ZUANTRIP 0.4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

ZUANTRIP 0.4 mg Modified Release Hard Capsules 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 ZUANTRIP 0.4 mg is and what it is used for.
2. What you need to know before you take ZUANTRIP 0.4 mg.
3. How to take ZUANTRIP 0.4 mg.
4. Possible side effects.
5. Storage of ZUANTRIP 0.4 mg.
6. Contents of the pack and other information.

1. What ZUANTRIP 0.4 mg is and what it is used for

ZUANTRIP belongs to a group of medicines called alpha-1 adrenergic receptor blockers that relax the muscles in the prostate and in the urinary tract.

ZUANTRIP is used to relieve the urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). By relaxing the muscles, ZUANTRIP allows urine to flow more easily and facilitates urination.

2. What you need to know before you take ZUANTRIP 0.4 mg

Do not take ZUANTRIP 0.4 mg if:

• you have a history of low blood pressure when standing up, which causes dizziness or fainting.
• you have severe liver problems.

Warnings and precautions:

Consult your doctor or pharmacist before taking ZUANTRIP 0.4 mg.

dizziness or fainting, especially after standing up. ZUANTRIP may lower your blood pressure, causing these symptoms. You should sit or lie down until the symptoms have disappeared.severe kidney problems.The normal dose of ZUANTRIP may not have the expected effect when the kidneys are not functioning normally.

Before starting treatment with ZUANTRIP, your doctor should examine you to confirm that your symptoms are actually caused by an enlarged prostate.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age because it does not work in this population.

Using ZUANTRIP 0.4 mg with other medicines:

ZUANTRIP may affect the way other medicines work in your body, and other medicines may affect the way ZUANTRIP works. Therefore, it is essential that you inform your doctor if you are taking:

• medicines to lower your blood pressure (e.g., verapamil and diltiazem)
• medicines to treat HIV (e.g., ritonavir or saquinavir)
• medicines to treat fungal infections (e.g., ketoconazole, itraconazole, voriconazole, or fluconazole)
• medicines to prevent blood clotting (warfarin)
• anti-inflammatory medicines (diclofenac)
• medicines to treat infections (e.g., erythromycin, clarithromycin)
• immunosuppressants (e.g., cyclosporine)

Tell your doctor or pharmacistif you are using or have recently used or might use any other medicines, including those obtained without a prescription.

Taking ZUANTRIP 0.4 mg with food, drinks, and alcohol

You should take ZUANTRIP with a glass of water after breakfast or the first meal of the day.

Pregnancy, breastfeeding, and fertility

ZUANTRIP is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorders) has been detected. This means that semen does not leave the body through the urethra but instead goes into the bladder (retrograde ejaculation) or that the volume of ejaculation is reduced or absent (inability to ejaculate).

Driving and using machines:

There is no information on the effects of ZUANTRIP on the ability to drive and use machines. You should keep in mind that ZUANTRIP causes dizziness and fainting. Only drive or operate machines if you feel well.

ZUANTRIP 0.4 mg contains sodium:

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

3. How to take ZUANTRIP 0.4 mg

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist.

The normal doseis one capsule per day after breakfastor the first meal of the day.

The capsule should be swallowed whole, with a glass of water while standing or sitting (not while lying down). It is essential that you do not break or chew the capsule, as this may affect the proper functioning of ZUANTRIP.

If you have mild to moderate kidney or liver disease, you can take the normal dose of tamsulosin.

If you take more ZUANTRIP 0.4 mg 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 medicine and the amount ingested.

If you take more ZUANTRIP 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. Your doctor may administer medicines to restore your blood pressure and fluid levels and may monitor your body function.

When necessary, your doctor may proceed with gastric lavage and administration of a laxative to eliminate ZUANTRIP that is not yet in the blood.

If you forget to take ZUANTRIP 0.4 mg

Do not take a double dose to make up for the forgotten dose. Take the next dose at the usual time.

If you stop taking ZUANTRIP 0.4 mg

When treatment with ZUANTRIP is stopped prematurely, the original symptoms may return. Therefore, take ZUANTRIP for the time indicated by your doctor, even if your symptoms have disappeared. Always consult your doctor if you consider stopping 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.

Stop taking ZUANTRIP and contact your doctor immediately if you experience:

• Rare side effects (may affect up to 1 in 1000 people): sudden swelling of the hands, feet, lips, tongue, or throat, causing difficulty breathing and/or itching and skin rash, caused by an allergic reaction (angioedema).
• Very rare side effects (may affect up to 1 in 10,000 people): skin rash, inflammation, and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (Stevens-Johnson syndrome).
• Side effects with unknown frequency (frequency cannot be estimated from the available data): severe inflammation and blistering of the skin known as erythema multiforme.

Common side effects(may affect up to 1 in 10 people)

Dizziness, abnormal ejaculation, retrograde ejaculation, inability to ejaculate.

Uncommon side effects(may affect up to 1 in 100 people)

Headache, heartbeats are noticeable (palpitations); reduction of blood pressure when standing up, which causes dizziness, fainting, or fainting spells (orthostatic hypotension); swelling and irritation in the nose (rhinitis), constipation, diarrhea, nausea, vomiting, rash, hives (urticaria), feeling of weakness (asthenia), itching.

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

Fainting (syncope).

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

Painful erection (priapism)

Side effects with unknown frequency(frequency cannot be estimated from the available data).

Blurred vision, loss of vision, nosebleeds, dry mouth.

During eye surgery due to cataracts or increased eye pressure (glaucoma), a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may not dilate properly, and the iris (the colored part of the eye) may become floppy during surgery. For more information, see section 2. Warnings and precautions.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of ZUANTRIP 0.4 mg

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

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of the month shown.

Store the blister in the original package.

Keep the container tightly closed.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of ZUANTRIP 0.4 mg

• The active substance is tamsulosin hydrochloride 0.4 mg.
• The other ingredients (excipients) are:

Capsule: Microcrystalline cellulose (E 460), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 percent, polysorbate 80 (E 433), sodium lauryl sulfate, triethyl citrate, and talc.

Capsule body: Gelatin, indigo carmine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

Appearance of the product and contents of the pack

Modified release capsules of orange/greenish color. The capsules contain white or almost white pellets.

They are presented in cartons with blisters or bottles containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, or 200 modified release capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

GP-PHARM, S.A.

Polígono Industrial Els Vinyets-Els Fogars Sector 2. Carretera comarcal C244, Km 22

08777 Sant Quintí de Mediona (Spain)

Manufacturer:

or

Synthon BV

Microweg, 22

P.O. Box 7071 (Nijmegen)

NL-6545 Netherlands

or

Medis International a.s.

Prumyslová 961/16,

747 23 Bolatice

Czech Republic

or

Pharmazet Group s.r.o.

Trtinová 260/1

Cakovice

196 00 Prague 9

CZECH REPUBLIC

This leaflet was approved in March 2024

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