TAMSULOSIN STADA 0.4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Tamsulosin Stada 0.4 mg Modified Release Hard Capsules EFG

Tamsulosin Hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to anyone else, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet, see section 4.

Contents of the Package Leaflet

1. What is Tamsulosin Stada and what is it used for
2. What you need to know before taking Tamsulosin Stada
3. How to take Tamsulosin Stada
4. Possible side effects
5. Storage of Tamsulosin Stada
6. Package Contents and Additional Information

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

Tamsulosin is an α1A-adrenergic receptor blocker. It relaxes the prostate and urinary tract muscles.

Tamsulosin is prescribed to relieve urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). The relaxation of the muscles facilitates the passage of urine, making urination easier.

2. What you need to know before taking Tamsulosin Stada

Do not take Tamsulosin Stada:

• If you are allergic to tamsulosin or any of the other components of 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 up, causing dizziness, lightheadedness, or fainting.
• If you have severe liver damage.

Warnings and Precautions

Consult your doctor or pharmacist before taking Tamsulosin Stada:

• If you experience dizziness or lightheadedness, especially when standing up. Tamsulosin may lower your blood pressure, causing these symptoms. You should lie down or sit until these symptoms disappear.
• If you have severe kidney damage. The normal dose of tamsulosin may not have the expected effect when your kidneys are not functioning normally.
• If you experience swelling of the face or throat. These symptoms are indicative of angioedema (see section 2, Do not take Tamsulosin Stada). Stop taking tamsulosin immediately and contact your doctor. You should not take tamsulosin again.
• If you are going to undergo cataract surgery (loss of vision, especially blue color), if you are taking or have recently taken tamsulosin, a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur during surgery. IFIS can cause complications during surgery. It is recommended that you stop treatment 1-2 weeks before surgery. Consult your doctor and surgeon beforehand to discuss this situation.

Children

Do not give this medication to children or adolescents under 18 years of age, as it does not work in this population.

Other Medications and Tamsulosin Stada

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

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

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

Taking Tamsulosin Stada with Food and Drinks

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

Driving and Using Machines

There is no information on the effects of tamsulosin on the ability to drive and use machines. You should be aware that tamsulosin may cause dizziness and lightheadedness. Only drive or use machines if you feel well.

Tamsulosin Stada Contains Sodium

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

3. How to Take Tamsulosin Stada

Follow the administration instructions for this medication exactly as indicated by your doctor. If you are unsure, 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 that you do not break or crush the capsules, as this may affect the functioning of tamsulosin.

If you take more Tamsulosin Stada than you should

Your blood pressure may drop suddenly if you take more tamsulosin than you should. You may experience dizziness, lightheadedness, and fainting. Lie down to minimize the effects of low blood pressure and contact your doctor. Your doctor will provide 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 tamsulosin that has not been absorbed yet.

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

If you forget to take Tamsulosin Stada

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Common (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 instead goes into the bladder (retrograde ejaculation) or the volume of ejaculation is reduced or nonexistent (inability to ejaculate). This phenomenon is harmless.

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

Headache, faster than normal heartbeat (tachycardia), palpitations, low blood pressure when standing up, causing dizziness, lightheadedness, or fainting (orthostatic hypotension); swelling and irritation in the nose (rhinitis), constipation, diarrhea, nausea, vomiting, rash, itching, hives, feeling of weakness (asthenia).

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

Fainting (syncope), severe allergic reaction causing swelling of the face and throat (angioedema): contact your doctor immediately, do not take tamsulosin again (see section 2, Do not take Tamsulosin Stada).

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).

Not Known (frequency cannot be estimated from available data):

Severe skin rash (erythema multiforme, exfoliative dermatitis), nosebleeds (epistaxis), blurred vision or vision problems. During cataract surgery, a situation of small pupil, known as Intraoperative Floppy Iris Syndrome (IFIS), has been associated with tamsulosin 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, the following have been reported in association with the use of tamsulosin: irregular heartbeat (atrial fibrillation), irregular heartbeats (arrhythmia), and shorter than usual breathing (dyspnea).

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them 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 medication.

5. Storage of Tamsulosin Stada

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

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

Store in the original packaging to protect from moisture.

Keep the packaging tightly closed to protect from moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Tamsulosin Stada

• The active ingredient is tamsulosin hydrochloride, 0.4 mg.
• The other ingredients are:

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

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

Appearance of the Product and Package Contents

Modified release hard capsules, orange/greenish in color. The capsules contain white or almost white pellets.

They are available in blister packs 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.

Not all 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)

Spain

[email protected]

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

Date of the Last Revision of this Package Leaflet:October 2020

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