TAMSULOSIN COMBIX 0.4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Tamsulosina Combix 0.4 mg prolonged-release hard capsules EFG

tamsulosine, 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 others, 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 Tamsulosina Combix and what is it used for
2. What you need to know before taking Tamsulosina Combix
3. How to take Tamsulosina Combix
4. Possible side effects
5. Storage of Tamsulosina Combix
6. Package contents and additional information

1. What is Tamsulosina Combix and what is it used for

The active substance of Tamsulosina Combix is tamsulosine hydrochloride. It works by relaxing the muscles in the prostate and urethra (the tube that carries urine to the outside), allowing urine to pass more easily through the urethra and facilitating urination.

In the prostate gland, bladder, and urethra, there are specialized cells that contain alpha-1A receptors that cause the muscles of the urethra to tense. Tamsulosina Combix is an antagonist of alpha-1 adrenergic receptors, which reduces the action of these specialized cells and relaxes the muscles, facilitating the passage of urine.

Tamsulosina Combix is used in men for the treatment of lower urinary tract symptoms associated with an enlarged prostate gland (benign prostatic hyperplasia). These symptoms include difficulty starting urination, frequent need to urinate, feeling of not emptying the bladder completely, and having to get up several times during the night to urinate.

2. What you need to know before taking Tamsulosina Combix

Do not take Tamsulosina Combix

• If you are allergic(hypersensitive) to tamsulosine or any of the other components of this medication(listed in section 6).
• If you have severe liver problems
• If you have ever fainted or felt dizzy when sitting or standing up suddenly. Dizziness may occur sometimes when taking tamsulosine, especially if you are also taking other alpha-1 blockers. If you feel weak or dizzy, make sure to sit or lie down quickly until the symptoms have disappeared.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamsulosina Combix.

Be particularly careful withTamsulosina Combix (and tell your doctor)

• If you have kidney problems
• If you are going to undergo or have scheduled eye surgery due to cataracts or increased pressure in the eye (glaucoma).

Please inform your ophthalmologist that you have previously taken, are taking, or plan to take tamsulosine. The specialist may 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 going to undergo eye surgery due to cataracts or increased pressure in the eye (glaucoma).

Children and adolescents

Do not give this medication to children or adolescents under 18 years of age, as it has no effect on this population.

Use of Tamsulosina Combix with other medications

• Taking Tamsulosina Combix with other medications that belong to the same class (alpha-1 adrenergic receptor antagonists) may cause an undesirable decrease in blood pressure.
• It is especially important that you inform your doctor if you are being treated at the same time with medications that may decrease the elimination of Tamsulosina Combix from the body (e.g., ketoconazole, erythromycin).

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Taking Tamsulosina Combix with food, drinks, and alcohol

Tamsulosina Combix should be taken after breakfast or the first meal of the day.

Pregnancy, breastfeeding, and fertility

Tamsulosina Combix is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorder) has been observed. This means that the semen does not exit the body through the urethra, but instead enters the bladder (retrograde ejaculation) or that the volume of ejaculation is smaller or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

There is no evidence that Tamsulosina Combix affects the ability to drive or operate machines or equipment. However, you should keep in mind that it may cause dizziness, in which case you should not perform activities that require attention.

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

3. How to take Tamsulosina Combix

Follow the exact instructions for administration of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is 1 capsule per day, after breakfast or the first meal of the day. The capsule should be swallowed whole and not broken or chewed. Normally, Tamsulosina Combix is prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with Tamsulosina Combix.

If you take moreTamsulosina Combix than you should

Taking too much tamsulosine may cause an undesirable decrease in blood pressure and an increase in heart rate, with a feeling of fainting. Consult your doctor immediately if you have taken too much Tamsulosina Combix.

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 ingested.

If you forget to takeTamsulosina Combix

If you have forgotten to take Tamsulosina Combix as recommended, you can take your daily dose later on the same day. If you have missed a dose for one day, simply continue taking your daily capsule as prescribed. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Tamsulosina Combix

When treatment with Tamsulosina Combix is abandoned prematurely, your original symptoms may return. Therefore, take Tamsulosina Combix for the entire time your doctor prescribes it, even if your symptoms have disappeared. Always consult your doctor if you decide to stop treatment.

If you have any other 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 will experience them.

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

• Dizziness, especially when sitting or standing up.
• Abnormal ejaculation (ejaculation disorder). This means that the semen does not exit the body through the urethra, but instead enters the bladder (retrograde ejaculation) or that the volume of ejaculation is smaller or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

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

• Headache.
• Palpitations (the heart beats faster than normal and is also perceptible).
• Decrease in blood pressure, e.g., when standing up quickly while sitting or lying down, sometimes with a feeling of dizziness.
• Rhinitis or nasal congestion.
• Diarrhea.
• Feeling nauseous and vomiting.
• Constipation.
• Weakness (asthenia).
• Rashes, itching, and hives (urticaria).

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

• Fainting and sudden swelling of the soft tissues of the body (e.g., throat or tongue), difficulty breathing, and/or itching and skin rash, often as an allergic reaction (angioedema).

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

• Priapism (painful prolonged unwanted erection that requires immediate medical treatment).
• Severe skin rash, inflammation, and blisters on the skin and/or mucous membranes of the lips, eyes, mouth, nostrils, or genitals (Stevens-Johnson syndrome).

Unknown (frequency cannot be estimated from available data)

• Blurred vision or visual problems.
• Nosebleeds.
• Dry mouth.
• Severe skin rashes (erythema multiforme, exfoliative dermatitis).
• Abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia).
• Difficulty breathing (dyspnea).
• If you are undergoing eye surgery due to cataracts or increased pressure in the eye (glaucoma) and are taking or have recently taken Tamsulosina Combix, the pupil may dilate slightly, and the iris (the colored part of the eye) may become flaccid during the procedure.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tamsulosina Combix

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the blister pack and on the packaging after "EXP:". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Tamsulosina Combix

• The active substance is tamsulosine hydrochloride.
• The other components are polysorbate 80, methacrylic acid copolymer dispersion, triacetin, sodium lauryl sulfate, purified water, microcrystalline cellulose, and calcium stearate. They are used in the manufacture of the granules that are in the capsule.
• The capsule body contains FD & C Blue 2 (E 132), black iron oxide (E 172), red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin, purified water, sodium lauryl sulfate; the printing ink is Shellac (E904), anhydrous alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide (E172), potassium hydroxide, and purified water.

Appearance of the product and package contents

Tamsulosina Combix are green olive opaque/orange opaque capsules, size "2", hard gelatin, containing white to off-white granules with the inscription "CL 23" on the cap and "0.4" on the body of the capsule, printed with black ink.

The capsules are packaged in transparent PVC/PE/PVdC/Aluminum blisters.

The capsules are available in packs of 14, 20, 28, 30, 50, 56, 90, 98, and 100 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer:

Macleods Pharma UK Limited

Wynyard Park House,

Wynyard Avenue,

Wynyard, Billingham,

TS22 5TB, United Kingdom

Synoptis Industrial Sp. z o.o

ul. Rabowicka 15, Swarzedz,

62-020,

Poland

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50,

90449 Nürnberg,

Germany

Laboratori FUNDACIO DAU,

C/ De la letra C, 12-14,

Poligono Industrial de la Zona Franca,

08040 Barcelona,

Spain

Date of the last revision of this package leaflet: February 2021

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/