TAMSULOSINA 0.4 MG Kapsułki o przedłużonym uwalnianiu

Treść ulotki

1. Tamsulosina Aristo Pharma 0.4 mg modified-release hard capsules
   1. What is Tamsulosina Aristo Pharma and what is it used for
   2. What you need to know before taking Tamsulosina Aristo Pharma
2. Tamsulosina Aristo Pharma contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e.
   1. How to take Tamsulosina Aristo Pharma
   2. Possible side effects
   3. How to store Tamsulosina Aristo Pharma
   4. Package contents and other information

Tamsulosina Aristo Pharma 0.4 mg modified-release hard capsules

tamsulosin hydrochloride
Generic medicine

Read this leaflet carefully before you start taking 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 they have the same symptoms as you, as it may 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 Aristo Pharma is and what it is used for
• 2. What you need to know before you take Tamsulosina Aristo Pharma
• 3. How to take Tamsulosina Aristo Pharma
• 4. Possible side effects
• 5. How to store Tamsulosina Aristo Pharma
• 6. Contents of the pack and other information

1. What is Tamsulosina Aristo Pharma and what is it used for

The active substance contained in the capsules of Tamsulosina Aristo Pharma belongs to a group of
medicines called alpha1A-adrenoreceptor inhibitors.
The capsules are used for the treatment of symptoms associated with Benign Prostatic Hyperplasia (BPH), which is
caused by the benign enlargement of the prostate in male patients and can cause difficulty
in urinating and/or frequent need to urinate.
Tamsulosin works by relaxing the muscles of the prostate and bladder, helping to improve the flow
of urine.

2. What you need to know before taking Tamsulosina Aristo Pharma

Do not take Tamsulosina Aristo Pharma
1/5

• If you are allergic (hypersensitive) to tamsulosin hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• Hypersensitivity may manifest as sudden local swelling of the body's soft tissues
• (e.g. throat or tongue), difficulty breathing and/or itching and rash (especially associated with facial swelling, the so-called "angioedema")
• if you suffer from severe liver problems,
• If you have had low blood pressure in the past that has caused dizziness or fainting (for example, when sitting or standing up suddenly).

Warnings and precautions
Talk to your doctor or pharmacist before taking Tamsulosina Aristo Pharma

• periodic medical check-ups are necessary to monitor the development of the condition for which you are being treated.
• if you have been diagnosed with a severe kidney disease.
• if you experience dizziness or fainting while taking Tamsulosina Aristo Pharma. In this case, sit or lie down immediately until the symptoms disappear.
• if you are to undergo eye surgery for cataracts (clouding of the lens) or increased pressure in the eye (glaucoma). During the operation, the iris may become “floppy” (Intraoperative Floppy Iris Syndrome) (see section 4. "Possible side effects"). Therefore, inform your ophthalmologist if you are taking or have recently taken tamsulosin hydrochloride. The ophthalmologist can then take 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 or increased pressure in the eye (glaucoma).

Children and adolescents
This medicine is not suitable for children or adolescents under 18 years of age because efficacy has not been
established in this population.

Other medicines and Tamsulosina Aristo Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

• Taking Tamsulosina Aristo Pharma with other medicines belonging to the same class (alpha1-adrenoceptor antagonists), such as doxazosin, indoramin, prazosin, terazosin, may cause an unwanted drop in blood pressure.
• It is particularly important that you contact your doctor if you are being treated with medicines that reduce the elimination of Tamsulosina Aristo Pharma from the body (e.g. ketoconazole, erythromycin).

Pregnancy, breastfeeding and fertility
Tamsulosina Aristo Pharma is not indicated in women.
In men, abnormal ejaculation has been reported. This means that the seminal fluid does not exit
the body through the urethra, but instead enters the bladder (retrograde ejaculation) or that the volume of
ejaculate fluid is reduced or absent (anejaculation). This event is harmless.
2/5

Driving and using machines
Tamsulosina Aristo Pharma can cause dizziness. If this occurs, you should not drive vehicles or
use machines.

Tamsulosina Aristo Pharma contains sodium

Tamsulosina Aristo Pharma contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e.

essentially “sodium-free”.

3. How to take Tamsulosina Aristo Pharma

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
Dosage
The recommended dose is 1 hard capsule a day.
Method of administration
Take the capsule after breakfast or after the first meal of the day.
Take the capsule whole with some liquid (preferably a glass of water), do not crush it and do not
chew it.
Duration of treatment:
Normally, Tamsulosina Aristo Pharma is prescribed for long periods of time. The effects on the
urinary bladder and urination are maintained following long-term treatment with
Tamsulosina Aristo Pharma.

If you take more Tamsulosina Aristo Pharma than you should
Taking an excessive dose of Tamsulosina Aristo Pharma may induce an unwanted drop in
blood pressure and an increase in heart rate, associated with a feeling of weakness.
If you have accidentally taken a dose of Tamsulosina Aristo Pharma greater than prescribed
consult your doctor immediately.

If you forget to take Tamsulosina Aristo Pharma
If you have forgotten to take a dose, take it as soon as you remember. If it is almost time for the
next dose, skip the forgotten dose. Do not take a double dose to make up for a missed dose.

If you stop taking Tamsulosina Aristo Pharma
Do not stop treatment with Tamsulosina Aristo Pharma without consulting your doctor, even if you
feel better. When treatment with Tamsulosina Aristo Pharma is stopped prematurely,
your initial symptoms may reappear.
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.
3/5

Stop treatment and tell your doctor immediatelyor go to the nearest hospital emergency room if you experience the following symptoms:

• an allergic reaction (swelling of lips, face or neck leading to severe breathing difficulties, skin rash or hives
• a severe illness characterized by the formation of blisters on skin, mouth, eyes and genitals, called Stevens-Johnson syndrome (can affect up to 1 in 10,000 people)

This is a very serious side effect, it may require urgent medical attention or
hospitalization.
The following side effects have been reported:

Common(may affect up to 1 in 10 people):

• dizziness
• abnormal ejaculation, including retrograde ejaculation, lack of ejaculation (see section 2 “Pregnancy, breastfeeding and fertility”)

Uncommon(may affect up to 1 in 100 people):

• headache
• fast heartbeat, feeling of heart beating
• low blood pressure, for example when getting up quickly from sitting or lying down, often associated with dizziness and fainting
• blocked or runny nose (rhinitis)
• constipation, diarrhea, feeling unwell or sick
• skin rash, itching and hives
• weakness

Rare(may affect up to 1 in 1,000 people):

• fainting
• weakness and cases of sudden localized swelling of the soft tissues of the body (for example of the throat and tongue), difficulty breathing, itching and skin rash (rash), as often in an allergic reaction (angioedema)

Very rare(may affect up to 1 in 10,000 people):

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

Not known(frequency cannot be estimated from available data)

• abnormal irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea).
• blurred vision
• impaired vision
• nosebleeds
• dry mouth
• severe skin rashes (erythema multiforme, exfoliative dermatitis)

If you are about to undergo eye surgery for cataracts or
increased pressure in the eye (glaucoma), during the operation the so-called
4/5
iris flag syndrome (IFIS) may occur: the pupil may dilate poorly and the iris (the circular colored part of the eye) may become floppy during the operation. For more information see
section 2 “Warnings and precautions”.

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

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 box and the bottle after
“Exp”. The expiry date refers to the last day of that month.
Do not use this medicine after the expiry date which is stated on the box and the blister after
“Exp”. The expiry date refers to the last day of that month.
Blister packs: store in the original packaging.
Bottle: keep the container tightly closed.
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. Package contents and other information

What Tamsulosina Aristo Pharma contains

• The active ingredient is tamsulosin hydrochloride. Each hard capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other components are microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc, gelatin, indigotine (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Description of the appearance of Tamsulosina Aristo Pharma and package contents
Tamsulosina Aristo Pharma 0.4 mg capsules are hard gelatin capsules with a body of
orange color and a cap of olive-green color. The capsules contain granules of color from white to off-white.
The capsules have been specifically formulated to release tamsulosin hydrochloride slowly.
Tamsulosina Aristo Pharma 0.4 mg is available in blisters or bottles of 10, 14, 20, 28, 30, 50, 56, 60, 90,
100 or 200 modified-release hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
5/5
Aristo PharmaGmbH
Wallenroder Strasse 8-10
D-13435 Berlin
Germany

Manufacturer
SYNTHON BV- Microweg 22, 6545 CM Nijmegen (Netherlands)
SYNTHON Hispania S.L.- Castello 1 Poligono las Salinas, Sant Boi de Llobregat, 08830 Barcelona
(Spain)
Teva Operations Poland Sp. Z.o.o., ul. Mogilska 80, 31-546, Krakow (Poland)
AWD Pharma GmbH & Co. KG, Wasastrasse 50, 01445 Radebeul, (Germany)

Distributor
Aristo Pharma Italy S.r.l.
[email protected]

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Germany: Tamsulosin esparma 0.4 mg prolonged-release hard capsules
Italy: Tamsulosina Aristo Pharma
Spain: Tamsulosina Edigen 0.4 mg modified-release hard capsules
6/5