Starlix 120mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Nateglinide

Dostopno od:

Novartis Pharmaceuticals UK Ltd

Koda artikla:

A10BX03

INN (mednarodno ime):

Nateglinide

Odmerek:

120mg

Farmacevtska oblika:

Tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 06010203; GTIN: 5010678919080

Navodilo za uporabo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
STARLIX
® 60 MG FILM-COATED TABLETS
STARLIX
® 120 MG FILM-COATED TABLETS
STARLIX
® 180 MG FILM-COATED TABLETS
Nateglinide
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 Starlix is and what it is used for
2.
What you need to know before you take Starlix
3.
How to take Starlix
4.
Possible side effects
5.
How to store Starlix
6.
Contents of the pack and other information
1.
WHAT STARLIX IS AND WHAT IT IS USED FOR
WHAT STARLIX IS
Starlix belongs to a group of medicines called oral anti-diabetics.
WHAT STARLIX IS USED FOR
Starlix is used to treat patients with type 2 diabetes. It lowers
blood sugar (glucose).
Your doctor will prescribe Starlix together with another oral
anti-diabetic medicine containing
metformin.
HOW STARLIX WORKS
Insulin is a substance produced by the pancreas. It helps to decrease
blood sugar levels, especially
after meals. If you have type 2 diabetes, your body may not start
producing insulin quickly enough
after meals. Starlix works by stimulating the pancreas to produce
insulin more quickly. This helps to
control your blood sugar after meals.
Starlix tablets start to act quickly after you take them and are
eliminated from the body rapidly.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE STARLIX
Follow all instructions given to you by your doctor and pharmacist
carefully, even if they are different
from what is in this leaflet.
DO NOT TAKE STARLIX
-
if you are allergic to nateglinide or any of the other ingredients of
this medicine (list

Lastnosti izdelka

OBJECT 1
STARLIX 120MG FILM COATED TABLETS
Summary of Product Characteristics Updated 29-Jun-2015 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
STARLIX
®
120 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 120 mg nateglinide.
Excipient with known effect:
Lactose monohydrate: 283 mg per tablet.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
120 mg yellow, ovaloid tablets with “STARLIX“ marked on one side and
“120“ on the other.
4. Clinical particulars
4.1 Therapeutic indications
Nateglinide is indicated for combination therapy with metformin in
type 2 diabetic patients inadequately
controlled despite a maximally tolerated dose of metformin alone.
4.2 Posology and method of administration
Posology
Nateglinide should be taken within 1 to 30 minutes before meals
(usually breakfast, lunch and dinner).
The dosage of nateglinide should be determined by the physician
according to the patient's requirements.
The recommended starting dose is 60 mg three times daily before meals,
particularly in patients who are
near goal HbA
1c
. This may be increased to 120 mg three times daily.
Dose adjustments should be based on periodic glycosylated haemoglobin
(HbA
1c
) measurements. Since
the primary therapeutic effect of Starlix is to reduce mealtime
glucose, (a contributor to HbA
1c
), the
therapeutic response to Starlix may also be monitored with 1“2 hour
post-meal glucose.
The recommended maximum daily dose is 180 mg three times daily to be
taken before the three main
meals.
Special populations
_Elderly_
The clinical experience in patients over 75 years of age is limited.
_Paediatric population _
There are no data available on the use of nateglinide in patients
under 18 years of age, and therefore its
use in this age group is not recommended.
_Patients with hepatic impairment_
No dose adjustment is necessary for patients with mild to moderate
hepatic impairment. As patients with
severe liver disease were not