TAMSULOSINA 400 MICROGRAMS Hard capsules, prolonged release

Зміст інструкції

1. Tamsulosina Aurobindo Italia 0.4 mg modified-release hard capsules
   1. What is Tamsulosina Aurobindo Italia and what is it used for
   2. What you need to know before taking Tamsulosina Aurobindo Italia
   3. How to take Tamsulosina Aurobindo Italia
   4. Possible side effects
   5. How to store Tamsulosina Aurobindo Italia
   6. Contents of the pack and other information

Tamsulosina Aurobindo Italia 0.4 mg modified-release hard capsules

Tamsulosin hydrochloride

Generic medicine

Read this leaflet carefully before you start taking this medicine because 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 Aurobindo Italia is and what it is used for
• 2. What you need to know before you take Tamsulosina Aurobindo Italia
• 3. How to take Tamsulosina Aurobindo Italia
• 4. Possible side effects
• 5. How to store Tamsulosina Aurobindo Italia
• 6. Contents of the pack and other information

1. What is Tamsulosina Aurobindo Italia and what is it used for

The active ingredient of Tamsulosina Aurobindo Italia is tamsulosin, a drug with selective antagonist action on
α1A/α1D adrenergic receptors which reduces muscle tension in the prostate and urethra. This allows
urine to pass more quickly through the urethra, facilitating urination. In addition, it decreases
the sensation of urgency to urinate.
This medicine 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 flow), dripping, urgency and increased frequency of urination both during
the day and at night.

2. What you need to know before taking Tamsulosina Aurobindo Italia

Do not take Tamsulosina Aurobindo Italia:

• if you are allergic (hypersensitive) to tamsulosin or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may present 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 have 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 Aurobindo Italia.

Pay particular attention with Tamsulosina Aurobindo Italia

• Periodic medical checks are necessary to monitor the development of the condition for which you are being treated.
• Rarely, with the use of Tamsulosina Aurobindo Italia, 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, tell 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 Aurobindo Italia. 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
The use of this medicine is not indicated in children and adolescents up to 18 years of age.

Other medicines and Tamsulosina Aurobindo Italia
Taking Tamsulosina Aurobindo Italia 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 being treated with medicines that may decrease the elimination of Tamsulosina Aurobindo Italia from the body (e.g. ketoconazole, erythromycin). Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription.

Taking Tamsulosina Aurobindo Italia with food and drink
Tamsulosina Aurobindo Italia should be taken after breakfast or after the first meal of the day.

Pregnancy, breastfeeding and fertility
Tamsulosina Aurobindo Italia is for exclusive use in males and should not be taken by 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 Aurobindo Italia alters the ability to drive vehicles or use machinery or equipment. However, you should be aware of the possibility of dizziness and vertigo, in which case avoid engaging in activities that require attention.

Tamsulosina Aurobindo Italia and sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially ‘sodium-free’.

3. How to take Tamsulosina Aurobindo Italia

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The usual doseis 1 capsule a day to be taken in the morning, after breakfast or after the first meal
of the day, every day.
Swallow the capsule whole with a little water, without chewing or crushing it.
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Normally Tamsulosina Aurobindo Italia is prescribed for long periods of time. The effects on the
urinary bladder and urination are maintained following long-term treatment with
this medicine.

Use in patients with mild to moderate renal and hepatic impairment
No dose adjustment is required.

If you take more Tamsulosina Aurobindo Italia than you should
Taking an excessive dose of Tamsulosina Aurobindo Italia may induce an unwanted decrease in
blood pressure and an increase in heart rate, associated with a feeling of weakness.
If you have taken too many doses of Tamsulosina Aurobindo Italia, consult your doctor immediately.

If you forget to take Tamsulosina Aurobindo Italia
If you have forgotten to take the capsule after the first meal of the day, take it later in the same
day after eating something. If you have missed a day, continue to take the capsule of the day
at the usual scheduled time. Never take a double doseto make up for a missed dose.

If you stop taking Tamsulosina Aurobindo Italia
When treatment with Tamsulosina Aurobindo Italia is discontinued prematurely, initial symptoms may
reappear. Therefore, continue to take the medicine 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, this medicine can cause side effects, although not everybody gets them.
Contact your doctor if you experience any of the following side effects:

Common(may affect up to 1 in 10 people):
Dizziness, particularly when getting up from sitting or lying down.
Abnormal ejaculation (ejaculation disorders). This symptom means that the seminal fluid does not come
out of 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(may affect up to 1 in 100 people):
Headache, palpitations (the heart beats faster than normal and is also noticeable), decreased
blood pressure, for example when getting up quickly from sitting or lying down, often
associated with dizziness, stuffy or runny nose (rhinitis), diarrhea, nausea and vomiting, constipation, weakness (asthenia),
skin redness (rash), itching and hives.

Rare(may affect up to 1 in 1,000 people):
Fainting and cases of sudden swelling of soft tissues (e.g. lips, face or neck,
feeling of suffocation with difficulty breathing, skin redness (possibly also involving
hands and feet) with or without itching as manifestations of an allergic reaction (angioedema).

Very rare(may affect up to 1 in 10,000 people):
Painful and prolonged involuntary erection that requires immediate medical treatment (priapism).
Skin rash, inflammation, blistering on the skin and/or mucous membranes of lips, eyes,
mouth, nostrils or genitals (Stevens-Johnson syndrome).

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

• blurred vision; Page 3 of 4
• impaired vision;
• nosebleeds (epistaxis);
• severe skin rashes (erythema multiforme, exfoliative dermatitis);
• abnormal irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia), shortness of breath (dyspnea);
• if you are about to undergo eye surgery for cataracts or increased eye pressure (glaucoma) and are already taking or have recently taken Tamsulosina Aurobindo Italia, the pupil may dilate poorly and the iris (the colored circular part of the eye) may become floppy during surgery;
• 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 national reporting system at 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 Aurobindo Italia

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not use this medicine if you notice evident signs of deterioration.
Store in the original packaging.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tamsulosina Aurobindo Italia contains

• The active ingredient is tamsulosin hydrochloride. Each capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are: sodium alginate; methacrylic acid-ethyl acrylate copolymer (1:1); dibeenate glycerol; maltodextrin; sodium lauryl sulfate; macrogol; polysorbate 80; sodium hydroxide; simeticone; anhydrous colloidal silica.
• The components of the outer capsule are: gelatin; purified water; red iron oxide (E 172); titanium dioxide (E 171); yellow iron oxide (E 172).

Description of the appearance of Tamsulosina Aurobindo Italia and contents of the pack
Pack of 20 hard capsules in blisters.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) s.r.l., via San Giuseppe, 102 - 21047 Saronno (VA)

Manufacturer
Special Product’s Line S.p.A. - via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)
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