Tamsulosin Aurobindo

Patient Information Leaflet

Tamsulosin Aurobindo Italia 0.4 mg modified-release hard capsules

Tamsulosin hydrochloride
Generic medicine
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

The active substance of Tamsulosina Aurobindo Italia is tamsulosin, a selective antagonist of α1A/α1D adrenergic receptors which reduces muscular tone in the prostate and urethra. This allows urine to pass more easily through the urethra, thus facilitating urination. In addition, it reduces the sensation of urinary urgency.
This medicinal product is used in men for the treatment of lower urinary tract symptoms associated with benign prostatic enlargement (benign prostatic hyperplasia). These symptoms may include difficulty urinating (reduced urinary flow), dribbling, urgency, and increased frequency of urination both during the day and at night.

2. What you should know before taking Tamsulosin Aurobindo Italia

Do not take Tamsulosin Aurobindo Italia:

• if you are allergic (hypersensitive) to tamsulosin or to 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), 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 (such as sitting up from lying down or standing up).

Warnings and precautions
Talk to your doctor or pharmacist before taking Tamsulosin Aurobindo Italia.
Exercise particular caution with Tamsulosin Aurobindo Italia

• Regular medical check-ups are necessary to monitor the progression of the condition for which you are being treated.
• Rarely, fainting may occur with the use of Tamsulosin Aurobindo Italia, as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until symptoms subside.
• 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 intend to take Tamsulosin Aurobindo Italia. The specialist may then take appropriate precautions regarding the medicine and the surgical technique to be used. Ask your doctor whether you should postpone or temporarily discontinue treatment with this medicine before undergoing eye surgery for lens opacity (cataract) or increased eye pressure (glaucoma).

Children and adolescents
The use of this medicine is not indicated in children and adolescents under 18 years of age.
Other medicines and Tamsulosin Aurobindo Italia
Taking Tamsulosin Aurobindo Italia together with other medicines belonging to the same class (α1-adrenoreceptor antagonists) may cause an unintended drop in blood pressure.
It is particularly important to inform your doctor if you are concurrently being treated with medicines that may reduce the elimination of Tamsulosin 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 Tamsulosin Aurobindo Italia with food and drink
Tamsulosin Aurobindo Italia should be taken after breakfast or after the first meal of the day.
Pregnancy, breastfeeding and fertility
Tamsulosin Aurobindo Italia is for male use only and must not be taken by women.
In men, abnormal ejaculation (ejaculation disorders) has been reported. This means that 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 (failure to ejaculate). This effect is harmless.
Driving and operating machinery
It has not been shown that Tamsulosin Aurobindo Italia impairs the ability to drive vehicles or operate machinery or equipment. However, you should be aware of the possibility that dizziness and vertigo may occur; in such cases, avoid engaging in activities requiring attention.
Tamsulosin 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 exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The usual dose is 1 capsule daily, taken in the morning after breakfast or after the first meal of the day, every day.
Swallow the capsule whole with a glass of water, without chewing or crushing it.
Tamsulosina Aurobindo Italia is usually prescribed for long-term use. The effects on the urinary bladder and urination are maintained with continued long-term treatment with this medicine.

Use in patients with mild to moderate renal or 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 cause an unwanted drop in blood pressure and an increased heart rate, associated with a feeling of weakness.
If you have taken too much Tamsulosina Aurobindo Italia, contact your doctor immediately.

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

If you stop taking Tamsulosina Aurobindo Italia
If treatment with Tamsulosina Aurobindo Italia is stopped prematurely, the initial symptoms may return. Therefore, continue taking the medicine for the full 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor if you experience any of the following side effects:

Common (may affect up to 1 in 10 people):
Dizziness, especially when sitting down or standing up.
Abnormal ejaculation (ejaculation disorders). This symptom means that semen does not exit the body through the urethra but enters the urinary bladder (retrograde ejaculation), or that the volume of semen is reduced or absent (anejaculation). This event is harmless.

Uncommon (may affect up to 1 in 100 people):
Headache, palpitations (heart beating faster than normal and noticeably), reduction in 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 redness (rash), itching and urticaria.

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

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

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

• blurred vision;
• visual disturbances;
• 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 already taking or have recently taken Tamsulosina Aurobindo Italia, 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 effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 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.
Do not store above 25°C.
Do not use this medicine if you notice any visible signs of deterioration.
Store in the original packaging.
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 Aurobindo Italia contains

• The active substance is tamsulosin hydrochloride. Each capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other components are: sodium alginate; methacrylic acid-ethyl acrylate copolymer (1:1); glyceryl dibehenate; maltodextrin; sodium lauryl sulfate; macrogol; polysorbate 80; sodium hydroxide; simethicone; anhydrous colloidal silica.
• The components of the outer capsule shell 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 package contents
Pack containing 20 hard capsules in blister packs.
Marketing Authorization 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)