Leaflet: information for the user

Tamsulosina Stada 0.4 mg prolonged-release tablets EFG

hydrochloride of Tamsulosina

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

-Keep this leaflet, as 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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Tamsulosina Stada is and what it is used for

2.What you need to know before you start taking Tamsulosina Stada

3.How to take Tamsulosina Stada

4.Possible side effects

5.Storage of Tamsulosina Stada

6.Contents of the pack and additional information

Tamsulosina relaxes the muscles in the prostate and urinary tract. By relaxing the muscles, tamsulosina allows urine to pass more easily and facilitates urination. Additionally, it reduces the sensation of urgency.

Tamsulosina is used in men to alleviate urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). These symptoms may include difficulty urinating (weak stream), dripping, urgency, and the need to urinate frequently both at night and during the day.

Do not take Tamsulosina Stada if:

• You areallergic to tamsulosina or any of the other componentsof this medication (listed in section 6). Hypersensitivity may present as sudden swelling of the soft tissues of the body (e.g. the throat or tongue), difficulty breathing and/or itching and skin rash (angioedema);
• You have a drop in blood pressure when standing, which causesdizziness or fainting;
• You havesevere liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take tamsulosina if:

• You experiencedizziness or fainting, especially after getting up. Tamsulosina may lower your blood pressure, causing this. You should lie down or sit until the symptoms have disappeared;
• You havesevere kidney problems, consult your doctor;
• You are about to undergo eye surgery due to a cloudy lens (cataract) or glaucoma (increased pressure in the eye). You may develop a condition called Intraoperative Flaccid Iris Syndrome (see section 4, Possible side effects). Please inform your ophthalmologist if you are taking or have taken tamsulosina previously. The specialist will then take the necessary precautions regarding medication and surgical techniques. Consult your doctor if you should or should not postpone or temporarily discontinue taking this medication if you are about to undergo such surgery due to a cloudy lens (cataract) or increased pressure in the eye (glaucoma).

Regular medical check-ups are necessary to monitor the development of the disease you are being treated for.

You may observe remnants of tablets in your stool. Since the active ingredient of the tablet has already been released, there is no risk that the tablet will be less effective.

Children

Do not administer this medication to children or adolescents under 18 years old because it is not indicated in this population.

Use of Tamsulosina Stada with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medication.

Other medications may be affected by tamsulosina. These medications, in turn, may affect the proper functioning of tamsulosina. Tamsulosina may interact with:

• Diclofenac, analgesic and anti-inflammatory medication. This medication may accelerate the elimination of tamsulosina from the body, shortening the time of effectiveness of tamsulosina.
• Warfarin, medication to prevent blood coagulation. This medication may accelerate the elimination of tamsulosina from the body, shortening the time of effectiveness of tamsulosina.
• Other alpha-1A adrenergic receptor blockers1A. The combination may produce a drop in blood pressure, causing dizziness.
• Medications for fungal infections such as ketoconazole.
• Medications for HIV treatment such as ritonavir or indinavir.
• Erythromycin, an antibiotic for the treatment of infections.

Taking Tamsulosina Stada with food

Tamsulosina can be taken regardless of meals.

Pregnancy, breastfeeding, and fertility

Tamsulosina is not indicated for use in women.

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen does not release through the urethra, but rather goes to the bladder (retrograde ejaculation) or the volume of semen released is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and operating machinery

There is no evidence that tamsulosina affects the ability to drive and operate machinery. However, tamsulosina may cause dizziness. Only drive or operate machinery if you feel well.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Therecommended doseis 1 tablet per day. You can take tamsulosina with or without food, preferably at the same time every day.

The tablet should be swallowedwhole. It is importantnot to break or chew the tabletas this may affect the proper functioning of tamsulosina.

If you take more Tamsulosina Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you take more tamsulosina than you should, your blood pressure may drop suddenly. You may experience dizziness, weakness, vomiting, diarrhea, and fainting. Lie down to minimize the effects of low blood pressure and consult your doctor.

If you forget to take Tamsulosina Stada

If you have forgotten to take tamsulosina as recommended, you can take your dose later in the same day. If you have missed a dose one day, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Tamsulosina Stada

When treatment with tamsulosina is discontinued prematurely, your original symptoms may return. Therefore, take tamsulosina for the entire time your doctor prescribes, even if your symptoms have disappeared. Always consult your doctor if you decide to discontinue treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

It is rare for serious adverse reactions to occur.Contact your doctor immediatelyif you experience asevere allergic reaction that causes swelling of the face or throat(angioedema).

Frequent(may affect up to 1 in 10 patients)

• Dizziness
• Abnormal ejaculation (ejaculation disorders). This means that semen does not come out through the urethra, but instead enters the bladder (retrograde ejaculation), or the volume of ejaculation is reduced or absent (ejaculatory failure). This phenomenon is harmless.

Possibly frequent (may affect up to 1 in 100 patients)

• Headache
• Perceptible heartbeats (palpitations)
• Reduced blood pressure when standing, which causes dizziness or fainting (orthostatic hypotension)
• Swelling and irritation in the nose (rhinitis)
• Constipation
• Diarrhea
• Nausea
• Feeling sick. (vomiting)
• Rash
• Hives (urticaria)
• Sensation of weakness (asthenia)

Rare(may affect up to 1 in 1,000 patients)

• Fainting (syncope)

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

• Pain during erection (priapism)
• Severe disease with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome)

Frequency unknown(cannot be estimated from available data)

• Blurred vision
• Visual disturbance
• Nosebleeds (epistaxis)
• Severe skin rashes (erythema multiforme, exfoliative dermatitis)
• During eye surgery, a condition called Flaccid Iris Syndrome (IFIS) may occur: the pupil may dilate poorly and the iris (the colored part of the eye) may become flaccid during the surgery. For more information, see section 2, “Warnings and precautions”.
• Dry mouth

Other side effects (post-marketing experience):

In addition to the side effects mentioned earlier, cases of abnormal heart rhythm (atrial fibrillation), irregular heart rhythm (arrhythmia), rapid heart rhythm (tachycardia), and difficulty breathing (dyspnea) have been reported with the use of tamsulosin.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store in its original packaging to protect from light.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Tamsulosina Stada

•The active ingredient is 0.400 mg of hydrochloride of tamsulosina, equivalent to 0.367 mg of tamsulosina.

• The other components are: Internal tablet: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, red iron oxide (E172), magnesium stearate. External tablet: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and content of the packaging

Tamsulosina Stada is presented in the form of round, white tablets, with the inscription “T9SL” on one face and “0.4” on the other.

They are presented in packaging of 10, 18, 20, 28, 30, 50, 60, 90, 98, 100, and 200 prolonged-release tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratorio, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Responsible for manufacturing

Synthon Hispania, S.L.

Castello, 1.Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

or

Synthon BV

Microweg 22,6545 CMNijmegen

Netherlands

or

STADA Arzneimittel AG

Stadastrasse, 2-18

61118 Bad Vilbel

Germany

Last review date of this prospectus:November 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es