Leaflet: information for the user

Tamsulosin pensa 0.4 mg prolonged-release hard capsules EFG

Tamsulosin hydrochloride

Read this leaflet carefully before you start taking the medicine.

• 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, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you experience are serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist. See section 4.

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

2. Before taking Tamsulosin Pensa

3. How to take Tamsulosin Pensa

4. Possible side effects

5. Storage of Tamsulosin Pensa

6. Additional information

Tamsulosina Pensa belongs to a group of medicines called alpha 1 blockers1that reduces the tension of the prostate and urethra muscles.

This medicine is indicated for the treatment of symptoms associated with benign prostatic hyperplasia such as: difficultiesin urination, dribbling, urgent urination and frequent need to urinate both at night and during the day.

Do Not Take Tamsulosina Pensa

• If you are allergic (hypersensitive) to tamsulosina or to any of the other components of Tamsulosina Pensa.
• If you have orthostatic hypotension (dizziness due to a drop in blood pressure when sitting or standing up).
• If you have severe liver insufficiency.

Be Cautious with Tamsulosina Pensa

• If you have severe kidney insufficiency.
• Although rare, the use of Tamsulosina Pensa may cause dizziness, you should sit or lie down until the symptoms have disappeared.
• If you are to undergo eye surgery for cataracts, please inform your doctor before the surgery if you are taking or have taken Tamsulosina Pensa previously. This is because Tamsulosina Pensa may cause complications during the surgery, which can be taken into account and controlled by your ophthalmologist if informed beforehand.

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Use of Other Medications

Inform your doctor or pharmacist if you are using or have used recently other medications, including those acquired without a prescription.

The association with other medications in the same group may cause a decrease in blood pressure.

Diclofenaco (a nonsteroidal anti-inflammatory drug) and warfarin (used to prevent blood coagulation) may increase the elimination of tamsulosina from the body.

Pregnancy and Breastfeeding

Tamsulosina Pensa is indicated only for male patients.

Driving and Operating Machines

Due to the possibility of dizziness, you should exercise extreme caution when driving or operating machines.

Follow exactly the administration instructions for Tamsulosina Pensa as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Dosage

The usual dose is 1 capsule per day.

Administration Form

It should be administered orally.

The capsule should be taken after breakfast or the first meal of the day and swallowed whole without breaking and without chewing, with a glass of water while sitting or standing (do not lie down).

Your doctor will indicate the duration of your treatment with Tamsulosina Pensa. Do not discontinue treatment prematurely, as this may not produce the expected effect.

If you estimate that the effect of Tamsulosina Pensa is too strong or too weak, inform your doctor or pharmacist.

If you take more Tamsulosina Pensa 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.

Theoretically, an acute hypotension could occur after an overdose.

When dealing with significant amounts, gastric lavage and administration of activated charcoal and an osmotic laxative such as sodium sulfate may be performed.

If you forgot to take Tamsulosina Pensa

If you forgot to take your medication after breakfast or the first meal of the day, you can take it 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 have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, Tamsulosina Pensa can cause side effects, although not everyone will experience them.

The following side effects have been observed:

• Frequent (may affect between 1 and 10 in every 100 patients)

Nervous system disorders: dizziness.

• Rare (may affect between 1 and 10 in every 1,000 patients)

Nervous system disorders:headache.

Cardiac disorders:tachycardia (the heartbeat is faster than normal).

Vascular disorders: postural hypotension (reduction in blood pressure, for example, when standing up quickly after being seated or lying down, sometimes associated with dizziness).

Respiratory disorders:rhinitis.

Gastrointestinal disorders: constipation, diarrhea, nausea, vomiting.

Skin and subcutaneous tissue disorders:exanthema, pruritus, urticaria (inflammatory process of a superficial area of the skin).

Reproductive and breast disorders: ejaculation disturbances.

General disorders:asthenia (generalized feeling of weakness and lack of vitality).

• Rare (may affect between 1 and 10 in every 10,000 patients)

Nervous system disorders: syncope (sudden and transient loss of consciousness).

Skin and subcutaneous tissue disorders:angioedema (inflammatory process of a deep area of the skin).

• Very rare (may affect fewer than 1 in every 10,000 patients)

Reproductive and breast disorders:priapism (persistent erection of the penis in the absence of sexual excitement).

• Frequency not known

Gastrointestinal disorders:dry mouth

If you consider that any of the side effects you experience are severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

Do not store at a temperature above30°C.

Do not use Tamsulosina Pensa after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition ofTamsulosina Pensa

• The active ingredient is hydrochloride of tamsulosin. Each prolonged-release hard capsule contains 0.4 mg of hydrochloride of tamsulosin, equivalent to 0.367 mg of tamsulosin.
• The other components are:

Content of the capsule: sodium alginate (E-401), copolymer of methacrylic acid and ethyl acrylate (1:1), dibehenate of glycerol, maltodextrin, sodium lauryl sulfate, macrogol 6000, polysorbate 80 (E-433), sodium hydroxide (E-524), simethicone emulsion, anhydrous colloidal silica, and purified water.

Body and capsule coating: gelatin, purified water, red iron oxide (E-172), titanium dioxide (E-171), yellow iron oxide (E-172).

Appearance of the product and contents of the package

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

Holder of the marketing authorization:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

Bluepharma-Indústria Farmacêutica, S.A.

São Martinho do Bispo, 3045-016 Coimbra

PORTUGAL

This leaflet was approved in November 2013.

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/