Tamsulosin Stada 0.4 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tamsulosina Stada 0.4 mg prolonged-release tablets EFG

Tamsulosin hydrochloride

Read all of 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Tamsulosin relaxes the muscles in the prostate and urinary tract. By relaxing these muscles, tamsulosin allows urine to pass more easily and facilitates urination. In addition, it reduces the sensation of urgency.

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

2. What you need to know before taking Tamsulosina Stada

Do not take Tamsulosina Stada if:

• You are allergic to tamsulosin or to any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may present as sudden localized swelling of soft tissues of the body (e.g. throat or tongue), difficulty breathing and/or itching and skin rash (angioedema);
• You have a drop in blood pressure upon standing, causing dizziness or fainting;
• You have severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking tamsulosin if:

• You experience dizziness or fainting, especially after standing up. Tamsulosin may lower your blood pressure, causing these symptoms. You should lie down or sit until symptoms have resolved;
• You have severe kidney problems, consult your doctor;
• You are scheduled for eye surgery due to cataracts (clouding of the lens) or glaucoma (increased eye pressure). A condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur (see section 4, Possible side effects). Please inform your ophthalmologist if you are currently taking or have previously taken tamsulosin. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor whether you should delay or temporarily stop taking this medicine if you are undergoing surgery for cataracts or increased eye pressure (glaucoma).

Regular medical check-ups are necessary to monitor the progression of the condition for which you are being treated.

You may notice tablet remnants in your stools. Since the active ingredient of the tablet has already been released, there is no risk of reduced effectiveness of the tablet.

Children

Do not give this medicine to children or adolescents under 18 years of age, as it is not indicated in this population.

Use of Tamsulosina Stada with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Other medicines may be affected by tamsulosin. In turn, these medicines may affect how well tamsulosin works. Tamsulosin may interact with:

• Diclofenac, an analgesic and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from the body, shortening the duration of tamsulosin's effectiveness.
• Warfarin, a medicine used to prevent blood clotting. This medicine may accelerate the elimination of tamsulosin from the body, shortening the duration of tamsulosin's effectiveness.
• Other alpha1A-adrenergic receptor blockers. The combination may cause a drop in blood pressure, leading to dizziness.
• Medicines used to treat fungal infections such as ketoconazole.
• Medicines used to treat HIV such as ritonavir or indinavir.
• Erythromycin, an antibiotic used to treat infections.

Taking Tamsulosina Stada with food

Tamsulosin may be taken regardless of meals.

Pregnancy, breastfeeding and fertility

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (ejaculatory disorder) has been reported. This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or that the volume of ejaculate is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and use of machines

There is no evidence that tamsulosin affects the ability to drive or operate machinery. However, you should bear in mind that tamsulosin may cause dizziness. Only drive or operate machinery if you feel well.

3. How to take Tamsulosina Stada

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet per day. You may take tamsulosin with or without food, preferably at the same time each day.

The tablet must be swallowed whole. It is important not to break or chew the tablet, as this may affect the proper functioning of tamsulosin.

If you take more Tamsulosina Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you take more tamsulosin than you should, your blood pressure may suddenly decrease. 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 tamsulosin as recommended, you may take your dose later on the same day. If you have missed a day's dose, take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Tamsulosina Stada

When treatment with tamsulosin is stopped prematurely, your original symptoms may return. Therefore, take tamsulosin for as long as your doctor prescribes, even if your symptoms have disappeared. Always consult your doctor if you decide to discontinue treatment.

If you have any further questions 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 everyone gets them.

Serious adverse reactions are rare. Contact your doctor immediately if you experience a severe allergic reaction causing swelling of the face or throat (angioedema).

Common (may affect up to 1 in 10 patients)

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

Uncommon (may affect up to 1 in 100 patients)

• Headache
• Noticeable heartbeat (palpitations)
• Drop in blood pressure when standing up, causing dizziness or fainting (orthostatic hypotension)
• Swelling and irritation in the nose (rhinitis)
• Constipation
• Diarrhea
• Nausea
• Feeling unwell (vomiting)
• Rash
• Hives (urticaria)
• Feeling 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)

• Painful erection (priapism)
• Serious illness with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome)

Frequency not known (cannot be estimated from available data)

• Blurred vision
• Vision disturbances
• Nosebleeds (epistaxis)
• Severe skin rashes (erythema multiforme, exfoliative dermatitis)
• During eye surgery, a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during surgery. For further information, see section 2, “Warnings and precautions”.
• Dry mouth

Other adverse reactions (post-marketing experience):

In addition to the adverse reactions listed above, cases of irregular heart rhythm (atrial fibrillation), irregular heartbeat (arrhythmia), rapid heartbeat (tachycardia), and difficulty breathing (dyspnea) have been reported with the use of tamsulosin.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Stada

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

Store in the original container to protect from light.

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tamsulosina Stada

• The active substance is 0.400 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.
  • The other components are:
    Inner tablet: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, red iron oxide (E172), magnesium stearate.
    Outer tablet: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and contents of the pack

Tamsulosina Stada is presented as round, white tablets, with the imprint “T9SL” on one side and “0.4” on the other.

Available in packs containing 10, 18, 20, 28, 30, 50, 60, 90, 98, 100, and 200 prolonged-release tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern
(Barcelona)
[email protected]

Manufacturer

Synthon Hispania, S.L.
Castello, 1. Polígono Las Salinas
08830 Sant Boi de Llobregat
Spain

or

Synthon BV
Microweg 22, 6545 CM Nijmegen
The Netherlands

or

STADA Arzneimittel AG
Stadastrasse, 2-18
61118 Bad Vilbel
Germany

Date of the most recent review of this package leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es