natgillin/translations-raw huggingface dataset:
HbA1c (%)
(-0.8, -0.4) -0.8‡ (-1.0, -0.6) -0.7‡
24 - + &% † ((%) (95% CI) '
ongoing metformin therapy (N=453)
!
8.0
"+ 100 mg
-0.7
()
(-0.8, -0.5)
(- 0, 8, - 0, 5)
8
(N=453) '100 mg
Placebo-corrected mean
- 0, 7 ‡
Mean
8, 1
Mean change from
- 0, 9
Study
(- 0, 9, - 0, 5)
baseline HbA1c (%)
(N=163)
baseline HbA1c (%) † at Week 24
100 mg
Week 24† (95% CI)
- 0, 6 ‡
Sitagliptin 100 mg once daily added to -0.7‡ ongoing pioglitazone therapy (N=163) Sitagliptin 100 mg once daily added to
(N=102)
(-0.9, -0.5) -0.6‡
100 mg
ongoing glimepiride therapy (N=102) Sitagliptin 100 mg once daily added to
(- 1, 1, - 0, 7)
(-0.8, -0.3)
& (
ongoing glimepiride + metformin therapy (N=115) Initial therapy (twice daily):
- 1, 6 ‡ (- 1, 8, - 1, 3)
-0.9‡ (-1.1, -0.7) -1.6‡
50 mg + 500 mg (N=183) &
Sitagliptin 50 mg + metformin 500 mg (N=183) Initial therapy (twice daily):
- 1, 9
-1.4
(- 2, 3, - 1, 8)
(-1.8, -1.3)
50 mg + 1000 mg (N=178) * $† & -
Sitagliptin 50 mg + metformin 1000 mg (N=178)
).
8.8
‡
-1.9
HbA1c (%)
-2.1‡ (-2.3, -1.8)
18 -
* All Patients Treated Population (an intention-to-treat analysis). † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline value. ‡ p < 0.001 compared to placebo or placebo + combination treatment. § HbA1c (%) at week 18.
$TESAVEL 100 mg
In a study comparing the efficacy and safety of the addition of TESAVEL 100 mg once daily or glipizide (a sulphonylurea agent) in patients with inadequate glycaemic control on metformin monotherapy, sitagliptin was similar to glipizide in reducing HbA1c.
10
The mean glipizide dose used in the comparator group was 10 mg per day with approximately 40% of patients requiring a glipizide dose of ≤ 5 mg/ day throughout the study.
(32, 0%).
5.2 Pharmacokinetic properties
(4, 9%)
Absorption Following oral administration of a 100-mg dose to healthy subjects, sitagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 to 4 hours post-dose, mean plasma AUC of sitagliptin was 8.52 μ M• hr, Cmax was 950 nM.
87
The absolute bioavailability of sitagliptin is approximately 87%.
8, 52 µM• hr, Cmax - 950 nM. #%..
Plasma AUC of sitagliptin increased in a dose-proportional manner.
198
Distribution The mean volume of distribution at steady state following a single 100-mg intravenous dose of sitagliptin to healthy subjects is approximately 198 liters.
(38%).
The fraction of sitagliptin reversibly bound to plasma proteins is low (38%).
'
9 Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
79%
Approximately 79% of sitagliptin is excreted unchanged in the urine.
16%
Following a [14C]sitagliptin oral dose, approximately 16% of the radioactivity was excreted as metabolites of sitagliptin.
In vitro 2C9, 2D6, 1A2, 2C19
In vitro data showed that sitagliptin is not an inhibitor of CYP isozymes CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 or 2B6, and is not an inducer of CYP3A4 and CYP1A2.
,
The apparent terminal t1/ 2 following a 100-mg oral dose of sitagliptin was approximately 12.4 hours.
CYP CYP1A2.
Sitagliptin accumulates only minimally with multiple doses.
350 ml/ min.
The renal clearance was approximately 350 ml/ min.
/
Sitagliptin is not a substrate for OCT2 or OAT1 or PEPT1/ 2 transporters.
250 µM)
In vitro, sitagliptin did not inhibit OAT3 (IC50=160 μ M) or p-glycoprotein (up to 250 μ M) mediated transport at therapeutically relevant plasma concentrations.
In vitro
Characteristics in patients The pharmacokinetics of sitagliptin were generally similar in healthy subjects and in patients with type 2 diabetes.
OAT3 (IC50=160 µM)
Renal insufficiency A single-dose, open-label study was conducted to evaluate the pharmacokinetics of a reduced dose of sitagliptin (50-mg) in patients with varying degrees of chronic renal insufficiency compared to normal healthy control subjects.
$(50 mg). $(50 < 80 ml/ min),
The study included patients with renal insufficiency classified on the basis of creatinine clearance as mild (50 to < 80 ml/ min), moderate (30 to < 50 ml/ min), and severe (< 30 ml/ min), as well as patients with end-stage renal disease (ESRD) on hemodialysis.
(30
An approximately 2-fold increase in the plasma AUC of sitagliptin was observed in patients with moderate renal insufficiency, and an approximately 4-fold increase was observed in patients with severe renal insufficiency and in patients with ESRD on hemodialysis, as compared to normal healthy control subjects.
< 50 ml/ min) (ESRD)
Sitagliptin was modestly removed by hemodialysis (13.5% over a 3- to 4-hour hemodialysis session starting 4 hours postdose).
4. 2).
(See section 4.2.)
Child- Pugh ≤ 9). &
Hepatic insufficiency No dosage adjustment for TESAVEL is necessary for patients with mild or moderate hepatic insufficiency (Child-Pugh score ≤ 9).
Child- Pugh > 9)..
There is no clinical experience in patients with severe hepatic insufficiency (Child-Pugh score > 9).
19%
Elderly subjects (65 to 80 years) had approximately 19% higher plasma concentrations of sitagliptin compared to younger subjects.
-
Paediatric No studies with TESAVEL have been performed in paediatric patients.
&
These characteristics had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a composite analysis of Phase I pharmacokinetic data and on a population pharmacokinetic analysis of Phase I and Phase II data.
TESAVEL
5.3 Preclinical safety data
19
Renal and liver toxicity were observed in rodents at systemic exposure values 58 times the human exposure level, while the no-effect level was found at 19 times the human exposure level.
67
Incisor teeth abnormalities were observed in rats at exposure levels 67 times the clinical exposure level; the no- effect level for this finding was 58-fold based on the 14-week rat study.
.
Sitagliptin was not carcinogenic in mice.
58
In rats, there was an increased incidence of hepatic adenomas and carcinomas at systemic exposure levels 58 times the human exposure level.
,
No adverse effects upon fertility were observed in male and female rats given sitagliptin prior to and throughout mating.
-
In a pre-/ postnatal development study performed in rats sitagliptin showed no adverse effects.
,
Reproductive toxicity studies showed a slight treatment-related increased incidence of fetal rib malformations (absent, hypoplastic and wavy ribs) in the offspring of rats at systemic exposure levels more than 29 times the human exposure levels.
29
Maternal toxicity was seen in rabbits at more than 29 times the human exposure levels.
(E460)
Tablet core: microcrystalline cellulose (E460)
(E468) (E470b)
11 calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
3350
Film coating: polyvinyl alcohol macrogol 3350 talc (E553b) titanium dioxide (E171) red iron oxide (E172) yellow iron oxide (E172)
13 (E553b) (E171)
6.2 Incompatibilities
(E172)
Not applicable.
(E172)
6.3 Shelf life
6. 3, & +
3 years
3
6.4 Special precautions for storage
6. 4
This medicinal product does not require any special storage conditions.
% #
6.5 Nature and contents of container
(PVC/ PE/ PVDC 50 x 1
Opaque blisters (PVC/ PE/ PVDC and aluminum).
14, 28, 56, 84
Packs of 14, 28, 56, 84 or 98 film-coated tablets and 50 x 1 film-coated tablets in perforated unit dose blisters.
&
6.6 Special precautions for disposal
% #
7.
Hertford Road, Hoddesdon Hertfordshire EN11 9BU
Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
EU/ 1/ 07/ 435/ 001 EU/ 1/ 07/ 435/ 002 EU/ 1/ 07/ 435/ 003 EU/ 1/ 07/ 435/ 004 EU/ 1/ 07/ 435/ 005 EU/ 1/ 07/ 435/ 006
EU/ 1/ 07/ 435/ 001 EU/ 1/ 07/ 435/ 002 EU/ 1/ 07/ 435/ 003 EU/ 1/ 07/ 435/ 004 EU/ 1/ 07/ 435/ 005 EU/ 1/ 07/ 435/ 006
7
12 9.
/ 6 7
Date of first authorisation:
10
10 January 2008
2008
10.
$/ (EMEA): http: // www. emea. europa. eu /.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
TESAVEL 50 mg
TESAVEL 50 mg film-coated tablets
(sitagliptin phosphate monohydrate),
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
“ 112 ”
Round, light beige film-coated tablet with “ 112” on one side.
PPAR6
• to improve glycaemic control in combination with a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
PPAR6
For patients with type 2 diabetes mellitus in whom use of a PPARγ agonist (i. e. a thiazolidinedione) is appropriate, TESAVEL is indicated:
4. 3
4.2 Posology and method of administration
TESAVEL 100 mg
The dose of TESAVEL is 100 mg once daily.
4. 8).
(See section 4.4.)
TESAVEL
A double dose should not be taken on the same day.
[CrCl] ≥ 50 ml/ min),
14 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for TESAVEL is required.
% TESAVEL
Therefore, use of TESAVEL is not recommended in this patient population (see section 5.2).
. $
TESAVEL has not been studied in patients with severe hepatic insufficiency.
,
Elderly No dosage adjustment is necessary based on age.
,
Hypersensitivity to the active substance or to any of the excipients (see section 4.4 and 4.8).
In vitro
15 Metformin:
In vitro
Digoxin:
CYP3A4, CYP2C8, CYP2C9 '
Sitagliptin had a small effect on plasma digoxin concentrations.
100 mg TESAVEL
4.6 Pregnancy and lactation
. '
Studies in animals have shown reproductive toxicity at high doses (see section 5.3).
5. 3).
The potential risk for humans is unknown.
$
TESAVEL should not be used during breast-feeding.
. $
However, when driving or operating machines, it should be taken into account that dizziness and somnolence have been reported.
TESAVEL
16 4.8 Undesirable effects
.
In 9 large clinical trials of up to 2 years in duration, over 2700 patients have received treatment with TESAVEL 100 mg per day alone or in combination with metformin, a sulphonylurea (with or without metformin) or a PPARγ agent.
TESAVEL 100 mg
In these trials, the rate of discontinuation due to adverse experiences considered drug-related was 0.8% with 100 mg per day and 1.5% with other treatments.
2
Frequencies are defined as: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1000, < 1/ 100); rare (≥ 1/ 10000, < 1/ 1000); and very rare (< 1/ 10000).
((1/ 10);
Table 1.
9, 7%.%,
Uncommon
,
1 In this placebo-controlled 24-week study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ metformin compared to treatment with placebo/ metformin was 9.3% and 10.1%, respectively.
(6, 7%),
17 In an additional 1-year study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ metformin compared to sulphonylurea/ metformin was 14.5% and 30.3%, respectively.
(14, 0%
4 In this 24-week study of the combination of sitagliptin 100 mg once daily and pioglitazone, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ pioglitazone compared to patients treated with placebo/ pioglitazone was 9.1% and 9.0%, respectively.
)
In addition, in monotherapy studies of up to 24 weeks in duration of sitagliptin 100 mg once daily alone compared to placebo, adverse reactions considered as drug-related reported in patients treated with sitagliptin in excess (> 0.2% and difference > 1 patient) of that in patients receiving placebo are headache, hypoglycaemia, constipation, and dizziness.
*
The overall incidence of adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin was comparable to metformin alone (14.0% each) and greater than sitagliptin alone (6.7%), with the differences relative to sitagliptin alone primarily due to gastrointestinal adverse reactions.
Stevens- Johnson (
18 Post-marketing Experience:
4
19 Overall, sitagliptin improved glycaemic control when given as monotherapy, when used in combination with metformin (initial or add-on therapy), in combination with a sulphonylurea (with or without metformin), and in combination with a thiazolidinedione, as measured by clinically relevant reductions in HbA1c from baseline at study endpoint (see Table 2).
22
The number of patients with moderate to severe renal insufficiency was too low to confirm safe use of sitagliptin in this type of patients.
HbA1c *
Study
"+ #%)
baseline
#%), + &
baseline HbA1c (%)
+ "(! & 0
Week 24†
HbA1c (%)
Monotherapy Studies
&% † (
at Week 24†
24 - + &% † ((%) (95% CI) '
(95% CI)
!
Sitagliptin 100 mg once daily§ (N= 193) Sitagliptin 100 mg once daily (N= 229) Combination Therapy Studies Sitagliptin 100 mg once daily added to
- 0, 5
8.0 8.0
- 0, 6 ‡
-0.5 -0.6
(- 0, 8, - 0, 4) (N= 193) '100 mg - 0, 8 ‡
-0.6‡ (-0.8, -0.4) -0.8‡ (-1.0, -0.6) -0.7‡
(- 1, 0, - 0, 6)
ongoing metformin therapy (N=453)
(- 0, 8, - 0, 5)
(-0.8, -0.5)
23
20
#%), + &
Placebo-corrected mean
("+"
Mean
+ "(! & 0
Mean change from
HbA1c (%)
change in HbA1c (%) at
HbA1c
Study
24 - +
baseline
&% † (
baseline HbA1c (%)
24 - + &% † ((%) (95% CI)
Week 24†
(N=453) '100 mg
Sitagliptin 100 mg once daily added to
- 0, 7 ‡
HbA1c (%)
(- 0, 9, - 0, 5)
at Week 24†
(N=163)
(95% CI) -0.7‡
100 mg
ongoing pioglitazone therapy (N=163) Sitagliptin 100 mg once daily added to
'
21 Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
-
Sitagliptin was not carcinogenic in mice.
-
No adverse effects upon fertility were observed in male and female rats given sitagliptin prior to and throughout mating.
,
In a pre-/ postnatal development study performed in rats sitagliptin showed no adverse effects.
;
Reproductive toxicity studies showed a slight treatment-related increased incidence of fetal rib malformations (absent, hypoplastic and wavy ribs) in the offspring of rats at systemic exposure levels more than 29 times the human exposure levels.
(E468) (E470b)
23 calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
3350 (E553b) (E171)
Film coating: polyvinyl alcohol macrogol 3350 talc (E553b) titanium dioxide (E171) red iron oxide (E172) yellow iron oxide (E172)
(E172)
6.2 Incompatibilities
27 6. 2
6.3 Shelf life
&
Any unused product or waste material should be disposed of in accordance with local requirements.
EU/ 1/ 07/ 435/ 007 EU/ 1/ 07/ 435/ 008 EU/ 1/ 07/ 435/ 009 EU/ 1/ 07/ 435/ 010 EU/ 1/ 07/ 435/ 011 EU/ 1/ 07/ 435/ 012
EU/ 1/ 07/ 435/ 007 EU/ 1/ 07/ 435/ 008 EU/ 1/ 07/ 435/ 009 EU/ 1/ 07/ 435/ 010 EU/ 1/ 07/ 435/ 011 EU/ 1/ 07/ 435/ 012
7
24 9.
TESAVEL 100 mg
TESAVEL 100 mg film-coated tablets
100 mg
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
“ 277 ”
Round, beige film-coated tablet with “ 277” on one side.
[CrCl] ≥ 50 ml/ min),
26 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for TESAVEL is required.
.
Therefore, use of TESAVEL is not recommended in this patient population (see section 5.2).
'&. "
TESAVEL has not been studied in patients with severe hepatic insufficiency.
AUC Cmax p -
27 Metformin:
31 $
TESAVEL should not be used during breast-feeding.
TESAVEL
28 4.8 Undesirable effects
. $
In 9 large clinical trials of up to 2 years in duration, over 2700 patients have received treatment with TESAVEL 100 mg per day alone or in combination with metformin, a sulphonylurea (with or without metformin) or a PPARγ agent.
)
29 In an additional 1-year study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ metformin compared to sulphonylurea/ metformin was 14.5% and 30.3%, respectively.
Stevens- Johnson (
30 Post-marketing Experience:
4
31 Overall, sitagliptin improved glycaemic control when given as monotherapy, when used in combination with metformin (initial or add-on therapy), in combination with a sulphonylurea (with or without metformin), and in combination with a thiazolidinedione, as measured by clinically relevant reductions in HbA1c from baseline at study endpoint (see Table 2).
(- 0, 8, - 0, 4) (N= 193) '100 mg - 0, 8 ‡ (N= 229)
-0.6‡ (-0.8, -0.4) -0.8‡ (-1.0, -0.6) -0.7‡
("+"
-0.7
+ "(! & 0
(-0.8, -0.5)
! &
32
!
Placebo-corrected mean
&
Mean
HbA1c (%)
Mean change from
&% † (
baseline
24 - + &% † ((%) (95% CI) '
baseline HbA1c (%)
!
Week 24†
"+ 100 mg
Sitagliptin 100 mg once daily added to
()
HbA1c (%)
50 mg + m 500 mg (N=183) &
Sitagliptin 50 mg + metformin 500 mg (N=183) Initial therapy (twice daily):
'
33 Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
(E468) (E470b)
35 calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
40 (E553b) (E171)
6.2 Incompatibilities
EU/ 1/ 07/ 435/ 013 EU/ 1/ 07/ 435/ 014 EU/ 1/ 07/ 435/ 015 EU/ 1/ 07/ 435/ 016 EU/ 1/ 07/ 435/ 017 EU/ 1/ 07/ 435/ 018
EU/ 1/ 07/ 435/ 013 EU/ 1/ 07/ 435/ 014 EU/ 1/ 07/ 435/ 015 EU/ 1/ 07/ 435/ 016 EU/ 1/ 07/ 435/ 017 EU/ 1/ 07/ 435/ 018
7
36 9.
42 II
37 ANNEX II
3 (
B.
43 A
38 A.
.
Name and address of the manufacturer responsible for batch release
Merck Sharp & Dohme (Italia) S. p. A Via Emilia 21 IT- 27100 Pavia +
Via Emilia 21 IT-27100 Pavia Italy
7 6
Medicinal product subject to medical prescription.
CHMP.
Not applicable.
60
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2 presented in Module 1.8.1. of the Marketing Authorisation Application and any subsequent updates, is in place and functioning before and whilst the product is on the market.
)
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
(
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
•
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
44 III
39 ANNEX III
45 A.
40 A.
46
LABELLING
,
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TESAVEL 25 mg - # (
Outer carton for TESAVEL 25 mg film-coated tablets
) #
1.
TESAVEL 25 mg '
TESAVEL 25 mg film-coated tablets Sitagliptin
25 mg
Each tablet contains sitagliptin phosphate monohydrate equivalent to 25 mg of sitagliptin.
14 28 56 84 98 50 x 1
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets 50 x 1 film-coated tablets
47 10.
EXPIRY DATE
6 6 6
EXP
11.
42 10.
15.
Batch
TESAVEL 25 mg
TESAVEL 25 mg
48
43 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
TESAVEL 25 mg - # (
Blister for TESAVEL 25 mg film-coated tablets
TESAVEL 25 mg '
TESAVEL 25 mg tablets Sitagliptin
6
EXP
$:
Batch
49
OTHER
,
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
.
Outer carton for TESAVEL 50 mg film-coated tablets
/ 1
1.
TESAVEL 50 mg - # (
NAME OF THE MEDICINAL PRODUCT
TESAVEL 50 mg '
TESAVEL 50 mg film-coated tablets Sitagliptin
/
Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin.
50 10.
EXPIRY DATE
11.
45 10.
TESAVEL 50 mg
TESAVEL 50 mg
51
46 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
,
Blister for TESAVEL 50 mg film-coated tablets
. # +
1.
TESAVEL 50 mg '
TESAVEL 50 mg tablets Sitagliptin
52
OTHER
,
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TESAVEL 100 mg - # (
Outer carton for TESAVEL 100 mg film-coated tablets
TESAVEL 100 mg '
TESAVEL 100 mg film-coated tablets Sitagliptin
100 mg
Each tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg of sitagliptin.
53 10.
EXPIRY DATE
11.
48 10.
TESAVEL 100 mg
TESAVEL 100 mg
54
49 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
TESAVEL 100 mg - # (
Blister for TESAVEL 100 mg film-coated tablets
TESAVEL 100 mg '
TESAVEL 100 mg tablets Sitagliptin
55..
OTHER
56
50 B.
:
INFORMATION FOR THE USER
TESAVEL 25 mg - # (
TESAVEL 25 mg film-coated tablets Sitagliptin
) #
Read all of this leaflet carefully before you start taking this medicine.
(Sitagliptin)
- Keep this leaflet.
TESAVEL
You may need to read it again.
2.
- If you have any further questions, ask your doctor or pharmacist.
TESAVEL 4.
- This medicine has been prescribed for you.
TESAVEL 6. "
Do not pass it on to others.
TESAVEL
It may harm them, even
6
if their symptoms are the same as yours.
6
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
6
please tell your doctor or pharmacist.
TESAVEL
In this leaflet:
"$$- 4
How to take TESAVEL 4.
TESAVEL. 0
Possible side effects 5.
TESAVEL
How to store TESAVEL 6.
TESAVEL,
Further information
,,
1.
TESAVEL,
Type 2 diabetes is also called non-insulin-dependent diabetes mellitus, or NIDDM.
. '
However, when TESAVEL is used in combination with a sulphonylurea medicine, low blood sugar (hypoglycaemia) can occur.
*
Your doctor is now prescribing TESAVEL as an additional medicine to help control your blood sugar.
TESAVEL
What is type 2 diabetes?
,,
2.
TESAVEL
BEFORE YOU TAKE TESAVEL
(* TESAVEL -
Do not take TESAVEL
(
- if you are allergic (hypersensitive) to sitagliptin or any of the other ingredients of TESAVEL.
)
Take special care with TESAVEL Tell your doctor if you have or have had:
# 1
- type 1 diabetes
,
- diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss,
TESAVEL
nausea or vomiting)
-
- any kidney problems, or any past or present medical problems.
, TESAVEL
If you have kidney problems,
.
52
- TESAVEL
- an allergic reaction to TESAVEL
# TESAVEL
Your doctor may reduce the dose of your sulphonylurea medication.
.
This includes prescription and non-prescription medicines, and herbal supplements.
* *
Taking TESAVEL with food and drink You can take TESAVEL with or without food and drink.
.
Pregnancy and breast-feeding Women who are pregnant or plan to become pregnant should consult their doctor before taking TESAVEL.
TESAVEL. &
You should not use TESAVEL during pregnancy.
TESAVEL
You should not use TESAVEL if you are breast- feeding or plan to breast-feed.
.
However, when driving or operating machinery, it should be taken into account that dizziness and drowsiness have been reported.
TESAVEL
HOW TO TAKE TESAVEL
%: − 100 mg − −
Always take TESAVEL exactly as your doctor has told you.
TESAVEL.
You should check with your doctor or pharmacist if you are not sure.
100
The usual dose is: − one 100 mg film-coated tablet − once a day − by mouth
)
Your doctor will prescribe TESAVEL along with certain other medicines that lower blood sugar.
&
Continue to take TESAVEL as long as your doctor prescribes it so you can continue to help control your blood sugar.
(
It is important to stay on the diet, exercise and weight loss program recommended by your doctor while taking TESAVEL.
-
If you take more TESAVEL than you should If you take more than the prescribed dosage of TESAVEL, contact your doctor immediately.
1 100,
If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule.
TESAVEL:
Do not take a double dose of TESAVEL.
0 4
4.
TESAVEL
POSSIBLE SIDE EFFECTS
,
Like all medicines, TESAVEL may cause side effects, although not everybody gets them.
4
53 Very common side effects (more than 1 per 10 patients) Common side effects (less than 1 per 10 but more than 1 per 100 patients) Uncommon side effects (less than 1 per 100 but more than 1 per 1000 patients)
:
Common: nausea Uncommon: weight loss, loss of appetite, abdominal pain, diarrhoea, low blood sugar, drowsiness.