Prospect: information for the patient

TAMSULOSINA SUN 0.4 mg HARD CAPSULES WITH PROLONGED RELEASE EFG

tamsulosin hydrochloride

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

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

2. What you need to know before starting to take Tamsulosina SUN

3. How to take Tamsulosina SUN

4. Possible adverse effects

5. Storage of Tamsulosina SUN

6. Contents of the package and additional information

The active ingredient of Tamsulosina SUN is tamsulosin. It is a selective antagonist of α-1A/1Dadrenoceptors. It acts by relaxing the smooth muscle tension in the prostate and in the urethra, allowing urine to pass more easily through the urethraand facilitating urination. Additionally, it decreases the sensation of urgency.

Tamsulosina SUN is used in men for the treatment of lower urinary tract problems associated with an enlarged prostate gland (benign prostatic hyperplasia). These problems may include difficulty urinating (poor urine flow), urinary leakage, urgency, or the frequent need to urinate during the night and during the day.

Do not take Tamsulosina SUN

• If you are allergic to hydrochloride tamsulosin or to any of the other components of this medication (listed in section 6). Hypersensitivity may present as a local swelling of soft body tissues (e.g. the throat or tongue), difficulty breathing and/or itching and skin rash (angioedema).
• If you have severe liver problems
• If you experience dizziness due to a decrease in blood pressure when changing position (e.g. standing up after sitting or lying down) or feeling dizzy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamsulosina SUN

- If you need regular medical check-ups to monitor the development of the condition you are being treated for.

• Before starting treatment, inform your doctor if you have any other medical conditions.

- Rarely, dizziness may occur during the use of Tamsulosina SUN as with other medications of this type.

At the first signs of dizziness or weakness, sit or lie down until they disappear.

- If you have severe kidney or liver problems, inform your doctor.

- If you are undergoing or have scheduled eye surgery due to cataracts or increased eye pressure (glaucoma), inform your ophthalmologist that you have used, are using, or will use Tamsulosina SUN.Tamsulosina SUN may cause complications (Intraoperative Floppy Iris Syndrome [SIFI]) during surgery. The specialist may take the necessary precautions regarding medication and surgical techniques to be used. Ask your doctor if you should postpone or temporarily stop taking this medication while undergoing eye surgery due to cataracts or glaucoma.

Children and adolescents

Do not administer this medication to children or adolescents under 18 years old as this medication is not effective in this population group.

Taking Tamsulosina SUN with other medications

Inform your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication

Particularly, inform your doctor or pharmacist if you are taking:

- Diclofenac (a nonsteroidal anti-inflammatory drug) and warfarin (used to prevent blood coagulation).

- Medications that may potentially influence tamsulosin levels in the blood to reduce blood pressure, such as verapamil or diltiazem (used to reduce blood pressure), ritonavir and indinavir (used to treat HIV infection), ketoconazole, itraconazole, or erythromycin (used to treat fungal or bacterial infections).

The use of tamsulosin with other medications of the same class (alpha-1 adrenergic receptor antagonists such as doxazosin, indoramin, prazosin, or alfuzosin) may cause an undesirable decrease in blood pressure.

It is especially important to inform your doctor if you are being treated simultaneously with medications that may reduce the elimination of Tamsulosina SUN from the body (e.g. ketoconazole, erythromycin).

You should only take concomitant medications with Tamsulosina SUN if your doctor allows it.

Taking Tamsulosina SUN with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

This section is not relevant, as tamsulosin is not indicated for use in women.

Sexual function alterations have been observed in males treated with tamsulosin.

Driving and operating machinery

There is no evidence that Tamsulosina SUN 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 concentration.

Tamsulosina SUN contains yellow orange S, azorubine, and ponceau 4R

This medication may cause allergic reactions due to the presence of colorants: yellow orange S (E110), azorubine (E122), and Ponceau 4R (E124).

Tamsulosina Sun contains sodium.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose is one capsule per day, which should be taken after breakfast or the first meal of the day.The capsule should be taken while standing or sitting (not lying down) with a glass of water.

The capsule should be swallowed whole and not crushed or chewed, as this would affect the prolonged release of the active ingredient. Tamsulosina SUN is usually prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with Tamsulosina SUN.

If you take more Tamsulosina SUN than you should:

If you have taken too many capsules, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount taken.

Taking too many Tamsulosina SUN capsules could cause a decrease in your blood pressure and an increase in heart rate, with a sensation of dizziness. Contact your doctor immediately if you have taken too much Tamsulosina SUN.

If you forget to take Tamsulosina SUN:

If you forget to take your daily Tamsulosina SUN capsule, you can take it later in the same day. If you have forgotten to take a dose one day, simply continue taking your daily capsule the next day. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Tamsulosina SUN

If treatment is interrupted before the recommended time, the original symptoms may return. Use Tamsulosina SUN for the recommended period of time as advised by your doctor, even if the symptoms have disappeared. Before interrupting treatment, consult your doctor always.

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

Like all medications, Tamsulosina SUN may cause side effects, although not everyone will experience them.

Severe side effects are rare or very rare. Stop taking this medication and consult a doctor immediately if you experience any of the following symptoms; you may need medical treatment:

– Sudden swelling of soft tissues (e.g., throat or tongue), difficulty breathing and/or itching and skin rash, often in the form of an allergic reaction (angioedema) (may affect up to 1 in 1,000 people)

– Priapism (painful, persistent, and involuntary erection of the penis), in which immediate medical attention is needed (may affect up to 1 in 10,000 people)

– A severe inflammatory skin rash and mucous membrane inflammation, which is an allergic reaction to medications or other substances called Stevens-Johnson syndrome (may affect up to 1 in 10,000 people)

– Severe skin rashes (erythema multiforme, exfoliative dermatitis) (frequency cannot be estimated from available data).

The following side effects have also been reported:

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

• Dizziness, especially when sitting or standing up.
• Changes in ejaculation.
• Retropulsion of semen. This last phenomenon is harmless.
• Lack of ejaculation.

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

• Headache
• Palpitations (sensation of strong and rapid heartbeats)
• Decreased blood pressure, for example, when standing up quickly from a seated or lying position, associated with dizziness
• Nasal discharge or obstruction (rhinitis)
• Diarrhea, feeling dizzy and vomiting
• Constipation, weakness (asthenia), skin rash, itching, and urticaria.

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

• Fainting
• Weakness.

Unknown (frequency cannot be estimated from available data):

• Blurred vision, visual disturbance
• Nasal bleeding
• Dry mouth
• Irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia)
• Difficulty breathing (dyspnea).
• If you are to undergo eye surgery due to cataract opacity and are taking or have taken Tamsulosina SUN, the pupil may dilate slightly and the iris (the colored part of the eye) may become flaccid during the procedure.

If you are to undergo eye surgery due to cataract opacity or increased intraocular pressure (glaucoma) and are taking or have recently taken Tamsulosina SUN, there may be insufficient dilation of the pupil and falling of the iris (part of the colored circle of the eye) during surgery.

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 that appears in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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 packaging and labeling. 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 collection point at 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.

Tamsulosina SUN Composition

- The active ingredient is tamsulosin hydrochloride. Each prolonged-release hard capsule contains 0.4 mg of tamsulosin hydrochloride.

- The other components (excipients) are:

Capsule content: microcrystalline cellulose PH101, magnesium stearate, copolymer dispersion of methacrylic acid/ethyl acrylate (1:1), sodium hydroxide, triacetin, titanium dioxide (E171), talc.

Capsule body: gelatin, yellow-orange S (E110), ponceau 4R (E124), yellow quinoline (E104), brilliant blue (E133), titanium dioxide (E171).

Capsule coating: gelatin, yellow iron oxide (E172), brilliant blue (E133), azorubine (E122), titanium dioxide (E171).

Printing ink: shellac, black iron oxide (E172), potassium hydroxide.

Product appearance and packaging contents

Tamsulosina SUN 0.4 mg prolonged-release hard capsules are presented in the form of orange/brown clear number 2 capsules, with an "R" printed on the cap and "TSN400" in the body, in black. The capsules contain white or almost white granules.

Tamsulosina SUN is presented in packaging of 1, 2, 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, or 200 prolonged-release capsules.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer

Last reviewed date of this leaflet: March 2022

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/