Tamsulosin Sun 0.4 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

TAMSULOSIN SUN 0.4 mg SUSTAINED-RELEASE HARD CAPSULES EFG

tamsulosin hydrochloride

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

Package leaflet contents:

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

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

The active substance of Tamsulosin SUN is tamsulosin. It is a selective α-1A/1D adrenoceptor antagonist. It works by relaxing the smooth muscle tone in the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. In addition, it reduces the sensation of urgency.

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

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

Do not take Tamsulosin SUN

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamsulosin SUN

• If you require regular medical check-ups to monitor the condition for which you are being treated.

  • Before starting treatment, you must inform your doctor if you suffer from any other illness.

• Fainting episodes may rarely occur during treatment with Tamsulosin SUN, as with other medicines of this type.

At the first signs of dizziness or weakness, you should sit or lie down until symptoms resolve.

• 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 Tamsulosin SUN. Tamsulosin SUN may cause complications (Intraoperative Floppy Iris Syndrome [IFIS]) during eye surgery. The specialist may take appropriate precautions regarding medication and surgical techniques. Ask your doctor whether you should postpone or temporarily discontinue taking this medicine while undergoing eye surgery for cataracts or glaucoma.

Children and adolescents

Do not administer 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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• Diclofenac (an anti-inflammatory painkiller) and warfarin (used to prevent blood clotting).
• Medicines that may potentially affect tamsulosin blood levels or lower blood pressure, such as verapamil or diltiazem (used to lower blood pressure), ritonavir and indinavir (used to treat HIV infection), ketoconazole, itraconazole or erythromycin (used to treat fungal or bacterial infections).

Taking tamsulosin together with other medicines 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 medicines that may reduce the elimination of Tamsulosin SUN from the body (e.g. ketoconazole, erythromycin).

You should only take concomitant medicines with Tamsulosin SUN if your doctor permits 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 disturbances have been observed in men treated with tamsulosin.

Driving and using machines

There is no evidence that Tamsulosin SUN affects the ability to drive or operate machinery or equipment.

However, you should bear in mind that it may cause dizziness, in which case you should not perform activities requiring concentration.

Tamsulosin SUN contains Sunset Yellow FCF, Azorubine and Ponceau 4R

This medicine may cause allergic-type reactions due to the presence of colouring agents: Sunset Yellow FCF (E110), Azorubine (E122) and Ponceau 4R (E124).

Tamsulosin Sun contains sodium.

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

3. How to take Tamsulosin SUN

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose is one capsule daily, to 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 must be swallowed whole and must not be crushed or chewed, as this would affect the prolonged release of the active ingredient. Tamsulosin SUN is usually 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91.562.04.20, indicating the medicine and the amount taken.

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

If you forget to take Tamsulosin SUN:

If you forget to take your daily capsule of Tamsulosin SUN, you may take it later on the same day. If you have missed the dose for a day, simply continue taking your daily capsule the next day. Do not take a double dose to make up for the missed dose.

If you stop taking Tamsulosin SUN

If treatment is stopped earlier than recommended, the original symptoms may return. Use Tamsulosin SUN for the length of time recommended by your doctor, even if symptoms have disappeared. 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, Tamsulosin SUN may cause adverse effects, although not everyone experiences 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 require medical treatment:

• Sudden localized swelling of soft tissues (e.g., throat or tongue), difficulty breathing and/or itching and skin rash, often as an allergic reaction (angioedema) (may affect up to 1 in 1,000 people)
• Priapism (painful, persistent and involuntary penile erection), which requires immediate medical attention (may affect up to 1 in 10,000 people)
• A severe inflammatory skin and mucous membrane rash, an allergic reaction to drugs or other substances known as 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:

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

• Dizziness, especially when sitting down or standing up.
• Ejaculation disorders.
• Retrograde ejaculation. This means that semen does not exit through the urethra but instead enters the bladder. This phenomenon is harmless.
• Absence of ejaculation.

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

• Headache
• Palpitations (awareness of strong or rapid heartbeats)
• Decreased blood pressure, for example, when standing up quickly from a sitting or lying position, sometimes associated with dizziness
• Runny or blocked nose (rhinitis)
• Diarrhea, feeling nauseous and vomiting
• Constipation, weakness (asthenia), skin rash, itching and urticaria.

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

• Fainting
• Weakness.

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

• Blurred vision, visual disturbance
• Nosebleed
• Dry mouth
• Irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia)
• Difficulty breathing (dyspnea).
• If you are undergoing eye surgery due to lens opacity (cataract) and are currently taking or have previously taken Tamsulosin SUN, the pupil may dilate poorly and the iris (the colored circular part of the eye) may become floppy during the procedure.

If you are undergoing eye surgery due to lens opacity (cataract) or increased intraocular pressure (glaucoma) and are currently taking or have recently taken Tamsulosin SUN, inadequate pupil dilation and iris floppiness (part of the colored ring of the eye) may occur during surgery.

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the packaging and label. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If in doubt, please ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other 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 components (excipients) are:

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

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

Cap composition: 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 contents of the pack

Tamsulosin SUN 0.4 mg prolonged-release hard capsules are presented as size 2 orange/light brown coloured capsules, 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 available in packs containing 1, 2, 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100 or 200 prolonged-release capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Date of the most recent review of this leaflet: March 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/