Patient Information Leaflet

Tamsulosina Alter 0.4 mg Modified Release Hard Capsules

Tamsulosin Hydrochloride

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

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

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

-This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms, as it may harm them.

-If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

The active ingredient 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 the 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 an enlarged prostate (benign prostatic hyperplasia) such as: difficultiesin urination (weak urine stream), dripping, urgent urination and the need to urinate frequently both at night and during the day.

Do not takeTamsulosina Alter

-If you are allergic to tamsulosina or any of the other components of this medication (listed in section 6). Allergic symptoms may present as sudden swelling of the soft tissues of the body (e.g., the 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 check-ups are necessary to monitor the development of the disease you are being treated for.

-Although rare, the use of Tamsulosina Alter may cause dizziness, you should sit or lie down until the symptoms have disappeared.

-If you have severe kidney problems, consult your doctor.

-If you are scheduled to undergo or have scheduled eye surgery due to a cloudy lens (cataracts) or increased eye pressure (glaucoma). Please inform your ophthalmologist if you are taking, have taken previously, or are thinking of taking Tamsulosina Alter. The specialist will then take the necessary precautions regarding medication and surgical techniques. Consult your doctor if you should or should not postpone or temporarily discontinue taking this medication if you are scheduled to undergo eye surgery due to a cloudy lens (cataract) or increased eye pressure (glaucoma).

Children and adolescents

Do not administer this medication to children or adolescents under 18 years old

Taking Tamsulosina Alter with other medications

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

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

It is especially important to inform your doctor if you are being treated at the same time with medications that can reduce the elimination of tamsulosina 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, breastfeeding, 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 does not release through the urethra, but goes to the bladder (retrograde ejaculation) or the volume of semen is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and operating machinery

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

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

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

If you take more Tamsulosina Alter than you should

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

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Taking too many Tamsulosina Alter capsules may lead to an undesirable decrease in blood pressure and an increase in heart rate, with a sensation of dizziness.

If you forgot 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 on the same day.

If you have missed a dose one day, simply continue taking your daily capsule as prescribed.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Tamsulosina Alter

When treatment with Tamsulosina Alter is discontinued prematurely, your original discomforts may return. Therefore, take this medication for the entire time your doctor prescribes, even if your discomforts have disappeared. Always consult your doctor if you decide to discontinue treatment.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

-Dizziness, especially when sitting or standing up.

-Abnormal ejaculation (ejaculation alteration). This means that semen does not release through the urethra, but goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

• Poorly frequent (may affect up to 1 in 100 people)

-Headache, palpitations (the heart rate is faster than normal and is perceivable),reduction of blood pressure, for example, when getting up quickly after being in a seated or lying position, sometimes associated with dizziness, dripping or nasal obstruction (rinitis),diarrhea, sensation of nausea and vomiting, constipation, weakness (asthenia), skin rash, itching and hives (urticaria).

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

-Loss of consciousness and sudden swelling of soft body tissues (such as the throat or tongue), breathing difficulty and/or itching and skin rash, often as an allergic reaction (angioedema).

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

-Priapism (unwanted, 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 unknown (the frequency cannot be estimated from the available data):

-Blurred vision

-Vision alteration

-Nosebleed (epistaxis)

-Severe skin eruptions (erythema multiforme, exfoliative dermatitis)

-Irregular and abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulty (dyspnea)

-If you are to undergo eye surgery due to a cataract opacity or increased eye pressure (glaucoma), and you are taking or have taken this medicine before, during the surgery, the pupil may dilate slightly and the iris (the colored part of the eye) may become flaccid.

-Dry mouth.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above30°C. Store in the original packaging.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofTamsulosina Alter

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

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

Appearance of the product and content of the packaging

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

Holder of the marketing authorization

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

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 the last review of this prospectus:July 2017.

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.