Leaflet: information for the user

Tamsulosina Combix 0.4 mg prolonged-release hard capsules EFG

tamsulosina, hydrochloride

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

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

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

2. What you need to know before you start taking Tamsulosina Combix

3. How to take Tamsulosina Combix

4. Possible side effects

5. Storage of Tamsulosina Combix

6. Contents of the pack and additional information

The active ingredient of Tamsulosina Combix is tamsulosin hydrochloride. It acts by relaxing the muscles in the prostate and the urethra (the tube that carries urine out of the body),allowing urine to pass more easily through the urethra and facilitating urination.

In the prostate gland, the bladder, and the urethra, there are specialized cells that contain alpha1Areceptors that cause the urethral muscles to tense. Tamsulosina Combix is an alpha1Aadrenergic receptor antagonist, which reduces the action of these specialized cells and relaxes the muscles, facilitating urine flow.

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

Do not take Tamsulosina Combix

• If you areallergic(hypersensitive) totamsulosina or to any of the other components of this medication(listed in section 6).
• If you havesevere liver problems
• If you have everfainted or felt dizzy when sitting or standing up suddenly. Dizziness may occur occasionally when takingtamsulosina, especially if you are also taking other alpha1blockers. 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 especially careful withTamsulosina Combix (and tell your doctor)

• If you have kidney problems
• If you are about to undergo or have scheduled eye surgerydue to a cataract or increased eye pressure (glaucoma).

Please inform your ophthalmologist that you have previously taken, are taking, or plan to take tamsulosina. The specialist may take the necessary precautions regarding medication and surgical techniques. Consult your doctor if you should or should not postpone or temporarily discontinue taking this medication if you are about to undergo eye surgery due to a cataract or increased eye pressure (glaucoma).

Children and adolescents

Do not administer this medication to children or adolescents under 18 years old because it has no effect on this population.

Use of Tamsulosina Combix with other medications

- TakingTamsulosina Combixwith other medications belonging to the same class (alpha1adrenergic receptor antagonists) may cause an undesirable decrease in blood pressure.

- It is especially important to inform your doctor if you are being treated at the same time with medications that may reduce the elimination ofTamsulosina Combixfrom the body (for example, ketoconazole, erythromycin).

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

Taking Tamsulosina Combix with food, drinks, and alcohol

Tamsulosina Combixshould 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 semen does not exit the body through the urethra, but instead enters the bladder (retrograde ejaculation) or the volume of ejaculation is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and operating machinery

There is no evidence that Tamsulosina Combix affects the ability to drive or operate machines or equipment. However, you should be aware 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 tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for 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, taken 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 withTamsulosina Combix.

If you take moreTamsulosina Combix than you should

Taking too much tamsulosina can cause an unwanted drop in blood pressure and an increase in heart rate, with a feeling of dizziness. 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeTamsulosina Combix

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

If you interrupt treatment with Tamsulosina Combix

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

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

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

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

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

Less frequent (may affect up to 1 in 100 people):

• Headache.
• Palpitations (the heart beats faster than normal and is perceivable).
• Decrease in blood pressure, for example, when standing up quickly while sitting or lying down, sometimes with a feeling of dizziness.
• Runny nose or nasal congestion (rhinitis).
• 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 (prolonged and painful unwanted erection that requires immediate medical treatment).
• Skin rash, blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nostrils, or genitals (Stevens-Johnson syndrome).

Unknown (the frequency cannot be estimated from the 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 a clouding of the lens (cataracts) or increased pressure in the eye (glaucoma) and are taking or have recently takenTamsulosina Combix, the pupil may dilate slightly and the iris (the colored part of the eye) may become flaccid during the procedure.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 the 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.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the blister and on the packaging after “CAD:”. The expiration date is the last day of the month indicated.

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. If in 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 Tamsulosina Combix

Appearance of the product and contents of the package

Tamsulosina Combix are opaque greenish-yellow/opaque orange capsules, size “2”, hard gelatin, containing white to off-white granules with the inscription “CL 23” on the cap and “0.4” in the capsule body, printed with black ink.

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

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

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Combix Laboratories, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing:

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

Last review date of this leaflet: February 2021

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