TAMSULOSINA 0.4 MG Modified-release hard capsule

Содержание инструкции

1. TAMSULOSINA ABC 0.4 mg modified-release hard capsules
   1. What is TAMSULOSINA ABC and what is it 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

TAMSULOSINA ABC 0.4 mg modified-release hard capsules

Tamsulosin hydrochloride

“Generic medicine”

Read this leaflet carefully before you start to use this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is TAMSULOSINA ABC and what is it used for

The active ingredient of TAMSULOSINA ABC is tamsulosin, a drug with selective antagonist action on α /α adrenoreceptors which reduces muscle tension in the prostate and urethra. This allows urine to pass more quickly through the urethra, facilitating urination. In addition, it reduces the sensation of urgency to urinate.
TAMSULOSINA ABC is used in men for the treatment of lower urinary tract symptoms associated with an enlarged prostate (benign prostatic hyperplasia). These disorders may include difficulty urinating (reduced stream), dripping, 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 any of the excipients of TAMSULOSINA ABC. Hypersensitivity may manifest as sudden local swelling of soft body tissues (e.g. throat or tongue), difficulty breathing and/or itching and skin rash (angioedema),
• if you suffer from severe liver problems,
• if you experience fainting due to a drop in blood pressure when changing position (lying down to sitting or standing up).

Warnings and precautions
Consult your doctor or pharmacist before taking TAMSULOSINA ABC

• Periodic medical check-ups are necessary to monitor the development of the condition for which you are being treated.
• Rarely, with the use of TAMSULOSINA ABC, fainting may occur, as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until they disappear.
• If you suffer from severe kidney problems, inform your doctor.
• If you are to undergo or are on the waiting list for eye surgery for cataracts (clouding of the lens) or increased eye pressure (glaucoma). Inform the ophthalmologist if you have previously taken, are taking, or intend to take TAMSULOSINA ABC. The specialist may consequently adopt the most appropriate precautions regarding the medicine and the surgical technique to be used. Ask your doctor if you should postpone or temporarily suspend treatment with this medicine before undergoing eye surgery for cataracts (clouding of the lens) or increased eye pressure (glaucoma).

Children and adolescents
Do not administer this medicine to children or adolescents under 18 years of age as it is not effective in
this population.

Other medicines and TAMSULOSINA ABC
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Taking TAMSULOSINA ABC with other medicines belonging to the same class (alpha1-adrenoceptor antagonists) may cause an unwanted drop in blood pressure.
It is particularly important to inform your doctor if you are simultaneously undergoing treatment with
medicines that can decrease the elimination of Tamsulosin ABC from the body (e.g.,
ketoconazole, erythromycin).

TAMSULOSINA ABC with food and drink
TAMSULOSINA ABC should be taken after breakfast or after the first meal of the day.

Pregnancy, breastfeeding and fertility
The use of TAMSULOSINA ABC is not indicated in women.
In men, abnormal ejaculation (ejaculation disorders) has been reported. This means that the
seminal fluid does not exit the body through the urethra but enters the bladder (retrograde ejaculation)
or that the volume of ejaculate is reduced or absent (anejaculation). This event is harmless.

Driving and using machines
It has not been demonstrated that TAMSULOSINA ABC alters the ability to drive vehicles or to operate
machinery or equipment. However, you should be aware of the possibility that dizziness may occur, in which case you should not engage in activities that require attention.

TAMSULOSINA ABC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take TAMSULOSINA ABC

Always take TAMSULOSINA ABC exactly as your doctor or pharmacist has instructed. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is 1 capsule a day, to be taken after breakfast or after the first meal of the day, every day.
The capsule should be swallowed whole, without crushing or chewing it.
Normally TAMSULOSINA ABC is prescribed for long periods of time. The effects on the
urinary bladder and urination are maintained following long-term treatment with
TAMSULOSINA ABC.

If you take more TAMSULOSINA ABC than you should
Taking an excessive dose of TAMSULOSINA ABC may induce an unwanted drop in
blood pressure and an increase in 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 have forgotten to take a dose of TAMSULOSINA ABC, you can take it later in the same
day.
If you have missed a day, continue to take the capsule for the day at the usual scheduled time. Do not take
a double dose to make up for the forgotten one.

If you stop taking TAMSULOSINA ABC
When treatment with TAMSULOSINA ABC is discontinued prematurely, the initial symptoms may reappear.
Therefore, continue to take TAMSULOSINA ABC for the entire period of time
prescribed by your doctor, even if your symptoms have already disappeared. Always consult your doctor if you believe
that this therapy should be stopped.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, TAMSULOSINA ABC can cause side effects, although not everybody gets them.
Common side effects (less than 1 in 10 people, more than 1 in 100 people (1-10%)):

• dizziness, particularly when getting up when sitting or standing
• abnormal ejaculation (ejaculation disorders). This symptom means that the 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 (anejaculation). This event is harmless.

Uncommon side effects (more than 1 in 1000 people, less than 1 in 100 people (0.1-1%)):

• headache, palpitations (the heart beats faster than normal and is also noticeable), low blood pressure for example when getting up quickly from sitting or lying down often associated with dizziness, blocked or runny nose (rhinitis), diarrhoea, nausea and vomiting, constipation, weakness (asthenia), skin redness (rash), itching and hives

Rare side effects (more than 1 in 10,000 people, less than 1 in 1000 people (0.01-0.1%)):

• fainting and cases of sudden localised swelling of the soft tissues of the body (for example of the throat and tongue), difficulty breathing with or without itching and skin redness (rash), as often occurs in an allergic reaction (angioedema)

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

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

Side effects with unknown frequency (frequency cannot be estimated based on available data):

• blurred vision
• impaired vision
• nosebleeds (epistaxis)
• severe skin rashes (erythema multiforme, exfoliative dermatitis)
• abnormal irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia), shortness of breath (dyspnoea).
• if you are about to undergo eye surgery for cataracts or increased pressure in the eye (glaucoma) and are already taking or have recently taken TAMSULOSINA ABC, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the operation.
• dry mouth.

If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 TAMSULOSINA ABC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad.”. The
expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
Store at a temperature not exceeding 30 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TAMSULOSINA ABC contains

• The active ingredient 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 contents of the pack
Modified-release hard capsule - Box of 20 capsules in blisters.

Marketing Authorisation 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)