Patient Information Leaflet

Tamsulosina Stada 0.4 mg Modified Release Hard Capsules

Tamsulosin Hydrochloride

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

• Keep this leaflet, as 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 others even if they have similar symptoms, 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 is an α1A-adrenoreceptor blocker. It relaxes the prostate and urinary tract muscle.

Tamsulosina is prescribed to relieve urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). Relaxation of the muscle facilitates urine flow, making urination easier.

Do not take Tamsulosina Stada:

• If you are allergic to tamsulosina or any of the other ingredients in this medication, including those listed in section 6 [symptoms may include: swelling of the face and throat (angioedema)].
• If you have a history of low blood pressure when standing, causing dizziness, lightheadedness, or fainting.
• If you have severe liver dysfunction.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamsulosina Stada:

• If you experience dizziness or lightheadedness, especially after standing up. Tamsulosina may lower your blood pressure, causing these symptoms. You should lie down or sit until these symptoms disappear.
• If you have severe kidney dysfunction. The normal dose of tamsulosina may not be effective when your kidneys do not function normally.
• If you experience swelling of the face or throat. These symptoms correspond to angioedema (see section 2, Do not take Tamsulosina Stada). Stop taking tamsulosina immediately and contact your doctor. Do not take tamsulosina again.
• If you are undergoing cataract surgery (loss of vision, especially blue color), if you are taking or have taken tamsulosina recently, during surgery, a condition called Intraoperative Flaccid Iris Syndrome (IFIS) may occur. IFIS may cause complications during surgery. It is recommended that you interrupt treatment 1-2 weeks before the surgical intervention. Consult your doctor and surgeon beforehand to discuss this situation.

Children

Do not give this medication to children or adolescents under 18 years old because it does not work in this population.

Other medications and Tamsulosina Stada

Other medications may be affected by tamsulosina. They, in turn, may affect the action of tamsulosina. Tamsulosina may interact with:

• Diclofenac. A pain-relieving and anti-inflammatory medication. This medication may accelerate the elimination of tamsulosina from the body, and thus shorten the time tamsulosina is effective.
• Warfarin, a medication to prevent blood clots. This medication may accelerate the elimination of tamsulosina from the body, and thus shorten the time tamsulosina is effective.
• Medications to lower blood pressure such as verapamil or diltiazem.
• Medications for HIV treatment such as ritonavir or indinavir.
• Medications for fungal infections such as ketoconazole or itraconazole.
• Other α1A-adrenergic receptor blockers, such as doxazosin, indoramine, prazosin, or alfuzosin. The combination may lower your blood pressure, causing dizziness or lightheadedness.
• Erythromycin, an antibiotic used to treat infections.

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

Taking Tamsulosina Stada with food and drinks

Take tamsulosina with a glass of water after breakfast or after the first meal of the day.

Driving and operating machines

There is no information on the effects of tamsulosina on driving and operating machines. You should be aware that tamsulosina may cause dizziness and lightheadedness. Only drive or operate machines if you feel well.

Tamsulosina Stada contains sodium

This medication contains less than 23 mg of sodium (1mmol) per capsule; it is essentially “sodium-free”.

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

The recommended dose is one capsule per day taken after breakfast or after the first meal of the day.

The capsule should be swallowed whole with a glass of water while sitting or standing (do not lie down). It is essential not to break or crush the capsules as it may affect the functioning of tamsulosina.

If you take more Tamsulosina Stada than you should

Your blood pressure may drop suddenly if you take more tamsulosina than you should. You may experience dizziness, vertigo, and fainting. Lie down to minimize the effects of the drop in blood pressure and contact your doctor. Your doctor will provide you with medications to restore blood pressure and monitor your bodily functions. If necessary, your doctor will empty your stomach and administer a laxative to eliminate any remaining tamsulosina that has not been absorbed yet.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Tamsulosina Stada

Do not take a double dose to compensate for the missed doses. Take the next dose at your usual time. If you have any doubts about the use of this medication, ask your doctor or pharmacist.

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

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

Dizziness, abnormal ejaculation (alterations in ejaculation). This means that semen does not leave the body through the urethra, but rather goes towards the bladder (retrograde ejaculation) or the volume of ejaculation is reduced or non-existent (inability to ejaculate). This phenomenon is harmless.

Less frequent (may affect up to 1 in 100 people):

Headache, heart beating faster than normal (tachycardia), palpitations, decrease in blood pressure when standing, causing dizziness, dizziness, or fainting (orthostatic hypotension); nasal congestion and irritation (rhinitis), constipation, diarrhea, nausea, vomiting, rash, itching, urticaria, feeling of weakness (asthenia).

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

Fainting (syncope), severe allergic reaction that causes swelling of the face and throat (angioedema): contact your doctor immediately, do not take tamsulosina again (see section 2, DO NOT take Tamsulosina Stada).

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

Painful erection (priapism), severe disease with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

Unknown (frequency cannot be estimated from available data):

Severe skin eruptions (erythema multiforme, exfoliative dermatitis), nosebleed (epistaxis), blurred vision or vision problems. During cataract surgery, a situation of small pupil, known as Intraoperative Flaccid Iris Syndrome (IFIS), has been associated with tamsulosina therapy during post-marketing surveillance (see also section 2, Warnings and precautions), dry mouth.

Additional side effects (post-marketing experience):

In addition to the side effects described above, in association with the use of tamsulosina, abnormal heart rhythm (atrial fibrillation), irregular heartbeats (arrhythmia), and shorter-than-normal breathing (dyspnea) have been reported.

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System for the 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.

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.

Store in the original packaging to protect it from moisture.

Keep the packaging perfectly closed to protect it from moisture.

Medications should not be disposed of through drains or trash. Deposit empty packaging and unused medications at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of empty packaging and unused medications. By doing so, you will help protect the environment.

Composition of Tamsulosina Stada

-The active ingredient is tamsulosin hydrochloride, 0.4 mg.

-The other components are:

Capsule: microcrystalline cellulose, methacrylic acid copolymer and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, triethyl citrate, and talc.

Capsule body: gelatin, indigotin (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).

Appearance of the product and contents of the package

Hard-gelatin capsules with modified-release color orange/olive green. The capsules contain white or almost white pellets.

They are presented in blisters containing 10, 14, 15, 20, 28, 30, 48, 50, 56, 60, 90, 98, 100, or 200 modified-release capsules or bottles containing 60 or 250 modified-release capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18,

61118 Bad Vilbel

Germany

or

Synthon Hispania S.L.

Castelló, 1

Polígono las Salinas

08830 Sant Boi de Llobregat (Barcelona)

Spain

or

Eurogenerics N.V.

Heizel Esplanade, Heysel b22,

B-1020 Brussels

Belgium

or

GENUS PHARMACEUTICAL LTD

Linthwaite

HD7 5QH Huddersfield

United Kingdom

or

LAMP SAN PROSPERO S.p.A.,

Via della Pace, 25/A

41030 San Prospero – Modena

Italy

Last review date of this leaflet:October 2020

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/