TAMSUDIL 0.4 mg. 30 capsules

WHAT TAMSUDIL AND WHAT IT IS USED?
The active substance in Tamsudil (tamsulosin hydrochloride) selectively binds to specific receptors located primarily in the smooth muscle of the prostate, bladder neck and prostatic urethra. This leads to relaxation of smooth muscle, decrease their stress and improve the process of urination. Its impact on processes and expulsion of urine from the bladder, which occurs during prolonged therapy postpones the need for surgery.
Tamsudil be used for the treatment of functional disorders of the lower urinary tract caused by benign prostatic hyperplasia (BPH).
2. BEFORE YOU TAKE TAMSUDIL
Do not take Tamsudil if:
- You are allergic (hypersensitive) to tamsulosin or to any of the excipients.
- If you have ever had symptoms of orthostatic hypotension (fall in blood pressure when standing up, accompanied by dizziness or fainting).
- Severe hepatic impairment.
Take special care with Tamsudil:
- If changing body position from lying or sitting to standing, feeling dizzy or weakness that can lead to loss of consciousness, as these symptoms may be due to Tamsudil (risk of occurrence of such symptoms is particularly high in people who have had them before). At the first sign of these symptoms (dizziness, weakness), loans sitting or lying down and remain so until the passage of the complaints.
- If you suffer from severe renal insufficiency (creatinine clearance <10 T1 / min). In such
If you should observe strictly the doctor's recommendations.
- If you get an allergic reaction with swelling of soft tissues (angioedema), which have been rare
observed in the use of tamsulosin, seek medical advice immediately and stop taking Tamsudil. In this case, the product should not be administered again.
- If you undergo elective cataract surgery, since patients treated with tamsulosin
risk of development of "floppy iris syndrome" during surgery (syndrome small
pupil). In such cases you may need treatment with Tamsudil be suspended for some time before surgery or to take other appropriate measures.

Before initiation of therapy should be excluded other diseases causing symptoms
similar to those in benign prostatic hyperplasia. For this purpose, before the start of treatment and periodically thereafter, the doctor must perform a rectal examination and, when necessary, to appoint a study of prostate-specific antigen (PSA).
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines without a prescription.
Drug interaction studies have only been performed in adults.
No interactions with concomitant administration of Tamsulosin with atenolol, enalapril or theophylline. Concomitant administration of cimetidine increased the plasma levels of tamsulosin, while that of furosemide decreases, as plasma levels remain within normal limits, no dose adjustment is required.
In laboratory conditions, either diazepam or propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin does not alter the level of tamsulosin in human plasma.
In turn tamsulosin change the free levels of diazepam, propranolol, trichlormethiazide and chlormadinone.
In studies with administration of amitriptyline, salbutamol, glibenclamide and finasteride, no interaction was observed in the level of hepatic metabolism.
Diclofenac and warfarin, however, could increase the speed of the radiation from the body of tamsulosin.
Co-administration with other a-adrenoceptor antagonists may enhance the lowering
blood pressure effect.
Tamsudil and intake of foods and drinks:
Tamsudil should be taken after meals, it is recommended to do this after the breakfast.
Pregnancy and lactation
Not relevant, as Tamsudil is only intended for use in men.
Driving and using machines
In some patients Tamsudil may cause dizziness. These patients should not drive or operate machinery.

3. HOW TO TAKE TAMSUDIL?
Always take Tamsudil according to the instructions of the physician.
The dose is one capsule a day after breakfast or the first meal of the day. The capsules should be swallowed whole with a glass of water while standing or sitting.
Should not violate the integrity of the capsules, as this would break the modified release of the active substance.
If you used more than the prescribed dose Tamsudil:
If you take a higher dose than prescribed, immediately contact a doctor!
If you forget to take Tamsudil
If you miss a dose, take it at the next regular intake without increasing the dose.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Tamsudil can cause side effects, although not everybody gets them patient.
Adverse reactions:
Common side effects (in 1 to 10 in 100 people):
Nervous system disorders: vertigo.
Reproductive System: ejaculation disorders.
Uncommon side effects (1 to 10 in 1000):
Nervous system disorders: headaches.
Cardiac disorders: palpitations (awareness of heart beat).
Vascular disorders orthostatic hypotension (fall in blood pressure when standing up, accompanied by dizziness or fainting).
Respiratory disorders: rhinitis (runny nose).
Gastrointestinal disorders: constipation, diarrhea, nausea, vomiting.
Skin and subcutaneous tissue disorders: rash, itching, hives.
General disorders: fatigue, weakness
Rare side effects (1 to 10 in 10,000 people):
Nervous system disorders: syncope (fainting with brief loss of consciousness).
Skin and subcutaneous tissue disorders: angioedema (severe allergic reaction with swelling of the soft tissues).

Very rare side effects (in less than 1 in 10,000 people):
Skin and subcutaneous fabrics: a severe allergic reaction (Stevens-Johnson). Reproductive system: painful, prolonged, involuntary erection (priapism).
During the studies, after placing the medicinal product on the market, it has been found that during surgery of cataract may develop 'small pupil syndrome "(1R15), which is associated with therapy with tamsulosin.
In the period after placing the medicinal product on the market: In addition to the above
adverse reactions have been reported occurrence of atrial fibrillation, arrhythmias, palpitations and shortness of breath in the use of tamsulosin but the frequency and the role of tamsulosin for tyahnatapoyava are not precisely defined.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE TAMSUDIL?
No special storage conditions.

Keep out of reach of children.
Do not use Tamsudil after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of in wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. ADDITIONAL INFORMATION
The active substance is Tamsulozinov hydrochloride 0.4 mg.
The excipients are microcrystalline cellulose, methacrylic acid copolymer, ethyl acrylate (1: 1), polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc, gelatin, red iron oxide (E 172), titanovdioksid (E 171), iron oxide yellow ( E 172), indigo carmine (E132), black iron oxide (E 172), shellac GLASS, n-butyl alcohol, propylene glycol, purified water, isopropyl alcohol.