TAMSULOSIN ALTER 0.4 mg MODIFIED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Tamsulosina Alter 0.4 mg Modified 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.

-Keep this leaflet, you may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

The active substance of Tamsulosina Alter is tamsulosin. It is a selective antagonist of alpha-1A/1D adrenergic receptors. It reduces the tension of the smooth muscles of the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. It also decreases the sensation of urgency.

Tamsulosina Alter 0.4 mg is used in men for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (enlargement of the prostate gland) such as: difficulty urinating (weak urine stream), dribbling, urgent urination, and frequent need to urinate both at night and during the day.

2. What you need to know before taking Tamsulosina Alter

Do not takeTamsulosina Alter

-If you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6). Allergic symptoms may appear as 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 dizziness due to a drop in blood pressure when changing position (sitting or standing up).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamsulosina Alter.

-Regular medical examinations are necessary to monitor the development of the disease being treated.

-Although rare, the use of Tamsulosina Alter may cause fainting, and in the event of dizziness and weakness symptoms, you should 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), please inform your ophthalmologist if you are taking, have taken previously, or are planning to take Tamsulosina Alter. The specialist will then take the necessary precautions regarding medication and surgical techniques to be used. Consult your doctor if you should or should not postpone or temporarily suspend taking this medicine if you are going to undergo such surgery due to cataracts or glaucoma.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age.

Taking Tamsulosina Alter with other medicines

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

Taking Tamsulosina Alter with other medicines of the same group (alpha-1 adrenergic receptor antagonists) may cause an undesirable drop in blood pressure.

It is especially important that you inform your doctor if you are being treated at the same time with medicines that may decrease the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

Taking Tamsulosina Alter with food and drinks

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

Pregnancy, breast-feeding, and fertility

Tamsulosina Alter is not indicated for use in women.

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen is not released through the urethra but instead 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 Tamsulosina Alter affects the ability to drive or use tools or machines. However, you should be aware that dizziness may occur, in which case you should not perform activities that require attention.

3. How to take Tamsulosina Alter

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one capsule per day and should be taken after breakfast or the first meal of the day. The capsule should be swallowed whole and not broken or chewed. Normally, Tamsulosina Alter is prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with this medicine.

If you take more Tamsulosina Alter than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount ingested.

It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

Taking too many Tamsulosina Alter capsules may lead to an undesirable drop in blood pressure and an increase in heart rate, with a feeling of fainting.

If you forget to take Tamsulosina Alter

If you have forgotten to take your medication after breakfast or the first meal of the day, you can take it later within the same day.

In case you have missed the dose one day, you can simply continue taking your daily capsule as prescribed.

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

If you stop taking Tamsulosina Alter

When treatment with Tamsulosina Alter is abandoned prematurely, your original symptoms may return. Therefore, take this medicine 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 other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

-Dizziness, especially when sitting or standing up.

-Abnormal ejaculation (alteration of ejaculation). This means that semen is not released through the urethra but instead 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, palpitations (the heartbeat is faster than normal and also perceptible), reduction of blood pressure, for example, when standing up quickly after sitting or lying down, sometimes associated with dizziness, nasal congestion or runny nose (rhinitis), diarrhea, feeling of nausea and vomiting, constipation, weakness (asthenia), skin rash, itching, and hives (urticaria).

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

-Fainting and sudden local swelling of the soft tissues of the body (such as the 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 (undesirable, prolonged, and painful erection that requires immediate medical treatment).

-Skin rash, inflammation, and blisters on the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (Stevens-Johnson syndrome).

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

-Blurred vision

-Vision changes

-Nosebleeds (epistaxis)

-Severe skin rashes (erythema multiforme, exfoliative dermatitis)

-Abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea)

-If you are going to undergo eye surgery due to cataracts or increased pressure in the eye (glaucoma), and you are taking or have taken this medicine previously, during the operation, the pupil may dilate poorly and the iris (the colored part of the eye) may become flaccid.

-Dry mouth.

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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosina Alter

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 packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C. Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition ofTamsulosina Alter

• The active substance is tamsulosin hydrochloride. Each modified release hard capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are sodium alginate (E401), methacrylic acid-ethyl acrylate copolymer (1:1) (type C methacrylic acid copolymer), glycerol dibehenate, maltodextrin, sodium lauryl sulfate, macrogol 6000, polysorbate 80 (E433), sodium hydroxide (E524), simethicone emulsion 30%, and anhydrous colloidal silica.

The capsule ingredients are gelatin, red iron oxide (E172), yellow iron oxide (E172), and titanium dioxide (E171).

Appearance of the product and pack contents

Tamsulosina Alter is presented in the form of modified release hard capsules. The capsules are orange and contain white or yellowish granules. Each pack contains 30 capsules.

Marketing Authorisation Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Or

Bluepharma - Indústria Farmacêutica S.A.

São Martinho do Bispo

3045-016 Coimbra

Portugal

Date of last revision of this leaflet:July 2017.

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/.