Blerone XL 4mg capsules

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Tolterodine tartrate

זמין מ:

Zentiva Pharma UK Ltd

קוד ATC:

G04BD07

INN (שם בינלאומי):

Tolterodine tartrate

כמות:

4mg

טופס פרצבטיות:

Modified-release capsule

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 07040200; GTIN: 5000283656043

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
BLERONE XL 4MG
PROLONGED-RELEASE CAPSULES
Tolterodine tartrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
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.
IN THIS LEAFLET:
1. What Blerone XL is and what it is used for
2. What you need to know before you take Blerone XL
3. How to take Blerone XL
4. Possible side effects
5. How to store Blerone XL
6. Contents of the pack and other information 1. WHAT BLERONE XL IS AND WHAT IT IS USED FOR
The name of your medicine is Blerone XL 4mg
prolonged-release capsules (called Blerone XL throughout
this leaflet). The active substance in Blerone XL is
tolterodine. Tolterodine belongs to a class of medicinal
products called antimuscarinics.
Blerone XL is used for the treatment of the symptoms of
overactive bladder syndrome. If you have overactive bladder
syndrome, you may find that:
•
you are unable to control urination
•
you need to rush to the toilet with no advance warning
and/or go to the toilet frequently 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BLERONE XL
DO NOT TAKE BLERONE XL IF YOU:
•
are allergic to the active substance or any of the other
ingredients in this medicine (listed in section 6)
.
•
are unable to pass urine from the bladder (urinary retention).
•
have an uncontrolled narrow-angle glaucoma (high
pressure in the eyes with loss of eyesight that is not
being adequately treated)
.
•
suffer from myasthenia gravis (excessive weakness of
the muscles)
.
•
suffer from severe ulcerative colitis (ulceration and
inflammation of the colon)
.
•
suffer from a toxic m

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Blerone XL 4mg prolonged release capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged-release capsule contains 4 mg tolterodine tartrate,
which is equivalent to 2.74
mg of tolterodine.
Excipients with known effect: lactose monohydrate 65.408-68.992 mg,
Sodium laurilsulfate
and docusate sodium (correspond to 0.092988 mg of sodium).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged-release capsule, hard
Light blue opaque-light blue opaque size 1 hard gelatin capsules
containing four
white, round, biconvex coated tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Blerone XL is indicated in symptomatic treatment of urge incontinence
and/or
increased urinary frequency and urgency as may occur in patients with
overactive
bladder syndrome.
6.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
_ _
_Adults (including the elderly)_
The recommended dose is 4 mg once daily except in patients with
impaired liver function or
severely impaired renal function (GFR
≤
30 ml/min) for whom the recommended dose is 2
mg once daily (see sections 4.4 and 5.2). In case of troublesome
side-effects the dose may be
reduced from 4 mg to 2 mg once daily.
The effect of treatment should be re-evaluated after 2-3 months (see
section 5.1).
_ _
_Paediatric population_
The
efficacy
of
Blerone XL
has not
been
demonstrated in
children (see
section 5.1).
Therefore, Blerone XL is not recommended for children.
Method of administration
The prolonged-release capsules can be taken with or without food and
must be
swallowed whole.
6.3
CONTRAINDICATIONS
Tolterodine is contraindicated in patients with:
−
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
−
Urinary retention
−
Uncontrolled narrow angle glaucoma
−
Myasthenia gravis
−
Severe ulcerative colitis
−
Toxic megacolon.
6.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Tolterodine shall be used with caution in patients with:
−
Signif