Tamsulosin Pensa Pharma 0.4 mg modified-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tamsulosina pensa pharma 0.4 mg modified-release hard capsules EFG

tamsulosin hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What is Tamsulosina pensa pharma and what is it used for

The active substance in Tamsulosina pensa pharma is tamsulosin. It is a selective antagonist of alpha1A/1D adrenergic receptors. It reduces the tone of the smooth muscles in the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. In addition, it reduces the sensation of urgency.

Tamsulosin is used in men for the treatment of lower urinary tract symptoms associated with enlargement of the prostate gland (benign prostatic hyperplasia). These are symptoms such as: difficulty urinating (weak urinary stream), dribbling, urgency, and the need to urinate frequently both during the night and during the day.

2. What you need to know before starting to take Tamsulosina pensa pharma

Do not take Tamsulosina pensa pharma

• if you are allergic to tamsulosin or to any of the other ingredients of this medicine (listed in section 6).

Hypersensitivity may present as sudden localized swelling of soft body tissues (e.g. throat or tongue), difficulty breathing and/or itching and skin rash (angioedema).

• if you have severe liver problems.
• if you suffer from dizziness due to a drop in blood pressure when changing position (sitting or standing up).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine

• Periodic medical examinations are necessary to monitor the progression of the condition being treated.
• Fainting may rarely occur during treatment with tamsulosin, as may happen with other medicines of this type.
• At the first signs of dizziness or weakness, you should sit or lie down until symptoms subside.
• If you have severe kidney problems, consult your doctor.
• If you are scheduled for or undergoing eye surgery due to lens opacity (cataract), please inform your ophthalmologist if you have previously taken, are currently taking, or are considering taking tamsulosin. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor about whether you should postpone or temporarily discontinue this medicine prior to undergoing surgery for a cloudy lens (cataract).

Children and adolescents

Do not administer this medicine to children or adolescents under 18 years of age, as it is not effective in this population.

Other medicines and Tamsulosina pensa pharma

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

Taking tamsulosin together with other medicines of the same class (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 simultaneously with medicines that may reduce the elimination of tamsulosin from the body (e.g. ketoconazole, erythromycin).

Taking Tamsulosina pensa pharma with food and drinks

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

Pregnancy, breastfeeding and fertility

This section is not relevant, as tamsulosin is intended exclusively for male patients.

In men, abnormal ejaculation (ejaculatory disorder) has been reported. This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or that the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive or operate tools or machinery. However, you should bear in mind that dizziness may occur, in which case you should not perform activities requiring alertness.

3. How to take Tamsulosina pensa pharma

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

If you take more Tamsulosina pensa pharma than you should

Taking too much tamsulosina may lead to an unwanted drop in blood pressure and an increased heart rate, accompanied by a feeling of faintness.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Tamsulosina pensa pharma

If you have forgotten to take tamsulosina as directed, you may take your daily dose later on the same day. If you have missed a day's dose, 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 pensa pharma

When treatment with tamsulosina is stopped prematurely, your original symptoms may return. Therefore, take tamsulosina for as long as your doctor has prescribed, even if your symptoms have improved. Always consult your doctor if you decide to discontinue treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking your medicine and consult your doctor immediately if you experience any of the following allergic reactions:

• difficulty breathing
• swelling of the face, tongue or throat (angioedema)
• itching and skin rash

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

• dizziness
• abnormal ejaculation (ejaculation disorder). This means that semen does not exit the body through the urethra, but instead enters the bladder
• retrograde ejaculation
• reduced or absent ejaculate volume (ejaculatory insufficiency). This phenomenon is harmless.

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

• headache
• faster or irregular heartbeat
• dizziness, especially when standing up (orthostatic hypotension)
• runny or blocked nose
• constipation
• diarrhoea
• nausea (feeling sick or being sick)
• vomiting
• skin rash
• itching and hives (urticaria)
• feeling weak

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

• fainting

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

• unwanted, prolonged and painful erection (priapism)
• severe inflammatory rash of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals, which is an allergic reaction to medicines or other substances known as Stevens-Johnson syndrome

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

• nosebleeds
• blurred vision, visual disturbance
• dry mouth
• severe skin rashes (erythema multiforme, exfoliative dermatitis)

If you are undergoing eye surgery due to lens opacity (cataracts) and you are currently taking or have previously taken tamsulosin hydrochloride, during surgery the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy (see section 2 “Warnings and precautions”).

In addition to the adverse effects listed above,

• very rapid and uncoordinated heart contractions
• irregular heartbeat
• abnormally fast heart rate and
• difficulty breathing have been reported in association with tamsulosin hydrochloride. As these spontaneously reported events come from post-marketing experience worldwide, the frequency of these events and the role of tamsulosin hydrochloride in causing them cannot be reliably determined.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin pensa pharma

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister, container, and carton after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This helps protect the environment.

6. Contents of the pack and other information

Composition of Tamsulosina pensa pharma

Each capsule contains 0.4 mg of tamsulosin hydrochloride.

The other components are:

Pellets: Methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion*, microcrystalline cellulose, dibutyl sebacate, polysorbate 80 (E433).

Coating material: Methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion*, dibutyl sebacate, polysorbate 80 (E433), colloidal hydrated silica.

Calcium stearate

Hard gelatin capsule: Iron oxide red (E172), titanium dioxide (E171), iron oxide yellow (E172), iron oxide black (E172), Indigo carmine (E132), gelatin.

*The dispersion contains 0.7% sodium lauryl sulfate Ph. Eur./NF and 2.3% polysorbate 80 Ph. Eur./NF in solid substance, as emulsifiers.

Appearance of the product and contents of the container

Tamsulosina pensa pharma are hard capsules approximately 15.6 – 16.2 mm closed, opaque, with an orange body and olive-green cap. Tamsulosina pensa pharma is available in PVC/PVDC-aluminum blisters or HDPE bottles, both supplied in cardboard boxes.

PVC/PVDC-aluminum blisters containing 10, 20, 30, 50, 90 or 100 capsules.

Single-dose perforated PVC/PVDC-aluminum blisters containing 10 x 1, 20 x 1, 30 x 1, 50 x 1, 90 x 1 or 100 x 1 capsules.

HDPE bottles containing 30, 35, 50, 60, 90, 100, 112 or 200 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

LABORATORIOS LICONSA, S.A.

Avda. Miralcampo, No. 7

Pol. Ind. Miralcampo, 19200

Azuqueca de Henares, Guadalajara

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Denmark: Tamsuvilla 0.4 mg modified-release capsules, hard

Spain: Tamsulosina pensa pharma 0.4 mg modified-release hard capsules EFG

Portugal: Tansulosina Pensa

Date of the most recent revision of this leaflet: May 2024

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