Prospect: Information for the User

ZUANTRIP 0.4 mg Modified Release EFG Hard Capsules

Tamsulosin Hydrochloride

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3. How to take ZUANTRIP 0.4 mg.

4. Possible adverse effects.

5. Storage of ZUANTRIP 0.4 mg.

6. Contents of the pack and additional information.

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

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

Do not take ZUANTRIP 0.4 mg if:

?you areallergic to tamsulosin or to any of the other componentsof this medication (including those listed in section 6) (the symptoms may include:swelling of the face and throat(angioedema)).

• you have a history of low blood pressure when standing up, which causesdizziness or fainting.
• you havesevere liver problems..

Warnings and precautions:

Consult your doctor or pharmacist before starting to take ZUANTRIP 0.4 mg

• if you sufferdizziness or fainting, especially after getting up. ZUANTRIP may lower your blood pressure causing these symptoms. You should sit or lie down until the symptoms have disappeared.
• if you havesevere kidney problems.. The usual dose of ZUANTRIP may not have the expected effect when the kidneys do not function normally.
• if you are to undergo eye surgery due to a clouding of the lens (cataracts) or an increase in eye pressure (glaucoma). You may develop a condition called Intraoperative Floppy Iris Syndrome (see section 4. Possible side effects). Please inform your ophthalmologist if you are taking or have taken ZUANTRIP previously. The specialist will then take the necessary precautions regarding medication and surgical techniques to be used. Consult your doctor if you should or should not postpone or temporarily suspend taking this medication if you are to undergo surgery due to a clouding of the lens (cataracts) or an increase in eye pressure (glaucoma).

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

Children and adolescents

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

Use of ZUANTRIP 0.4 mg with other medications:

ZUANTRIP may affect the functioning of other medications in your body and other medications may affect the functioning of ZUANTRIP. Therefore, it is essential that you inform your doctor if you are taking:

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

Inform your doctor or pharmacistif you are using or have used recently or might have to use any other medication, even those acquired without a prescription.

Taking ZUANTRIP 0.4 mg with food, beverages, 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 rather goes into the bladder (retrograde ejaculation) or the volume of ejaculation is reduced or absent (inability to ejaculate).

Driving and operating machinery:

There is no information on the effects of ZUANTRIP on the ability to drive and operate machinery. You should be aware that ZUANTRIP causes dizziness and fainting. Only drive or operate machinery if you feel well.

ZUANTRIP 0.4 mg contains sodium:

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

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

The capsule must 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 may take the usual 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 medication 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 medications to restore your blood pressure and fluid levels, and may monitor your bodily function.

Your doctor may proceed to gastric lavage and administration of a laxative to eliminate ZUANTRIP that has not yet entered the bloodstream when necessary.

If you forget to take ZUANTRIP 0.4 mg

Do not take a double dose to compensate for the missed dose. Take the next dose at the usual time.

If you interrupt treatment with 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 interrupting treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicinemay cause side effects, although not everyone will experience 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 any or all of the following: 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 of unknown frequency (frequency cannot be estimated from available data): severe inflammation and blistering of the skin known as erythema multiforme.

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

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

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

Headache, palpitations; reduced blood pressure when standing, which causes dizziness, fainting, or dizziness (orthostatic hypotension); nasal congestion and irritation (rhinitis), constipation, diarrhea, nausea, vomiting, rash, urticaria, 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 of unknown frequency(frequency cannot be estimated from available data).

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

During eye surgery due to opacity of the lens (cataracts) or increased eye pressure (glaucoma) may occur a disease called Flaccid Iris Syndrome (IFIS): the pupil may dilate poorly and the iris (the colored circular part of the eye) may become flaccid during surgery. For more information see section 2. Warnings and precautions.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for 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 the blister pack in the original packaging.

Keep the packaging perfectly closed.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of ZUANTRIP 0.4 mg

• The active ingredient is tamsulosin hydrochloride 0.4 mg.
• The other components (excipients) are:

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

Capsule shell: Gelatin, indigotin (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and black iron oxide (E 172).

Appearance of the product and contents of the packaging

Modified-release capsules of orange/olive green color. The capsules contain white or almost white pellets.

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

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

GP-PHARM, S.A.

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

08777 Sant Quintí de Mediona (Spain)

Responsible 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 medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es