Tamsulosin ABC

Package Leaflet: Information for the Patient

TAMSULOSINA ABC 0.4 mg Modified-Release Hard Capsules

Tamsulosin hydrochloride
"Generic medicine"
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What TAMSULOSINA ABC is and what it is used for
2. What you need to know before taking TAMSULOSINA ABC
3. How to take TAMSULOSINA ABC
4. Possible side effects
5. How to store TAMSULOSINA ABC
6. Contents of the pack and other information

1. What TAMSULOSINA ABC is and what it is used for

The active substance of TAMSULOSINA ABC is tamsulosin, a selective antagonist of α /α adrenergic receptors which reduces muscular tension in the prostate and urethra. This allows urine to pass more quickly through the urethra, thus facilitating urination. In addition, it reduces the sensation of urinary urgency.
TAMSULOSINA ABC is used in men for the treatment of lower urinary tract symptoms associated with an enlarged prostate (benign prostatic hyperplasia). These symptoms may include difficulty urinating (reduced urinary stream), dribbling, urgency, and increased frequency of urination both during the day and at night.

2. What you need to know before taking TAMSULOSINA ABC

Do not take TAMSULOSINA ABC:

• if you are allergic (hypersensitive) to tamsulosin or to any of the excipients of TAMSULOSINA ABC. Hypersensitivity may present as sudden local swelling of soft body tissues (e.g. throat or tongue), breathing difficulties and/or itching and skin rash (angioedema),
• if you have severe liver problems,
• if you experience fainting due to a drop in blood pressure when changing position (sitting up from lying down or standing up).

Warnings and precautions
Talk to your doctor or pharmacist before taking TAMSULOSINA ABC:

• Regular medical check-ups are necessary to monitor the condition for which you are being treated.
• Fainting may rarely occur with the use of TAMSULOSINA ABC, as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until symptoms disappear.
• If you have severe kidney problems, inform your doctor.
• If you are scheduled for, or are on a waiting list for, eye surgery due to lens opacity (cataract) or increased eye pressure (glaucoma), inform your ophthalmologist if you have previously taken, are currently taking, or plan to take TAMSULOSINA ABC. The specialist may then take appropriate precautions regarding the medication and the surgical technique to be used. Ask your doctor whether you should delay or temporarily discontinue treatment with this medicine before undergoing eye surgery for lens opacity (cataract) or increased eye pressure (glau游戏副本

3. How to take TAMSULOSINA ABC

Always take TAMSULOSINA ABC exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 capsule daily, to be taken after breakfast or after the first meal of the day, every day.
The capsule must be swallowed whole, without crushing or chewing it.
TAMSULOSINA ABC is usually prescribed for long-term use. The effects on the urinary bladder and urination are maintained with continued long-term treatment with TAMSULOSINA ABC.

If you take more TAMSULOSINA ABC than you should
Taking an excessive dose of TAMSULOSINA ABC may cause an unintended drop in blood pressure and an increased heart rate, associated with a feeling of weakness.
If you have taken too many doses of TAMSULOSINA ABC, consult your doctor immediately.

If you forget to take TAMSULOSINA ABC
If you forget to take a dose of TAMSULOSINA ABC, you may take it later on the same day.
If you miss a day, continue taking the capsule at your usual time the next day. Never take a double dose to make up for a missed dose.

If you stop taking TAMSULOSINA ABC
If treatment with TAMSULOSINA ABC is stopped prematurely, the initial symptoms may return. Therefore, continue taking TAMSULOSINA ABC for the entire duration prescribed by your doctor, even if your symptoms have already improved. Always consult your doctor if you think this treatment should be stopped.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, TAMSULOSIN ABC may cause side effects, although not everybody experiences them.

Common (less than 1 in 10, more than 1 in 100 (1-10%)):

• dizziness, particularly when sitting down or standing up
• abnormal ejaculation (ejaculation disorders). This symptom means that seminal fluid does not exit the body through the urethra but enters the urinary bladder (retrograde ejaculation), or that the volume of seminal fluid is reduced or absent (failure to ejaculate). This event is harmless.

Uncommon (more than 1 in 1,000, less than 1 in 100 (0.1-1%)):

• headache, palpitations (the heart beats faster than normal and this is noticeable), reduced blood pressure, for example when standing up quickly from sitting or lying down, often associated with dizziness, stuffy or runny nose (rhinitis), diarrhoea, nausea and vomiting, constipation, weakness (asthenia), skin rash, itching and urticaria.

Rare (more than 1 in 10,000, less than 1 in 1,000 (0.01-0.1%)):

• fainting and sudden localized swelling of soft tissues of the body (e.g. throat and tongue), difficult breathing with or without itching and skin rash, as often seen in an allergic reaction (angioedema).

Very rare (less than 1 in 10,000 (<0.01%)):

• priapism (painful, prolonged and involuntary erection requiring immediate medical treatment)
• skin rash, inflammation, blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nostrils or genitals (Stevens-Johnson syndrome).

Frequency not known (frequency cannot be estimated from the available data):

• blurred vision
• visual impairment
• nosebleeds (epistaxis)
• severe skin rashes (erythema multiforme, exfoliative dermatitis)
• abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulty (dyspnoea)
• if you are about to undergo eye surgery for clouding of the lens (cataract) or increased eye pressure (glaucoma) and you are currently taking or have recently taken TAMSULOSIN ABC, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during surgery
• dry mouth

If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TAMSULOSIN ABC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
The stated expiry date applies to the product in its original, unopened packaging, correctly stored.
Store below 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TAMSULOSINA ABC contains

• The active substance is tamsulosin hydrochloride. Each capsule contains 0.4 mg of tamsulosin hydrochloride.
• The excipients are microcrystalline cellulose, methacrylic acid, ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triacetin, talc, calcium stearate.
• Capsule shell: Hard capsule: gelatin, titanium dioxide (E 171), indigotine (E 132), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

Description of the appearance of TAMSULOSINA ABC and package contents
Modified-release hard capsule – Pack of 20 capsules in blister packs.
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin
Manufacturers
DOPPEL FARMACEUTICI S.r.l. - Via Volturno, 48 - 20089 Quinto de’Stampi - Rozzano (Milan)
FAMAR ITALIA S.p.A. - Via Zambeletti, 25 - Baranzate (Milan)