SEGLUROMET 7.51000 MG

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Viambatanisho vya kazi:

ERTUGLIFLOZIN (L-PGA); METFORMIN

Inapatikana kutoka:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

ATC kanuni:

A10BD23

Dawa fomu:

FILM COATED TABLETS

Tungo:

METFORMIN 1000 MG; ERTUGLIFLOZIN (L-PGA) 7.5 MG

Njia ya uendeshaji:

PER OS

Dawa ya aina:

Required

Viwandani na:

MERCK SHARP & DOHME CORP., USA

Eneo la matibabu:

METFORMIN AND ERTUGLIFLOZIN

Matibabu dalili:

Segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:• in patients not adequately controlled on their maximally tolerated dose of metformin alone• in patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetes • in patients already being treated with the combination of ertugliflozin and metformin as separate tablets.

Idhini ya tarehe:

2019-01-28

Taarifa za kipeperushi

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS
REGULATIONS (PREPARATIONS) 1986
This medicine is to be supplied upon physician’s prescription only
SEGLUROMET
® 2.5/1000 MG
SEGLUROMET
® 7.5/1000 MG
FILM-COATED TABLET
Each Segluromet 2.5/1000 mg film-coated tablet contains:
2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1000
mg of metformin
hydrochloride.
Each Segluromet 7.5/1000 mg film-coated tablet contains:
7.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1000
mg of metformin
hydrochloride.
For a list of inactive ingredients see section 6 “FURTHER
INFORMATION”.
See also section 2.10, “IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS OF THE MEDICINE”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
•
This leaflet contains concise information about the medicine. If you
have any further
questions, refer to the doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their ailment is similar.
1.
WHAT THE MEDICINE IS INTENDED FOR ?
Segluromet is intended, in addition to diet and exercise, to improve
the control of sugar levels
in the blood in adults aged 18 years and older with type 2 diabetes:
which are treated with
metformin alone or in combination with other medicines and their sugar
levels are not
controlled, or for patients that receive a combination of metformin
and ertugliflozin as
separate tablets.
THERAPEUTIC GROUP:
Segluromet contains two active substances, ertugliflozin and
metformin.
•
Ertugliflozin belongs to a group of medicines called sodium glucose
co-transporter-2
(SGLT2) inhibitors.
•
Metformin belongs to a group of medicines called biguanides.
HOW SEGLUROMET WORKS
•
Ertugliflozin works by blocking the SGLT2 protein in your kidneys
causing increased
excretion of the glucose in the urine.
•
Metformin works by inhibiting sugar (glucose) production in the liver.
WHAT IS TYPE 2 DIABETES?
Type 2 diabetes is a condition in whic

Tabia za bidhaa

1
1.
NAME OF THE MEDICINAL PRODUCT
Segluromet
®
2.5 mg/1,000 mg
Segluromet
®
7.5 mg/1,000 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Segluromet 2.5 mg/1,000 mg
Each tablet contains 2.5 mg ertugliflozin (as ertugliflozin
L-pyroglutamic acid) and 1,000 mg of
metformin hydrochloride.
Segluromet 7.5 mg/1,000 mg
Each tablet contains 7.5
mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg
metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Segluromet 2.5 mg/1,000 mg
Pink, 19.1 x 10.6 mm oval, film-coated tablet debossed with
“2.5/1000” on one side and plain on the
other side.
Segluromet 7.5 mg/1,000 mg
Red, 19.05 x 10.57 mm oval, film-coated tablet debossed with
“7.5/1000” on one side and plain on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Segluromet is indicated in adults aged 18 years and older with type 2
diabetes mellitus as an adjunct to
diet and exercise to improve glycaemic control:
•
in patients not adequately controlled on their maximally tolerated
dose of metformin alone
•
in patients on their maximally tolerated doses of metformin in
addition to other medicinal
products for the treatment of diabetes
•
in patients already being treated with the combination of
ertugliflozin and metformin as separate
tablets.
_ _
(For study results with respect to combinations and effects on
glycaemic control, see sections 4.4, 4.5
and 5.1.)
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one tablet twice daily. The dosage should be
individualised on the basis of
the patient’s current regimen, effectiveness, and tolerability using
the recommended daily dose of
5 mg or 15 mg of ertugliflozin, while not exceeding the maximum
recommended daily dose of
metformin.
In patients with volume depletion, correcting this condition prior to
initiation of Segluromet is
recommended (see section 4.4).
If a dose is missed, it should be taken as soon as the patient
remembers. Pati