TAMSULOSIN PENSA 0.4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Tamsulosina Pensa 0.4 mg prolonged-release hard capsules EFG

Tamsulosine hydrochloride

Read the entire package leaflet carefully before starting to take the medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to 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 adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this package leaflet, inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

1. What is Tamsulosina Pensa and what is it used for
2. Before taking Tamsulosina Pensa
3. How to take Tamsulosina Pensa
4. Possible side effects
5. Storage of Tamsulosina Pensa
6. Additional information

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

Tamsulosina Pensa belongs to the group of medications called alpha-1 receptor blockers, which reduces the tension of the prostate and urethra muscles.

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

2. Before taking Tamsulosina Pensa

Do not take Tamsulosina Pensa

• If you are allergic (hypersensitive) to tamsulosine or 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 failure.

Be careful with Tamsulosina Pensa

• If you have severe kidney failure.
• Although rare, the use of Tamsulosina Pensa may cause fainting, and if you experience symptoms of dizziness and weakness, you should sit or lie down until they disappear.
• If you are going to undergo cataract surgery, please inform your doctor before the operation if you are taking or have taken Tamsulosina Pensa previously. This is because Tamsulosina Pensa may cause complications during the operation, which can be taken into account and controlled by your ophthalmologist if informed beforehand.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Use of other medications

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

Combination with other medications of the same group may cause a drop in blood pressure.

Diclofenac (an anti-inflammatory pain reliever) and warfarin (used to prevent blood clotting) may increase the elimination of tamsulosine from the body.

Pregnancy and breastfeeding

Tamsulosina Pensa is indicated only for male patients.

Driving and using machines

Due to the possibility of dizziness, you should be extremely cautious when driving or operating machines.

3. How to take Tamsulosina Pensa

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

Remember to take your medication.

Dosage

The normal dose is 1 capsule per day.

Method of administration

It should be administered orally.

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

Your doctor will indicate the duration of your treatment with Tamsulosina Pensa. Do not stop treatment before, as it may not have the expected effect.

If you think the effect of Tamsulosina Pensa is too strong or 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 Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

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

Theoretically, acute hypotension may 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 forget to take Tamsulosina Pensa

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

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

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

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

4. Possible side effects

Like all medications, Tamsulosina Pensa may cause side effects, although not everyone experiences them.

The following side effects have been observed:

• Frequent (may affect 1 to 10 out of 100 patients)

Nervous system disorders: dizziness.

• Uncommon (may affect 1 to 10 out of 1,000 patients)

Nervous system disorders:headache.

Cardiac disorders:tachycardia (faster than normal heartbeat).

Vascular disorders: postural hypotension (reduction of blood pressure, for example, when standing up quickly after sitting 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 skin area).

Reproductive system and breast disorders: ejaculation disorders.

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

• Rare (may affect 1 to 10 out of 10,000 patients)

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

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

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

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

• Frequency not known

Gastrointestinal disorders:dry mouth

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects

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

5. Storage of Tamsulosina Pensa

Keep out of the reach and sight of children.

Do not store above 30°C.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of Tamsulosina Pensa

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

Capsule content: sodium alginate (E-401), methacrylic acid and ethyl acrylate copolymer (1:1), glycerol dibehenate, 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 cap: gelatin, purified water, red iron oxide (E-172), titanium dioxide (E-171), yellow iron oxide (E-172).

Appearance and packaging of the product

Tamsulosina Pensa is 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.

Marketing authorization holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Bluepharma-Indústria Farmacêutica, S.A.

São Martinho do Bispo, 3045-016 Coimbra

PORTUGAL

This package leaflet was approved in November 2013.

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