TAMSULOSIN SUN 0.4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Patient Information: Summary of Product Characteristics

TAMSULOSIN SUN 0.4 mg PROLONGED-RELEASE HARD CAPSULES EFG

PROLONGED-RELEASE EFG

tamsulosin hydrochloride

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

Contents of the pack:

1. What Tamsulosin Sun is and what it is used for
2. What you need to know before you take Tamsulosin Sun
3. How to take Tamsulosin Sun
4. Possible side effects
5. Storage of Tamsulosin Sun
6. Contents of the pack and further information

1. What Tamsulosin Sun is and what it is used for

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

Tamsulosin Sun is used in men for the treatment of lower urinary tract symptoms associated with an enlarged prostate (benign prostatic hyperplasia). These symptoms may include difficulty urinating (poor urine flow), loss of urine, urgency, or the need to urinate frequently during the night and during the day.

2. What you need to know before you take Tamsulosin Sun

Do not take Tamsulosin Sun

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamsulosin Sun.

• If you need regular medical check-ups to monitor the development of the condition for which you are being treated.
• Before starting treatment, you must inform your doctor if you have any other illness.

• Rarely, fainting spells may occur during the use of Tamsulosin Sun, as with other medications of this type.

At the first signs of dizziness or weakness, you should 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 pressure in the eye (glaucoma), inform your ophthalmologist that you have used, are using, or will use Tamsulosin Sun. Tamsulosin Sun may cause complications (Intraoperative Floppy Iris Syndrome [IFIS]) 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 suspend taking this medication while undergoing eye surgery due to cataracts or glaucoma.

Children and adolescents

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

Taking Tamsulosin Sun with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

In particular, inform your doctor or pharmacist if you are taking:

• Diclofenac (an anti-inflammatory pain reliever) and warfarin (used to prevent blood clotting).
• Medicines that may potentially affect tamsulosin blood levels 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).

Taking tamsulosin with other medications of the same class (alpha-1 adrenergic receptor antagonists, such as doxazosin, indoramin, prazosin, or alfuzosin) may cause an unwanted 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 decrease the elimination of Tamsulosin Sun from the body (e.g., ketoconazole, erythromycin).

You should only take concomitant medications with Tamsulosin Sun if your doctor allows it.

Taking Tamsulosin Sun with food, drinks, and alcohol

Tamsulosin 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 disorders have been observed in males treated with tamsulosin.

Driving and using machines

There is no evidence that Tamsulosin Sun affects the ability to drive or use machines or equipment.

However, you should keep in mind that it can cause dizziness, in which case you should not perform activities that require concentration.

Tamsulosin Sun contains yellow orange S, azorubine, and Ponceau 4R

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

Tamsulosin Sun contains sodium.

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

3. How to take Tamsulosin Sun

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of 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 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. Normally, Tamsulosin Sun is prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with Tamsulosin Sun.

If you take more Tamsulosin Sun than you should:

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

Taking too many Tamsulosin Sun capsules could cause a decrease in your blood pressure and an increase in heart rate, with a feeling of fainting. Contact your doctor immediately if you have taken too much Tamsulosin Sun.

If you forget to take Tamsulosin Sun:

If you forgot to take your daily capsule of Tamsulosin Sun, you can take it later during the same day. In case you forgot the dose one day, simply continue taking your daily capsule the next day. Do not take a double dose to make up for the forgotten dose.

If you stop taking Tamsulosin Sun

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

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

4. Possible side effects

Like all medicines, Tamsulosin Sun can cause side effects, although not everybody gets them.

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

• Sudden local swelling of the 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), which requires immediate medical attention (may affect up to 1 in 10,000 people).
• A severe inflammatory skin and mucous membrane rash, which is an allergic reaction to drugs 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 the available data).

The following side effects have also been reported:

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

• Dizziness, especially when sitting or standing up.
• Ejaculation disorders.
• Retrospective ejaculation. This means that semen is not released through the urethra but goes into the bladder. This phenomenon is harmless.
• Lack of ejaculation.

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

• Headache.
• Palpitations (feeling of strong and rapid heartbeats).
• Decrease in blood pressure, for example, when standing up quickly from a sitting or lying position, sometimes associated with dizziness.
• Nasal discharge or nasal congestion (rhinitis).
• Diarrhea, feeling dizzy, and vomiting.
• Constipation, weakness (asthenia), skin rash, itching, and hives.

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

• Fainting spells.
• Weakness.

Not known (frequency cannot be estimated from the available data):

• Blurred vision, visual disturbance.
• Nosebleeds.
• Dry mouth.
• Irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia).
• Breathing difficulties (dyspnea).
• If you are going to undergo eye surgery due to cataracts and are already taking or have taken Tamsulosin Sun, the pupil may not dilate properly and the iris (the colored part of the eye) may become flaccid during the procedure.

If you need to undergo eye surgery due to cataracts or increased pressure in the eye (glaucoma) and are taking or have recently taken Tamsulosin Sun, insufficient dilation of the pupil and iris drop (part of the colored circle of the eye) may occur during surgery.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Sun

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

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the packaging and label. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Tamsulosin Sun

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

• The other ingredients (excipients) are:

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

Body of the capsule: gelatin, yellow orange S (E110), Ponceau 4R (E124), quinoline yellow (E104), brilliant blue (E133), titanium dioxide (E171).

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

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

Appearance of the product and pack contents

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

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Date of last revision of this leaflet: March 2022

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