Santizor XL 4mg capsules

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Tolterodine tartrate

Dostupno od:

Upjohn UK Ltd

ATC koda:

G04BD07

INN (International ime):

Tolterodine tartrate

Doziranje:

4mg

Farmaceutski oblik:

Modified-release capsule

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 07040200; GTIN: 5013457010657

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
SANTIZOR XL 4MG PROLONGED-RELEASE CAPSULES, HARD
TOLTERODINE TARTRATE
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.
WHAT IS IN THIS LEAFLET:
1.
What Santizor XL is and what it is used for
2.
What you need to know before you take Santizor XL
3.
How to take Santizor XL
4.
Possible side effects
5.
How to store
Santizor XL
6.
Contents of the pack and other information
1. WHAT SANTIZOR XL IS AND WHAT IT IS USED FOR
Santizor XL contains the active substance tolterodine. Tolterodine
belongs to a class
of medicinal products called antimuscarinics.
Santizor 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 SANTIZOR XL
DO NOT TAKE
SANTIZOR XL:
•
If you are allergic (hypersensitive) to tolterodine or any of the
other
ingredients of this medicine (listed in section 6)
•
If you are unable to pass urine from the bladder (urinary retention)
•
If you have an uncontrolled narrow-angle glaucoma (high pressure in
the
eyes with loss of eyesight that is not being adequately treated)
•
If you suffer from myasthenia gravis (excessive weakness of the
muscles)
•
If you suffer from severe ulcerative colitis (ulceration and
inflammation of
the colon)
•
If you suffer from a toxic megacolon (acute dilatation of the colon).
•
Page 1 of 6
WARNINGS

Svojstava lijeka

OBJECT 1
SANTIZOR XL 4 MG, PROLONGED-RELEASE CAPSULES,
HARD
Summary of Product Characteristics Updated 04-Aug-2015 | Pfizer
Limited
1. Name of the medicinal product
Santizor XL 4 mg, prolonged-release capsules, hard
2. Qualitative and quantitative composition
Each prolonged-release capsule contains tolterodine tartrate 4 mg
corresponding to 2.74 mg tolterodine.
Each 4 mg prolonged-release capsule contains a maximum of 123 mg of
sucrose.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Prolonged-release capsule, hard
The 4 mg prolonged-release capsule is blue size 3 capsule with white
printing (symbol and 4).
4. Clinical particulars
4.1 Therapeutic indications
Symptomatic treatment of urge incontinence and/or increased urinary
frequency and urgency as may
occur in patients with overactive bladder syndrome.
4.2 Posology and method of administration
_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 undesirable effects the
dose may be reduced from 4 mg to 2
mg once daily.
The prolonged-release capsules can be taken with or without food and
must be swallowed whole.
The effect of treatment should be re-evaluated after 2-3 months (see
section 5.1).
_Paediatric population:_
Efficacy of Santizor XL has not been demonstrated in children (See
section 5.1). Therefore, Santizor XL
is not recommended for children.
4.3 Contraindications
Tolterodine is contraindicated in patients with:
- Urinary retention
- Uncontrolled narrow angle glaucoma
- Myasthenia gravis
- Known hypersensitivity to tolterodine or to any of the excipients
listed in section 6.1
- Severe ulcerative colitis
- Toxic megacolon
4.4 Special warnings and precautions for use
Tolterodine shall be used with caution in patients with
- Significant bladder outlet obstruction at risk of urinary retention
- Gastrointestinal obs