorders  
headache common 
Gastrointestinal disorders  
abdominal pain common 
gastroesophageal reflux disease common 
diarrhoea common 
acute pancreatitis not known 
Hepatobiliary disorders  
hepatic dysfunction including hepatic failure not known 
Skin and subcutaneous tissue disorders   
pruritus common 
rash common 
exfoliative skin conditions including 
Stevens-Johnson syndrome 
erythema multiforme 

 
not known 
not known 

angioedema not known 
urticaria not known 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
The highest doses of alogliptin administered in clinical studies were single doses of 800 mg to healthy 
subjects and doses of 400 mg once daily for 14 days to patients with type 2 diabetes mellitus 
(equivalent to 32 times and 16 times the recommended daily dose of 25 mg alogliptin, respectively).  
 
Management 
 
In the event of an overdose, appropriate supportive measures should be employed as dictated by the 
patient’s clinical status.  
 

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Minimal quantities of alogliptin are removed by haemodialysis (approximately 7% of the substance 
was removed during a 3-hour haemodialysis session). Therefore, haemodialysis is of little clinical 
benefit in overdose. It is not known if alogliptin is removed by peritoneal dialysis. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs used in diabetes; dipeptidyl peptidase 4 (DPP-4) inhibitors. 
 
ATC code: A10BH04. 
 
Mechanism of action and pharmacodynamic effects 
 
Alogliptin is a potent and highly selective inhibitor of DPP-4, >10,000-fold more selective for DPP-4 
than other related enzymes including DPP-8 and DPP-9. DPP-4 is the principal enzyme involved in 
the rapid degradation of the incretin hormones, glucagon-like peptide-1 (GLP-1) and GIP 
(glucose-dependent insulinotropic polypeptide), which are released by the intestine and levels are 
increased in response to a meal. GLP-1 and GIP increases insulin biosynthesis and secretion from 
pancreatic beta cells, while GLP-1 also inhibits glucagon secretion and hepatic glucose production. 
Alogliptin therefore improves glycaemic control via a glucose-dependent mechanism, whereby insulin 
release is enhanced and glucagon levels are suppressed when glucose levels are high.  
 
Clinical efficacy 
 
Alogliptin has been studied as monotherapy, as initial combination therapy with metformin or a 
thiazolidinedione, and as add-on therapy to metformin, or a sulphonylurea, or a thiazolidinedione 
(with or without metformin or a sulphonylurea), or insulin (with or without metformin).  
 
Administration of 25 mg alogliptin to patients with type 2 diabetes mellitus produced peak inhibition 
of DPP-4 within 1 to 2 hours and exceeded 93% both after a single 25 mg dose and after 14 days of 
once-daily dosing. Inhibition of DPP-4 remained above 81% at 24 hours after 14 days of dosing. 
When the 4-hour postprandial glucose concentrations were averaged across breakfast, lunch and 
dinner, 14 days of treatment with 25 mg alogliptin resulted in a mean placebo-corrected reduction 
from baseline of -35.2 mg/dL. 
 
Both 25 mg alogliptin alone and in combination with 30 mg pioglitazone demonstrated significant 
decreases in postprandial glucose and postprandial glucagon whilst significantly increasing 
postprandial active GLP-1 levels at Week 16 compared to placebo (p<0.05). In addition, 25 mg 
alogliptin alone and in combination with 30 mg pioglitazone produced statistically significant 
(p<0.001) reductions in total triglycerides at Week 16 as measured by postprandial incremental 
AUC(0-8) change from baseline compared to placebo. 
 
A total of 14,779 patients with type 2 diabetes mellitus, including 6,448 patients treated with 25 mg 
alogliptin and 2,476 patients treated with 12.5 mg alogliptin, participated in one phase 2 or 13 phase 3 
(including the cardiovascular outcomes study) double-blind, placebo- or active-controlled clinical 
studies conducted to evaluate the effects of alogliptin on glycaemic control and its safety. In these 
studies, 2,257 alogliptin-treated patients were ≥ 65 years old and 386 alogliptin-treated patients were 
≥ 75 years old. The studies included 5,744 patients with mild renal impairment, 1,290 patients with 
moderate renal impairment and 82 patients with severe renal impairment / end-stage renal disease 
treated with alogliptin.  
 
Overall, treatment with the recommended daily dose of 25 mg alogliptin improved glycaemic control 
when given as monotherapy and as initial or add-on combination therapy. This was determined by 
clinically relevant and statistically significant reductions in glycosylated haemoglobin (HbA1c) and 
fasting plasma glucose compared to control from baseline to study endpoint. Reductions in HbA1c 



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were similar across different subgroups including renal impairment, age, gender and body mass index, 
while differences between races (e.g. White and non-White) were small. Clinically meaningful 
reductions in HbA1c compared to control were also observed with 25 mg alogliptin regardless of 
baseline background treatment. Higher baseline HbA1c was associated with a greater reduction in 
HbA1c. Generally, the effects of alogliptin on body weight and lipids were neutral. 
 
Alogliptin as monotherapy 
Treatment with 25 mg alogliptin once daily resulted in statistically significant improvements from 
baseline in HbA1c and fasting plasma glucose compared to placebo-control at Week 26 (Table 2). 
 
Alogliptin as add-on therapy to metformin 
The addition of 25 mg alogliptin once daily to metformin hydrochloride therapy (mean 
dose = 1,847 mg) resulted in statistically significant improvements from baseline in HbA1c and 
fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2). Significantly 
more patients receiving 25 mg alogliptin (44.4%) achieved target HbA1c levels of ≤ 7.0% compared to 
those receiving placebo (18.3%) at Week 26 (p<0.001).  
 
The addition of 25 mg alogliptin once daily to metformin hydrochloride therapy (mean 
dose = 1,835 mg) resulted in improvements from baseline in HbA1c at Week 52 and Week 104. At 
Week 52, the HbA1c reduction by 25 mg alogliptin plus metformin (-0.76%, Table 3) was similar to 
that produced by glipizide (mean dose = 5.2 mg) plus metformin hydrochloride therapy (mean 
dose = 1,824 mg, -0.73%). At Week 104, the HbA1c reduction by 25 mg alogliptin plus metformin 
(-0.72%, Table 3) was greater than that produced by glipizide plus metformin (-0.59%). Mean change 
from baseline in fasting plasma glucose at Week 52 for 25 mg alogliptin and metformin was 
significantly greater than that for glipizide and metformin (p<0.001). By Week 104, mean change 
from baseline in fasting plasma glucose for 25 mg alogliptin and metformin was -3.2 mg/dL compared 
with 5.4 mg/dL for glipizide and metformin. More patients receiving 25 mg alogliptin and metformin 
(48.5%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving glipizide and metformin 
(42.8%) (p=0.004). 
 
Alogliptin as add-on therapy to a sulphonylurea 
The addition of 25 mg alogliptin once daily to glyburide therapy (mean dose = 12.2 mg) resulted in 
statistically significant improvements from baseline in HbA1c at Week 26 when compared to the 
addition of placebo (Table 2). Mean change from baseline in fasting plasma glucose at Week 26 for 
25 mg alogliptin showed a reduction of 8.4 mg/dL compared to an increase of 2.2 mg/dL with placebo. 
Significantly more patients receiving 25 mg alogliptin (34.8%) achieved target HbA1c levels of 
≤ 7.0% compared to those receiving placebo (18.2%) at Week 26 (p=0.002).  
 
Alogliptin as add-on therapy to a thiazolidinedione 
The addition of 25 mg alogliptin once daily to pioglitazone therapy (mean dose = 35.0 mg, with or 
without metformin or a sulphonylurea) resulted in statistically significant improvements from baseline 
in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2). 
Clinically meaningful reductions in HbA1c compared to placebo were also observed with 25 mg 
alogliptin regardless of whether patients were receiving concomitant metformin or sulphonylurea 
therapy. Significantly more patients receiving 25 mg alogliptin (49.2%) achieved target HbA1c levels 
of ≤ 7.0% compared to those receiving placebo (34.0%) at Week 26 (p=0.004).  
 
Alogliptin as add-on therapy to a thiazolidinedione with metformin 
The addition of 25 mg alogliptin once daily to 30 mg pioglitazone and metformin hydrochloride 
therapy (mean dose = 1,867.9 mg) resulted in improvements from baseline in HbA1c at Week 52 that 
were both non-inferior and statistically superior to those produced by 45 mg pioglitazone and 
metformin hydrochloride therapy (mean dose = 1,847.6 mg, Table 3). The significant reductions in 
HbA1c observed with 25 mg alogliptin plus 30 mg pioglitazone and metformin were consistent over 
the entire 52-week treatment period compared to 45 mg pioglitazone and metformin (p<0.001 at all 
time points). In addition, mean change from baseline in fasting plasma glucose at Week 52 for 25 mg 
alogliptin plus 30 mg pioglitazone and metformin was significantly greater than that for 45 mg 
pioglitazone and metformin (p<0.001). Significantly more patients receiving 25 mg alogliptin plus 



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30 mg pioglitazone and metformin (33.2%) achieved target HbA1c levels of ≤ 7.0% compared to those 
receiving 45 mg pioglitazone and metformin (21.3%) at Week 52 (p<0.001).  
 
Alogliptin as add-on therapy to insulin (with or without metformin) 
The addition of 25 mg alogliptin once daily to insulin therapy (mean dose = 56.5 IU, with or without 
metformin) resulted in statistically significant improvements from baseline in HbA1c and fasting 
plasma glucose at Week 26 when compared to the addition of placebo (Table 2). Clinically meaningful 
reductions in HbA1c compared to placebo were also observed with 25 mg alogliptin regardless of 
whether patients were receiving concomitant metformin therapy. More patients receiving 25 mg 
alogliptin (7.8%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving placebo (0.8%) 
at Week 26.  
 

Table 2: Change in HbA1c (%) from baseline with alogliptin 25 mg at Week 26  
by placebo-controlled study (FAS, LOCF) 

Study Mean baseline 
HbA1c (%) (SD) 

Mean change from 
baseline in HbA1c 

(%)† (SE) 

Placebo-corrected 
change from baseline 

in HbA1c (%)† 
(2-sided 95% CI) 

Monotherapy placebo-controlled study 
Alogliptin 25 mg 
once daily 
(n=128) 

7.91 
(0.788) 

-0.59 
(0.066) 

-0.57* 
(-0.80, -0.35) 

Add-on combination therapy placebo-controlled studies 
Alogliptin 25 mg 
once daily with 
metformin 
(n=203) 

7.93 
(0.799) 

-0.59 
(0.054) 

-0.48* 
(-0.67, -0.30) 

Alogliptin 25 mg 
once daily with a 
sulphonylurea 
(n=197) 

8.09 
(0.898) 

-0.52 
(0.058) 

-0.53* 
(-0.73, -0.33) 

Alogliptin 25 mg 
once daily with a 
thiazolidinedione ± 
metformin or a 
sulphonylurea 
(n=195) 

8.01 
(0.837) 

-0.80 
(0.056) 

-0.61* 
(-0.80, -0.41) 

Alogliptin 25 mg 
once daily with 
insulin + metformin 
(n=126) 

9.27 
(1.127) 

-0.71 
(0.078) 

-0.59* 
(-0.80, -0.37) 

FAS = full analysis set 
LOCF = last observation carried forward 
† Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values 
* p<0.001 compared to placebo or placebo+combination treatment 
 
 



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Table 3: Change in HbA1c (%) from baseline with alogliptin 25 mg 
by active-controlled study (PPS, LOCF) 

Study Mean baseline 
HbA1c (%) (SD) 

Mean change from 
baseline in HbA1c 

(%)† (SE) 

Treatment-corrected 
change from baseline 

in HbA1c (%)† 
(1-sided CI) 

Add-on combination therapy studies 
Alogliptin 25 mg 
once daily with 
metformin vs a 
sulphonylurea + 
metformin 
 
Change at Week 52 
(n=382) 
 
Change at 
Week 104 (n=382) 

 
 
 
 
 
 

7.61 
(0.526) 

 
7.61 

(0.526) 

 
 
 
 
 
 

-0.76 
(0.027) 

 
-0.72 

(0.037) 

 
 
 
 
 
 

-0.03 
(-infinity, 0.059) 

 
-0.13* 

(-infinity, -0.006) 
Alogliptin 25 mg 
once daily with a 
thiazolidinedione + 
metformin vs a 
titrating 
thiazolidinedione + 
metformin 
 
Change at Week 26 
(n=303) 
 
Change at Week 52 
(n=303) 

 
 
 
 
 
 
 
 

8.25 
(0.820) 

 
8.25 

(0.820) 
 

 
 
 
 
 
 
 
 

-0.89 
(0.042) 

 
-0.70 

(0.048) 
 

 
 
 
 
 
 
 
 

-0.47* 
(-infinity, -0.35) 

 
-0.42* 

(-infinity, -0.28) 

PPS = per protocol set 
LOCF = last observation carried forward 
* Non inferiority and superiority statistically demonstrated 
† Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values 
 
 
Patients with renal impairment 
The efficacy and safety of the recommended doses of alogliptin were investigated separately in a 
subgroup of patients with type 2 diabetes mellitus and severe renal impairment/end-stage renal disease 
in a placebo-controlled study (59 patients on alogliptin and 56 patients on placebo for 6 months) and 
found to be consistent with the profile obtained in patients with normal renal function. 
 
Elderly (≥ 65 years old) 
The efficacy of alogliptin in patients with type 2 diabetes mellitus and ≥ 65 years old across a pooled 
analysis of five 26-week placebo-controlled studies was consistent with that in patients < 65 years old. 
 
In addition, treatment with 25 mg alogliptin once daily resulted in improvements from baseline in 
HbA1c at Week 52 that were similar to those produced by glipizide (mean dose = 5.4 mg). 
Importantly, despite alogliptin and glipizide having similar HbA1c and fasting plasma glucose 
changes from baseline, episodes of hypoglycaemia were notably less frequent in patients receiving 
25 mg alogliptin (5.4%) compared to those receiving glipizide (26.0%). 
 



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Clinical safety 
 
Cardiovascular Safety 
In a pooled analysis of the data from 13 studies, the overall incidences of cardiovascular death, non 
fatal myocardial infarction and non-fatal stroke were comparable in patients treated with 25 mg 
alogliptin, active control or placebo. 
 
In addition, a prospective randomised cardiovascular outcomes safety study was conducted with 
5,380 patients with high underlying cardiovascular risk to examine the effect of alogliptin compared 
with placebo (when added to standard of care) on major adverse cardiovascular events (MACE) 
including time to the first occurrence of any event in the composite of cardiovascular death, nonfatal 
myocardial infarction and nonfatal stroke in patients with a recent (15 to 90 days) acute coronary 
event. At baseline, patients had a mean age of 61 years, mean duration of diabetes of 9.2 years, and 
mean HbA1c of 8.0%. 
 
The study demonstrated that alogliptin did not increase the risk of having a MACE compared to 
placebo [Hazard Ratio: 0.96; 1-sided 99% Confidence Interval: 0-1.16]. In the alogliptin group, 11.3% 
of patients experienced a MACE compared to 11.8% of patients in the placebo group.  
 

Table 4. MACE Reported in cardiovascular outcomes study 
 Number of Patients (%) 

Alogliptin 
25 mg Placebo 

N=2,701 N=2,679 
Primary Composite Endpoint [First 
Event of CV Death, Nonfatal MI and 
Nonfatal Stroke] 

305 (11.3) 316 (11.8) 

 Cardiovascular Death* 89 (3.3) 111 (4.1) 
 Nonfatal Myocardial Infarction 187 (6.9) 173 (6.5) 
 Nonfatal Stroke 29 (1.1) 32 (1.2) 
*Overall there were 153 subjects (5.7%) in the alogliptin group and 
173 subjects (6.5%) in the placebo group who died (all-cause 
mortality). 

 
 
There were 703 patients who experienced an event within the secondary MACE composite endpoint 
(first event of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke and urgent 
revascularization due to unstable angina). In the alogliptin group, 12.7% (344 subjects) experienced an 
event within the secondary MACE composite endpoint, compared with 13.4% (359 subjects) in the 
placebo group [Hazard Ratio = 0.95; 1-sided 99% Confidence Interval: 0-1.14]. 
 
Hypoglycaemia 
In a pooled analysis of the data from 12 studies, the overall incidence of any episode of 
hypoglycaemia was lower in patients treated with 25 mg alogliptin than in patients treated with 
12.5 mg alogliptin, active control or placebo (3.6%, 4.6%, 12.9% and 6.2%, respectively). The 
majority of these episodes were mild to moderate in intensity. The overall incidence of episodes of 
severe hypoglycaemia was comparable in patients treated with 25 mg alogliptin or 12.5 mg alogliptin, 
and lower than the incidence in patients treated with active control or placebo (0.1%, 0.1%, 0.4% and 
0.4%, respectively). In the prospective randomised controlled cardiovascular outcomes study, 
investigator reported events of hypoglycemia were similar in patients receiving placebo (6.5%) and 
patients receiving alogliptin (6.7%) in addition to standard of care. 
 
In a clinical study of alogliptin as mono-therapy, the incidence of hypoglycaemia was similar to that of 
placebo, and lower than placebo in another study as add-on to a sulphonylurea.  
 



13 

Higher rates of hypoglycaemia were observed with triple therapy with thiazolidinedione and 
metformin and in combination with insulin, as observed with other DPP-4 inhibitors.  
 
Patients (≥ 65 years old) with type 2 diabetes mellitus are considered more susceptible to episodes of 
hypoglycaemia than patients < 65 years old. In a pooled analysis of the data from 12 studies, the 
overall incidence of any episode of hypoglycaemia was similar in patients ≥ 65 years old treated with 
25 mg alogliptin (3.8%) to that in patients < 65 years old (3.6%). 
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Vipidia in one or more subsets of the paediatric population in the treatment of type 2 diabetes mellitus 
(see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetics of alogliptin has been shown to be similar in healthy subjects and in patients 
with type 2 diabetes mellitus.  
 
Absorption 
 
The absolute bioavailability of alogliptin is approximately 100%.  
 
Administration with a high-fat meal resulted in no change in total and peak exposure to alogliptin. 
Vipidia may, therefore, be administered with or without food.  
 
After administration of single, oral doses of up to 800 mg in healthy subjects, alogliptin was rapidly 
absorbed with peak plasma concentrations occurring 1 to 2 hours (median Tmax) after dosing. 
 
No clinically relevant accumulation after multiple dosing was observed in either healthy subjects or in 
patients with type 2 diabetes mellitus.  
 
Total and peak exposure to alogliptin increased proportionately across single doses of 6.25 mg up to 
100 mg alogliptin (covering the therapeutic dose range). The inter-subject coefficient of variation for 
alogliptin AUC was small (17%).  
 
Distribution 
 
Following a single intravenous dose of 12.5 mg alogliptin to healthy subjects, the volume of 
distribution during the terminal phase was 417 L indicating that the active substance is well distributed 
into tissues.  
 
Alogliptin is 20-30% bound to plasma proteins. 
 
Biotransformation 
 
Alogliptin does not undergo extensive metabolism, 60-70% of the dose is excreted as unchanged 
active substance in the urine.  
 
Two minor metabolites were detected following administration of an oral dose of [14C] alogliptin, 
N-demethylated alogliptin, M-I (< 1% of the parent compound), and N-acetylated alogliptin, M-II 
(< 6% of the parent compound). M-I is an active metabolite and is a highly selective inhibitor of 
DPP-4 similar to alogliptin; M-II does not display any inhibitory activity towards DPP-4 or other 
DPP-related enzymes. In vitro data indicate that CYP2D6 and CYP3A4 contribute to the limited 
metabolism of alogliptin.  
 



14 

In vitro studies indicate that alogliptin does not induce CYP1A2, CYP2B6 and CYP2C9 and does not 
inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4 at concentrations 
achieved with the recommended dose of 25 mg alogliptin. Studies in vitro have shown alogliptin to be 
a mild inducer of CYP3A4, but alogliptin has not been shown to induce CYP3A4 in studies in vivo.  
 
In studies in vitro, alogliptin was not an inhibitor of the following renal transporters; OAT1, OAT3 
and OCT2. 
 
Alogliptin exists predominantly as the (R)-enantiomer (> 99%) and undergoes little or no chiral 
conversion in vivo to the (S)-enantiomer. The (S)-enantiomer is not detectable at therapeutic doses.  
 
Elimination 
 
Alogliptin was eliminated with a mean terminal half-life (T1/2) of approximately 21 hours.  
 
Following administration of an oral dose of [14C] alogliptin, 76% of total radioactivity was eliminated 
in the urine and 13% was recovered in the faeces.  
 
The average renal clearance of alogliptin (170 mL/min) was greater than the average estimated 
glomerular filtration rate (approx. 120 mL/min), suggesting some active renal excretion.  
 
Time-dependency 
 
Total exposure (AUC(0-inf)) to alogliptin following administration of a single dose was similar to 
exposure during one dose interval (AUC(0-24)) after 6 days of once daily dosing. This indicates no 
time-dependency in the kinetics of alogliptin after multiple dosing. 
 
Special populations 
 
Renal impairment 
A single-dose of 50 mg alogliptin was administered to 4 groups of patients with varying degrees of 
renal impairment (CrCl using the Cockcroft-Gault formula): mild (CrCl = > 50 to ≤ 80 mL/min), 
moderate (CrCl = ≥ 30 to ≤ 50 mL/min), severe (CrCl = < 30 mL/min) and end-stage renal disease on 
haemodialysis.  
 
An approximate 1.7-fold increase in AUC for alogliptin was observed in patients with mild renal 
impairment. However, as the distribution of AUC values for alogliptin in these patients was within the 
same range as control subjects, no dose adjustment for patients with mild renal impairment is 
necessary (see section 4.2).  
 
In patients with moderate or severe renal impairment, or end-stage renal disease on haemodialysis, an 
increase in systemic exposure to alogliptin of approximately 2- and 4-fold was observed, respectively. 
(Patients with end-stage renal disease underwent haemodialysis immediately after alogliptin dosing. 
Based on mean dialysate concentrations, approximately 7% of the active substance was removed 
during a 3-hour haemodialysis session.) Therefore, in order to maintain systemic exposures to 
alogliptin that are similar to those observed in patients with normal renal function, lower doses of 
alogliptin should be used in patients with moderate or severe renal impairment, or end-stage renal 
disease requiring dialysis (see section 4.2).  
 
Hepatic impairment 
Total exposure to alogliptin was approximately 10% lower and peak exposure was approximately 
8% lower in patients with moderate hepatic impairment compared to healthy control subjects. The 
magnitude of these reductions was not considered to be clinically relevant. Therefore, no dose 
adjustment is necessary for patients with mild to moderate hepatic impairment (Child-Pugh scores 
of 5 to 9). Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh 
score > 9, see section 4.2). 
 



15 

Age, gender, race, body weight 
Age (65-81 years old), gender, race (white, black and Asian) and body weight did not have any 
clinically relevant effect on the pharmacokinetics of alogliptin. No dose adjustment is necessary (see 
section 4.2).  
 
Paediatric population 
The pharmacokinetics of alogliptin in children and adolescents < 18 years old has not been 
established. No data are available (see section 4.2).  
 
5.3 Preclinical safety data 
 
Nonclinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology and toxicology. 
 
The no-observed-adverse-effect level (NOAEL) in the repeated dose toxicity studies in rats and dogs 
up to 26 and 39 weeks in duration, respectively, produced exposure margins that were approximately 
147- and 227-fold, respectively, the exposure in humans at the recommended dose of 25 mg alogliptin. 
 
Alogliptin was not genotoxic in a standard battery of in vitro and in vivo genotoxicity studies. 
 
Alogliptin was not carcinogenic in 2-year carcinogenicity studies conducted in rats and mice. Minimal 
to mild simple transitional cell hyperplasia was seen in the urinary bladder of male rats at the lowest 
dose used (27 times the human exposure) without establishment of a clear NOEL (no observed effect 
level). 
 
No adverse effects of alogliptin were observed upon fertility, reproductive performance, or early 
embryonic development in rats up to a systemic exposure far above the human exposure at the 
recommended dose. Although fertility was not affected, a slight, statistical increase in the number of 
abnormal sperm was observed in males at an exposure far above the human exposure at the 
recommended dose.  
 
Placental transfer of alogliptin occurs in rats. 
 
Alogliptin was not teratogenic in rats or rabbits with a systemic exposure at the NOAELs far above the 
human exposure at the recommended dose. Higher doses of alogliptin were not teratogenic but 
resulted in maternal toxicity, and were associated with delayed and/or lack of ossification of bones and 
decreased foetal body weights. 
 
In a pre- and postnatal development study in rats, exposures far above the human exposure at the 
recommended dose did not harm the developing embryo or affect offspring growth and development. 
Higher doses of alogliptin decreased offspring body weight and exerted some developmental effects 
considered secondary to the low body weight.  
 
Studies in lactating rats indicate that alogliptin is excreted in milk. 
 
No alogliptin-related effects were observed in juvenile rats following repeat-dose administration for 
4 and 8 weeks. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core 
 
Mannitol 
Microcrystalline cellulose  



16 

Hydroxypropylcellulose 
Croscarmellose sodium 
Magnesium stearate  
 
Film-coating 
 
Hypromellose 
Titanium dioxide (E171) 
Iron oxide red (E172)  
Iron oxide yellow (E172) 
Macrogol 8000 
 
Printing ink 
 
Shellac 
Iron oxide black (E172) 
 
6.2 Incompatibilities 
 
Not applicable.  
 
6.3 Shelf life 
 
4 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions.  
 
6.5 Nature and contents of container 
 
Polychlorotrifluoroethylene (PCTFE)/polyvinyl chloride (PVC) blisters with push through aluminium 
lidding foil. Pack sizes of 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Takeda Pharma A/S 
Dybendal Alle 10 
2630 Taastrup 
Denmark 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/844/001-030 
 
 



17 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 19 September 2013 
Date of latest renewal: 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 
 
 
 
 
 
 
 
 
 

http://www.ema.europa.eu/


18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
 



19 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Takeda Ireland Ltd. 
Bray Business Park  
Kilruddery 
Co Wicklow 
Ireland 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic Safety Update Reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are 
set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of 
Directive 2001/83/EC and any subsequent updates published on the European medicines 
web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT  
 
• Risk Management Plan (RMP) 

 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in 
the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed 
subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
 
 
 
 
 
 
 



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 



21 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 



22 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vipidia 6.25 mg film-coated tablets 
 
alogliptin  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 6.25 mg alogliptin (as benzoate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
10film-coated tablets 
14 film-coated tablets 
28 film-coated tablets 
30 film-coated tablets 
56 film-coated tablets 
60 film-coated tablets 
84 film-coated tablets 
90 film-coated tablets 
98 film-coated tablets 
100 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 



23 

 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Takeda Pharma A/S 
Dybendal Alle 10 
2630 Taastrup 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/844/001 10 film-coated tablets 
EU/1/13/844/002 14 film-coated tablets 
EU/1/13/844/003 28 film-coated tablets 
EU/1/13/844/004 30 film-coated tablets 
EU/1/13/844/005 56 film-coated tablets 
EU/1/13/844/006 60 film-coated tablets 
EU/1/13/844/007 90 film-coated tablets 
EU/1/13/844/008 98 film-coated tablets 
EU/1/13/844/009 100 film-coated tablets 
EU/1/13/844/028 84 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Vipidia 6.25 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
2D barcode carrying the unique identifier included. 
 
 



24 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 
 



25 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vipidia 6.25 mg tablets 
 
alogliptin  
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Takeda  
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



26 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vipidia 12.5 mg film-coated tablets 
 
alogliptin  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 12.5 mg alogliptin (as benzoate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
10 film-coated tablets 
14 film-coated tablets 
28 film-coated tablets 
30 film-coated tablets 
56 film-coated tablets 
60 film-coated tablets 
84 film-coated tablets 
90 film-coated tablets 
98 film-coated tablets 
100 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



27 

9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Takeda Pharma A/S 
Dybendal Alle 10 
2630 Taastrup 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/844/010 10 film-coated tablets 
EU/1/13/844/011 14 film-coated tablets 
EU/1/13/844/012 28 film-coated tablets 
EU/1/13/844/013 30 film-coated tablets 
EU/1/13/844/014 56 film-coated tablets 
EU/1/13/844/015 60 film-coated tablets 
EU/1/13/844/016 90 film-coated tablets 
EU/1/13/844/017 98 film-coated tablets 
EU/1/13/844/018 100 film-coated tablets 
EU/1/13/844/029 84 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Vipidia 12.5 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
2D barcode carrying the unique identifier included. 
 
 



28 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 
 



29 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vipidia 12.5 mg tablets 
 
alogliptin  
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Takeda  
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



30 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vipidia 25 mg film-coated tablets 
 
alogliptin  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 25 mg alogliptin (as benzoate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
10 film-coated tablets 
14 film-coated tablets 
28 film-coated tablets 
30 film-coated tablets 
56 film-coated tablets 
60 film-coated tablets 
84 film-coated tablets 
90 film-coated tablets 
98 film-coated tablets 
100 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 



31 

 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Takeda Pharma A/S 
Dybendal Alle 10 
2630 Taastrup 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/844/019 10 film-coated tablets 
EU/1/13/844/020 14 film-coated tablets 
EU/1/13/844/021 28 film-coated tablets 
EU/1/13/844/022 30 film-coated tablets 
EU/1/13/844/023 56 film-coated tablets 
EU/1/13/844/024 60 film-coated tablets 
EU/1/13/844/025 90 film-coated tablets 
EU/1/13/844/026 98 film-coated tablets 
EU/1/13/844/027 100 film-coated tablets 
EU/1/13/844/030 84 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Vipidia 25 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
2D barcode carrying the unique identifier included. 
 
 



32 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 
 



33 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vipidia 25 mg tablets 
 
alogliptin  
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Takeda  
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 



34 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



35 

Package leaflet: Information for the patient 
 

Vipidia 25 mg film-coated tablets 
Vipidia 12.5 mg film-coated tablets 
Vipidia 6.25 mg film-coated tablets 

alogliptin 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Vipidia is and what it is used for  
2. What you need to know before you take Vipidia 
3. How to take Vipidia 
4. Possible side effects  
5. How to store Vipidia 
6. Contents of the pack and other information 
 
 
1. What Vipidia is and what it is used for 
 
Vipidia contains the active substance alogliptin which belongs to a group of medicines called DPP-4 
inhibitors (dipeptidyl peptidase-4 inhibitors) which are “oral anti-diabetics”. It is used to lower blood 
sugar levels in adults with type 2 diabetes. Type 2 diabetes is also called non-insulin-dependent 
diabetes mellitus or NIDDM. 
 
Vipidia works to increase the levels of insulin in the body after a meal and decrease the amount of 
sugar in the body. It must be taken together with other anti-diabetic medicines, which your doctor will 
have prescribed for you, such as sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide), 
metformin and/or thiazolidinediones (e.g. pioglitazone) and metformin and/or insulin.  
 
Vipidia is taken when your blood sugar cannot be adequately controlled by diet, exercise and one or 
more of these other oral anti-diabetic medicines. It is important that you continue to take your other 
anti-diabetic medicine, and continue to follow the advice on diet and exercise that your nurse or doctor 
has given you. 
 
 
2. What you need to know before you take Vipidia 
 
Do not take Vipidia: 
- if you are allergic to alogliptin or any of the other ingredients of this medicine (listed in 

section 6) 
- if you have had a serious allergic reaction to any other similar medicines that you take to control 

your blood sugar. Symptoms of a serious allergic reaction may include; rash, raised red patches 
on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in 
breathing or swallowing. Additional symptoms may include general itching and feeling of heat 
especially affecting the scalp, mouth, throat, palms of hands and soles of feet (Stevens-Johnson 
syndrome). 

 



36 

Warnings and precautions  
Talk to your doctor or pharmacist before taking Vipidia: 
- if you have type 1 diabetes (your body does not produce insulin) 
- if you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is 

unable to breakdown glucose because there is not enough insulin). Symptoms include excessive 
thirst, frequent urination, loss of appetite, nausea or vomiting and rapid weight loss 

- if you are taking an anti-diabetic medicine known as sulphonylurea (e.g. glipizide, tolbutamide, 
glibenclamide) or insulin. Your doctor may want to reduce your dose of sulphonylurea or 
insulin when you take any of them together with Vipidia in order to avoid too low blood sugar 
(hypoglycaemia) 

- if you have kidney disease, you can still take this medicine but your doctor may reduce the dose 
- if you have liver disease 
- if you suffer from heart failure 
- if you are taking insulin or an anti-diabetic medicine, your doctor may want to reduce your dose 

of the other anti-diabetic medicine or insulin when you take either of them together with Vipidia 
in order to avoid low blood sugar 

- if you have or have had a disease of the pancreas 
 
Children and adolescents  
Vipidia is not recommended for children and adolescents under 18 years due to the lack of data in 
these patients. 
 
Other medicines and Vipidia 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Pregnancy and breast-feeding  
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
There is no experience of using Vipidia in pregnant women or during breast-feeding. Vipidia should 
not be used during pregnancy or breast-feeding. Your doctor will help you to decide whether to 
continue breast-feeding or to continue using Vipidia. 
 
Driving and using machines 
Vipidia is not known to affect your ability to drive and use machines. Taking Vipidia in combination 
with other anti-diabetic medicines called sulphonylureas, insulin or combination therapy with 
thiazolidinedione plus metformin can cause too low blood sugar levels (hypoglycaemia), which may 
affect your ability to drive and use machines. 
 
 
3. How to take Vipidia 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
Your doctor will prescribe Vipidia together with one or more other medicines to control your blood 
sugar levels. Your doctor will tell you if you need to change the amount of other medicines you take. 
 
The recommended dose of Vipidia is 25 mg once a day. 
 
Patients with kidney disease 
If you have kidney disease your doctor may prescribe you a reduced dose. This may be 12.5 mg or 
6.25 mg once a day, depending on the severity of your kidney disease.  
 



37 

Patients with liver disease 
If you have mildly or moderately reduced liver function, the recommended dose of Vipidia is 25 mg 
once a day. This medicine is not recommended for patients with severely reduced liver function due to 
the lack of data in these patients. 
 
Swallow your tablet(s) whole with water. You can take this medicine with or without food. 
 
If you take more Vipidia than you should 
If you take more tablets than you should, or if someone else or a child takes your medicine, contact or 
go to your nearest emergency centre straight away. Take this leaflet or some tablets with you so that 
your doctor knows exactly what you have taken.  
 
If you forget to take Vipidia 
If you forget to take a dose, take it as soon as you remember it. Do not take a double dose to make up 
for a forgotten dose. 
 
If you stop taking Vipidia 
Do not stop taking Vipidia without consulting your doctor first. Your blood sugar levels may increase 
when you stop taking Vipidia. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
STOP taking Vipidia and contact a doctor immediately if you notice any of the following serious 
side effects: 
 
Not known (frequency cannot be estimated from the available data): 
- An allergic reaction. The symptoms may include: a rash, hives, swallowing or breathing 

problems, swelling of your lips, face, throat or tongue and feeling faint.  
- A severe allergic reaction: skin lesions or spots on your skin that can progress to a sore 

surrounded by pale or red rings, blistering and/or peeling of the skin possibly with symptoms 
such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy 
eyes and mouth sores (Stevens-Johnson syndrome and Erythema multiforme). 

- Severe and persistent pain in the abdomen (stomach area) which might reach through to your 
back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas 
(pancreatitis). 

 
You should also discuss with your doctor if you experience the following side effects: 
 
Common (may affect up to 1 in 10 people): 
- Symptoms of low blood sugar (hypoglycaemia) may occur when Vipidia is taken in 

combination with insulin or sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide). 
Symptoms may include: trembling, sweating, anxiety, blurred vision, tingling lips, paleness, 
mood change or feeling confused. Your blood sugar could fall below the normal level, but can 
be increased again by taking sugar. It is recommended that you carry some sugar lumps, sweets, 
biscuits or sugary fruit juice. 

- Cold like symptoms such as sore throat, stuffy or blocked nose,  
- Rash 
- Itchy skin 
- Headache 
- Stomach ache 
- Diarrhoea 
- Indigestion, heartburn 



38 

 
Not known: 
- Liver problems such as nausea or vomiting, stomach pain, unusual or unexplained tiredness, 

loss of appetite, dark urine or yellowing of your skin or the whites of your eyes. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Vipidia 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The 
expiry date refers to the last day of that month. 
 
This medicinal product does not require any special storage conditions.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Vipidia contains  
- The active substance is alogliptin.  
Each 25 mg tablet contains alogliptin benzoate equivalent to 25 mg alogliptin, 
- The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, 

croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), red iron 
oxide (E172), macrogol 8000, shellac and black iron oxide (E172). 

Each 12.5 mg tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin 
- The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, 

croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), yellow 
iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172). 

Each 6.25 mg tablet contains alogliptin benzoate equivalent to 6.25 mg alogliptin 
- The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, 

croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), red iron 
oxide (E172), macrogol 8000, shellac and black iron oxide (E172). 

 
What Vipidia looks like and contents of the pack 
- Vipidia 25 mg film-coated tablets (tablets) are light red, oval (approximately 9.1 mm long by 

5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-25” printed in grey ink on 
one side. 

- Vipidia 12.5 mg film-coated tablets (tablets) are yellow, oval (approximately 9.1 mm long by 
5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-12.5” printed in grey ink 
on one side. 

- Vipidia 6.25 mg film-coated tablets (tablets) are light pink, oval (approximately 9.1 mm long by 
5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-6.25” on printed in grey 
ink on one side. 

 
Vipidia is available in blister packs containing 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 tablets. 
 
Not all pack sizes may be marketed. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


39 

Marketing Authorisation Holder 
Takeda Pharma A/S 
Dybendal Alle 10 
2630 Taastrup 
Denmark  
 
Manufacturer 
Takeda Ireland Limited 
Bray Business Park 
Kilruddery 
Co. Wicklow 
Ireland 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien/ 
Luxembourg/Luxemburg 
Takeda Belgium 
Tél/Tel: +32 2 464 06 11 
takeda-belgium@takeda.com 
 

Lietuva 
Takeda UAB 
Tel: +370 521 09 070 
lt-info@takeda.com 

България 
Такеда България 
Тел.: +359 2 958 27 36; +359 2 958 15 29 
 

Magyarország 
Takeda Pharma Kft. 
Tel: +361 2707030 

Česká republika 
Takeda Pharmaceuticals Czech Republic s.r.o. 
Tel: +420 234 722 722 
 

Malta 
Takeda Italia S.p.A. 
Tel: +39 06 502601 

Danmark 
Takeda Pharma A/S 
Tlf/Tel: +45 46 77 11 11 
 

Nederland 
Takeda Nederland bv 
Tel: +31 23 56 68 777 
nl.medical.info@takeda.com 
 

Deutschland 
Takeda GmbH 
Tel: 0800 825 3325 
medinfo@takeda.de 
 

Norge 
Takeda AS 
Tlf: +47 6676 3030 
infonorge@takeda.com 
 

Eesti 
Takeda Pharma AS 
Tel: +372 617 7669 
 

Österreich 
Takeda Pharma Ges m.b.H 
Tel: +43 (0) 800-20 80 50 

Ελλάδα 
TAKEDA ΕΛΛΑΣ Α.Ε 
Tel: +30 210 6387800 
gr.info@takeda.com 
 

Polska 
Takeda Polska Sp. z o.o. 
tel. +48 22 608 13 00 
 

España 
Takeda Farmacéutica España S.A. 
Tel: +34 917 14 99 00 
spain@takeda.com 
 

Portugal 
Takeda Farmacêuticos Portugal, Lda. 
Tel: +351 21 120 1457 
 



40 

France 
Takeda France S.A.S 
Tél: +33 1 46 25 16 16  
 

România 
Takeda Pharmaceuticals SRL 
Tel: +40 21 335 03 91 
 

Hrvatska 
Takeda Pharmaceuticals Croatia d.o.o 
Tel: +385 1 377 88 96 
 

Slovenija 
Takeda GmbH, Podružnica Slovenija 
Tel: +386 (0) 59 082 480 
 

Ireland 
Takeda Products Ireland Limited 
Tel: +353 (0) 1 6420021 
 

Slovenská republika 
Takeda Pharmaceuticals Slovakia s.r.o. 
Tel: +421 (2) 20 602 600 
 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
vistor@vistor.is 
 

Suomi/Finland 
Takeda Oy 
Tel. +358 20 746 5000 
 

Italia 
Takeda Italia S.p.A. 
Tel: +39 06 502601 

Sverige 
Takeda Pharma AB 
Tel: +46 8 731 28 00 
infosweden@takeda.com 
 

Κύπρος 
Takeda Pharma A/S 
Τηλ: +45 46 77 11 11 
 

United Kingdom 
Takeda UK Ltd 
Tel: +44 (0) 1628 537 900 
 

Latvija 
Takeda Latvia SIA 
Tel: +371 67840082 
 

 

 
This leaflet was last revised in  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.  
 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
	A. LABELLING
	B. PACKAGE LEAFLET