TAMSULOSIN SYNTHON 0.4 mg PROLONGED-RELEASE TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tamsulosin Synthon 0.4 mg prolonged-release tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Tamsulosin reduces the tension of the prostate and urethra muscles. By relaxing the muscles, tamsulosin allows urine to pass more easily through the urethra and facilitates urination. Additionally, it decreases the sensation of urgency.

Tamsulosin 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 urinating (weak urine stream), dripping, urgent urination, and frequent need to urinate both at night and during the day.

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

Do not take Tamsulosin Synthon

• if you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may present as sudden local swelling of the body's soft tissues (e.g., throat or tongue), difficulty breathing, and/or itching and skin rash (angioedema).
• if you have a history of low blood pressure when changing positions (sitting or standing), causing dizziness, drowsiness, or fainting.
• if you have severe liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take tamsulosin:

• if you experience fainting or dizziness, especially when standing up. Tamsulosin may lower your blood pressure, causing these symptoms. At the first symptoms of dizziness or weakness, sit or lie down until they have disappeared.
• If you have severe kidney problems, consult your doctor.
• If you are going to undergo or have scheduled eye surgery due to cataracts or increased pressure in the eye (glaucoma). A condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may not dilate properly, and the iris (the colored part of the eye) may become floppy during surgery. Please inform your ophthalmologist if you have taken, are taking, or are planning to take tamsulosin. The specialist can then take the necessary precautions regarding medication and surgical techniques to be used. Consult your doctor if you should postpone or temporarily suspend taking this medicine if you are going to undergo such surgery due to cataracts or increased pressure in the eye (glaucoma).

Regular medical examinations are necessary to monitor the development of the condition for which you are being treated.

You may notice a residue of the tablet in your stool. Since the active ingredient has already been released from the tablet, there is no risk that the tablet will be less effective.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age because it does not work in this population.

Taking other medicines

Other medicines may be affected by tamsulosin. They, in turn, may affect tamsulosin. Tamsulosin may interact with:

• diclofenac, a pain reliever and anti-inflammatory. This medicine may accelerate the elimination of tamsulosin from your body, reducing its effectiveness.
• warfarin, a medicine to prevent blood clotting. This medicine may accelerate the elimination of tamsulosin from your body, reducing its effectiveness.
• another α1A-adrenergic blocker. The combination may lower blood pressure, causing dizziness or fainting.
• ketoconazole, a medicine for the treatment of fungal skin infections. This medicine may increase the effect of tamsulosin.

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

Taking Tamsulosin Synthon with food, drinks, and alcohol

You can take Tamsulosin Synthon with or without food.

Pregnancy, breastfeeding, and fertility

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorder) has been observed. This means that semen is not released through the urethra but goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory failure). This phenomenon is harmless.

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive or operate machinery. However, you should be aware that dizziness may occur, in which case you should not perform activities that require attention.

3. How to take Tamsulosin Synthon

Follow exactly the administration instructions indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

The usual dose is 1 tablet per day. You can take tamsulosin with or without food, preferably at the same time of day.

Swallow the tablet whole. It is essential that you do not crush or chew the tablets, as this may affect the efficacy of tamsulosin.

Tamsulosin is not designed for use in children.

If you take more Tamsulosin Synthon than you should

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 medicine and the amount taken.

If you take more tamsulosin than you should, it may lead to an undesired decrease in blood pressure. You may experience dizziness, weakness, vomiting, diarrhea, and fainting. Lie down to minimize the effects of low blood pressure and then contact your doctor.

If you forget to take Tamsulosin Synthon

If you have forgotten to take tamsulosin as recommended, you can take your daily dose later on the same day. If you have missed a dose one day, you can simply continue taking your daily tablet as prescribed.

Do not take a double dose to make up for forgotten doses.

If you stop taking Tamsulosin Synthon

When treatment with tamsulosin is abandoned prematurely, your original symptoms may return. Therefore, take tamsulosin 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 further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects are rare. Contact your doctor immediately if you experience a severe allergic reaction that causes swelling of the face or throat (angioedema).

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

Dizziness, especially when sitting or standing.

Abnormal ejaculation (ejaculation disorder). This means that semen is not released through the urethra but goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory failure). This phenomenon is harmless.

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

Headache • Feeling heartbeats (palpitations) • Low blood pressure, for example, when standing up quickly, causing dizziness, drowsiness, or fainting (orthostatic hypotension) • Runny or stuffy nose (rhinitis) • Constipation • Diarrhea • Feeling sick • Vomiting • Weakness (asthenia) • Skin rash • Itching and hives (urticaria).

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

Fainting (syncope)

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

Painful erection (priapism) that requires immediate medical treatment • Severe skin rash, inflammation, and blisters on the skin of the lips, eyes, mouth, or genitals (Stevens-Johnson syndrome).

Frequency not known(cannot be estimated from the available data):

Blurred vision • Loss of vision • Nosebleed (epistaxis) • Dry mouth.

Severe skin rash (erythema multiforme, exfoliative dermatitis)

Abnormal heart rhythm (atrial fibrillation) • Irregular heartbeat (arrhythmia) • Fast heartbeat (tachycardia) • Difficulty breathing (dyspnea)

If you are going to undergo eye surgery due to cataracts or increased pressure in the eye (glaucoma), a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may not dilate properly, and the iris (the colored part of the eye) may become floppy during surgery. For more information, see section 2, warnings and precautions.

Reporting of side effects

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

5. Storage of Tamsulosin Synthon

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Store this medicine in the original package to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tamsulosin Synthon

The active substance is tamsulosin hydrochloride 0.4 mg, equivalent to 0.367 mg of tamsulosin.

The other ingredients are:

Core (inside the tablet):microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, red iron oxide (E172), magnesium stearate.

Outer tablet:microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, magnesium stearate.

Appearance of Tamsulosin Synthon and pack size

White, round, uncoated tablets with a diameter of 9 mm, engraved on one side with "T9SL" and with "0.4" on the other side.

It is available in blister packs of 20 and 30 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Synthon B.V.

Microweg 22

6545 CM Nijmegen

Netherlands

Manufacturer:

Synthon Hispania, S.L.

Castello 1, Poligono Las Salinas

08830 Sant Boi de Llobregat

Barcelona, Spain

or

Synthon BV.

Microweg, 22,

6545 CM. Nijmegen

Netherlands

Date of last revision of this leaflet: November 2015

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/.