Zuantrip 0.4 mg modified-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

ZUANTRIP 0.4 mg modified-release hard capsules EFG

Tamsulosin hydrochloride

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What ZUANTRIP 0.4 mg is and what it is used for.
2. What you need to know before taking ZUANTRIP 0.4 mg.
3. How to take ZUANTRIP 0.4 mg.
4. Possible side effects.
5. How to store 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 alpha1-adrenergic receptor blockers, which relax the muscles in the prostate and urinary tract.

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

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

Do not take ZUANTRIP 0.4 mg if:

• you are allergic to alprazolam or any of the other ingredients of this medicine (listed in section 6).
• you have a severe respiratory insufficiency.
• you have a form of glaucoma called "narrow-angle glaucoma".
• you have severe liver problems.
• you are taking itraconazole or ketoconazole (medicines for fungal infections).

?Are you allergic to tamsulosin or to any of the other components of this medicine (listed in section 6) (symptoms may include: swelling of the face and throat (angioedema)).

• You have a history of low blood pressure upon standing, causing dizziness or fainting.
• You have severe liver problems.

Warnings and precautions:

Talk to your doctor or pharmacist before starting ZUANTRIP 0.4 mg

• if you experience dizziness or fainting, especially after standing up. ZUANTRIP may lower blood pressure, causing these symptoms. You should sit or lie down until symptoms have passed.
• if you have severe kidney problems. The standard dose of ZUANTRIP may not have the expected effect when kidneys are not functioning normally.
• if you are scheduled for eye surgery due to cataracts or increased eye pressure (glaucoma). A condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur (see section 4. Possible side effects). Please inform your ophthalmologist if you are currently taking or have previously taken ZUANTRIP. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor whether you should delay or temporarily stop taking this medicine before undergoing surgery for cataracts or glaucoma.

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

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age, as it is not effective in this population.

Use of ZUANTRIP 0.4 mg with other medicines:

ZUANTRIP may affect how other medicines work in your body, and other medicines may affect how ZUANTRIP works. Therefore, it is important to 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 pharmacist if you are using, have recently used, or might need to 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 after your 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 reported. This means that semen does not exit the body through the urethra but instead enters 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 or operate machinery. You should bear in mind that ZUANTRIP may cause dizziness and fainting. Only drive or operate machinery if you feel well.

ZUANTRIP 0.4 mg contains sodium:

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

3. How to take ZUANTRIP 0.4 mg

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist.

The usual dose is one capsule once daily 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 important 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 impairment, you may still 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 Toxicology Information Service at telephone number 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 immediately. Your doctor may administer medications to restore your blood pressure and fluid levels, and may monitor your bodily functions.

If necessary, your doctor may perform gastric lavage and administer a laxative to eliminate any ZUANTRIP not yet absorbed into the bloodstream.

If you forget to take ZUANTRIP 0.4 mg

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

If you stop taking ZUANTRIP 0.4 mg

If treatment with ZUANTRIP is stopped prematurely, the original symptoms may return. Therefore, take ZUANTRIP for as long as your doctor prescribes, even if your symptoms have improved. Always consult your doctor before stopping treatment.

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

4. Possible adverse effects

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

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

• Rare adverse effects (may affect up to 1 in 1,000 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 due to an allergic reaction (angioedema).
• Very rare adverse 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).
• Adverse effects with unknown frequency (frequency cannot be estimated from available data): severe inflammation and blistering of the skin known as erythema multiforme.

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

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

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

Headache, awareness of heartbeat (palpitations); drop in blood pressure upon standing, causing dizziness, fainting or collapse (orthostatic hypotension); nasal swelling and irritation (rhinitis), constipation, diarrhoea, nausea, vomiting, rash, hives (urticaria), feeling of weakness (asthenia), itching.

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

Fainting (syncope).

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

Painful erection (priapism).

Adverse effects with unknown frequency (frequency cannot be estimated from available data)

Blurred vision, vision loss, nosebleeds, dry mouth.

During eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during surgery. For further information, see section 2. Warnings and precautions.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse 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 stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Store the blister in the original container.

Keep the container tightly closed.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the container and other information

Composition of ZUANTRIP 0.4 mg

• The active substance is tamsulosin hydrochloride 0.4 mg.
• The other components (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 shell: Gelatin, indigotine (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 container

Modified-release orange/olive-green capsules. 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.

Only certain 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:

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Synthon BV

Microweg, 22

P.O. Box 7071 (Nijmegen)

NL-6545 Netherlands

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Medis International a.s.

Prumyslová 961/16,

747 23 Bolatice

Czech Republic

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Pharmazet Group s.r.o.

Trtinová 260/1

Cakovice

196 00 Prague 9

CZECH REPUBLIC

This Patient Information Leaflet has been approved in March 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