Faramsil 400microgram modified-release tablets

Summary of Product characteristics

                                OBJECT 1
FARAMSIL 400 MICROGRAM PROLONGED-RELEASE
TABLETS
Summary of Product Characteristics Updated 14-Feb-2018 | Sandoz
Limited
1. Name of the medicinal product
Faramsil 400 microgram Prolonged-release Tablets
2. Qualitative and quantitative composition
Each film-coated prolonged-release tablet contains 0.4 mg tamsulosin
hydrochloride.
Excipient(s) with known effect:
Each film-coated prolonged-release tablet contains 18.75 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated prolonged-release tablet
Round, bi-convex, brown film-coated tablet with debossing “0.4” on
one side and “SZ” on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of lower urinary tract symptoms (LUTS) associated with
benign prostatic hyperplasia (BPH).
4.2 Posology and method of administration
Posology
One tablet daily can be taken independently of food.
Method of administration
For oral use.
The tablet should be swallowed whole and should not be crushed or
chewed as this will interfere with the
prolonged release of the active ingredient.
Special populations
Renal impairment: no dose adjustment is required in patients with
renal impairment
Hepatic impairment: no dose adjustment is required in patients with
mild to moderate hepatic impairment
(see also section 4.3)
Paediatric population
The safety and efficacy of tamsulosine in children <18 years have not
been established. Currently
available data are described in section 5.1
4.3 Contraindications
Hypersensitivity to tamsulosin, including drug-induced angio-oedema,
or to any of the excipients listed in
section 6.1.
A history of orthostatic hypotension.
Severe hepatic insufficiency.
4.4 Special warnings and precautions for use
As with other alpha1-blockers, a reduction in blood pressure can occur
in individual cases during
treatment with tamsulosin, leading in rare cases to syncope. At the
first signs of orthostatic hypotension
(dizziness, weakness), the patient should sit or lie down until the
sympto
                                
                                Read the complete document