TAMSULOSIN STADA 0.4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Tamsulosin 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Tamsulosin Stada is and what it is used for
2. What you need to know before you take Tamsulosin Stada
3. How to take Tamsulosin Stada
4. Possible side effects
5. Storage of Tamsulosin 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 the muscles, tamsulosin allows urine to flow more easily and makes it easier to urinate. It also reduces the feeling 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 you take Tamsulosin Stada

Do not take Tamsulosin Stada if:

• You are allergic to tamsulosin or any of the other ingredientsof this medicine (listed in section 6). Hypersensitivity may present as sudden local swelling of the 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 when standing up, which causes dizziness or fainting;
• You have severe liver problems.

Warnings and precautions

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

• You experience dizziness or fainting, especially after standing up. Tamsulosin may lower your blood pressure, causing this. You should lie down or sit until the symptoms have disappeared;
• You have severe kidney problems, consult your doctor;
• You are going to undergo eye surgery due to a cataract or glaucoma. A condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may not dilate enough and the iris (the colored part of the eye) may become floppy during surgery. Please inform your ophthalmologist if you are taking or have taken tamsulosin before. The specialist can then take the necessary precautions regarding the medication and surgical techniques to be used. Consult your doctor if you should postpone or temporarily stop taking this medicine if you are going to undergo such surgery due to a cataract or glaucoma.

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

You may notice remains 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 give this medicine to children or adolescents under 18 years of age because it is not indicated in this population.

Using Tamsulosin Stada with other medicines

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

Other medicines may be affected by tamsulosin. These medicines, in turn, may affect the proper functioning of tamsulosin. Tamsulosin may interact with:

• Diclofenac, a pain-relieving and anti-inflammatory medicine. This medicine may speed up the elimination of tamsulosin from the body, shortening the time of effectiveness of tamsulosin.
• Warfarin, a medicine to prevent blood clotting. This medicine may speed up the elimination of tamsulosin from the body, shortening the time of effectiveness of tamsulosin.
• Other alpha-1A adrenergic receptor blockers. The combination may cause a drop in blood pressure, causing dizziness.
• Medicines for treating fungal infections such as ketoconazole.
• Medicines for treating HIV such as ritonavir or indinavir.
• Erythromycin, an antibiotic for treating infections.

Taking Tamsulosin Stada with food

Tamsulosin can be taken independently of meals.

Pregnancy, breastfeeding, and fertility

Tamsulosin is not indicated for use in women.

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

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive and use machines. You should be aware that tamsulosin may cause dizziness. Only drive or operate machines if you feel well.

3. How to take Tamsulosin Stada

Follow exactly the administration instructions of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

If you take more Tamsulosin Stada than you should

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

If you take more tamsulosin 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 Tamsulosin Stada

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

If you stop taking Tamsulosin Stada

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

If you have any further questions on 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.

It is rare for serious side effects to occur. Contact your doctor immediatelyif you experience a severe allergic reaction that causes swelling of the face or throat(angioedema).

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• Headache
• Perceptible heartbeat (palpitations)
• Drop in blood pressure when standing up, causing dizziness or fainting (orthostatic hypotension)
• Nasal congestion and irritation (rhinitis)
• Constipation
• Diarrhea
• Nausea
• Feeling sick (vomiting)
• Rash
• Hives (urticaria)
• Feeling of weakness (asthenia)

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

• Fainting (syncope)

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

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

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

• Blurred vision
• Visual disturbance
• Nosebleeds (epistaxis)
• Severe skin rash (erythema multiforme, exfoliative dermatitis)
• During eye surgery, a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may not dilate enough and the iris (the colored part of the eye) may become floppy during 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 above, cases of abnormal heart rhythm (atrial fibrillation), irregular heartbeat (arrhythmia), fast heartbeat (tachycardia), and difficulty breathing (dyspnea) have been reported with the use of tamsulosin.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, 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 package to protect from light.

Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Tamsulosin Stada

• The active substance is 0.400 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.
  • The other ingredients 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 pack contents

Tamsulosin Stada is presented in the form of round, white tablets with the inscription "T9SL" on one side and "0.4" on the other.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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

Netherlands

or

STADA Arzneimittel AG

Stadastrasse, 2-18

61118 Bad Vilbel

Germany

Date of last revision of this leaflet:November 2024

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