- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
PosologyOne capsule daily, to be taken after breakfast or the first meal of the day.
Paediatric populationThe safety and efficacy of tamsulosin in children <18 years have not been established.Currently available data are described in section 5.1.
Use in renal impairmentNo dose adjustment is warranted in renal impairment.
Use in hepatic impairmentNo dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see also section 4.3 Contraindications).
Method of administrationFor oral use. The capsule must be swallowed whole and must not be crunched or chewed as this interferes with the prolonged release of the active substance.
|System Organ Class||Common (≥1/100 to <1/10)||Uncommon (≥1/1,000 to <1/100)||Rare (≥1/10,000 to <1/1,000)||Very rare (<1/10,000)||Not known (cannot be estimated from the available data)|
|Nervous system disorders||Dizziness (1.3%)||Headache||Syncope|
|Eye disorders||Vision blurred, Visual impairment|
|Vascular disorders||Orthostatic hypotension|
|Respiratory, thoracic and mediastinal disorders||Rhinitis||Epistaxis|
|Gastrointestinal disorders||Constipation, Diarrhoea, Nausea, Vomiting||Dry mouth|
|Skin and subcutaneous tissue disorders||Rash, Pruritus, Urticaria||Angioedema||Stevens-Johnson syndrome||Erythema multiforme, Dermatitis exfoliative|
|Reproductive system and breast disorders||Ejaculation disorders, Retrograde ejaculation, Ejaculation failure||Priapism|
|General disorders and administration site conditions||Asthenia|
Post-marketing experienceIn addition to the adverse events listed above, atrial fibrillation, arrhythmia, tachycardia and dyspnoea have been reported in association with tamsulosin use. Because these spontaneously reported events are from the worldwide post-marketing experience, the frequency of events and the role of tamsulosin in their causation cannot be reliably determined.
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via www.mhra.gov.uk/yellowcard.
Mechanism of actionTamsulosin binds selectively and competitively to the postsynaptic α1-adrenoceptors, in particular to subtypes α1A and α1D. It brings about relaxation of prostatic and urethral smooth muscle.
Pharmacodynamic effectsTamsulosin increases the maximum urinary flow rate. It relieves obstruction by relaxing smooth muscle in prostate and urethra thereby improving voiding symptoms.It also improves the storage symptoms in which bladder instability plays an important role.These effects on storage and voiding symptoms are maintained during long-term therapy. The need for surgery or catheterisation is significantly delayed.α1-adrenoceptor antagonists can reduce blood pressure by lowering peripheral resistance. No reduction in blood pressure of any clinical significance was observed during studies with tamsulosin.
Paediatric populationA double blind, randomized, placebo-controlled, dose ranging study was performed in children with neuropathic bladder. A total of 161 children (with an age of 2 to 16 years) were randomized and treated at 1 of 3 dose levels of tamsulosin (low [0.001 to 0.002 mg/kg], medium [0.002 to 0.004 mg/kg], and high [0.004 to 0.008 mg/kg]), or placebo. The primary endpoint was number of patients who decreased their detrusor leak point pressure (LPP) to <40 cm H2O based upon two evaluations on the same day. Secondary endpoints were: Actual and percent change from baseline in detrusor leak point pressure, improvement or stabilization of hydronephrosis and hydroureter and change in urine volumes obtained by catheterisation and number of times wet at time of catheterisation as recorded in catheterisation diaries. No statistically significant difference was found between the placebo group and any of the 3 tamsulosin dose groups for either the primary or any secondary endpoints. No dose response was observed for any dose level.
AbsorptionTamsulosin is absorbed from the intestine and is almost completely bioavailable. Absorption of tamsulosin is reduced by a recent meal. Uniformity of absorption can be promoted by the patient always taking tamsulosin after breakfast or the first meal of the day. Tamsulosin shows linear kinetics.After a single dose of tamsulosin in the fed state, plasma levels of tamsulosin peak at around 6 hours and, in the steady state, which is reached by day 5 of multiple dosing, Cmax in patients is about two thirds higher than that reached after a single dose. Although this was seen in elderly patients, the same finding would also be expected in young ones.There is a considerable inter-patient variation in plasma levels both after single and multiple dosing.
DistributionIn man, tamsulosin is about 99% bound to plasma proteins and volume of distribution is small (about 0.2 l/kg).
BiotransformationTamsulosin has a low first pass effect, being metabolised slowly. Most tamsulosin is present in plasma in the form of unchanged active substance. It is metabolised in the liver. In rats, hardly any induction of microsomal liver enzymes was seen to be caused by tamsulosin. None of the metabolites are more active than the original compound.No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see section 4.3).
EliminationTamsulosin and its metabolites are mainly excreted in the urine with about 9% of a dose being present in the form of unchanged drug. After a single dose of tamsulosin in the fed state, and in the steady state in patients, elimination half-lives of about 10 and 13 hours, respectively, have been measured.
Capsule content:Microcrystalline cellulose (E460),Methacrylic acid - ethyl acrylate copolymer 1:1 (including: polysorbate 80, sodium laurylsulfate),Talc,Triethyl citrate,Calcium stearate.
Capsule shell:Yellow iron oxide (E172), Black iron oxide (E172), Red iron oxide (E172),Titanium dioxide (E171),Gelatine.
Consilient Health Ltd
No. 1 Church Road, Richmond upon Thames, Surrey, TW9 2QE, UK
+44(0)20 3751 1889
+44(0) 20 3751 1888